RemeGen’s Disitamab Vedotin (RC48) Clears for Phase I Study in HER2-Positive Tumors
RemeGen Ltd (HKG: 9995), a biopharmaceutical company, has announced that it has received approval from...
Drug
Junshi Biosciences’ JS401 Receives NMPA Approval for Hyperlipidemia Clinical Trial
Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biopharmaceutical company, has announced that it...
Ocumension Therapeutics’ Zerviate NDA Accepted for Review by China’s NMPA
Ocumension Therapeutics (HKG: 1477), a leading Chinese ophthalmology specialist, has announced that the National Medical...
Fosun Pharmaceutical’s FCN-159 Earns Breakthrough Therapy Designation for Histiocyte Tumors
The Center for Drug Evaluation (CDE) website has announced that Shanghai Fosun Pharmaceutical (Group) Co.,...
Aosaikang Pharmaceutical Receives NMPA Review for ASKC200 Liniment from Propella Therapeutics
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the National Medical Products Administration...
Convalife Pharmaceuticals’ Mefuparib Earns Orphan Drug Designation for Cholangiocarcinoma
Shanghai-based Convalife Pharmaceuticals has announced that it has received orphan drug designation (ODD) status from...
Overland ADCT BioPharma Achieves Primary Endpoint in Zynlonta Phase II Study for R/R DLBCL
Joint venture Overland ADCT BioPharma (CY) Ltd, a partnership between China’s Overland Pharmaceuticals and Swiss...
Novartis’ Jakavi Secures NMPA Approval for Acute GVHD Treatment in China
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received a new indication...
Chengdu Hyperway Pharmaceuticals’ HBW-004285 Gets NMPA Tacit Approval for Pain Treatment
China-based Chengdu Hyperway Pharmaceuticals has announced receiving tacit clinical trial approval from the National Medical...
Grand Pharmaceutical’s APP13007 Achieves Clinical Endpoints in US Trials for Post-Operative Treatment
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that a Phase II clinical study...
Sirnaomics Commences Phase I Clinical Trial for Factor Xl RNAi Drug STP122G
Sirnaomics Ltd (HKG: 2257) has announced the commencement of a single-center, randomized, double-blind, placebo-controlled, sequence...
Shanghai Fosun Pharmaceutical Submits Market Approval Filing for Daxibotulinumtoxin A in China
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced a market approval filing to...
Junshi Biosciences’ Senaparib Meets Primary Endpoint in Phase III Ovarian Cancer Study
China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has declared that the Phase III FLAMES study...
Luye Pharma’s Bevacizumab Biosimilar Accepted for Review in Brazil by ANVISA
China-based Luye Pharma Group (HKG: 2186) has announced that the market approval filing for its...
Priority Review Status Anticipated for HH-003, BI655130, VIS649, and Remternetug by CDE
The Center for Drug Evaluation (CDE) website has indicated that Huahui Health’s HH-003, Boehringer Ingelheim’s...
Bristol-Myers Squibb Launches Zeposia in China for Multiple Sclerosis Treatment
Global pharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced the market launch in China...
Zelgen Biopharmaceuticals’ ZG006 Earns FDA Approval for Small-Cell Lung Cancer Trial
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical trial approval from...
JW Therapeutics’ Carteyva Receives NMPA Approval for Moderate-to-Severe SLE Clinical Trial
China-based JW Therapeutics (HKG: 2126) has announced receiving tacit clinical trial approval from the National...
Takeda Pharma’s Iclusig Poised for Priority Review by CDE for Leukemia Treatments
The Center for Drug Evaluation (CDE) website has indicated that Takeda Pharma’s (TYO: 4502) Iclusig...
FDA Issues Complete Response Letters to Six Novel Drugs in Q1 2023
According to an analysis, the US FDA issued complete response letters (CRLs) to six novel...