CDE Adds Two New Drugs to Rare Disease “Caring Program – Extension” Pilot – SZJ0107 and JAB-8263 Included
According to the latest announcement from the Center for Drug Evaluation (CDE) of the National...
Drug
Celgenyx Secures FDA IND Clearance for CG101 Off‑the‑Shelf iPSC‑Derived Cell Therapy in Acute Myeloid Leukemia – Multicenter Phase I Study to Begin
Celgenyx, Inc. announced today that CG101, its self‑developed off‑the‑shelf immune cell therapy product for the...
TJ Biopharma and Biogen Win NMPA Approval for Felzartamab (JINGFEI) in Multiple Myeloma – First Commercial Milestone Under Greater China Licensing Deal
TJ Biopharma and Biogen Inc. (NASDAQ: BIIB) announced today that felzartamab for injection (brand name:...
Ark Biopharmaceutical’s First-in-Class AFC AK0406 Wins NMPA Approval for Influenza Prevention Clinical Trials
Shanghai Ark Biopharmaceutical Co., Ltd. announced that its independently developed first-in-class long-acting antiviral drug-Fc conjugate...
Youcare Pharmaceutical’s YKYY033 siRNA Injection Wins US FDA Approval to Conduct Clinical Trials for Arterial and Venous Thrombosis
Youcare Pharmaceutical (SHA: 688658) announced that YKYY033 injection has received approval from the US Food...
AstraZeneca and Daiichi Sankyo’s Enhertu Wins China Approval for First-Line HER2-Positive Metastatic Breast Cancer in Combination With Pertuzumab
AstraZeneca plc (NYSE: AZN) and Daiichi Sankyo (TYO: 4568) announced that a new indication for...
Hengrui Pharma’s SHR-7590 Injection Wins NMPA Clinical Trial Approval for Ulcerative Colitis and Crohn’s Disease
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its SHR-7590 injection has...
IMPACT Therapeutics Nominates KAT6A-Specific PROTAC IMP2794 as Preclinical Candidate From Proprietary TPD Platform
IMPACT Therapeutics, Inc. (HKG: 7630) announced the nomination of IMP2794 as a preclinical candidate (PCC)...
Akeso’s Ivonescimab Wins NMPA Approval for First-Line Advanced Squamous Non-Small Cell Lung Cancer in Combination With Chemotherapy
Akeso Biopharma (HKG: 9926) announced that the National Medical Products Administration (NMPA) of China has...
Insilico Medicine Nominates ISM0900, AI‑Designed Oral Lp(a) Inhibitor, as 9th Preclinical Candidate of 2026
Insilico Medicine (HKG: 3696) announced the nomination of ISM0900 — a potent, highly selective, oral...
Wantai’s 9‑Valent HPV Vaccine Wins Thailand Approval – China’s First and World’s Second 9vHPV Vaccine Expands Into Southeast Asia
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. (SHA: 603392) announced that its self‑developed 9‑valent human...
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...
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)...