Zhifei Biological Submits Clinical Trial Application in China for Nasal Spray Recombinant RSV Vaccine Based on Chimpanzee Adenovirus Vector
Zhifei Biological (SHE: 300122) announced that it has submitted a clinical trial application in China...
Drug
Keymed Biosciences’ Bispecific Antibody CM512 Achieves All Endpoints in Phase 2 Trial for Chronic Rhinosinusitis With Nasal Polyps
Keymed Biosciences Inc. (HKG: 2162) announced that the Phase 2 trial of CM512 injection, a...
CSPC Pharmaceutical Group’s Monkeypox mRNA Vaccine SYS6037 Receives FDA Approval to Conduct Clinical Trials in the US
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its Category 1 preventive biologic product SYS6037...
BeOne Medicines Announces Imdelltra (Tarlatamab), First-in-Class DLL3/CD3 T-Cell Engager Co-Developed With Amgen, Enters Clinical Use Across 17 Chinese Cities
BeOne Medicines Ltd. (NASDAQ: ONC; HKG: 6160; SHA: 688235) announced that Imdelltra (tarlatamab for injection)...
Astellas Submits NDA in Japan for Fezolinetant, a First-in-Class Nonhormonal NK3 Receptor Antagonist for Menopausal Vasomotor Symptoms
Astellas Pharma Inc. (TYO: 4503) announced that it has submitted a New Drug Application (NDA)...
Huadong Medicine’s Sinclair Secures EU MDR CE Certification for KIO015 Chitosan Skin Booster Kytogen Defend
Huadong Medicine (SHE: 000963) announced that KIO015 — a novel, patented carboxymethyl chitosan solution for...
GenFleet Therapeutics Initiates Phase 3 Trial of GFH375 for KRAS G12D‑Mutant NSCLC in China, First Patient Enrolled
GenFleet Therapeutics (HKG: 2595) announced that “Kylin‑Flight 01,” the registrational Phase 3 clinical trial of...
Salubris’s SAL0195 siRNA Drug Wins NMPA Nod for Lp(a) Clinical Trials
Salubris Pharmaceuticals (SHE: 002294) announced that its self‑developed innovative siRNA drug SAL0195 has been approved by...
Grand Pharma’s GPN01530-2 RDC Drug Snags FDA Fast Track for Solid Tumor Diagnosis
Grand Pharmaceutical Group Limited (HKG: 0512) announced that GPN01530-2, a global innovative radionuclide drug conjugate (RDC)...
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...
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...