SciClone’s Tasurgratinib NDA Accepted by NMPA for FGFR2+ Biliary Tract Cancer
SciClone Pharmaceuticals Inc. (HKG: 6600) announced that the National Medical Products Administration (NMPA) has accepted for...
Drug
Hengrui Pharma’s Trastuzumab Rezetecan Filing Accepted for HER2+ Colorectal Cancer Indication
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA)...
Takeda’s Oveporexton Wins FDA Priority Review for Narcolepsy Type 1, Potential First Orexin Agonist
Takeda Pharmaceutical Company Limited (TYO: 4502, NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA)...
GSK’s RSV Vaccine Filing Accepted by NMPA for China Market Entry
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the Center for Drug Evaluation (CDE) of China’s NMPA...
Pfizer’s Cresemba Wins NMPA Pediatric Approval for Invasive Fungal Infections
Pfizer Inc. (NYSE: PFE) announced that the National Medical Products Administration (NMPA) has approved an indication...
Eli Lilly’s Omvoh Wins NMPA Approval for Crohn’s Disease and Ulcerative Colitis in China
The National Medical Products Administration (NMPA) has approved Eli Lilly and Company’s (NYSE: LLY) Omvoh (mirikizumab),...
Changchun High-Tech’s GenSci136 Wins NMPA Approval for IgA Nephropathy Clinical Trial
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun GeneScience...
Sanofi’s Wayrilz Wins FDA Breakthrough and Japan Orphan Designation for Rare Blood Disorder
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy...
Eisai Biogen’s LEQEMBI Subcutaneous Autoinjector Wins NMPA Priority Review in China
Eisai Co., Ltd. and Biogen Inc. (NASDAQ: BIIB) announced that the Biologics License Application (BLA) for...
Huadong Medicine and Shian Biotech Advance siRNA Obesity Therapy to Preclinical Stage
Huadong Medicine Co., Ltd (SHE: 000963) announced a key milestone in its strategic collaboration with...
Delonix Bioworks’ DX-104 Becomes First China-Approved Engineered OMV Vaccine, Targets $1.3 Billion MenB Market
Delonix Bioworks announced that DX-104, its Group B meningococcal (MenB) vaccine candidate, has received clinical...
Sino Biopharm Completes Phase III Enrollment for LM-302 ADC in Gastric Cancer
Sino Biopharmaceutical Ltd (HKG: 1177) announced completion of patient enrollment for the registrational Phase III...
Gilead’s Kite Pharma Secures FDA Label Expansion for Yescarta in Primary CNS Lymphoma
Kite Pharma, a Gilead Sciences (NASDAQ: GILD) subsidiary, announced that the U.S. Food and Drug...
Hengrui Pharma’s HRS-4642 Wins Breakthrough Therapy Designation for KRAS G12D Pancreatic Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS-4642, its KRAS G12D-targeting...
Pfizer’s Hympavzi Wins FDA Priority Review for Pediatric Hemophilia Expansion
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted...
Zhongsheng Pharma Reports Positive Phase III Data for Onradivir Pediatric and Adolescent Influenza Trials
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced positive top-line results from two Phase III...
InnoCare Pharma’s ICP-538 Becomes First VAV1 Molecular Glue Degrader to Enter China Clinical Trials
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that its self-developed VAV1-targeting molecular glue degrader,...
Betta Pharma Secures NMPA Approval for Beizeting, First Domestic Pertuzumab Biosimilar in China
Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced that the National Medical Products Administration (NMPA) has...
Kelun-Biotech’s Jiatailai Secures Fourth NMPA Approval for HR+/HER2- Breast Cancer Indication
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that the National Medical Products Administration (NMPA)...
Fosun Pharma’s Fumaining Wins Priority Review for NF1 Adult Indication in China
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that the National Medical Products...