Shanghai Henlius Biotech Earns GMP Certification for Prolia/Xgeva Biosimilar HLX14 and Perjeta Biosimilar HLX11
China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that it has received Good Manufacturing Practice...
Biosimilars
Chengdu Kanghong Receives NMPA Approval for Clinical Trials of KH813 in Metastatic nsq-NSCLC
China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) announced that it has received clinical...
Huadong Medicine Files for NMPA Approval of Ranibizumab Biosimilar
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market approval filing for a...
Betta Pharmaceuticals Partners with BioRay for Herceptin Biosimilar Anruize
China-based Betta Pharmaceuticals (SHE: 300558) announced a strategic partnership with fellow domestic firm BioRay Biopharmaceutical....
Bio-Thera Solutions Terminates BAT3306 Trial Amid Biosimilar Policy Shifts
Guangzhou-based biotech Bio-Thera Solutions (SHA: 688177) announced the termination of a multi-center, randomized, double-blinded Phase...
Bio-Thera Solutions’ BAT2206 Biosimilar of Stelara Gains FDA Approval
Guangzhou-based Bio-Thera Solutions Ltd. (SHA: 688177) announced that it has received Biologic License Application (BLA)...
Shanghai Henlius Biotech Doses First Patient in Phase I/III Study of HLX13 for Hepatocellular Carcinoma
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the completion of first patient dosing in a...
Nanjing King-Friend Bio’s Biosimilar Victoza Approved by FDA
China-based Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (SHA: 603707) announced that its Abbreviated New Drug...
Organon Acquires U.S. Rights to TOFIDENCE from Biogen
Organon (NYSE: OGN) announced today that it has acquired regulatory and commercial rights in the...
Henlius and Organon’s HLX11 Biosimilar Clears EMA Validation Hurdle
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Medicines...
Huadong Medicine’s Semaglutide Injection Accepted for Review by China’s NMPA
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA)...
Bio-Thera Solutions Inks Licensing Deal with Dr. Reddy’s for Biosimilar Commercialization
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has entered into a licensing agreement with India-headquartered Dr. Reddy’s...
Tonghua Dongbao Initiates Phase III Trial for Insulin Degludec, Liraglutide Combo in Type 2 Diabetes
China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has initiated a Phase III clinical study for its...
Bio-Thera Solutions Inks Licensing Deal with World Medicine for BAT2206
China-based Bio-Thera Solutions (SHA: 688177) has entered into a licensing agreement with World Medicine, granting...
Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from...
Sandoz Launches Pyzchiva Biosimilar of J&J’s Stelara in US
Switzerland-based Sandoz (SWX: SDZ) announced the launch of Pyzchiva, a biosimilar version of Johnson &...
Huadong Medicine’s Biosimilar Tresiba Accepted by NMPA for Review
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar...
Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai,...
Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the...
Huadong Medicine’s Biosimilar SaiYueXin Seeks NMPA Approval for Crohn’s Disease
Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin,...