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Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Receives Priority Review from China’s NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. The drug is intended for the treatment of adult…
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Duality Biologics Initiates Global Clinical Trial for DB-1419 in Advanced Solid Tumors
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Duality Biologics, Inc., a biopharmaceutical company based in China, has reached a significant milestone with the dosing of the first patient in its Phase I/IIa clinical study for the in-house developed antibody drug conjugate (ADC) DB-1419. The study is aimed at evaluating the safety and efficacy of DB-1419 in patients…
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AstraZeneca and Daiichi Sankyo’s Dato-DXd Misses Overall Survival Endpoint but Shows Promise in NSCLC Subgroup
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AstraZeneca (NASDAQ: AZN) and its co-development partner, Japan’s Daiichi Sankyo, have released data from the TROPION-Lung01 Phase III study, which focuses on the TROP-2-targeted antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The molecule did not achieve…
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Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
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European Commission Approves Merck’s Keytruda-Padcev Combo for First-Line Urothelial Carcinoma Treatment
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Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States, has announced that the European Commission (EC) has granted approval for the use of Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. This…
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GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
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SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its antibody drug conjugate (ADC), GQ1005, targeting HER2 in patients with non-surgical/metastatic breast cancer. Preclinical studies have shown that…
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China’s Evopoint Biosciences and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
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BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Evopoint Biosciences’ EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs). Evopoint Biosciences’ XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated…
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Doma Biopharmaceutical Receives FDA Clearance for Phase I Trial of EGFR-MET Targeting ADC, DM005
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a Chinese pharmaceutical firm, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for its innovative bispecific antibody-drug conjugate (ADC), DM005. This development marks a significant milestone for the company as it advances its pipeline towards…
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Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
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Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. This trial will focus on maintenance therapy for…
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Shanghai Fudan-Zhangjiang Enrolls First Patient in Phase III Trial for TROP2 ADC FDA018 in TNBC
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 1349) and the Shanghai Stock Exchange (SHA: 688505), has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate FDA018. This TROP2 antibody-drug conjugate (ADC) is…
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China’s CDE Approves Multitude Therapeutics’ AMT-676 for Clinical Study in Solid Tumors
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The Center for Drug Evaluation (CDE) of China has granted clinical study approval for Multitude Therapeutics Inc.’s proprietary injectable drug candidate, AMT-676, as indicated on the CDE website. The drug is intended for the treatment of solid tumors. AMT-676 is an antibody-drug conjugate (ADC) that targets CDH17, a gene situated…
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Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced…
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Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing…
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Jiangsu Hansoh and GSK Receive FDA Breakthrough Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
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Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK counterpart GSK plc (NYSE: GSK) have jointly announced that they have received the prestigious Breakthrough Therapy Designation (BTD) from the US FDA for their candidate HS-20093, also known as GSK5764227. This B7-H3-targeted antibody-drug conjugate (ADC)…
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Jiangsu Hansoh Pharmaceutical and GSK Win FDA Breakthrough Therapy Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
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LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE: GSK), has been awarded the Breakthrough Therapy Designation (BTD) by the US FDA for their jointly developed antibody-drug conjugate (ADC) HS-20093, also known as GSK5764227. The therapy is intended for the treatment of patients with…
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Genmab CEO Signals Potential for China Partnership as BioNTech Exits acasunlimab Collaboration
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COPENHAGEN—In a strategic pivot following BioNTech (NASDAQ: BNTX)’s withdrawal from their co-development partnership on the PD-L1 x 4-1BB bispecific antibody acasunlimab, Denmark-based Genmab A/S (NASDAQ: GMAB) is reportedly seeking a commercial partner for its entry into the China market. This update was provided by CEO Jan Van de Winkel during…
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Sichuan Kelun Pharmaceutical’s H1 2024 Report Highlights MSD Collaboration Milestones
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CHENGDU—Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has released its financial report for the first half of 2024, detailing significant updates on its collaboration with US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK). The partnership, focused on the co-development of antibody drug conjugates (ADCs), has seen substantial progress…
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Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
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TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
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BioNTech’s BNT326/YL202 Clears FDA Hurdle, Advancing in Clinical Trials for Solid Tumor Treatment
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FRANKFURT—BioNTech SE (NASDAQ: BNTX), a leading German biotechnology company, has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase I clinical trial for BNT326/YL202, an anti-HER3 targeted antibody drug conjugate (ADC). This development paves the way for the resumption of trials…
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Multitude Therapeutics and Adcendo ApS Partner on Anti-TF ADC, Targeting Global Cancer Treatment
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SHANGHAI/COPENHAGEN—In a strategic move to bolster cancer treatment options, Shanghai-based medical technology company Multitude Therapeutics Inc. has entered into a licensing agreement with Denmark’s Adcendo ApS, a specialist in antibody drug conjugates (ADCs). The deal grants Adcendo exclusive global rights to develop and commercialize an anti-human tissue factor (TF) ADC,…
