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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2026-02-06
Kelun-Biotech Announces Fourth Indication for Sacituzumab Tirumotecan (sac-TMT) ...
MoreCHENGDU, China, February 4, 2026—Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that a new indication application for its TROP2-directed ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) has been approved by the National Medical Products Administration (NMPA) of China for treatment of adult patients with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer (BC) who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting. This approval for HR+/HER2- BC after at least one prior line of chemotherapy marks the fourth indication for sac-TMT approved for marketing in China.
The approval is based on the positive results from the Phase III OptiTROP-Breast02 study which was selected as a Late-Breaking Abstract (LBA) and presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) Congress.
The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT monotherapy compared to investigator's choice of chemotherapy in patients with unresectable or metastatic HR+/HER2- BC. Of the patients enrolled in this Phase III study, 95.7% had visceral metastases, 75.9% had liver metastases; 52.9% were HER2-zero (IHC 0), while 47.1% were HER2-low (IHC 1+ or IHC 2+/ISH-). All patients had received prior CDK4/6 inhibitor and taxane therapy; 56.6% had received ≥2 lines of prior chemotherapy in the advanced or metastatic setting.
Results showed that sac-TMT demonstrated a statistically significant and clinically meaningful increase in progression-free survival (PFS) as assessed by the Blinded Independent Central Review (BICR) compared to chemotherapy (8.3 vs. 4.1 months; hazard ratios (HR), 0.35; 95% CI: 0.26-0.48; p<0.0001). Consistent PFS benefits were observed across all pre-specified subgroups, including HER2-zero and HER2-low, number of chemotherapy lines received in the advanced or metastatic setting, presence of baseline visceral and liver metastases and previous CDK4/6 inhibitor use. According to BICR-assessed PFS results, the hazard ratios in the HER2-zero and HER2-low (IHC 1+ or IHC 2+/ISH-) subgroups were 0.39 (95% CI: 0.26-0.57) and 0.31 (95% CI: 0.20-0.48), respectively. A trend towards overall survival (OS) benefit and a significantly higher objective response rate (ORR) (41.5% vs. 24.1%) were also observed compared with chemotherapy. [1]
Currently, Phase III clinical studies of sac-TMT with or without pembrolizumab (KEYTRUDA®[2]) for the treatment of chemotherapy-naïve HR+/HER2- BC who have received prior ET have been initiated globally (NCT06312176) and in China (NCT07071337).
About HR+/HER2- Breast Cancer
Breast cancer is one of the most common malignant tumors that seriously threaten women's health worldwide. In 2022, there were about 2,297,000 new cases of breast cancer and 666,000 deaths worldwide. Among them, HR+/HER2- breast cancer is the most common subtype, accounting for about 70% of all breast cancer cases, and advanced HR+/HER2- breast cancer has a poor prognosis. This subtype is typically sensitive to hormonal therapy, and therefore, endocrine therapy combined with a CDK4/6 inhibitor constitutes the standard treatment. However, for patients with HR+/HER2- advanced breast cancer whose disease progresses on endocrine therapy, chemotherapy is widely used in clinical while it is associated with low response rate (ORR approximately 14%-22.9%) and limited survival benefit (mPFS approximately 4.0-4.9 months).
About Sac-TMT
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
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 sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).
To date, four indications for sac-TMT have been approved and marketed in China for: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications listed above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.
Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating16 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, 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. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
Reference Sources：
[1] Fan Y, Li H, Wang H, et al. ESMO Congress 2025, LBA23.
[2] KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
2026-01-16
Kelun-Biotech Showcases Innovative Achievements and Future Development Strategy ...
MoreCHENGDU, China, Jan. 16, 2026 /PRNewswire/ -- From January 12 to 15, 2026, the 44th J.P. Morgan Healthcare Conference (JPMHC) was held in San Francisco, California, USA. Dr. Ge Michael, President and CEO of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK), was invited to attend the conference and delivered a keynote speech on the morning of January 15 (local time) and presented the Company's latest achievements in drug R&D, commercialization, and globalization, and outlined its innovation strategy and future development plans.
Since initiating its innovation journey in 2012, Kelun-Biotech has rapidly emerged as a leader in China's innovative drug field, building differentiated technology platforms and robust R&D pipelines. Leveraging its global leading OptiDC™ platform for antibody-drug conjugates (ADCs) and novel drug conjugates (DCs), the Company continuously advances the differentiated development of ADCs and novel DCs, forming a gradient portfolio for treating multiple tumor types. Currently, Kelun-Biotech has two ADC products on market: sacituzumab tirumotecan (sac-TMT, 佳泰莱®) and trastuzumab botidotin (舒泰莱®), covering breast cancer and lung cancer indications. Additionally, nine uniquely designed ADC and novel DC drugs—including cutting-edge directions such as bispecific ADC and radiopharmaceutical conjugate (RDC) are in clinical stage. For high-incidence tumor types in China, such as breast cancer, lung cancer, and gastrointestinal tumors, the Company has initiated nine pivotal studies, while multiple Phase II clinical studies targeting gynecological tumors are progressing steadily. Furthermore, Kelun-Biotech has also developed several non-DC candidates and expanded indications into non-oncology areas.
Over the past year, Kelun-Biotech has presented multiple research findings at international academic conferences and published in authoritative journals: three were selected for oral presentations at the American Society of Clinical Oncology (ASCO) annual meeting, and three were selected as Late-Breaking Abstracts (LBA) for oral presentations at the European Society for Medical Oncology (ESMO) Congress. Among these, the results of the OptiTROP-Lung04 study of sac-TMT for treating EGFR-mutant Non-Small Cell Lung Cancer (NSCLC) after TKI therapy were presented at the Presidential Symposium session of ESMO and simultaneously published in The New England Journal of Medicine, highlighting its global academic and clinical value.
In terms of commercialization, Kelun-Biotech has formed a competitive initial product portfolio. Its core product, the TROP2-directed ADC sac-TMT, has been approved in China for three indications: second-line and above triple-negative breast cancer, second-line and third-line EGFR-mutated NSCLC. The HER2-directed ADC trastuzumab botidotin was approved last year for second-line and above HER2-positive breast cancer, becoming the first domestically developed HER2-directed ADC approved for this indication. Furthermore, the anti-EGFR monoclonal antibody Cetuximab N01 (达泰莱®) for RAS wild-type colorectal cancer and the anti-PD-L1 monoclonal antibody tagitanlimab (科泰莱®) for nasopharyngeal carcinoma have been launched. Another small-molecule RET inhibitor A400 is expected to be approved within the year, bringing the total number of commercialized products in China to five. Currently, three of the Company's commercialized products, covering five indications, have been included in the National Reimbursement Drug List (NRDL), further benefiting a broad population of cancer patients.
While strengthening its presence in the domestic market, Kelun-Biotech is actively expanding overseas. It has established collaborations with MSD, Ellipses, Windward Bio and Crescent Biopharma to maximize the value of its pipeline value and corporate worth. Among these, MSD is evaluating 16 global Phase III clinical studies of sac-TMT.
The breakthroughs in both clinical development and commercialization are driven by the Company's sustained investment in innovative R&D. With over a decade of accumulation in the ADC field, Kelun-Biotech's proprietary OptiDC™ platform enables differentiated design of drug candidates, which combines specific targets or targeting mechanisms with the most suitable payload-linker strategy to balance efficacy and safety. Additionally, the company is adopting a "multi-pronged" innovation strategy to continuously enhance platform capabilities. By exploring novel targets, new payloads, and diverse conjugation technologies, it is expanding the application boundaries across both oncology and non-oncology fields.
Looking ahead, Kelun-Biotech will consolidate its foundations in R&D, technologies, platforms, and operations by Ｅxecuting five key development strategies. Concurrently, the Company will elevate its globalization strategy, enhancing its capabilities in product development, registration, and commercialization in ex-China market, advancing on its path to becoming a world-class biopharmaceutical company.
Please refer to the "Investor Relations-Investor Calendar" page of the company's official website for the presentation materials. You can visit the website for further details.
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. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, 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. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
2026-01-07
Kelun-Biotech to Attend the 44th J.P. Morgan Healthcare Conference, Sharing Its ...
MoreThe 44th J.P. Morgan Healthcare Conference (JPMHC) will be held in San Francisco, California, USA, from January 12 to 15, 2026. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company”, 6990.HK) has been invited to attend the conference and Dr. Michael Ge, President and CEO of Kelun-Biotech, will share the company’s latest business progresses as well as its innovation capabilities and strategies.
Presentation Time: Thursday, January 15, 2026 at 9:30 AM Pacific Standard Time
Presentation Venue: Westin St. Francis, San Francisco, USA
J.P. Morgan Annual Healthcare Conference is honored as a “benchmark for development and investment in the global healthcare area”. During the conference, Kelun-Biotech will join massive seasoned experts and industry leaders to discuss cutting-edge trends in biopharmaceutical innovation. Based on the ongoing transformation moment of the global pharmaceutical industry, the company will actively pursue mutually beneficial partnership opportunities on the international stage.
You can visit “Investor Relations - Investor Calendar” page of Kelun-Biotech’s official website for participation of live webcast of presentation session, and watch replay within 30 days after the conference.
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. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, 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. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
2026-01-05
Kelun-Biotech Receives Investigational New Drug Approval for ITGB6-Targeted ADC ...
MoreCHENGDU, China, Jan. 5, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that its Investigational New Drug (IND) application for SKB105 (also known as CR-003), an internally developed integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of advanced solid tumors.
In December 2025, Kelun-Biotech and Crescent Biopharma, Inc. ("Crescent") entered into a strategic collaboration for SKB105/CR-003 and SKB118 (a PD-1 x VEGF bispecific antibody, also known as CR-001). Under the collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside of Greater China. In addition, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China. The IND application for SKB118/CR-001 has been cleared by the U.S. Food and Drug Administration (FDA) with a global Phase I/II clinical trial for the treatment of advanced solid tumors is set to commence shortly. Kelun-Biotech plans to submit an IND application for SKB118/CR-001 to the Center for Drug Evaluation of the National Medical Products Administration of China in the near future.
About SKB105 (also known as CR-003)
SKB105 is a differentiated ADC targeting ITGB6 with a topoisomerase I inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 incorporates proprietary Kthiol® irreversible conjugation technology, linking an anti-ITGB6 fully human Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) to a clinically validated cleavable linker. This design aims to enhance stability and tumor-specific payload delivery while reducing adverse effects. In preclinical models, SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile.
About SKB118(also known as CR-001)
SKB118/CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells' ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, SKB118/CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. SKB118/CR-001's anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, particularly in conjunction with ADCs.
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. Kelun-Biotech 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. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
2026-01-05
Kelun-Biotech Announces Breakthrough Therapy Designation Granted in China for Sa...
MoreCHENGDU, China, January 5, 2026 -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company,” 6990.HK) today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) in combination with MSD’s anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA®[1]) was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have PD-L1 tumor proportion score (TPS)≥1% and are EGFR-negative and ALK-negative.
BTD is granted for treatment regimens that provide effective treatment or prevention for conditions with no currently available therapy, or that demonstrate significant clinical advantages over currently available treatments. For drugs included in the breakthrough therapy process, if relevant conditions are met, applications for conditional approval and priority review and approval can be submitted when applying for marketing authorization.
Previously, the company announced that results from the Phase III clinical trial of OptiTROP-Lung05, evaluating sac-TMT in combination with pembrolizumab as first-line treatment for PD-L1-positive NSCLC, demonstrated a statistically significant and clinically meaningful improvement in its primary endpoint of progression-free survival (PFS). A positive trend was also observed in overall survival (OS). OptiTROP-Lung05 is the first Phase III study of an immunotherapy and ADC combination to meet its primary endpoint in the first-line treatment of NSCLC. Granting of BTD for the first-line treatment of PD-L1-positive NSCLC indication offers pathways to expedite the review and potential approval process of sac-TMT for this indication.
To date, sac-TMT has received five BTDs for:
locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022;
locally advanced or metastatic EGFR-mutant NSCLC after progression on EGFR-TKI therapy in January 2023;
locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023;
first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024;
In combination with anti-PD-L1 monoclonal antibody tagitanlimab for the first-line treatment of locally advanced or metastatic non-squamous NSCLC without actionable genomic alterations in June 2025.
About sac-TMT
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
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 sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).
To date, three indications for sac-TMT have been approved and marketed in China for: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; Unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. The first two indications listed above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of cancer patients.
Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. In addition, the sNDA for sac-TMT for second-line and above treatment of HR+/HER2- BC was accepted by the Center for Drug Evaluation of the National Medical Products Administration, and was included in the priority review and approval process.
As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.
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. Kelun-Biotech 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. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
[1] KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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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
2023-03-13
KLUS Pharma is Attending 2023 BIO-Europe Spring!
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KLUS Pharma will attend Bio-Europe Spring partnering event held live in Basel, Switzerland from March 20-22 and virtually from March 28-30, 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://partneringone.informaconnect.com/event/731/
We look forward to meeting potential collaborators at the event!
Business Development Team
Monday, March 13, 2023
2022-12-22
Merck and Kelun-Biotech Announce Exclusive License and Collaboration Agreement for Seven Investigational Antibody-drug Conjugate Candidates for the Treatment of Cancer
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Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd), a clinical-stage biotech company focused on biologic and small molecule discovery and development, today announced that the companies have entered into an exclusive license and collaboration agreement to develop seven investigational preclinical antibody-drug conjugates (ADC) for the treatment of cancer.
“Advances in ADC technologies are yielding a new generation of candidates designed to more precisely target and deliver potent anticancer agents to the tumor site,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We continue to augment our oncology pipeline and look forward to working with the Kelun-Biotech team to advance these candidates to the patients that need them.”
Under the agreement, Kelun-Biotech has granted Merck exclusive global licenses to research, develop, manufacture and commercialize multiple investigational preclinical ADC therapies and exclusive options to obtain additional licenses to ADC candidates. Kelun-Biotech retains the right to research, develop, manufacture and commercialize certain licensed and option ADCs for mainland China, Hong Kong and Macau.
“The further expansion of our collaboration with Merck provides a strong endorsement for our technology from a leader in the development of cancer treatments,” said Dr. Junyou Ge, chief Ｅxecutive officer of Kelun-Biotech. “We are grateful for our partnership with the Merck scientists.” Kelun-Biotech will receive an upfront payment of $175 million from Merck. Kelun-Biotech is also eligible to receive future development, regulatory and sales milestone payments totaling up to $9.3 billion, if Kelun-Biotech does not retain mainland China, Hong Kong and Macau rights for the option ADCs and all candidates achieve regulatory approval, plus tiered royalties on net sales for any commercialized ADC product. Merck also intends to make an equity investment in Kelun-Biotech. The transaction is subject to customary closing conditions including regulatory approval under the Hart-Scott Rodino (HSR) Act and approvals by the shareholders of Kelun-Biotech and Sichuan Kelun Pharmaceutical Co., Ltd.
This announcement follows previously disclosed research collaboration and licensing agreements for two ADC candidates including MK-2870 (also known as SKB-264), an investigational TROP2 targeting ADC currently being evaluated in late-stage clinical trials.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
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About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube, and LinkedIn.
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About Kelun-Biotech
Kelun-Biotech is a clinical-stage biotech company established in 2016, a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, engaged in biologic therapeutics as well as small molecule discovery and development. The company focuses on unmet medical needs such as oncology and autoimmune conditions and strives to be a leader in novel therapeutic discovery and development. Since its inception, Kelun-Biotech has established multi-modal drug discovery platforms based on global standards and made important development breakthroughs in antibody-drug conjugation, immuno-oncology, bispecific antibody and novel small molecule targeting and designs.
Kelun-Biotech’s current pipeline includes 33 therapeutic programs for the treatment of cancers, autoimmune conditions, infectious diseases, and metabolic syndromes. Fourteen programs are in clinical development in China, two of which have entered into clinical development in the US. Most notably, Kelun-Biotech has built out a proprietary ADC platform which is protected by a complex patent portfolio. Our comprehensive ADC capabilities range from novel target discovery, payload screening, linker design, as well as GMP manufacturing. As of today, Kelun-Biotech is advancing over 10 novel ADC programs in varying stages of development.
For additional information, please contact klbio_bd@kelun.com (China) or bd@kluspharma.com (US).
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2021 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Business Development Team
Thursday, December 22, 2022
2022-12-14
2022 SABCS | Kelun-Biotech TROP2-ADC (SKB264, MK-2870) Phase 2 Study Poster
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The 45th Annual San Antonio Breast Cancer Symposium (SABCS) will commence on December 6th, 2022. A series of groundbreaking study data is expected to be presented at this conference, and the participants will also discuss how to apply the latest findings to clinical practice in order to improve the current treatment paradigm for breast cancer patients.
The efficacy and safety data of Kelun-Biotech’s TROP2-ADC (SKB264, MK-2870) in the Phase II expansion study in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) were presented in a scientific poster, which was released on the official SABCS website and displayed and exchanged at the conference site, and the detailed contents are provided below.
Main contents of the Presented Poster
This was a Phase 2 expansion study that enrolled 59 patients with previously treated locally advanced or metastatic triple-negative breast cancer to receive SKB264 monotherapy (23 patients in the 4 mg/kg group and 36 patients in the 5 mg/kg group) with a 2-week treatment cycle. The data cut-off was October 10th, 2022, with a median follow-up of 12.8 months.
Baseline characteristics: 59 patients were enrolled (23 in 4 mg/kg group, 36 in 5 mg/kg group); 88% had previously received 3 or more regimens, 40.7% had previously received 5 or more regimens, and 28.8% of patients had previously received anti-PD-1/L1 therapy. 57 patients were available for TROP2 testing, and 54.2% had high TROP2 expression (defined as H-score >200-300).
Efficacy: Among 55 patients with evaluable response (21 in 4 mg/kg group, 34 in 5 mg/kg group), confirmed objective response rate (ORR) was 40% (22/55), disease control rate (DCR) was 80% (44/55), and confirmed ORR was 55.2% (16/29) in patients with high TROP2 expression. The confirmed ORR was as high as 62.5% in the high TROP2-expressing group dosed at 5 mg/kg. Median duration of sustained response (DoR) was 11.5 months, median PFS was 5.7 months, median OS was 14.6 months, and 12-month OS was 66.4%.
Safety: Treatment-related adverse events (TRAEs) ≥Grade 3 were reported in 57.6% (34/59) of patients. The most common ≥Grade 3 TRAEs (≥10%) were neutrophil count decrease (25.4%), white blood cell count decrease (23.7%), and platelet count decrease (16.9%). TRAEs led to dose reductions in 10.2% (6/59) of patients. No deaths due to TRAEs occurred and no interstitial lung disease (ILD) was observed.
In patients with metastatic TNBC treated with multiple prior lines of therapy, SKB264 demonstrated a manageable safety and promising antitumor activity. CDE has granted Breakthrough Therapy Designation for SKB264 as a single agent in locally advanced or metastatic TNBC, and this year will mark the debut of SKB264 clinical data being shared at an international conference for breast cancer. Currently, SKB264 monotherapy is rapidly advancing in a Phase III registrational study for the treatment of locally advanced or metastatic TNBC (NCT05347134), and also as a combination therapy with KL-A167 (anti-PD-L1 monoclonal antibody) for metastatic TNBC in the first-line setting (NCT05445908). Further clinical data for SKB264 in the treatment of breast cancer is expected to be shared in the near future.
About SKB264 (TROP2-ADC)
SKB264 is a new generation of antibody-drug conjugates (ADCs) composed of a humanized monoclonal antibody targeting TROP2, an enzymatically cleavable linker, and a new topoisomerase I inhibitor that Kelun-Biotech has independent intellectual property rights, which combines the specificity of monoclonal antibodies to target antigens on the surface of tumor cells and the high efficacy of cytotoxic drugs.
Based on preliminary clinical data, SKB264 is currently conducting Phase II and Phase III clinical trials of single drug/combination for multiple tumor types. In 2022, the research and development of SKB264 is progressing rapidly. Since January, 6 clinical studies have been approved (5 in China and 1 in the United States).
About Kelun-Biotech
Kelun Biotech is a clinical-stage biotech company established in 2016, a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, engaged in biologic therapeutics as well as small molecule discovery and development. The company focuses on unmet medical needs such as oncology and autoimmune conditions and strives to be a leader in novel therapeutic discovery and development. Since its inception, Kelun-Biotech has established multi-modal drug discovery platforms based on global standards and made important development breakthroughs in antibody-drug conjugation, immuno-oncology, bispecific antibody and novel small molecule targeting and designs.
Kelun-Biotech’s current pipeline includes 55 therapeutic programs for the treatment of cancers, autoimmune conditions, infectious diseases, and metabolic syndromes. Fourteen programs are in clinical development in China, two of which have entered into clinical development in the US. Most notably, Kelun-Biotech has built out a proprietary ADC platform which is protected by a complex patent portfolio. Our comprehensive ADC capabilities range from novel target discovery, payload screening, linker design, as well as GMP manufacturing. As of today, Kelun-Biotech is advancing 10 novel ADC programs in varying stages of development.
Business Development Team
Wednesday, December 14, 2022
2022-11-14
KLUS Pharma is Attending BIO Partnering at JPM 2023!
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KLUS Pharma is Attending BIO Partnering @ JPMorgan Healthcare Conference in San Francisco, CA (January 9-12, 2023).
KLUS Pharma will attend the annual BIO Partnering @ JPM held in San Francisco, CA. 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.
Attending BIO Partnering during JPMorgan Healthcare Conference Week? Click the link below to request a meeting with KLUS Pharma through the BIO partnering system! #JPM2023
https://login.partnering.bio.org/inova-business-platform/webclient/#/bio/11900/company/144762
We look forward to meeting new potential partners at the event!
Business Development Team, KLUS Pharma
Monday, November 14, 2022
2022-09-08
KLUS Pharma is Attending BioPharm America in Boston!
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KLUS Pharma will attend the annual BioPharm America conference held in Boston, MA from September 28-29 and virtually from October 4-5, 2022. As part of Kelun-Biotech, a mid-sized innovative drug developer based in Chengdu, China, we are advancing a broad pipeline of small molecules, monoclonal antibodies, ADCs, and cell therapies covering various therapeutic areas, including oncology, autoimmune, metabolic, and cardiovascular diseases. With more than 10 projects in clinical trials and dozens of promising preclinical candidates under evaluation, we are seeking strategic partnerships to accelerate the development of these potential drug products on a global scale. We look forward to meeting potential next collaborators at the event!
Business Development Team
Thursday, September 8, 2022
2022-07-26
Kelun-Biotech Announces Oncology Research Collaboration and License Agreement with MSD
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Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd), a clinical-stage biotech company focused on biologic and small molecule discovery and development, announced today that it has entered into a collaboration and exclusive license agreement with MSD (the tradename of Merck & Co., Inc Rahway NJ USA), to develop an investigational antibody drug conjugate (ADC) for the treatment of solid tumors.
Under the terms of the agreement, Kelun-Biotech has granted MSD global, exclusive rights to develop, manufacture and commercialize an investigational ADC. Kelun-Biotech and MSD will also collaborate on the early clinical development of the investigational ADC. In return, Kelun-Biotech will receive an upfront payment of$35mm and is eligible to receive future development, approval and commercial milestone payments totaling up to $901mm, plus tiered royalties on net sales.
This latest transaction follows MSD’s decision earlier this year to exercise an option for worldwide rights, except for the Greater China region (including Mainland China, Hong Kong, Macau, and Taiwan), to SKB-264, an investigational TROP2 targeting ADC. SKB-264 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic triple-negative breast cancer and in Phase 2 trials for non-small cell lung cancer and advanced solid tumors. Kelun-Biotech and MSD will collaborate on certain early clinical development plans, including evaluating the potential of SKB-264 as a monotherapy and in combination with KEYTRUDA (pembrolizumab) for advanced solid tumors.
“These collaborations with MSD underscore the sophistication and capabilities of Kelun-Biotech's ADC platform and the potential of our ADC therapeutics,” said Dr. Junyou Ge, Chief Ｅxecutive Officer of Kelun-Biotech. “Incorporating MSD’s deep and broad global expertise with Kelun-Biotech’s innovation power has the potential to generate great development synergy, significantly accelerating the development and commercialization of the collaboration programs. These collaborations will also strengthen our strategic position in building a global, innovative, fully-integrated biopharmaceutical company.”
“The collaboration with Kelun-Biotech strengthens and diversifies MSD’s oncology pipeline as we seek to further the potential of ADCs to provide more treatment options and improve outcomes for people with cancer,” commented Dr. Eric H. Rubin, senior vice president, oncology early development, MSD Research
Laboratories. “We look forward to advancing this collaboration with the Kelun-Biotech team.”
About Kelun-Biotech
Kelun Biotech is a clinical-stage biotech company established in 2016, a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, engaged in biologic therapeutics as well as small molecule discovery and development. The company focuses on unmet medical needs such as oncology and autoimmune conditions and strives to be a leader in novel therapeutic discovery and development. Since its inception, Kelun-Biotech has established multi-modal drug discovery platforms based on global standards and made important development breakthroughs in antibody-drug conjugation, immuno-oncology, bispecific antibody and novel small molecule targeting and designs.
Kelun-Biotech’s current pipeline includes 55 therapeutic programs for the treatment of cancers, autoimmune conditions, infectious diseases, and metabolic syndromes. Fourteen programs are in clinical development in China, two of which have entered into clinical development in the US. Most notably, Kelun-Biotech has built out a proprietary ADC platform which is protected by a complex patent portfolio. Our comprehensive ADC capabilities range from novel target discovery, payload screening, linker design, as well as GMP manufacturing. As of today, Kelun-Biotech is advancing 10 novel ADC programs in varying stages of development.
For additional information, please contact klbio_bd@kelun.com (China) or bd@kluspharma.com (US).
Kelun-Biotech Business Development Team
KLUS Pharma Business Development Team
Tuesday, July 26, 2022