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AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
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AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2)…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for CD33-Targeting ADC in Acute Myeloid Leukemia
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Sichuan Biokin Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange as (SHA: 688506), has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its antibody-drug conjugate (ADC), BL-M11D1. This therapy targets CD33…
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Doma Biopharmaceutical Receives Green Light for Clinical Trial of Novel ADC DM001 Targeting Solid Tumors
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a biotech firm with a presence in China and the United States, has received approval from China’s National Medical Products Administration to commence a clinical study for its innovative Category 1 drug DM001. This bispecific antibody drug conjugate (ADC) is designed to target advanced or…
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HitGen Inc. Partners with Ablink Biotech to Develop Antibody-Oligonucleotide Conjugates
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China-based HitGen Inc. (SHA: 688222) has entered into a partnership with compatriot firm Ablink Biotech to integrate their world-leading trillion-level DNA-Encoded Libraries (DELs), a comprehensive small nucleic acid drug discovery and production platform, and a 300 billion-level biopharmaceutical molecule library. The collaboration aims to provide research and development services for…
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Sichuan Biokin’s BL-B01D1 Earns Breakthrough Therapy Designation for Esophageal Cancer from China’s CDE
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that its bispecific antibody drug conjugate (ADC), BL-B01D1, has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) in China. The designation is for the treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who…
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CSPC Pharmaceutical’s ADC CPO301 Earns Second Fast-Track Designation in the US for NSCLC Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC) CPO301 has received another fast-track status in the United States for the treatment of non-small cell lung cancer (NSCLC). The EGFR targeted ADC has been granted this status for the treatment of epidermal growth…
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MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
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Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov
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Duality Biologics, Inc., a biopharmaceutical company specializing in the development of innovative therapies, has registered a Phase I clinical trial for its drug candidate DB-2304 on ClinicalTrials.gov as of October 3, 2024. The trial is designed to enroll 70 healthy volunteers and is anticipated to conclude in the first half…
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BeiGene’s FGFR2b ADC BG-C137 Enters Phase I Clinical Trial for Advanced Solid Tumors
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On October 3, 2024, BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) registered a Phase I clinical trial for BG-C137, an antibody-drug conjugate (ADC) for the treatment of advanced solid tumors, on ClinicalTrials.gov. The trial plans to enroll 68 patients with advanced solid tumors and is expected to be completed by…
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FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
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Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC candidate, Rina-S, as registered on ClinicalTrials.gov on October 1, 2024. The trial aims to enroll 530 patients with platinum-resistant advanced ovarian cancer to compare Rina-S head-to-head with chemotherapy, with an anticipated preliminary completion date in…
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NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
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The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a novel antibody-drug conjugate (ADC) developed by AbbVie (NYSE: ABBV), for the treatment of relapsed/refractory small cell lung cancer (SCLC) and other neuroendocrine tumors . ABBV-706 is a targeted therapy that binds to SEZ6, a protein…
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Alphamab Oncology Strikes Licensing Deal with CSPC Pharma for HER2 Targeted ADC in China
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm CSPC Pharmaceutical Group Ltd (HKG: 1093). The deal grants CSPC exclusive license and sub-license rights to Alphamab’s JSKN003 in mainland China for development, sales, and commercialization related to oncology indications.…
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Sichuan Biokin’s Partner Bristol-Myers Squibb Gets FDA Nod for Bispecific ADC Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced that its U.S. partner Bristol-Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/IIa study for BL-B01D1, an in-house developed bispecific antibody drug conjugate (ADC), in patients with advanced…
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AbbVie Submits First BLA for c-Met Targeting ADC Telisotuzumab Vedotin to FDA
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AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company in the U.S., has announced the filing of a first Biologics License Application (BLA) for telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate (ADC) targeting tumors that overexpress the c-Met protein. The U.S. Food and Drug Administration (FDA) has accepted the filing for…
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Elevation Oncology’s Claudin 18.2 Targeting ADC Earns FDA Fast Track Designation for Gastric Cancer
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Elevation Oncology, Inc. (NASDAQ: ELEV), a biopharmaceutical company based in the U.S., has announced that it has received Fast Track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational therapy EO-3021 (SYSA1801). This antibody-drug conjugate (ADC) targets Claudin 18.2 and is being developed for the treatment…
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CDE’s BL-B01D1 on Track for Breakthrough Therapy Designations for EGFR Wild-Type and Mutant NSCLC
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The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer…
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Sichuan Kelun-Biotech Reports 32.2% Revenue Growth in 2024 H1, Driven by MSD Partnership
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced its financial results for the first half of 2024, reporting a 32.2% year-on-year (YOY) increase in revenues to RMB 1.383 billion, which includes a USD 90 million cooperation payment from its U.S. partner Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK),.…
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GSK’s Blenrep-BorDex Combo Earns Breakthrough Therapy Designation in China for Multiple Myeloma
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The UK-based pharmaceutical colossus, GSK (LON: GSK, NYSE: GSK), has secured a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its antibody-drug conjugate, Blenrep (belantamab mafodotin), used in combination with bortezomib and dexamethasone (BorDex). This regulatory milestone for the treatment of relapsed or refractory multiple myeloma…
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Alphamab Oncology’s JSKN003 ADC Achieves Positive Safety and Efficacy Outcomes in Phase I Studies
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Alphamab Oncology (HKG: 9966), a leading player in the oncology space, has reported encouraging results from its Phase I clinical studies of JSKN003, a HER2-targeted antibody-drug conjugate (ADC), at the 2024 European Society of Medical Oncology (ESMO) Congress. The studies, conducted in Australia and China, targeted advanced and metastatic solid…
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Merck and Daiichi Sankyo’s HER3-DXd ADC Patritumab Deruxtecan Passes Phase 3 Trial After FDA Rejection
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Merck (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced that their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) has passed Phase 3 HERTHENA-Lung 02 study, months after the drug was rejected by the U.S. FDA due to manufacturing issues following its presentation at this year’s ESMO conference. The companies will discuss…
