Eisai and Biogen Secure Australian TGA Approval for Lecanemab in Early Alzheimer’s Disease
Eisai (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) announced today that the Australian Therapeutic Goods...
Drug
Fosun Kairos Secures NMPA Approval for Second CAR‑T Product, FKC889, Targeting Relapsed/Refractory B‑Cell ALL
Fosun Kairos, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196),...
Mabwell Bioscience Hits Phase II Milestone with First‑Patient Dose of 9MW3011, the Only Anti‑TMPRSS6 Monoclonal Antibody for Polycythemia Vera
Shanghai‑listed Mabwell Bioscience (SHA: 688062) announced today that its anti‑TMPRSS6 monoclonal antibody 9MW3011 (R&D code 9MW3011/DISC‑3405)...
FibroGen Launches Phase 2 Dose‑Optimization Trial for CD46‑Targeted ADC FG‑3246 in Metastatic Castration‑Resistant Prostate Cancer
FibroGen, Inc. (NASDAQ: FGEN) announced today the start of a randomized, open‑label Phase 2 monotherapy trial...
DualityBio Initiates Global Phase Ia/Ib Study of ADAM9‑Targeting ADC DB‑1317
Hong Kong‑listed Duality Biologics (DoalityBio, HKG: 9606) announced that the first patient has been dosed...
Hengrui Pharma & Glenmark Partner on Trastuzumab Rezecan ADC for HER2‑Positive Lung Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced an exclusive licensing agreement with Glenmark...
Jiangsu Hengrui Receives NMPA Acceptance for SHR7280 Oral GnRH Antagonist
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products...
RM Bio‑Tech Secures CDE Approval for HF001 Stem‑Cell Therapy in Type 2 Diabetes
Beijing RM Bio‑Tech Co., Ltd. announced that the Center for Drug Evaluation (CDE) under the...
Jiangsu Hengrui’s Adebrelimab New Indication Accepted by NMPA for Stage II‑IIIB NSCLC
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products...
Yantai Dongcheng Secures NMPA Approval for 225Ac‑LNC1011 Alpha‑Particle Radiopharmaceutical to Target Prostate Cancer
China‑based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that its investigational 225Ac‑LNC1011 injection...
Sino Biopharmaceutical Reports First‑Patient Enrollment for LM‑2417 Phase I Trial
China‑based Sino Biopharmaceutical (HKG: 1177) announced today that its internally‑developed Class 1 innovative drug LM‑2417 has...
Stealth BioTherapeutics Receives FDA Accelerated Approval for Forzinity in Barth Syndrome
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Stealth BioTherapeutics’ Forzinity (elamipretide)...
Genrix Bio Secures Exclusive Deal for Vecantoxatug and Silevimig with CMS
China‑based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) and China Medical System Holdings Ltd....
Roche’s SC Lunsumio Gains CHMP Recommendation for Relapsed Follicular Lymphoma
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products...
Roche’s giredestrant Yields Positive PFS Results in evERA Phase III Study
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that its Phase III evERA trial has met both co‑primary...
Eisai Secures FDA Fast Track for Etalanetug, a Tau Antibody Targeting MTBR
Eisai Co. Ltd. (TYO: 4523) announced today that its investigational tau‑protein antibody etalanetug (E2814) has...
Pfizer to Acquire Metsera for $4.9 B, Expanding Its Obesity & Cardiometabolic Pipeline
Pfizer Inc. (NYSE: PFE) announced today that it will acquire Metsera, Inc. (NASDAQ: MTSR), a...
Youcare Pharma Secures FDA Approval for YKYY013, a Novel siRNA Therapy for Chronic Hepatitis B
Youcare Pharmaceutical Group (SHA: 688658) announced that the U.S. Food and Drug Administration (FDA) has...
Huadong Medicine Secures FDA IND Approval for HDM2017 ADC
Huadong Medicine Co., Ltd. (SHE: 000963) announced today that the U.S. Food and Drug Administration...
Sichuan Kelun‑Biotech’s A400 Receives NDA Acceptance in China
Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the Center for Drug Evaluation...