AstraZeneca Launches Tezspire in China, Bringing First‑In‑Class TSLP Inhibitor Tezepelumab to Severe Asthma and CRSwNP Patients
AstraZeneca plc (NYSE: AZN) announced the official market launch in China of Tezspire (generic name:...
Drug
Guangdong Regulator Issues Recall, Traceability and Emergency Response Rules for Imported Hong Kong–Macao Pharmaceuticals and Medical Devices in GBA
The Guangdong Medical Products Administration issued three landmark policy documents governing imported Hong Kong and...
Fosun Pharma Launches Phase 2 Trial of FXS7553 DPP‑1 Inhibitor for COPD in China
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that FXS7553 has initiated a...
Asieris Pharmaceuticals Wins FDA Clearance for APL‑2501, an Anti‑CLDN6/9 ADC in Advanced Solid Tumors
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that its independently developed APL‑2501 has received...
Hengrui Pharmaceuticals Wins NMPA Clearance for Phase II Trial of HRS‑4729, a Triple‑Agonist Peptide Drug for Type 2 Diabetes
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its drug HRS‑4729 has...
CanSino Biologics Files NDA in China for Td5cp, a First-In-Nation Adolescent and Adult DTaP Booster Vaccine
CanSino Biologics (HKG: 6185) announced that it has submitted a New Drug Application (NDA) in...
Easton Pharmaceutical Doses First Patient in Phase I/II Trial of HP‑002, a Brain‑Penetrant BTK PROTAC for B‑Cell Non‑Hodgkin Lymphoma
Easton Pharmaceutical Co., Ltd. (SHA: 688513) announced that Phase I/II clinical trials are underway for...
Shanghai Ark Biopharmaceutical Wins FDA Clearance for Ziresovir Phase II Trials in Severe Pediatric RSV
Shanghai Ark Biopharmaceutical Co., Ltd. announced that the US Food and Drug Administration (FDA) has...
Chongqing Pharscin Wins China Clinical Trial Approval for ORIC‑1327 in Glaucoma and Ocular Hypertension
Chongqing Pharscin Pharmaceutical Co., Ltd. (SHE: 002907) announced that its drug candidate ORIC‑1327 has received...
Yiling Pharmaceutical Files IND in China for LB220-D08, a First-In-Class Factor B Inhibitor for aHUS
Yiling Pharmaceutical (SHE: 002603) announced that it has submitted an Investigational New Drug (IND) application...
Pfizer and Valneva See EMA Validate MAA for PF‑07307405, the First‑Potential Blockbuster Lyme Disease Vaccine
Pfizer Inc. (NYSE: PFE) and Valneva SE (NASDAQ: VALN) announced that the European Medicines Agency...
Bristol-Myers Squibb Secures FDA Approval for Iberdomide Combination in Multiple Myeloma – First‑Ever Nod Based on MRD‑Negative Response Data
Bristol-Myers Squibb (BMS) (NYSE: BMY) announced that the US Food and Drug Administration (FDA) has...
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...
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)...