CDE Introduces New Guidelines for Generic Drug Quality and Efficacy Consistency Evaluation
The Center for Drug Evaluation (CDE) has released a new set of Guidelines for “the...
Hepagene Therapeutics’ HPG7233 Receives US FDA IND Approval for NASH Treatment
Hong Kong-based biopharmaceutical company Hepagene Therapeutics Inc. has announced that the US Food and Drug...
Abbisko Therapeutics’ Irpagratinib Receives FDA Clearance for Phase I Study in HCC
Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received...
Sino Biopharmaceutical Submits IND Application for AT2R Antagonist TRD205 to FDA
Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biotech company, has announced the filing of...
Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses...
J&J and HHS Expand Public Health Initiative with Asha Therapeutics
Johnson & Johnson (J&J; NYSE: JNJ) and the US Department of Health and Human Services...
CDC Provisionally Recommends Pfizer’s Abrysvo for Maternal Immunization Against RSV
The US Centers for Disease Control and Prevention (CDC) has issued a provisional recommendation for...
Boehringer Ingelheim and Eli Lilly’s Jardiance Wins FDA Approval for CKD Prevention
Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have received regulatory approval from the US...
MSD’s Keytruda Meets Endpoints in Urothelial Carcinoma Trial but Misses in NSCLC Study
Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released...
Betta Pharmaceuticals’ CFT8919 Accepted for Review by China’s NMPA for EGFR L858R Solid Tumors
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a China-based pharmaceutical company, has announced that the National...
Simcere Pharmaceutical Reports 25.2% Revenue Growth in 2023 Interim Financials
China-based Simcere Pharmaceutical Group (HKG: 2096) has released its interim financial report for 2023, revealing...
3D Medicines’ H1 2023 Report Highlights 70.3% YOY Growth in Envafolimab Sales
China-based oncology specialist 3D Medicines (HKG: 1244) has released its financial report for the first...
Acotec Scientific Holdings Receives Japanese Marketing Approval for Peripheral Support Catheter Vericor
Acotec Scientific Holdings Ltd (HKG: 6669), a China-based medical device company, has announced that it...
Chime Biologics Partners with Panolos Bioscience to Speed Up Multi-Specific Protein Development
China-based Contract Development and Manufacturing Organization (CDMO) Chime Biologics Ltd has announced a strategic cooperation...
Hangzhou Qihan Biotechnology Secures Over $13.8 Million in Pre-Series B Financing
Hangzhou Qihan Biotechnology Co., Ltd, a leading xenotransplantation specialist based in China, has reportedly raised...
CNIPA Upholds Alynlam Pharmaceutical’s PCSK9 siRNA Patent Against Junshi Biosciences Challenge
The China National Intellectual Property Administration (CNIPA) has rejected a challenge filed by Junshi Biosciences...
Everest Medicines Partners with Kezar Life Sciences to Commercialize Zetomipzomib in Asia
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced a strategic collaboration and license...
I-Mab Regains Global Rights to CD47 Antibody Lemzoparlimab Following AbbVie Deal Termination
China-based biopharmaceutical company I-Mab (NASDAQ: IMAB) has received a notice from US-based AbbVie Global Enterprises...
Sanofi’s Dupixent Secures NMPA Approval for Pruritigo Nodosa Treatment in China
France-based pharmaceutical company Sanofi (NASDAQ: SNY) has announced that it has received another indication approval...
EU Chamber of Commerce in China Releases Position Paper, Addresses Pharma and Healthcare
The EU Chamber of Commerce in China has released its bi-annual “European Business in China...