Lepu Biopharma’s Pucotenlimab Receives Conditional NMPA Approval for MSI-H/dMMR Tumors
The National Medical Products Administration (NMPA) has granted conditional market approval to Lepu Biopharma Co.,...
Drug
Tris Pharma and Pediatrix’s Methylphenidate Tablet, Ipsen’s Triptorelin Injection Awarded Priority Review by CDE
The Center for Drug Evaluation (CDE) website shows that US-based Tris Pharma and Pediatrix Therapeutics’...
InnoCare’s Tafasitamab Receives First Prescription in China’s Bo’Ao Lecheng Pilot Zone
China-based InnoCare (HKG: 9969) announced that the first prescription for its pipeline candidate tafasitamab (trade...
Livzon’s V-01 and V-01D-351 Vaccines Show Strong Safety, Immunity as COVID Boosters
China-based Livzon Pharmaceutical Group (HKG: 1513) released clinical data for its recombinant novel coronavirus fusion...
CANbridge Pharmaceuticals Doses First Patient in CAN103 Gaucher Disease Trial
China-based rare disease firm CANbridge Pharmaceuticals announced the dosing of the first patient in a...
DAC Biotech’s DXC005 ADC Doses First Patient in Beijing Cancer Hospital Trial
China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing of its...
Kexing Pharmaceutical Launches Phase III Influenza Vaccine Study in Chile
China-based Kexing Pharmaceutical (SHA: 688136) announced the start of a Phase III clinical trial in...
Henlius Biotech’s HLX14 Biosimilar Wins TGA Approval for Global Phase III Osteoporosis Study
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) received approval from Australia’s Therapeutic Goods Administration (TGA)...
Luye Pharma’s Rotigotine Microspheres Meet Phase III Goals in Parkinson’s Study
China-based Luye Pharma Group (HKG: 2186) announced that its Phase III clinical study for rotigotine...
Eli Lilly’s Retevmo Wins Special Approval in China’s Lecheng Medical Pilot Zone
Eli Lilly & Co. (NYSE: LLY) has secured special approval for its RET kinase inhibitor...
Innovent Biologics’ Mazdutide Meets Phase II Goals in Type 2 Diabetes Study
China-based Innovent Biologics Inc. (HKG: 1801) announced that its Phase II study of mazdutide (IBI362/OXM3)...
Sihuan Pharma’s Fourth-Gen Insulin Degludec NDA Accepted by NMPA for Review
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that its New Drug Application (NDA)...
Sihuan Pharma’s Anaprazole Enters Phase II Study for Reflux Esophagitis
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that its subsidiary Xuanzhu Biopharmaceutical Co.,...
Sesen Bio Terminates Vicineum Development After FDA Talks, Citing Phase III Costs
Sesen Bio Inc. (NASDAQ: SESN) announced the termination of clinical development for Vicineum (VB4-845), its...
Roche’s Chugai Launches Edirol in China for Postmenopausal Osteoporosis
Swiss pharma giant Roche’s subsidiary Chugai Pharmaceutical Co Ltd has officially launched Edirol (eldecalcitol), an...
Humanwell Healthcare’s RFUS-144 Wins NMPA Approval for Pruritus Clinical Study
China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced that its Category 1 drug RFUS-144...
Hengrui Medicine Launches Revelutamide for Metastatic Prostate Cancer in China
Hengrui Medicine has launched revelutamide (SHR3680; trade name: Erion), China’s homegrown innovative androgen receptor (AR)...
HutchMed Initiates Phase I Study of CD47 Monoclonal Antibody HMPL-A83 in China
China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I clinical study...
Kexing Pharmaceutical’s SHEN26 COVID-19 Drug Receives NMPA Approval for Clinical Trials
China-based Kexing Pharmaceutical (SHA: 688136) announced that its oral small-molecule COVID-19 drug SHEN26, co-developed with...
ImmuneOnco’s IMM2902 Receives FDA Fast-Track Designation for CD47/HER2 Targeting
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that the U.S. Food and Drug Administration (FDA) has...