Zhongsheng’s RAY1225 Wins NMPA Approval for Obesity‑Sleep Apnea Study as Phase III Wraps Up
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced that China’s National Medical Products Administration (NMPA)...
Drug
Changchun High‑Tech’s GenSci145 PI3Kα Inhibitor Cleared by NMPA for Solid Tumor Study
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that China’s National Medical Products...
Eisai/Biogen’s LEQEMBI Autoinjector Wins FDA Priority Review for Weekly Alzheimer’s Dosing
Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) announced that the U.S. Food and Drug...
Daiichi Sankyo Secures Breakthrough Therapy Designation for CDH6‑Targeted ADC Raludotatug Deruxtecan in Ovarian Cancer
Daiichi Sankyo (TYO: 4568) announced that Raludotatug Deruxtecan (R‑DXd, DS‑6000a), a first‑in‑class CDH6‑targeted antibody‑drug conjugate (ADC),...
Hengrui Pharma’s SHR‑7877 Gets NMPA Nod for Small Cell Lung Cancer Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that SHR‑7877 has received National Medical Products...
AbbVie Secures Second China Approval for Risankizumab in Ulcerative Colitis
AbbVie Inc. (NYSE: ABBV) announced that China’s National Medical Products Administration (NMPA) has approved Risankizumab (SKYRIZI)...
Enhertu Wins China NMPA Approval for Second‑Line HER2‑Positive Gastric Cancer
AstraZeneca plc (AZ, NASDAQ: AZN) and Daiichi Sankyo Company, Limited (TYO: 4568) announced that Enhertu (trastuzumab deruxtecan)...
AstraZeneca’s Imfinzi Wins China Approval for Endometrial Cancer, Securing Seventh Indication
AstraZeneca (AZ, NASDAQ: AZN) announced that Imfinzi (durvalumab) has been officially approved in China for use...
Lilly’s Sofetabart Wins FDA Breakthrough Status for Platinum‑Resistant Ovarian Cancer
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has...
Henlius’s HLX701 Gets NMPA Nod for Phase Ib/II Advanced CRC Combination Study
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Alteogen Licenses ALT‑B4 Hyaluronidase to Tesaro for $285M Subcutaneous Dostarlimab Deal
Alteogen Inc. (KOSDAQ: 196170) announced an exclusive license agreement with Tesaro, a GSK subsidiary, granting worldwide...
Shanghai Pharma’s iNKT Cell Therapy B023 Gets NMPA Nod for Advanced Solid Tumors
Shanghai Pharmaceuticals Holding Co., Ltd (SPH, HKG: 2607, SHA: 601607) announced that its B023 cell...
Biokin’s Iza-bren ADC Receives NMPA Filing Acceptance for ESCC, World’s First EGFR×HER3 Bispecific
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that China’s National Medical Products Administration (NMPA)...
Kawin Technology Withdraws Hepatitis B Filing for Peginterferon Alfacon‑2 After NMPA Feedback
Kawin Technology (SHA: 688687) announced it has voluntarily withdrawn its market filing for peginterferon alfacon‑2...
Merson’s Bemejing Wins First CNMR “Overseas Version” Drug Price Certificate
Beijing Merson Pharmaceutical Co., Ltd. announced that its Bemejing (timolol maleate gel) has obtained China’s...
Ocumension’s OT-703 DME Implant Enrolls 195 Patients in China Real-World Study
Ocumension Therapeutics (HKG: 1477) announced completion of enrollment for a real‑world study of OT-703 (fluocinonide...
AIM Vaccine’s PCV20 Gets NMPA Clinical Approval, Challenging Pfizer’s Monopoly
AIM Vaccine Co., Ltd (HKG: 6660) announced that China’s National Medical Products Administration (NMPA) has...
Grand Pharmaceutical Files TLX591-CDx PSMA Diagnostic for Prostate Cancer in China
Grand Pharmaceutical Group Limited (HKG: 0512) announced it has filed TLX591-CDx (Illuccix, gallium Ga 68...
D3 Bio’s KRAS Programs Advance: FDA Clears Phase I G12D Inhibitor D3S‑003 and Phase II G12C‑ERK Combo
D3 Bio announced FDA clearance for two clinical programs: a Phase I first‑in‑human study for D3S‑003,...
Aidea’s ADC205 HIV Combo Gets NMPA Nod for Clinical Trials, Targeting $2.8B Market
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced that China’s National Medical Products Administration (NMPA)...