Innovent Biologics Secures FDA Fast Track for IBI3003 Trispecific Antibody in Multiple Myeloma
Innovent Biologics, Inc. (HKG: 1801) announced that the U.S. Food and Drug Administration (FDA) has...
Drug
Aucta Pharma Files for Hong Kong IPO with CNS and Rare Disease Pipeline
Shanghai Aucta Pharmaceuticals Co., Ltd. made its initial public offering (IPO) filing to the Hong...
BioArctic Partner Eisai Submits EMA Application for Four-Week Lecanemab Dosing in Alzheimer’s
BioArctic AB (OTCMKTS: BRCTF) partner Eisai (TYO: 4523) announced submission of a proposed Marketing Authorisation Variation...
Nuance Pharma Secures NMPA Review for Ensifentrine COPD Maintenance Therapy
Nuance Pharma announced that its market filing for Ohtuvayre (ensifentrine) as maintenance treatment for patients...
Visen Pharma Secures NMPA Approval for Skytrofa in Pediatric Growth Hormone Deficiency
Visen Pharmaceuticals (HKG: 2561), a joint venture between Ascendis Pharma (Denmark) and Vivo Capital, announced...
Ascletis Doses First Patient in US Phase II Diabetes Study for Oral GLP‑1 ASC30
Ascletis Pharma Inc. (HKG: 1672) announced that the first patient has been dosed in a 13‑week...
Sanofi’s Amlitelimab Hits Phase III Goals in Atopic Dermatitis, Targets Q4W/Q12W Dosing Edge
Sanofi (NASDAQ: SNY) announced positive results from two global Phase III studies (SHORE and COAST 2) for amlitelimab,...
Huahui Health’s Libevitug Wins NMPA Approval as World’s First HDV Antibody Therapy
Huahui Health announced that China’s National Medical Products Administration (NMPA) has granted conditional approval for...
AstraZeneca’s Soliris Wins NMPA Approval for Pediatric Myasthenia Gravis
AstraZeneca plc (AZ, NASDAQ: AZN) announced that China’s National Medical Products Administration (NMPA) has approved Soliris...
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)...
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...