BeOne Medicines’ BGB-16673 Granted PRIME Designation by EMA for Waldenström’s Macroglobulinemia
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced on July 31, 2025,...
Drug
Neurodawn’s Subsidiary Receives NMPA Approval for First LHI Treatment RK-4 Injection
China-based Neurodawn Pharmaceutical Co., Ltd.’s wholly-owned subsidiary, Fuzhou Ningdan Rongkang Biomedical Technology Co., Ltd. (Ningdan...
Haisco’s Ciprofol NDA Accepted by FDA: A Milestone for Chinese Anesthesia Innovation
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that the New Drug Application (NDA)...
AstraZeneca’s Ultomiris Gains NMPA Approval for Neuromyelitis Optica Spectrum Disorder
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced that China’s National Medical Products Administration (NMPA)...
Chipscreen’s Next-Gen Brain-Penetrant Aurora B Inhibitor CS231295 Gains FDA Clearance for Advanced Solid Tumors
On July 31, 2025, the investigational new drug (IND) application for Shenzhen Chipscreen Biosciences Co.,...
Hengrui Receives Clinical Clearance for HRS-5041 in Prostate Cancer Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received clinical clearance from...
Sanofi’s SAR446523 Gains FDA Orphan Drug Status for Relapsed or Refractory Multiple Myeloma
French pharmaceutical major Sanofi (NASDAQ: SNY) reported that the U.S. Food and Drug Administration (FDA)...
Zhaoke Ophthalmology’s Melphalan Granted FDA Orphan Drug Designation for Pediatric Retinoblastoma
China-based Zhaoke Ophthalmology Ltd (HKG: 6622), a leader in ophthalmic solutions, today announced that its...
HRAIN Biotech’s HICARA Approved by NMPA for Relapsed/Refractory LBCL
The National Medical Products Administration (NMPA) officially approved the New Drug Application (NDA) for lenecabtagene...
Eli Lilly’s Jaypirca Achieves Primary Endpoint in Phase III BRUIN CLL-314 Trial
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) announced on July 29, 2025, that...
Shanghai Pharmaceuticals’ B019 Injection Approved for SLE Clinical Trials
Shanghai Pharmaceuticals Holding Co., Ltd’s (SPH, HKG: 2607, SHA: 601607) announced that it has received...
Bayer’s Sevabertinib Granted Priority Review by China’s NMPA for NSCLC Treatment
German pharmaceutical giant Bayer AG (ETR: BAYN) announced on July 28, 2025, that the marketing...
Huadong Medicine Receives NMPA Approval for Phase III Trial of Psoriasis Cream MC2-01
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received approval from the...
YolTech’s YOLT-203 Gains Orphan Drug Designation for Primary Hyperoxaluria Type 1 Treatment
China-based YolTech Therapeutics announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products...
Cedicine Biotech’s Umbilical Cord Blood Mononuclear Cell Injection Gains CDE Approval for Clinical Trial
China-based Cedicine Biotechnology announced today that the Center for Drug Evaluation (CDE) of the National...
Alphamab Oncology’s JSKN003 Granted FDA Orphan Drug Designation for Gastric and Gastroesophageal Junction Cancer
China-based Alphamab Oncology (HKG: 9966) announced today that its drug candidate JSKN003 has received Orphan...
Pierre Fabre’s Braftovi Approved in China for BRAF V600E-mutant Metastatic Colorectal Cancer
France-based Pierre Fabre Laboratories announced that Braftovi (encorafenib) in combination with cetuximab has been approved...
Henlius Biotech’s HLX14 Recommended for EU Approval by EMA’s CHMP
China-based Shanghai Henlius Biotech, Inc. (HKG: 2696) announced on July 28, 2025, that the European...
Eli Lilly’s Mounjaro Approved by China’s NMPA for Type 2 Diabetes Treatment with Insulin
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) announced that the National Medical Products Administration...
Antengene’s XPOVIO Approved for New Multiple Myeloma Indication by China’s NMPA
China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced that the China National Medical Products Administration...