我们决定向甘孜泸定、雅安石棉捐赠300万元现金、300万元物资，目前已成功对接甘孜州红十字会、雅安市红十字会，今天下午已经完成打款，物资根据当地所需正在紧急集结。对于灾区需要的其他支持，我们也当全力以赴。”
9月6日下午，四川科伦药业股份有限公司相关负责人告诉记者，针对四川泸定6.8级地震中受灾严重的泸定县和石棉县，他们紧急启动灾害应急处理方案，并进行现金和物资捐赠。
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2024-05-24
ASCO 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB2...
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(May 24th, Chengdu and New Jersey) The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Illinois, the United States of America from May 31 to June 4, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) will present two clinical stage study results at ASCO.
1.The Phase 3 OptiTROP-Breast01 study of its anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT) (formerly SKB264/MK-2870) in patients with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC).
? Session: Special clinical science symposium (Abstract #104; Next-Generation Antibody–Drug Conjugates: The Revolution Continues),
? Time: June 2, 2024, 9:45 AM to 11:15 AM local time
2. The Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with KL-A167 (an anti-PD-L1 mAb) as 1L treatment for patients with advanced non-small cell lung cancer (NSCLC)
? Session: oral (Abstract #8502; Lung Cancer—Non-Small Cell Metastatic Oral)
? Time: May 31, 2024, 2:45 PM to 5:45 PM local time.
Sac-TMT is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) at clinical stage.
The abstracts for the above studies were published on ASCO’s official website on [May 23, 2024], local time. The study results are summarized as follows:
TNBC
Patients were randomly assigned (1:1) to receive sac-TMT (n = 130) or chemotherapy (n = 133). The median age was 51 years; 87% had visceral metastases; 26% received prior PD-1/PD-L1 inhibitors; 48% received three or more prior lines of chemotherapy for advanced disease. The primary endpoint of progression free survival (PFS) was met based on interim analysis (data cut-off: Jun 21, 2023) with a 69% reduction in risk of progression or death (HR 0.31; 95% CI, 0.22 to 0.45; P <0.00001).
The median PFS, as assessed by BICR, was 5.7 months (95% CI, 4.3 to 7.2) with sac-TMT and 2.3 months (95% CI, 1.6 to 2.7) with chemotherapy; PFS rate at 6 months was 43.4% vs 11.1%. In the subset of patients with trophoblast cell-surface antigen 2 (TROP2) H-score > 200, the median PFS was 5.8 months with sac-TMT and 1.9 months with chemotherapy (HR 0.28; 95% CI, 0.17 to 0.48). At the first planned interim analysis for overall survival (OS) (data cut-off: Nov 30, 2023) with median follow-up of 10.4 months, OS was statistically significant in favor of sac-TMT (HR 0.53; 95% CI, 0.36 to 0.78; P =0.0005); the median OS was not reached (95% CI, 11.2 to NE) with sac-TMT and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The objective response rate (ORR) assessed by BICR was 43.8% with sac-TMT and 12.8% with chemotherapy.
Most common grade ≥ 3 treatment-related adverse events (TRAEs) (sac-TMT vs. chemotherapy) were neutrophil count decreased (32.3% vs. 47.0%), anemia (27.7% vs. 6.1%) and white blood cell count (WBC) decreased (25.4% vs. 36.4%).
A Phase 3 global study led by MSD of sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC) in TNBC who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery (NCT06393374) and a Phase 3 study led by the Company of sac-TMT in China for 1L treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC (NCT06279364) are ongoing.
NSCLC
Patients with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive sac-TMT 5 mg/kg Q3W plus KL-A167 1200 mg Q3W (cohort 1A) or sac-TMT 5 mg/kg Q2W plus KL-A167 900 mg Q2W (cohort 1B) in a non-randomized manner until disease progression or unacceptable toxicity. As of January 02, 2024, 40 and 63 patients have been enrolled in cohort 1A and 1B, respectively. Median ages were 63/63 years (cohort 1A/1B); 97.5%/85.7% had Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 1; 30.0%/33.3%, 32.5%/30.2% and 37.5%/36.5% of patients had programmed death ligand 1 (PD-L1) expression < 1%, 1%-49% and ≥ 50% of tumor cells by IHC 22C3 pharmDx assay, respectively.
After median follow up of 14.0 months for cohort 1A, the ORR was 48.6% (18/37, 2 pending confirmation), disease control rate (DCR) was 94.6% and median PFS was 15.4 months (95% CI: 6.7, NE) with a 6-month PFS rate of 69.2%. After median follow-up of 6.9 months for cohort 1B, the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with a 6-month PFS rate of 84.6%. Additional subgroup analyses of cohort 1B are shown in the following table:
*Including confirmed or unconfirmed response. ORR was calculated based on response evaluable population defined as patients with ≥ 1 on-study scans.
In cohorts 1A and 1B, the most common Grade ≥ 3 TRAEs were neutrophil count decreased (30.0%/30.2%), WBC decreased (5.0%/17.5%), anemia (5.0%/15.9%), rash (5.0%/6.3%) and drug eruption (7.5%/0). Treatment-related adverse events leading to discontinuation of sac-TMT occurred in 1 patient of cohort 1B due to drug hypersensitivity, and there were no treatment-related deaths.
Two Phase 3 global studies led by MSD of sac-TMT in patients with 3L+ EGFR mutant NSCLC (NCT06074588), and 2L EGFR mutant NSCLC (NCT06305754) and a Phase 3 study led by the Company of sac-TMT in China in patients with 2L EGFR mutant NSCLC (NCT05870319) are ongoing. Additionally, Three Phase 3 global studies led by MSD of sac-TMT plus pembrolizumab are ongoing: One in patients with 1L Metastatic Squamous NSCLC (NCT06422143) , a second in patients with metastatic NSCLC expressing PD-L1 ≥ 50% (NCT06170788), and the third in patients with resectable NSCLC not achieving a pathological complete response (NCT06312137) .
2024-04-08
AACR 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB2...
More2024 American Association for Cancer Research (AACR) Annual Meeting is being held in San Diego, California, the United States of America from April 5th to 10th, 2024, local time.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, the “Company”) will present two study results of anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) during the AACR meeting scheduled below. The abstracts for the studies have been published on the official website of the AACR on April 5th, 2024, local time (See link below).
1. The updated efficacy and safety results for its anti-TROP2 ADCSKB264/sac-TMT in patients with previously treated advanced non-small cell lung cancer (NSCLC) from a phase 2 study in a poster session scheduled on April 9 2024, 1:30 PM - 5:00 PM local time (Abstract Presentation Number: CT247).
2.The preliminary efficacy and safety results for its anti-TROP2 ADC SKB264/sac-TMT in patients with previously treated advanced gastric or gastroesophageal junction (GEJ) cancer from a phase 2 study as an oral presentation, which is scheduled in a session on April 9 2024, 2:30 PM - 4:30 PM local time (Abstract Presentation Number: CT038).
The study results are summarized as follows:
NSCLC
Patients with previously treated advanced NSCLC were enrolled to receive SKB264/sac-TMT at 5 mg/kg Q2W until disease progression or unacceptable toxicity (KL264-01, NCT04152499). The data cut-off date was November 22, 2023.
Five Phase 3 global studies of SKB264/sac-TMT in patients with NSCLC are ongoing. Including two Phase 3 global studies of SKB264/sac-TMT in patients with 3L+ EGFR mutant NSCLC (NCT06074588), and 2L EGFR mutant NSCLC (NCT06305754) and a Phase 3 study ofSKB264/sac-TMT in China in patients with 2L EGFR mutant NSCLC (NCT05870319). Additionally two Phase 3 global studies of SKB264/sac-TMT plus pembrolizumab in patients with metastatic NSCLC expressing programmed death ligand 1 (PD-L1)≥ 50% (NCT06170788) and resectable NSCLC not achieving pathological complete response (NCT06312137) are ongoing.
As of the Data Cut-off date, 43 NSCLC patients had been enrolled and the median follow-up was 17.2 months. 21 patients with EGFR wild type had received a median of 3 prior regimens of therapy including anti-PD-1/L1 inhibitors. 22 patients with EGFR mutant had progressed on or after TKI therapy, 50% of whom also failed at least one line of chemotherapy. Updated efficacy results are shown in the following:
*Including confirmed or unconfirmed response. Based on response evaluable patients (≥1 on-study scans) with 4 patients (2 EGFR mutant patients with non-squamous histology and 2 EGFR wild type patients with squamous histology) excluded.
The most common Grade ≥3 treatment-related adverse events (TRAEs) were neutrophil count decreased (34.9%), anemia (30.2%), white blood cell (WBC) count decreased (25.6%), stomatitis (9.3%), and rash (7.0%). No TRAEs leading to treatment discontinuation or deaths occurred. No drug-related interstitial lung disease (ILD)/pneumonitis was reported.
Gastric/GEJ cancer
Patients with previously treated inoperable advanced gastric/GEJ adenocarcinoma were enrolled to receive SKB264/sac-TMT monotherapy at 5 mg/kg Q2W until disease progression or unacceptable toxicity in Phase 2 expansion cohort of KL264-01 study (NCT04152499). Patients with heavily pre-treated gastric/GEJ cancer were enrolled first, and then the cohort was amended to enroll patients with only one prior therapy of chemotherapy and anti-PD-1/L1 therapy. The data cut-off date was Nov 22, 2023.
As of the data cut-off date, a total of 48 patients were enrolled and followed up for at least 9 weeks. 24 patients (50.0%) had received one prior line of therapy (2L), while 24 patients (50.0%) had received ≥ 2 prior lines of therapy (3L+). 40 patients (83.3%) had received prior anti-PD-1/L1 inhibitors. Of 41 response-evaluable patients (defined as ≥ 1 on-study scans), the objective response rate (ORR) was 22.0% (9 partial responses, 2 pending confirmation) and disease control rate (DCR) was 80.5%. The ORRs in the 2L and 3L+ setting were 27.3% (including 2 pending confirmation) and 15.8%, respectively. Median duration of response (DoR) was 7.5 months. In the subset of 3L+ patients (n=24 including 54.2% of patients with ≥ 4 prior lines of therapy) with more mature follow-up (median follow up of 14.6 months), the median progression free survival (mPFS) was 3.7 months (95% CI: 2.6, 5.4) and median overall survival (mOS) was 7.6 months (95% CI: 5.3, 15.5).
The most common ≥ Grade 3 TRAEs were anemia (20.8%), neutrophil count decreased (18.8%), WBC decreased (12.5%) and neutropenia (6.3%). No TRAEs leading to treatment discontinuation or deaths occurred. No neuropathy or drug-related ILD/pneumonitis was reported.
A Phase 3 global study of SKB264/sac-TMT monotherapy versus standard of care (SOC) chemotherapy in 3L+ gastric/GEJ adenocarcinoma is being planned.
Press Contact: Xinwei Li, klbio_pr@kelun.com
2024-03-13
The FOURTH BTD! TROP2-ADC SKB264 (MK-2870) Granted Breakthrough Therapy designat...
MoreOn 8th March 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech)’s innovative core product TROP2-ADC SKB264 (also known as MK-2870) was granted Breakthrough Therapy Designation（BTD） by the Center for Drug Evaluation（ CDE） of the National Medical Products Administration (NMPA) of China for first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative triple negative breast cancer (TNBC). SKB264 (MK-2870) is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA).
This is the fourth Breakthrough Therapy Designation for SKB264 (MK-2870) granted by the NMPA. Previously, SKB264 (MK-2870) was granted BTD for:
July 2022, locally advanced or metastatic TNBC.
January 2023, EGFR-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) after progression on EGFR tyrosine kinase inhibitor (TKI) therapy.
June 2023, locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer in patients who have previously received at least two lines of systematic chemotherapy.
Breast cancer is one of the most common malignant tumors in women, with its incidence showing an increasing trend year by year. The International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) estimated that in 2020, there were over 2.26 million new cases of breast cancer globally, accounting for 11.7% of all tumors, making it the most prevalent cancer [1]. Triple-negative breast cancer (TNBC) is a clinical subtype that is negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2), comprising 10.0% to 20.8% of all breast cancer types. Triple-negative breast cancer is characterized by high heterogeneity, a high rate of recurrence and metastasis, and a poorer prognosis compared to other types of breast cancer. It lacks effective and specific treatment methods [2]. Currently, the primary treatment for PD-L1 negative TNBC is chemotherapy, which offers limited survival benefits, highlighting the urgent need for new treatment plans. For patients with inoperable locally advanced, recurrent, or metastatic PD-L1 negative triple-negative breast cancer, the first-line standard treatment in China still involves chemotherapy, including single-agent or combination chemotherapy [3]. Compared to single-agent chemotherapy, combination chemotherapy has greater toxicity and offers limited survival benefits.
BTD is designed to expedite the development of new drugs for serious diseases that have shown significant efficacy or safety over existing therapies in preliminary clinical trials. For new drugs included in the Breakthrough Therapy List, CDE will prioritize the allocation of resources for communication, enhanced guidance, and promotion of drug development. If the relevant conditions have been assessed to be met, an application for conditional approval and an application for priority review and approval may also be submitted at the time of the application for drug marketing authorization. This will help accelerate the SKB264 (MK-2870) development process and address the unmet clinical needs of Chinese patients as soon as possible.
参考文献：
[1] Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J(Engl).2022 Feb 9; 135(5):584-590.
[2] 三阴性乳腺癌含铂方案临床应用专家共识（2021版）.中华肿瘤防治杂志2021年6月第28卷第12期.
[3] 《中国临床肿瘤学会（CSCO）乳腺癌诊疗指南2023版》.
2024-03-13
Kelun Biotech and Ellipses corporate pipeline A400(EP0031) has been granted Fast...
MoreOur key product A400(EP0031), a small molecule rearranged during transfection (RET) kinase inhibitor program, has been granted Fast Track designation by the United States Food and Drug Administration (FDA) for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC).
A400 (EP0031) is a second-generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations.
In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international drug development company, an exclusive, royalty-bearing, sub licensable license to develop, manufacture and commercialize A400 (EP0031) in all countries excluding Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand.
In June 2022, the FDA approved an investigational new drug application for A400 (EP0031), and a phase 1/2 trial is ongoing in patients with malignant tumors with RET gene alteration.
In November 2023, A400 was granted Orphan Drug Designation by the FDA for the treatment of RET fusion-positive solid tumors.
In preclinical studies, A400 (EP0031) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. A400 (EP0031) also demonstrated good penetration of the blood brain barrier in animal models. Data shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on A400 (EP0031) showed promising anti-tumor efficacy in patients with advanced RET+ solid tumors, highlighted by ORR of 80.8% and 69.7% for 1L and 2L+ advanced RET+ NSCLC, respectively, based on results from its ongoing phase 1/2 trial. In both cases, DCR of over 96% were reported.
At present, the Company is conducting A400 (EP0031) pivotal clinical study in China for RET- positive NSCLC.
About Ellipses Pharma Limited
Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
2024-03-04
INCLUSION IN STOCK LIST OF STOCK CONNECT SOUTHBOUND TRADING LINK
Morepursuant to the Notice of Adjustment of Stock List of Southbound Trading Link of the Shanghai-Hong Kong Stock Connect ( 关于沪港通下港股通目标调整的通知) made by the Shanghai StockExchange on March 1, 2024, the Company will be included in the list of eligible shares of the Southbound Trading Link of the Shanghai-Hong Kong Stock Connect with effect from March 4, 2024.
2024-02-26
Kelun-Biotech (6990.HK) attended the FinanceAsia 2023 Annual Awards celebration ...
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On February 21, 2024, the prestigious international finance magazine, FinanceAsia, held its 2023 annual achievement awards ceremony in Hong Kong. Kelun-Biotech (6990.HK) was invited to attend the celebration dinner and was awarded the "Best IPO in Asia and Hong Kong for 2023" honor.
FinanceAsia is regarded as one of the most representative professional monthly magazine in Asia's capital market and has significant influence in the investment industry. Founded in 1996, its sponsored "FinanceAsia Achievement Awards" is one of the most influential and credible industry award selections in the Asia-Pacific region, the award ceremony is an significant annual gathering in the investment industry.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
2024-01-11
CEO of Kelun-Biotech Dr. Micheal Ge delivered a presentation on The 42nd JPM Ann...
MoreThe 42nd J.P. Morgan Annual Healthcare Conference（“JPMHC”）2024 is taking place on January 8-11 at San Fracisco, USA, members of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech) senior management team participated in the conference. Dr. Micheal Ge, CEO of Kelun-Biotech, delivered a presentation about innovation strength and business progress of Kelun-Biotech.
Presentation Title: Dedicated to human health with a caring heart
Presentation Time: Pacific Standard Time (PST) Tuesday 8:00 AM, January 9, 2024
As one of the pioneers in the antibody-drug conjugates (ADC) development company, Kelun-Biotech has established world leading ADC platform “OptiDC?”, as well as a rich and differentiated ADC R&D pipeline covers unmet clinical needs in the field of oncology. Our core product Trops-ADC and Her2 ADC are expected to be approved for NDA in China this year. Meanwhile, Kelun-Biotech is accelerating the development progress of over 10 clinical and pre-clinical ADC and ADC-derivative products. With the support of the Kelun Group, Kelun-Biotech has built mature R&D, manufacturing and quality control system, the company is now building a commercialization team to form the marketing system. Kelun-Biotech’s innovation capability has gained high recognition from global partners, including MSD, and the capital market. Kelun-Biotech is rapidly developing a unique growth curve as an ADC R&D pharmaceutical enterprise.
Dr.Michael Ge said: “It’s our pleasure to meet again with global industry leaders, innovative technology creators and members of the investment community here at JPMHC. Our top priority is to rapidly advance our differentiated pipeline programs into and through the clinic for disease conditions with significant medical needs. We will continue to innovate and optimize our ADC platform, discover novel payloads, linkers, engineer novel ADC designs, and expand clinical application of antibody drug conjugates to non-oncology disease areas. Build upon our end-to-end drug development capabilities, infrastructure, and commercialization readiness. Furthermore, we plan to extend our global footprints through strategic partnerships and maximize our pipeline and portfolio value. We look forward to achieving and updating you on the 2024 milestones in the coming year”.
Presentation Slides is available on the investor relations page of Kelun-Biotech website at: 投资者关系 - 四川科伦博泰生物医药股份有限公司 (kelun-biotech.com)
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
2023-12-11
First TROP2-ADC in China! CDE Accepted the New Drug Application for SKB264 (MK-2...
MoreSichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) announced that the new drug application (the “NDA”) for SKB264 (MK-2870, Brand name: 佳泰莱) in adult patients with unrespectable locally advanced, metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). SKB264 (MK-2870) is expected to be the first domestic TROP2-ADC to be approved for marketing in China. This SKB264 New Drug Application is based on a multi-center, randomized, controlled phase 3 clinical study of SKB264 (MK-2870) monotherapy for second line or above locally advanced or metastatic
SKB264 new drug application has been included in the priority review and approval process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). For drugs that included in the priority review, CDE will prioritize the review and verification procedures to effectively shorten the approval timeframe for launching clinical-valuable new drugs to the market. The Company plans to publish the Phase III clinical trial data at the Academic Conference 2024 and promote the early launch of SKB264, to enrich the clinical treatments for patients with second-line and above TNBC.
Breast cancer is the number one malignant tumor that seriously threatens women's health all over the world, and its incidence is increasing year by year. TNBC is a subtype of breast cancer with specific molecular expression characteristics, invasive behavior and metastatic patterns, and has a poorer prognosis than other subtypes of breast cancer, with higher rates of local recurrence and distant metastasis, and the 5-year survival rate is only 13% for advanced TNBC patients (National Cancer Institute 2022). Due to the lack of therapeutic targets such as endocrine and HER2, TNBC is insensitive to both hormonal and targeted therapies, and the current treatment is still based on chemotherapeutic agents. For patients with second-line and above TNBC, the progression-free survival of current clinically available chemotherapy regimens is less than 3 months, and overall survival is about 5-8 months (Kazmi et al. 2020, O'Shaughnessy et al. 2021), and there is a large and urgent unmet clinical need for more effective therapeutic agents
On December 2023, Kelun-Biotech updated efficacy and safety results from a phase II expansion cohort in patients with previously treated metastatic TNBC for SKB264 (MK-2870) have been presented at the 46th San Antonio Breast Cancer Symposium (SABCS). (SABCS 2023 news link here)
About SKB264 (MK-2870)
SKB264 is a representative innovative ADC targeting TROP2, developed by Kelun-Biotech 's internationally renowned ADC research and development platform—OptiDC. It consists of a humanized anti-TROP2 monoclonal antibody with high affinity and targeting, combined with the self-developed small toxin molecule T030 (a topoisomerase I inhibitor) through a stability-optimized CL2A linker. The drug-to-antibody ratio (DAR) averages as high as 7.4. The stability of SKB264 has been enhanced in two main ways, allowing more ADC to effectively reach tumor cells. Firstly, the antibody end of the linker uses a sulfonamide pyrimidine connector, which allows for irreversible coupling with the antibody. Secondly, T030 contains a methyl sulfone structure, which can securely bind with the toxin end of the linker. The linker of SKB264 is affected by both extracellular pH-sensitive cleavage and intracellular enzymatic cleavage within tumor cells, which leads to efficient release of the small toxin molecule to exert its anti-tumor effects. T030 activity is similar to that of DXd and also shows a “bystander effect”. In summary, SKB264 exerts its anti-tumor effect in three ways. Firstly, the pH-sensitive linker can cleave and release T030 in the acidic tumor microenvironment. Secondly, after being engulfed by tumor cells, SKB264 releases T030 via enzymatic cleavage. Thirdly, T030 can also penetrate the cell membrane to exert a "bystander effect" to kill surrounding tumor cells. With a high-affinity monoclonal antibody, highly active toxin molecule, good stability, and high DAR value, the overall design of SKB264 contributes to its robust anti-tumor activity which has been preliminarily demonstrated in clinical studies to date.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize SKB264 (MK-2870) in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
SKB264 has received 3 BTDs from the CDE of China’s NMPA for the treatment of locally advanced or metastatic TNBC, locally advanced or metastatic EGFR-mutated non-small cell lung cancer which has failed EGFR-TKI therapy, and locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer which has received at least second-line systemic therapy.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs.
At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the Phase III or NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
References:
1. National Cancer Institute (2022) Cancer Stat Facts: Female Breast Cancer Subtypes.
2.[Kazmi S, Chatterjee D, Raju D, et al. (2020)] Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin, gemcitabine, or capecitabine. Breast Cancer Research and Treatment; 184(2):559-565.
3.[O'Shaughnessy J, Punie K, Oliveira M, et al. (2021)] Assessment of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) cohort by agent in the phase 3 ASCENT study of patients (pts) with metastatic triple-negative breast cancer (mTNBC). (2021): 1077-1077. https://meetinglibrary.asco.org/record/198258/abstract
Forward-Looking Statements
This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.
It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.
2023-11-27
Kelun-Biotech announced that A400/EP0031 has been granted Orphan Drug Designatio...
MoreKelun-Biotech announces that KL590586 (EP0031) (small molecule RET kinase inhibitor, also named A400) program, licensed to global ex-China partner Ellipses Pharma, has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of RET fusion-positive solid tumors.
Orphan drugs are drugs used for the prevention, treatment and diagnosis of rare diseases. The FDA grants ODD for investigational treatments for rare diseases, such as RET fusion-positive solid tumours, defined as affecting fewer than 200,000 people in the United States. The designation is an important milestone in the development of innovative drugs, it is expected to accelerate the progress of clinical trials in the United States. ODD qualifies the developer for certain incentives with the goal of accelerating drug development for patients, including tax credits and seven years of market exclusivity in the US upon approval by the FDA.
A400 (EP0031) is a next generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations. Therefore, A400 (EP0031) may overcome resistance mechanisms to first generation SRIs. In preclinical studies, A400 (EP0031) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. A400 (EP0031) also demonstrated good penetration of the blood brain barrier in animal models. At present, Kelun-Biotech is conducting A400 (EP0031) pivotal clinical study in China for RET-positive non-small cell lung cancer.
In March 2021, Kelun-Biotech granted Ellipses an exclusive license for A400 (EP0031) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China and parts of the Asia-Pacific region such as Korea, Singapore, Malaysia.
In June 2022, the FDA approved an investigational new drug application for A400 (EP0031), and a Phase 1/2 trial is ongoing in patients with malignant tumors with RET gene alteration.
About RET altered malignancies
RET fusions and mutations are present in a wide range of tumors, including non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancer, as well as colorectal cancer, so targeting RET gene changes is promising as a treatment for all types of cancer. However, for patients with RET gene alteration, the effect of traditional chemotherapy and immunotherapy is limited, especially for patients with drug resistance after first-generation SRI treatment, the acceptable treatment options are limited, and the prognosis is poor, and there are still unmet clinical needs.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and establishing an globalized drug development and industrialization platform for the unmet medical needs in China and worldwide. The Company is committed to becoming an leading global enterprise in the field of innovation drugs.
At the present, the company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with multiple global trials conducted simultaneously in several regions including China, Europe, and the United States. The company has established one of the world’s leading in-house developed ADC platform, OptiDC, and has four ADC projects in the clinical stage (two of which are in the phase III or NDA stage, respectively) and several projects in the preclinical stage.
For more information, please visit https://kelun-biotech.com/.
About Ellipses Pharma Limited
Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients. For more information, please visit www.ellipses.life
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2023-11-27
Kelun-Biotech announced that A400/EP0031 has been granted Orphan Drug Designation from the US Food and Drug Administration by ex-China partner Ellipses Pharma
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Kelun-Biotech announces that KL590586 (EP0031) (small molecule RET kinase inhibitor, also named A400) program, licensed to global ex-China partner Ellipses Pharma, has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of RET fusion-positive solid tumors.
Orphan drugs are drugs used for the prevention, treatment and diagnosis of rare diseases. The FDA grants ODD for investigational treatments for rare diseases, such as RET fusion-positive solid tumours, defined as affecting fewer than 200,000 people in the United States. The designation is an important milestone in the development of innovative drugs, it is expected to accelerate the progress of clinical trials in the United States. ODD qualifies the developer for certain incentives with the goal of accelerating drug development for patients, including tax credits and seven years of market exclusivity in the US upon approval by the FDA.
A400 (EP0031) is a next generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations. Therefore, A400 (EP0031) may overcome resistance mechanisms to first generation SRIs. In preclinical studies, A400 (EP0031) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. A400 (EP0031) also demonstrated good penetration of the blood brain barrier in animal models. At present, Kelun-Biotech is conducting A400 (EP0031) pivotal clinical study in China for RET-positive non-small cell lung cancer.
In March 2021, Kelun-Biotech granted Ellipses an exclusive license for A400 (EP0031) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China and parts of the Asia-Pacific region such as Korea, Singapore, Malaysia.
In June 2022, the FDA approved an investigational new drug application for A400 (EP0031), and a Phase 1/2 trial is ongoing in patients with malignant tumors with RET gene alteration.
About RET altered malignancies
RET fusions and mutations are present in a wide range of tumors, including non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancer, as well as colorectal cancer, so targeting RET gene changes is promising as a treatment for all types of cancer. However, for patients with RET gene alteration, the effect of traditional chemotherapy and immunotherapy is limited, especially for patients with drug resistance after first-generation SRI treatment, the acceptable treatment options are limited, and the prognosis is poor, and there are still unmet clinical needs.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and establishing an globalized drug development and industrialization platform for the unmet medical needs in China and worldwide. The Company is committed to becoming an leading global enterprise in the field of innovation drugs.
At the present, the company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with multiple global trials conducted simultaneously in several regions including China, Europe, and the United States. The company has established one of the world’s leading in-house developed ADC platform, OptiDC, and has four ADC projects in the clinical stage (two of which are in the phase III or NDA stage, respectively) and several projects in the preclinical stage.
For more information, please visit https://kelun-biotech.com/.
About Ellipses Pharma Limited
Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients. For more information, please visit www.ellipses.life
2023-11-13
First Patient Completed Dose Administration in Phase III Registrational Clinical Study of Kelun-Biotech SKB264 for the Treatment of Second-line and Above HR+/HER2- Breast Cancer
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First Patient Completed Dose Administration in Phase III Registrational Clinical Study of Kelun-Biotech SKB264 for the Treatment of Second-line and Above HR+/HER2- Breast Cancer
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (otherwise known as Kelun-Biotech, stock code: 6990.HK) completed the first patient dose administration in China for its Phase III registrational study of the innovative TROP2 ADC product, SKB264 (also known as MK-2870) recently. This study, led by Professor Xu Binghe from the Cancer Hospital of Chinese Academy of Medical Sciences, is investigating the use of SKB264 for the treatment of second-line and above hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
SKB264 (MK-2870), which is jointly developed with MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA), is one of the core products of Kelun-Biotech and possesses independent intellectual property rights, is the first domestically produced TROP2-ADC to secure Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of HR+/HER2- breast cancer and has subsequently entered into Phase III registrational studies. Accordingly, Kelun-Biotech has carefully designed a comprehensive development plan for this core asset in China. Currently, SKB264 monotherapy is being investigated in Phase III registrational clinical studies for HR+/HER2- breast cancer patients in the second-line setting and beyond. Additionally, SKB264 in combination or uncombination with A167 (anti-PD-L1 monoclonal antibody) is undergoing Phase II investigational studies in first-line patients. In addition, SKB264 for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior systemic therapies, with at least 1 of those therapies targeting an advanced or metastatic stage, has been approved for in Priority Review by the CDE.
According to the latest data of the International Agency for Research on Cancer (IARC), 2.3 million new cases of breast cancer occurred worldwide in 2020, accounting for about 25% of female malignancies. Surpassing lung cancer for the first time, it is becoming the most common malignant tumor and poses a serious threat to the health of women worldwide. The annual number of new cases of female breast cancer in China (416,000) is far higher than that in other countries, ranking first in the world. Approximately 60% of breast cancer patients in China have tumors that express HR+/HER2-, and about 70%[1-2] with a higher proportion abroad. As SKB264 (MK-2870) progressively advances into the Phase III registrational clinical study for second-line and above HR+/HER2- breast cancer, and successfully administered the initial patient dosage, this provides an encouraging indication that SKB264 (MK-2870) is poised to benefit a larger population of HR+/HER2- breast cancer patients in the near future.
About SKB264 (MK-2870)
SKB264 is an innovative TROP2-directed ADC which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with a DAR of 7.4 (novel topoisomerase I inhibitors) [3].
SKB264 has received 3 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC), locally advanced or metastatic EGFR-mutated non-small cell lung cancer which has failed EGFR-TKI therapy, and locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer which has received at least second-line systemic therapy.
Based on preliminary clinical data, SKB264 is currently being evaluated in Phase Ⅱ and Phase Ⅲ clinical trials as either a single agent or combination therapy in multiple solid tumors.
Domestic development:
the Phase Ⅲ registrational clinical study of SKB264 monotherapy in patients with advanced or metastatic TNBC who have failed at least second-line therapy has arrived the primary endpoint and is expected to be the first domestic TROP2-ADC to be approved for marketing.
Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant EGFR-mutated NSCLC are rapidly advancing.
Several Phase Ⅱ clinical studies in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are conducting smoothly.
Developments abroad:
Kelun-Biotech has granted MSD the exclusive rights to develop, manufacture, and commercialize SKB264 (MK-2870) in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). Currently, MSD has initiated a clinical study of MK-2870 EGFR-mutant NSCLC, and several other global multicenter registrational clinical studies are under preparation.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a subsidiary of Kelun Pharmaceutical Holdings, which focuses on the R&D, manufacture, commercialization and international cooperation of biotechnology-derived pharmaceuticals and innovative small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug development and industrialization platform around the unmet clinical needs of the world and China, the Company is committed to becoming an internationally leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed, and 4 ADCs are in clinical trials (including 2 in the registrational Phase III or NDA filing stage), along with several projects in preclinical development. At present, the company has 33 innovative projects for the treatment of major diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 projects are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries including China, Europe, and the United States. To learn more, please visit https://kelun-biotech.com/ .
References:
[1] 郑莹, 等. 中国癌症杂志, 2013(08):10-18.
[2] DeSantis CE, et al. CA Cancer J Clin, 2016, 66(1):31-42.
[3] Cheng Yezhe, et al. Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. Frontiers in Oncology, Vol 12, 2022.
Forward-Looking Statements
This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.
It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.
2023-10-23
The team from Kelun-Biotech held a meeting with representatives from MSD in Madrid, Spain
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On October 20, 2023, the European Society for Medical Oncology (ESMO) Conference grandly commenced in Madrid, Spain. The ESMO Conference is the most esteemed and influential oncology conference in Europe, and this annual event garners the participation of top-tier experts and scholars from around the globe. By disseminating the latest findings in cancer clinical research, the ESMO Conference provides a high-quality platform for dialogue and learning for oncologists and other relevant stakeholders, thereby significantly influencing the practice of oncology.
During the ESMO Conference, Kelun-Biotech and MSD had a cordial meeting in Madrid on the afternoon of October 21st, local time. The leadership team and clinical team from both parties were present at ‘this meeting.
During the meeting, the management and project teams of Kelun-Biotech and MSD deliberated on the research and development progress of the multi-ongoing clinical collaboration projects and the preclinical projects that will soon enter into clinical stage. They engaged in extensive discussions regarding the potential synergy and upcoming plans for Ｅxecution of global clinical studies for the collaboration projects. Both teams are expected to work closely together to accelerate the development of projects in the clinical stage, including the rapid expansion of indications, exploration of monotherapy and combination therapy activities, and therapeutic benefit in the early-stage setting of certain cancers. This amicable meeting has significantly bolstered the foundation of collaboration between Kelun-Biotech and MSD and considerably advanced the subsequent clinical development of the ongoing collaboration projects. In addition, there is a possibility for Kelun and MSD to explore other collaboration opportunities on new target ADC assets.
On the morning of October 22nd (local time), the ESMO Conference published the results from a Phase I/II basket study in the form of a mini-oral presentation. This study investigated the innovative TROP2-ADC (SKB264, also known as MK-2870), which is under joint development by both Kelun-Biotech and MSD, for the treatment of patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). This oral presentation is based on an abstract that was published on the ESMO official website on October 16th.
About Kelun-Biotech
Kelun-Biotech is a subsidiary of Kelun Pharmaceutical Holdings, which focuses on the R&D, manufacture, commercialization and international cooperation of biotechnology-derived pharmaceuticals and innovative small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug development and industrialization platform around the unmet clinical needs of the world and China, the Company is committed to becoming an internationally leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed, and 4 ADCs are in clinical trials (including 2 in the registrational Phase III or NDA filing stage), along with several projects in preclinical development. At present, the company has 33 innovative projects for the treatment of major diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 projects are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries including China, Europe, and the United States. To learn more, please visit https://kelun-biotech.com/ .
2023-09-14
Tapping into a new filed | The signing ceremony of the cooperation between Kelun-Biotech and the Affiliated Hospital of Southwest Medical University was successfully completed!
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On September 14, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. reached an exclusive license agreement with the Affiliated Hospital of Southwest Medical University on the bone-targeting radiolabeled drug TBM-001. Kelun-Biotech will obtain the global exclusive rights to the TBM-001 project, including worldwide research, development, production, and commercial promotion, and global sublicensing rights. Kelun-Biotech will pay the Affiliated Hospital of Southwest Medical University a total of 38.5 million yuan for the initial contract payment and development milestones, as well as royalties from foreign re-licensing and net sales after product launch.
The signing ceremony was held at Nanyuan Hotel in Luzhou City, Sichuan Province. The Deputy Mayor of Luzhou City Suping Luo, the Vice President of Southwest Medical University Minhai Nie, the Party Secretary of the Affiliated Hospital of Southwest Medical University Yong Xu, the Dean Yong Jiang, the Chairman of Kelun-Biotech Gexin Liu, and the General Manager of Kelun-Biotech Junyou Ge, etc. attended the signing ceremony.
The radionuclide-drug conjugate (RDC) drug is an emerging tumor precision diagnostic and therapeutic drug developed based on radionuclide-targeting ligand molecular coupling technology. RDC uses tumor target-specific molecules as carriers to guide radionuclides to accurately target tumors and achieve brachytherapy, which has unique advantages in early diagnosis of tumors and therapeutic evaluation.TBM-001 is an innovative RDC drug independently developed by Professor CY's team from the Department of Nuclear Medicine of the Affiliated Hospital of Southwest Medical University, and intended to be used for early diagnosis of bone tumor metastasis and precision targeted therapy. According to data from clinical researches initiated by the investigators, TBM-001 has shown effectiveness and safety superior to existing radioactive drug for bone metastasis in imaging diagnosis and treatment of late-stage prostate cancer, breast cancer, lung cancer and other bone metastases of malignant tumor, and significantly improved the quality of life of patients.
Regarding this cooperation, Gexin Liu, the chairman of Kelun-Biotech, stated that radioactive drug is an industry that require high investment with a high barrier of entry. The strong alliance between a regional leading university and high-level technology company is an important measure to break through key technologies and resource links in the industry, and an effective way to promote independent innovation and achievement transformation in the field of nuclear medicine in our country. Both parties are leaders in their respective fields. We all boasts distinct advantages in nuclear medicine discovery, clinical transformation, and conjugated drugs represented by ADC, and we all have industry-leading innovative achievements. This signing marks a new stage in the strategic cooperation between the two parties, highlighting our pragmatic development philosophy and our will and belief in working together for a win-win outcome and benefiting patients in the field of targeting radionuclide-drug conjugate.
Regarding this cooperation, Junyou Ge, the general manager of Kelun-Biotech, stated that RDC has become a new hot topic for anti-tumor drug research and development following Antibody-Drug Conjugates (ADC) at present. TBM-001 is a bone-targeting RDC with differentiated advantages. The innovative technology of Affiliated Hospital of Southwest Medical University and its philosophy are very consistent with Kelun-Biotech's strategy to strengthen the innovative advantages in the field of targeted drug conjugates, so we are pleased to cooperate with the Affiliated Hospital of Southwest Medical University. The Department of Nuclear Medicine has mature platform resources in the discovery of radioactive drugs and the clinical transformation of diagnosis and treatment. Combined with Kelun-Biotech's technical advantages in the ADC field and a complete new drug research and development system, both parties shall be benefited to jointly enter the RDC frontier field with high resource and technical barriers.
Minhai Nie, the Vice President of Southwest Medical University, stated that the Department of Nuclear Medicine has deep technical experience in clinical diagnosis, treatment, research and development of radiopharmaceuticals and clinical transformation. It possesses a Class IV "Radiopharmaceuticals Use Permit" and obtained National Drug Clinical Trial Accreditation. We look forward to our cooperation based on complementary advantages and efficient collaboration to realize the commercial value of TBM-001 as soon as possible, allowing patients with bone metastases from tumors to use more effective drugs at an earlier date.
Suping Luo, the Deputy Mayor of Luzhou City, congratulates both parties on reaching a cooperation on the TBM-001 project. She mentioned that the municipal party committee and the municipal government will fully support our cooperation, and they will provide corresponding services to support the strong alliance between Kelun-Biotech and the Affiliated Hospital of Southwest Medical University to help them grow and develop. She hopes that both parties will leverage their own advantages to achieve a perfect combination of conjugate and nuclear medicine, provide new treatment techniques to ensure the health of the people, and promote the high-quality development of the bio-nuclear medicine industry in Luzhou, Sichuan, and even the whole country.
In December 2022, the Affiliated Hospital of Southwest Medical University reached an cooperation with the "National Engineering Research Center for Bio-targeted Drugs" of Kelun-Biotech. The cooperation have started in the field of radioactive drugs. In addition to TBM-001, the Company and the Affiliated Hospital of Southwest Medical University have also initiated the co-development of other RDC drugs targeting unmet clinical needs. Kelun-Biotech will work together with partners in the industry to integrate superior resources, fully utilize the technical advantages of the OptiDC platform, and accelerate the pace in tapping into the new filed of RDC.
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About the Affiliated Hospital of Southwest Medical University
The affiliated hospital of Southwest Medical University was established in August 1950, located in Luzhou City, Sichuan Province. It is a tertiary general hospital directly under the Health Commission of Sichuan Provincial. It serves nearly 60 million people in the combined region of Sichuan, Chongqing, Yunnan, and Guizhou provinces. The hospital currently has two campuses, Zhongshan and Kangjian Center, and is a comprehensive clinical teaching hospital integrating medical treatment, teaching, and scientific research.
About the Nuclear Medicine Department of the Affiliated Hospital of Southwest Medical University
The Department of Nuclear Medicine at the Affiliated Hospital of Southwest Medical University is a top-tier nuclear medicine department in China. According to the big data analysis of SCI papers of nuclear medicine published worldwide in 2022 released by the authoritative organization Healsan Consulting LLC, the Affiliated Hospital of Southwest Medical University ranks third in the world and first in China in terms of the impact of its SCI papers of nuclear medicine.
About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) (hereinafter referred to as "Kelun-Biotech") is a holding subsidiary of Kelun Pharmaceutical. It is committed to the R&D, manufacturing, commercialization, and international cooperation of biotechnological drugs and innovative small molecule drugs. Kelun-Biotech has been committed to addressing medical needs in China and globally. With a key focus on major disease areas such as cancer, autoimmunity, inflammation, and metabolism, it aims to build an international drug R&D and industrialization platform, striving to become a leading innovative enterprise. Kelun-Biotech has made significant progress in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and innovative small molecule drugs with new targets. Kelun-Biotech has successfully established the internationally renowned ADC R&D platform OptiDC, with 4 ADCs investigated in clinical studies (2 of which are in the registration Phase III or NDA stage, respectively), and several ADCs in preclinical studies. Kelun-Biotech currently has 33 innovative projects for the treatment of major diseases such as cancer, autoimmunity, inflammation, and metabolism, including 14 in clinical stage. Several clinical trials are multi-center studies conducted simultaneously in multiple countries including China, Europe and America.
2023-09-11
The first of its kind in China! Kelun-Biotech's Cetuximab Solution for Infusion Accepted for market registration application by the National Medical Products Administration.
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On September 11, 2023, Kelun-Biotech announced that the major product A140 solution for infusion (Cetuximab Solution for Infusion, trade name: Datalai?) was recently accepted for marketing application by the Center for Drug Evaluation of the National Medical Products Administration (acceptance number: CXSS2300075).
A140 solution for infusion is the first cetuximab solution for infusion that filed an application for marketing in China. It is intended for the treatment of metastatic colorectal cancer with wild-type RAS genes: used in combination with FOLFOX or FOLFIRI regimens for first-line treatment; and in combination with irinotecan for patients who have failed treatment containing irinotecan. At the same time, it is also intended for the treatment of head and neck squamous cell carcinoma (HNSCC): used in combination with platinum and fluorouracil chemotherapy for first-line treatment of recurrent and/or metastatic diseases; and in combination with radiotherapy for the treatment of locally advanced diseases.
This product is a recombinant epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody (mAb), which inhibits the growth and survival of tumor cells expressing EGFR. The A140 solution for infusion is firstly developed in China to be filed for production in accordance with the “Guidelines for Design of Clinical Trials of Injectable Cetuximab Biosimilar (for Trial Implementation)” using the original cetuximab as a reference drug. The reference drug ctuximab (trade name: Erbitux?) was approved for import into China in 2007. The approved indications in China include metastatic colorectal cancer and HNSCC. As of 2022, the global market size of cetuximab has reached 1.73 billion US dollars, and the sales in China have reached 2.253 billion yuan. Due to reasons such as drug accessibility, the clinical demand for cetuximab has not been met. A140 solution for infusion has the same amino acid sequence and mechanism of action as cetuximab, and its proposed indications are consistent with Erbitux?. The A140 solution for infusion will provide significantly increased accessibility once the Application is approved, and will bring compliant, safe, and effective treatment options to more patients.
In recent years, due to factors such as population aging and unhealthy lifestyles caused by improved living standards (such as sedentary lifestyle, high-fat and high-protein diets, etc.), the incidence of colorectal cancer in China has been on the rise. According to the epidemiological data of cancer released by the National Cancer Center of China in 2022, there were 408,000 new cases of colorectal cancer and 196,000 deaths in China. The incidence and mortality rates of colorectal cancer ranked second and fourth among all malignant tumors, respectively. Currently, cetuximab is one of the main treatment options for metastatic colorectal cancer with the primary tumor located in the left half of the colon and expressing wild-type RAS EGFR.
Head and neck squamous cell carcinoma (HNSCC) is the most common malignant tumor in the head and neck area. In 2022, there were about 78,000 new cases of HNSCC and over 40,000 deaths in China. The incidence and mortality rates of HNSCC ranks seventh and sixth among all malignant tumors in Chinese men, respectively. Since cetuximab was approved globally for first-line treatment of recurrent or metastatic HNSCC and used in combination with radiotherapy for locally advanced HNSCC, it has allowed many HNSCC patients worldwide to receive treatment plans containing cetuximab, which improved their quality of life and extended their life expectancy.
The application for registration of A140 solution for infusion is based on information from a series of studies, including pharmacologic comparative study, non-clinical comparative study, and clinical comparative study. The Phase III clinical safety and efficacy study of A140 is a randomized, double-blinded, parallel-controlled, multi-centered Phase III clinical study comparing the efficacy, safety and immunogenicity of A140 and the original cetuximab combination chemotherapy regimen (mFOLFOX6 regimen) for first-line treatment of RAS wild-type metastatic colorectal cancer.
About Kelun-Biotech
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) (hereinafter referred to as "Kelun-Biotech") is a holding subsidiary of Kelun Pharmaceutical. It is committed to the R&D, manufacturing, commercialization, and international cooperation of biotechnological drugs and innovative small molecule drugs. Kelun-Biotech has been committed to addressing medical needs in China and globally. With a key focus on major disease areas such as cancer, autoimmunity, inflammation, and metabolism, it aims to build an international drug R&D and industrialization platform, striving to become a leading innovative enterprise. Kelun-Biotech has made significant progress in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and innovative small molecule drugs with new targets. Kelun-Biotech has successfully established the internationally renowned ADC R&D platform OptiDC, with 4 ADCs investigated in clinical studies (2 of which are in the registration Phase III or NDA stage, respectively), and several ADCs in preclinical studies. Kelun-Biotech currently has 33 innovative projects for the treatment of major diseases such as cancer, autoimmunity, inflammation, and metabolism, including 14 in clinical stage. Several clinical trials are multi-center studies conducted simultaneously in multiple countries including China, Europe and America. For more information, please visit https://kelun-biotech.com/.
2023-09-07
Passionate Competition for Championship in Badminton The seventh Kelun-Biotech Badminton Match was successfully concluded.
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To enrich the leisure life of employees, improve their physical fitness, and enhance team cohesion, the labor union of Kelun-Biotech held the seventh badminton match on September 2, 2023. There were 7 participating teams, with nearly 90 employees, at this match. Regular team matches and fun games (juggling, serving, and drawing) were arranged. The participating players fought hard on the court, showcasing the charm of sports competition. The entire event was full of exciting moments.
The match was conducted under the following principle, i.e., " It’s not winning that matters, but friendship and safety". Before the competition, each team took their spare time for serious training to continuously improving their skills in order to get prepared to achieve excellent results. During the competition, they strove hard and sweat on the court. Off the court, each team communicated with one another and made progress together. Meanwhile, the members of the organizing committee and the chief referee took their responsibilities and made fair judgments. Their heart-devoted contrition ensured the smooth running of this badminton match.
Intense battles have unfolded between the teams since the beginning of the match. The players fought for every point with full vigor and vitality, and participated in the competition with full passion, high morale, and a spirit of unity. Although the team members were randomly grouped without good rapport, this does not affect their performance on the field. During the break, the team leaders timely arranged tactics and mobilized their team members to ensure that they sprint on the court in the best condition.
After intense competition, the first, second, and third places were finally determined, and the Excellent Team Award was bestowed. Each team received rewards such as sports backpacks, fascia guns, and badminton strings.
The badminton match is not just a competitive event, but also an opportunity to promote employee communication and cooperation. Through the match, employees not only exercised their bodies and improved their technical skills, but also enhanced friendship and cooperation between departments. Meanwhile, this match fully demonstrates the spirit of our employees who unite as one to make positive and striving efforts, and further highlights the cultural charm of "health, happiness, and confidence" in the company.
2023-09-06
Kelun-Biotech Appears at the 2023 CIFTIS Selected for the Ten-Year Achievement Exhibition and as Demonstration Case for Science & Technology Innovation Service .
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From September 2 to 6, 2023, the 2023 China International Fair for Trade in Services (abbreviated as "CIFTIS"), with the annual theme of "Opening up Leads to Development, Cooperation Delivers the Future", was held in Beijing. Only two companies from Sichuan Province were selected, one of which was Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (abbreviated as " Kelun-Biotech "). Kelun-Biotech was successfully selected for the 2023 CIFTIS Ten-Year Achievement Exhibition and as "Demonstration Case for Science & Technology Innovation Service".
This year's CIFTIS has set up a special area for the China Service Trade Achievement Exhibition, presenting the achievements of China's service trade development over the past 10 years. The Sichuan Comprehensive Exhibition Hall covers an area of 100 square meters. Its main thread of display is Chengdu, the innovative demonstration city, and the seven national service export bases. Based on a concentrated display of high-quality physical objects, it showcases the innovative development achievements and characteristic highlights of Sichuan's service trade.
(Kelun-Biotech's large molecular model displayed at the ten-year achievement exhibition of CIFTIS)
Kelun-Biotech reached a cooperation with the international pharmaceutical giant Merck, with upfront and milestone payments totaling up to 11.8 billion US dollars, thereby setting a new record for the amount of foreign authorization transactions for innovative drugs in China. Therefore, it was successfully included in the ten-year achievement exhibition for its historic breakthrough from a basically "importer of services" to "exporter of services".
Kelun-Biotech's "OptiDC" innovative Antibody Drug Conjugate (ADC) platform is one of the only two service demonstration cases selected in Sichuan. Kelun-Biotech's "OptiDC" innovative Antibody Drug Conjugate (ADC) platform has developed a complete ADC core component library, which can design the best combination and make effective optimization according to the biological characteristics of the target, thereby proposing the optimal ADC to meet the medical needs in various indications. With its strong R&D strength and the synergistic effect of multi-platform technology, Kelun-Biotech has become a technology exporter among the world's top biopharmaceutical companies, thus opening a new paradigm of service trade.
2023-08-28
Kelun-Biotech Announces Interim Results for 2023
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Kelun-Biotech Announces Interim Results for 2023:
Global Strategic Partnership and Rich Pipeline Boost Significant Revenue Growth in the First Half of the Year
Chengdu, China, August 28, 2023 – Today, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, HKEX: 6990.HK), an innovative biopharmaceutical company focusing on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs, announced its interim results for the six months ended June 30, 2023.
The announcement shows that Kelun-Biotech’s revenue for the first half of 2023 amounts to approximately RMB 1,046 million, an increase of 203.3% compared to the same period last year. The increase is mainly attributable to the receipt of the non-refundable upfront payment of USD175.0 million from Merck Sharp & Dohme LLC (together with its affiliates, “MSD”) in March 2023 pursuant to the license and collaboration agreement we entered into with MSD to develop up to seven preclinical ADC (antibody drug conjugate) assets for the treatment of cancer. Thanks to the revenue from license and collaboration agreements, and provision of research and development service, Loss for the period are RMB 31.13 million ，the loss for the period has significantly narrowed by 88.5% year-on-year.
R&D and commercialization work together to contribute to the long-term value accumulation
Kelun-Biotech’s core product, SKB264, was granted a Breakthrough Therapy Designation (BTD) in January, 2023 by the National Medical Products Administration (NMPA) for EGFR-TKI failed EGFR-mutant locally advanced or metastatic NSCLC and another BTD in June for locally advanced or metastatic hormone receptor positive (HR)+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) which has previously received at least 2L systemic chemotherapy. In addition, the clinical development of SKB264 made significant progress in the first half of 2023: In June, the company released the data of phase II study of SKB264 in patients with locally advanced or metastatic NSCLC at the 2023 ASCO Annual Meeting, demonstrating promising efficacy and controlled safety of SKB264; In July, achieved first-patient-in for a pivotal phase III trial of SKB264 for EGFR-mutant locally advanced or metastatic non-squamous NSCLC (TKI failure) in China; In August, the phase III clinical trial of SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple negative breast cancer (TNBC) who have failed second-line or above prior standard of care met the primary endpoint.
In May 2023, Kelun-Biotech submitted an NDA to the NMPA for another core product, A166 (HER2 ADC), targeting 3L+ advanced HER2+ BC. The company is also conducting a confirmatory phase III trial in China for 2L+ advanced HER2+ BC and multiple phase Ib clinical trials in China to explore the therapeutic potential of A166 for other advanced HER2+ solid tumors, including gastric cancer and colorectal cancer.
In addition, Kelun-Biotech is making significant progress with other key products. SKB315 (Claudin 18.2 ADC) is undergoing the phase Ia clinical trial in China for patients with advanced solid tumors; The phase Ia clinical trials of SKB410 for advanced solid tumors, which also received IND approval from the NMPA, successfully enrolled the first patient in July 2023; We have completed patient enrollment of the phase III trial of A167 in combination with chemotherapy as a 1L treatment for RM-NPC; We have completed patient enrollment of the phase III trial of A167 in combination with chemotherapy as a 1L treatment for RM-NPC; We have completed patient enrolment of A140 (Cetuximab biosimilar) in November 2022 with an anticipated NDA filing with NMPA for RAS wild-type mCRC in the second half of 2023. In July, the company commenced pivotal trial of A400 (RET inhibitor) for advanced RET+ NSCLC, a trial of A400 for advanced RET+ medullary thyroid carcinoma received IND approval from the NMPA.
Considering the research and development progress of its drug pipelines, Kelun-Biotech is setting up a fully-fledged commercialization team to prepare and implement the marketing and commercialization of its strategic products. Currently, Kelun-Biotech has established a department structure within the company, consisting of various departments such as Marketing, Access and Commerce, Medical Affairs, Sales, and Strategic Planning and Commercial Excellence.
Stable global strategic partnership, Kelun-Biotech has achieved a significant revenue growth
In January 2023, MSD subscribed for the Shares in Kelun-Biotech at a consideration of
approximately USD 1 million as part of the Series B Financing. In March, the receipt of the non-refundable upfront payment of USD 175.0 million from Merck Sharp & Dohme LLC (together with its affiliates, “MSD”) in March 2023 pursuant to the license and collaboration agreement we entered into with MSD to develop up to seven preclinical ADC (antibody drug conjugate) assets for the treatment of cancer. In the first half year of 2023, we had various exchanges and visits with MSD management, and we made concerted efforts to promote the progress of the project and continued to deepen the results of strategic cooperation. Currently, clinical-stage products such as SKB264, SKB315, A410 as well as other preclinical-stage products developed in collaboration with MSD are being advanced and developed in an orderly manner as planned.
Kelun-Biotech entered into a collaboration and license agreement with Ellipses, under which it granted Ellipses an exclusive, royalty-bearing, sublicensable license to develop, manufacture and commercialize A400 in all countries excluding Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand. Kelun-Biotech has received certain milestone payments from Ellipses during the Reporting Period. A clinical trial application of A400 was approved by the Spanish Agency of Medicines and Medical Devices (AEMPS) in February 2023. As of July 26, 2023, seven and four clinical research centers in the United States and Europe, respectively, were in use for A400.
Strong capital operation promotes innovation strategy
In February, 2023, Kelun-Biotech completed Series B Financing and raised over USD 200 million.
In July, 2023, Kelun-Biotech was successfully listed on the Main Board of the Stock Exchange. The net proceeds arising from the Listing and the full exercise of the Over-Allotment Option amounted to approximately HK$1454.9 million.
Dr. Ge Junyou, Ｅxecutive Director and General Manager of Kelun-Biotech, commented: “The significant revenue growth in the first half of 2023 is a strong testament to Kelun-Biotech’s continuous efforts to advance its clinical value-oriented and differentiated oncology and non-oncology pipeline, enhance its drug development capabilities, continue to seek strategic partners, and optimize its operation system, among other correct strategic tactics. Looking ahead to the second half of the year, Kelun-Biotech will further advance the research and development progress of various pipelines, refine the commercialization strategies for each late-stage drug candidate, and continue to pursue a flexible strategy to capture the commercial value in major international markets, through forging synergistic license and collaboration opportunities worldwide.”
About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, please visit https://kelun-biotech.com/.
Forward-Looking Statements
This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.
It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.