Advenchen Lab’s AL8326 and Hengrui’s SHR-A1811 Receive Breakthrough Therapy Designations
The Center for Drug Evaluation (CDE) website indicates that Advenchen Lab’s AL8326 and Hengrui Pharmaceuticals’...
ADC / XDC
Biokin’s BL-B01D1 Receives NMPA Approval for Phase II Solid Tumor Study
China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that it has received approval...
Tot Biopharmaceutical Terminates Phase III Study for HER2-Targeted ADC TAA013
Tot Biopharmaceutical International Co., Ltd (HKG: 1875) has announced the termination of the Phase III...
RemeGen Gains NMPA Approval for Phase I/IIa Study of RC88 with Junshi Bio’s PD-1 Inhibitor
China-based pharmaceutical firm RemeGen (HKG: 9995) has received approval from the National Medical Products Administration...
Bio-Thera Solutions Initiates First Patient Dosing in Phase I Study of BAT8007
China-based Bio-Thera Solutions, Ltd. (SHA: 688177) has announced the first patient dosing in a multi-center,...
Antengene to Begin Phase I Clinical Study of ATG-022 for Advanced Solid Tumors
China-based Antengene Corporation Ltd (HKG: 6996) is poised to commence a Phase I clinical study...
Bio-Thera Solutions Initiates Phase I Study for Trop2-Targeting ADC BAT8008
China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced the first patient dosing in a multi-center,...
Astellas and Seagen File for NMPA Approval of Enfortumab Vedotin for Urothelial Carcinoma
Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced...
Bio-Thera Solutions Initiates Phase I Study for Trop2-Targeting ADC BAT8008
China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced the first patient dosing in a multi-center,...
Astellas and Seagen File for NMPA Approval of Enfortumab Vedotin for Urothelial Carcinoma
Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced...
Zhejiang Medicine’s ARX788 Shows Positive Results in Breast Cancer Study
China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has announced positive results from a Phase II/III...
Enhertu Approved in China for HER2-Positive Breast Cancer
Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and...
Kelun-Biotech Files for Hong Kong IPO with Goldman Sachs and CITIC Securities
China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its high-end preparation subsidiary,...
Lepu and Keymed License CLDN18.2 ADC CMG901 to AstraZeneca
China-based firms Lepu Biopharma Co., Ltd (HKG: 2157) and Keymed Biosciences Inc. (HKG: 2162) have...
Hengrui Pharmaceuticals Gains NMPA Approval for SHR-A1921 Clinical Study
Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving the go-ahead from the National Medical Products...
RemeGen Gains NMPA Approval for RC48 and Pyrotinib Clinical Study
China-based RemeGen Ltd (HKG: 9995) has announced receiving the go-ahead from the National Medical Products...
CSPC Pharmaceutical Licenses ADC SYS6002 to Corbus Pharmaceuticals
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced a licensing agreement with Massachusetts-based Corbus...
Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for Breakthrough Designation
China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its SHR-A1811, an HER2 targeted antibody-drug...
Mabwell’s Novel ADC 9MW2921 Accepted for NMPA Review
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that a clinical trial filing...
Antengene Launches Phase I CLINCH Study for ATG-022 in Australia
China-based Antengene Corporation Ltd (HKG: 6996) has received approval from Australia’s Therapeutic Goods Administration (TGA)...