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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2023-08-14
Kelun-Biotech announces that a Phase III clinical trial of SKB264 (MK-2870, TROP2-ADC) in unresectable locally advanced, recurrent or metastatic TNBC has met its primary endpoint
Chengdu, China, August 14, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced today that its innovative TROP2-AD...
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Chengdu, China, August 14, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced today that its innovative TROP2-ADC (SKB264, also known as MK-2870) met the primary endpoint in the randomized, controlled, open-label, multi-center Phase III clinical trial of SKB264 for injection versus investigator selected regimens 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.
Kelun-Biotech recently held an Independent Data Monitoring Committee (IDMC) meeting to review the interim analysis data of the Phase III clinical trial of SKB264. The IDMC resolution indicated that the trial met the primary endpoint of progression-free survival (PFS) as assessed by the Independent Review Committee (IRC), and at a pre-specified interim analysis, SKB264 demonstrated a statistically significant improvement in PFS, compared with the control group receiving standardized chemotherapy. Based on the results from the interim analysis, Kelun-Biotech plans to communicate with the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China regarding the submission of a new drug application (NDA) of SKB264.
Dr. Ge Junyou, Ｅxecutive Director and General Manager of Kelun-Biotech, commented, "TNBC is one of the most aggressive and prevalent subtypes of breast cancer (BC) with huge unmet medical needs. Patients with TNBC who have received second-line or later treatment have an overall survival of 5.2 to 8.4 months [1]. SKB264 has been granted breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic TNBC. For drugs included in the list of BTD, the CDE will prioritize resource allocation for communication and guidance to facilitate drug development. This will help accelerate the development and commercialization of SKB264 to provide high-quality treatment options for patients with advanced TNBC."
SKB264 is one of the core products with independent intellectual property rights of Kelun-Biotech, and will be supported by an extensive development plan. This clinical trial, which met its primary endpoint, is the first registrational Phase III study of SKB264 (MK-2870) in China. In addition, Kelun-Biotech is also advancing a Phase II trial of SKB264 with or without KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) as a first-line treatment for advanced TNBC, and another randomized, open-label, multicenter Phase III clinical study of SKB264 versus investigator’s choice regimens in patients with unresectable locally advanced, recurrent or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who had failed at least one line of chemotherapy is expect to be launched in the second half of 2023.
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) [2].
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.
SKB264 is currently conducting Phase II and Phase III clinical trials of monotherapy/combination in multiple solid tumors. In China, the Phase III registrational clinical study of SKB264 monotherapy for patients with advanced or metastatic TNBC who have failed at least second-line therapy is progressing smoothly, and SKB264 is expected to become the first domestic TROP2-ADC approved for the Chinese market. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant and EGFR-mutated non-small cell lung cancer (NSCLC) are also rapidly advancing. Several Phase II clinical studies of SKB264 in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are ongoing. Kelun-Biotech has licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize SKB264 in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
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/.
References:
[1] O'Shaughnessy, Joyce, et al. 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.
[2] 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.
2023-08-01
Selected for oral presentation! Kelun-Biotech to announce latest clinical study results of SKB264 (MK-2870, TROP2-ADC) for treatment of HR+/HER2- breast cancer at ESMO Congress 2023
Chengdu, China, August 1, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced that it will present the data from...
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Chengdu, China, August 1, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced that it will present the data from a Phase I/II clinical trial of the innovative TROP2-ADC (SKB264, MK-2870) jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc Rahway NJ USA) at the European Society for Medical Oncology (ESMO) Congress 2023 to be held in Madrid, Spain from October 20 to 24, 2023. The data will be presented in the form of an oral presentation and will focus on the treatment of previously-treated patients with metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In June of this year, SKB264 was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic HR+/HER2- breast cancer which has received at least second-line systemic therapy.
The abstract of this oral presentation is titled "SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): results from a phase I/II, single-arm, basket trial", and the presentation number is 380MO. Details of the abstract are expected to be released on the official website of the ESMO Congress on October 16, 2023, local time.
The ESMO Congress is the most prestigious and influential oncology conference in Europe. It brings together clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all around the world each year. By sharing the latest cutting-edge data, it provides unparalleled networking opportunities and high quality education for oncologists and other stakeholders.
About SKB264 (MK-2870)
SKB264 is an innovative ADC targeting TROP2 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 DAR of 7.4 (novel topoisomerase I inhibitors) [1].
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, locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have failed EGFR-TKI therapy and the treatment of 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.
SKB264 is currently conducting Phase II and Phase III clinical trials of monotherapy/combination in multiple solid tumors. In China, the Phase III registrational clinical study of SKB264 monotherapy for patients with advanced or metastatic triple-negative breast cancer (TNBC) who have failed at least second-line therapy is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for the Chinese market. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant and EGFR-mutated non-small cell lung cancer (NSCLC) are also rapidly advancing. Several Phase II clinical studies of SKB264 in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are ongoing. Kelun-Biotech has licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to research, develop, produce and commercialize SKB264 in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
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, manufacture, 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, visit
References:
[1] 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 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.
You are cautioned 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.
2023-07-11
Kelun-Biotech successfully listed on the main board of HKEX
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) announced its official listing on the main board of Hong Kong Exchanges and Clearing Limit...
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Hong Kong, China, July 11, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) announced its official listing on the main board of Hong Kong Exchanges and Clearing Limited (HKEX), with the stock code: 6990.HK. Shares started trading at 60.60 Hong Kong dollars (“HKD”) in the morning. By midday close, Kelun-Biotech’s share price went up by 3.80%, with a total market value of HKD13.58 billion.
As the largest Initial Public Offering (IPO) in the medical and health sector of the Hong Kong stock market in the past two years and one of the most popular investment projects in the medical and health sector recently, Kelun-Biotech’s listing on HKEX has attracted high attention and great interest from both local and international investors.
As a global unicorn enterprise, Kelun-Biotech has established a strategic partnership with Merck Sharp & Dohme LLC (together with its affiliates, “MSD”), one of the top ten multinational pharmaceutical companies in the world, and has entered into nine out-license agreements with MSD to develop up to nine ADC assets with upfront and milestone payments totaling up to USD11.8 billion. In addition, Kelun-Biotech has also received support from blue chip healthcare investors such as IDG Capital, CMG-SDIC Capital, Lilly Asia Ventures, Hillhouse, Cinda, and Sherpa, and has introduced five cornerstone investors including RTW Funds, Laurion Capital Ｍaster Fund, TruMed, CUAM, and Kelun International in this IPO.
Mr. Liu Gexin, Chairman of the Board of Kelun-Biotech said: “As the core subsidiary carrying the innovation mission of Kelun Pharmaceutical, Kelun-Biotech’s successful entry into the international capital market today marks a significant stage victory for Kelun Pharmaceutical’s ‘innovation-driven’ development strategy. With this listing as an opportunity, Kelun-Biotech will continuously improve its corporate governance structure and undertake corporate social responsibilities; accelerate the clinical research of indication-oriented anti-tumor drugs, and expand differentiated non-oncology drug portfolio; focus on key areas, and build more competitive platforms and pipelines. Leveraging Kelun Pharmaceutical’s decades-long experience in the domestic market, and the continuously deepening strategic cooperation with MSD, we will promote the development and commercialization process of planned projects, and strive to become an innovation-oriented pharmaceutical company with a global vision and industry competitiveness, to reward investors and society with excellent performance!"
Since its incorporation in 2016, Kelun-Biotech has been dedicated to the R&D, manufacturing and commercialization of novel drugs in oncology, immunology and other therapeutic areas. Kelun-Biotech is one of the first movers in the development of antibody drug conjugates (ADCs), with over a decade of accumulated experience in ADC development and is one of the first biopharmaceutical companies in China, and one of the few globally, to establish an in-house developed ADC platform, OptiDC. Relying on the platform, Kelun-Biotech has built a strong asset portfolio with 33 highly differentiated and clinically valuable pipelines centered around two ADCs, SKB264 and A166. Among the pipelines, 14 are in clinical stage, five in pivotal trial- or NDA registration-stage, nine in phase 1-or phase 2-stage.
With the Gong ringing and stock market opening at 9:30, the shares of Kelun-Biotech began to trade officially, and received a warm market response. Looking forward, Dr. Ge Junyou, Ｅxecutive Director and General Manager of Kelun-Biotech said: "We will continue to advance and enhance our drug R&D capabilities. In addition to optimizing our R&D platforms and developing novel technologies to support the R&D of innovative drugs, we will strengthen the development of clinical-stage drugs in partnership with strategic partners such as MSD, in the fields of rapid indication expansion, monotherapy and combination therapy, late- and early-line. Furthermore, we will continue to expand cGMP manufacturing and quality control facilities, enhance commercialization system and capabilities, and promote the marketing of more excellent innovative drugs, to bring better treatment options for patients in China and around the world."
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, manufacture, 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, visit http://kelun-biotech.com/.
2023-06-16
SKB264 (MK-2870) is approved for clinical trials in the European Union
CTA of Kelun-Biotech's TROP2-ADC (SKB264, MK-2870) in combination with pembrolizumab is approved in the European Union.
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On June 19, 2023, Kelun-Biotech announced that the innovative TROP2-ADC (SKB264, also known as MK-2870), which is being developed in collaboration with MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA), in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) for Phase II clinical studies in select patients with a variety of advanced solid tumors, has been approved for clinical trials in the European Union. This is an international multicenter clinical study which is currently approved in multiple countries and territories, including China, the United States, Canada, Australia, and now the European Union, fully demonstrating the strength of Kelun-Biotech in conducting clinical studies on a global scale. MSD and Kelun-Biotech are working closely to continually advance the international development of SKB264.
At present, immune checkpoint inhibitors, mainly represented by anti-PD-1/PD-L1 therapies, have played an important role in treating cancer across a variety of tumors. In order to improve outcomes for patients, combination therapies are being explored, including combination with chemotherapy, targeted therapy, radiotherapy, other types of immunotherapy, and more.
ADCs specifically target tumor cells to deliver cytotoxic molecules that induce immunogenic cell death (ICD) and trigger innate and adaptive immune responses, allowing large numbers of T cells to infiltrate tumor cells and thereby improving immunotherapeutic efficacy. Clinical trial data in multiple cancer types have shown that anti-PD-1 therapies in combination with ADCs may be able to improve efficacy compared to either agent alone. TROP2 is highly expressed in a variety of epithelial-derived tumors and can promote tumor cell proliferation, invasion, and metastasis, and is a promising target for broad-spectrum anti-tumor therapy. TROP2-ADCs specifically target TROP2-expressing tumor cells to deliver cytotoxic effects, and have shown encouraging anti-tumor activity as monotherapy in several clinical trials, and has the potential to improve anti-tumor efficacy in combination with immune checkpoint inhibitors such as anti-PD-1/PD-L1 therapies.
About SKB264 (MK-2870)
SKB264 is an innovative ADC targeting TROP2 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 DAR of 7.4 (novel topoisomerase I inhibitors) [2].
SKB264 (MK-2870) has received 2 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer and locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have failed EGFR-TKI therapy.
SKB264 (also known as MK-2870) is currently conducting Phase II and Phase III clinical trials of monotherapy/combination in multiple solid tumors. In China, the Phase III registrational clinical study of SKB264 monotherapy for patients with advanced or metastatic triple-negative breast cancer (TNBC) who have failed at least second-line therapy is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for the Chinese market. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant and EGFR-mutated non-small cell lung cancer (NSCLC) are also rapidly advancing. Several Phase II clinical studies of SKB264 in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are ongoing. Kelun-Biotech has licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to research, develop, produce and commercialize SKB264 in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
About Kelun-Biotech
Kelun-Biotech is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacture, 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 including China, Europe, and the United States.
References:
[1] Merck & Co., Inc. Investor Event at ASCO 2023
[2] 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.
2023-05-27
Kelun-Biotech to present recent clinical data for SKB264 (TROP2 ADC) at ASCO 2023
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2023 ASCO | Kelun Biotech SKB264 (TROP2-ADC) releases research data of non-small cell lung cancer for the first time
On May 25, US Eastern Time, the official website of the 2023 ASCO Annual Meeting published abstracts of some of the selected studies for the meeting. The innovative TROP2-ADC (SKB264, MK-2870) jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc Rahway NJ USA), with the Phase 2 expansion study data for previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), has been published on the official website of ASCO.
The data cut-off is February 9, 2023, and the median follow-up time is 11.5 months.
Efficacy: 39 NSCLC patients were evaluable for efficacy (who had received SKB264 at 5 mg/kg, Q2W): the objective response rate (ORR) was 44% (17/39), the disease control rate (DCR) was 95% (37/39), the median duration of response (DoR) was 9.3 months, and the 6-month DoR rate was 77%.
In the EGFR mutant subgroup, all patients were EGFR-TKI resistant, and 50% of the patients had received at least one chemotherapy regimen. Subgroup analysis showed that the ORR was 60% (12/20), the disease control rate (DCR) was 100% (20/20), and the median progression-free survival (PFS) was 11.1 months, with 9-month PFS rate of 66.7%.
In the EGFR wild-type subgroup, all patients had previously failed anti-PD-1/L1 therapy and the median prior lines of therapy was 2. Among this subgroup, the ORR was 26% (5/19), the DCR was 89% (17/19), the median PFS was 5.3 months, and the 9-month overall survival (OS) rate was 80.4%.
Safety: Grade ≥3 treatment-related adverse events (TRAEs) were reported in 67.4% (29/43) of patients. The most common Grade ≥3 TRAEs (≥ 5%) were decreased neutrophil count, anemia, decreased white blood cell count, oral mucositis, rash, and decreased lymphocyte count. Most blood-related adverse events occurred within two months of starting SKB264 treatment and recovered after treatment with granulocyte colony-stimulating factor and erythropoietin. TRAEs led to a dose reduction rate of 23.3%, and no discontinuation or death due to TRAEs occurred. No neurotoxicity or drug-related interstitial lung disease (ILD)/pneumonitis was observed.
In previously treated patients with locally advanced or metastatic NSCLC, SKB264 demonstrated encouraging antitumor activity and a manageable safety profile. A Phase 3 registrational study of SKB264 for the treatment of locally advanced or metastatic NSCLC is in progress.
About SKB264 (TROP2-ADC)
SKB264 is a new generation of antibody-drug conjugates (ADC) composed of a humanized
monoclonal antibody targeting TROP2, an enzymatically cleavable linker and a novel topoisomerase I inhibitor for which Kelun-Biotech has independent intellectual property rights. SKB264 combines the specificity of monoclonal antibodies to target antigens on the surface of tumor cells and the high cell-killing efficiency of cytotoxic drugs. SKB264 has been granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer and locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
Based on preliminary clinical data, SKB264 is currently conducting Phase 2 and Phase 3 clinical trials involving monotherapy and combination therapy for multiple tumor types. In China, the Phase 3 registrational clinical study of SKB264 monotherapy for advanced or metastatic TNBC patients who have failed at least second-line treatment is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for marketing. Phase 3 clinical research of SKB264 monotherapy for TKI-resistant EGFR-mutated non-small cell lung cancer patients is also rapidly advancing. Several Phase 2 clinical studies of SKB264 combined with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (anti-PD-L1 monoclonal antibody) are under development. In addition, Kelun-Biotech has granted an exclusive license to MSD to manufacture, develop, and commercialize SKB264 (also known as MK-2870) outside of Greater China territories (Greater China includes Mainland China, Hong Kong, Macau and Taiwan). Global clinical research in several major countries, including United States, Canada, Australia, France, Spain, Belgium and Poland, are currently ongoing while additional multi-center clinical studies are also under preparation.
About Kelun-Biotech
Kelun-Biotech is a holding subsidiary of Kelun Pharmaceutical, focusing on the R&D, production, commercialization and international cooperation of innovative biologics and small molecule drugs. Focusing on the unmet clinical needs in China and the rest of world, the company aims to treat major diseases, including solid tumors, autoimmune, inflammatory and metabolic diseases. By building an international drug R&D and industrialization platform, the company strives to become an international leading enterprise in the field of innovation. Significant progress has been made in the field of biologic drugs, including ADC, monoclonal antibody, bispecific antibody, as well as novel targets for innovative small molecule drug discovery, etc. The world-renowned ADC R&D platform, OptiDC, has been successfully established, from which 4 ADCs are in the clinical research stage, and several are in the preclinical research stage. The company currently has 33 innovative projects for the treatment of major diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, including 14 projects advancing in clinical research, of which 3 are being carried out concurrently in China and the United States.
Business Development Team
Saturday, May 27, 2023
2023-05-27
KLUS Pharma to attend 2023 ASCO Annual Meeting
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KLUS Pharma will attend 2023 ASCO Annual Meeting in Chicago from June 2-6th.
KLUS Pharma is the US subsidiary of Kelun-Biotech, a mid-sized innovative biopharma company based in Chengdu, China. Kelun-Biotech is committed to the development of innovative therapies to address the unmet needs of patients with advanced cancer and other serious illnesses. Currently, we are advancing several antibody-drug conjugates (ADCs) and immuno-oncology assets in ongoing clinical trials for advanced solid tumors, including lung, breast, gastric, and others. We are excited to share recent progress and review the latest data updates being presented at ASCO and look forward to meeting potential collaborators and colleagues!
Business Development Team
Saturday, May 27, 2023
2023-04-14
KLUS Pharma to attend the 2023 BIO International Convention
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KLUS Pharma will attend the BIO International Convention partnering event held live in Boston, MA from June 5-8, 2023.
KLUS Pharma is the US subsidiary of Kelun-Biotech, a mid-sized innovative biopharma company based in Chengdu, China. Kelun-Biotech is advancing a broad pipeline of small molecules, monoclonal antibodies, antibody drug conjugates (ADCs), and cell therapies for the treatment of cancer, autoimmune, metabolic, and cardiovascular diseases. With over ten clinical-stage assets and dozens of promising preclinical candidates, we are actively seeking strategic partners to help accelerate the global development of these promising therapeutic candidates. In addition, we are also seeking in-licensing opportunities for the Greater China market, including innovative therapeutics in oncology, autoimmune, metabolic, and cardiovascular diseases areas. Clinical-stage assets with preliminary safety and efficacy data are preferred. We also consider selective generic products suitable for the China market in the following therapeutic spaces: neurology, infectious disease, reproductive health, and fertility treatments.
Click the link below to request a meeting with KLUS Pharma through the BIO partnering system!
https://login.partnering.bio.org/inova-business-platform/webclient/#/bio/12401/hub
We look forward to meeting potential collaborators at the event!
Business Development Team
Friday, April 14, 2023
2023-04-11
KLUS Pharma to attend 2023 AACR Annual Meeting
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KLUS Pharma will attend the 2023 AACR Annual Meeting held live in Orlando, Florida from April 14-19.
KLUS Pharma is the US subsidiary of Kelun-Biotech, a mid-sized innovative biopharma company based in Chengdu, China. Kelun-Biotech is advancing a broad pipeline of small molecules, monoclonal antibodies, and antibody-drug conjugates (ADCs) for the treatment of cancer. With multiple programs in late stage clinical trials, such as HER2 ADC to treat HER2+/HR- metastatic breast cancer, and TROP2 ADC for the treatment of a wide range of solid tumors, Kelun-Biotech is aiming to address the unmet needs of cancer patients by bringing novel, safer, and affordable medicines to market. In this current competitive landscape, we believe it is more important than ever to work with potential collaborators to achieve meaningful advances in this field, including exploring combination therapy synergies, leveraging regional/global clinical trial resources, and striving to improve existing discovery and development capabilities.
Therefore, we are looking forward to meeting potential collaborators and exploring all the latest ground-breaking research to be presented at AACR Annual Meeting, which has served as a premier event for scientists, clinicians, industry, and patients to meet and share knowledge for advancing the treatment of cancer.
Business Development Team
Tuesday, April 11, 2023