Alebund’s AP301 NDA Accepted by NMPA for Hyperphosphatemia in CKD Dialysis Patients
Alebund Pharmaceuticals (Jiangsu) Limited (HKG: 9637) announced that the New Drug Application (NDA) for its core...
Drug
Sino Biopharma’s benmelstobart-anlotinib Combo Wins NMPA Nod for First-Line sq-NSCLC
Sino Biopharmaceutical Limited (HKG: 1177) announced that benmelstobart in combination with chemotherapy, sequentially followed by anlotinib,...
Daiichi Sankyo Enlists Innovent Biologics as Exclusive China Partner for Vanflyta FLT3 Inhibitor in AML
Daiichi Sankyo Co., Ltd. (TYO: 4568) and Innovent Biologics, Inc. (HKG: 1801) announced an exclusive entrusted promotion...
CARsgen Therapeutics Secures NMPA Clinical Trial Approval for Allogeneic CAR-T Therapy CT1190B in Relapsed/Refractory Large B-Cell Lymphoma
CARsgen Therapeutics (HKG: 2171) announced that its allogeneic CAR-T cell therapy CT1190B has received clinical...
Takeda Expands Revestive Approval in China with New 1.25 mg Specification for Pediatric Short Bowel Syndrome Patients as Young as 4 Months
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that China’s National Medical Products Administration...
Hengrui Pharmaceuticals Secures Fifth NMPA Approval for Ivarmacitinib in Non-Radiographic Axial Spondyloarthritis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its self-developed Class 1...
Westlake Consortium Secures NMPA Approval for Iscartrelvir, Novel Oral 3CLpro Inhibitor for Mild-to-Moderate COVID-19
The Category 1 innovative drug Iscartrelvir, jointly developed by Westlake University, Westlake Laboratory, and Westlake...
Hengrui Pharmaceuticals Secures Third NMPA Approval for Trastuzumab Rezetecan in HER2-Positive Colorectal Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its HER2-targeting antibody-drug conjugate...
TransThera Sciences Secures NMPA Conditional Approval for Tinengotinib in Advanced Cholangiocarcinoma with FGFR2 Alterations
TransThera Sciences (HKG: 2617) announced that China’s National Medical Products Administration (NMPA) has granted conditional...
Takeda Receives FDA Approval for ORZEYFUL (oveporexton), First Oral OX2R Agonist for Narcolepsy Type 1 in Adults
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug...
Shandong Boan Biotech Submits BLA to Brazil’s ANVISA for Aflibercept Biosimilar BA9101, Expanding Global Ophthalmic Footprint
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of a Biologics License Application...
Eli Lilly’s KRAS G12C Inhibitor Olomorasib Receives Second FDA Breakthrough Therapy Designation for Advanced Pancreatic Cancer
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA)...
CSPC Pharmaceutical’s NDA for Anbenitamab-HB1801 Combination Accepted by China NMPA as Neoadjuvant Therapy for HER2+ Breast Cancer
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the New Drug Application (NDA) for its...
Leads Biolabs’ Trispecific T-Cell Engager LBL-051 Enters Phase Ia Trial for Refractory Autoimmune Diseases Through Oblenio Bio Partnership
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that Oblenio Bio, a NewCo jointly established...
Allergan Aesthetics’ BOTOX Cosmetic sBLA Accepted by FDA for Masseter Muscle Prominence, Poised to Become First Neurotoxin Indication
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), announced that the U.S. Food and Drug...
Sino Biopharmaceutical’s BCL-2 Inhibitor TQB3909 Tablet Receives CDE Acceptance for CLL/SLL Treatment in Relapsed/Refractory Patients
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary Chia Tai Tianqing Pharmaceutical (CTTQ)‘s New...
Haixi Pharma’s Oral nAMD Drug Candidate HX9428 Receives FDA Clearance for Phase 2 Trials, Offering Alternative to Intravitreal Injections
Fujian Haixi Pharmaceuticals Co., Ltd. (HKG: 2637) announced that the Investigational New Drug (IND) application...
Sanofi Secures European Commission Approval for MenQuadfi Pediatric Indication Extension to Infants from Six Weeks of Age
Sanofi (NASDAQ: SNY) announced that the European Commission (EC) has approved an extension of the...
Alphamab Oncology’s Anbenitamab NDA Accepted by China NMPA for HER2+ Breast Cancer Neoadjuvant Treatment, Granted Priority Review
Alphamab Oncology (HKG: 9966) announced that the New Drug Application (NDA) for Anbenitamab (trade name:...