HELP Therapeutics Secures NMPA Approval for HiCM388, China’s First Cell‑Based Therapy for STEMI
HELP Therapeutics Corp., a pioneer in cell‑based therapeutics, announced that the National Medical Products Administration...
Cell-therapy
BMS Acquires Orbital for $1.5 B in RNA‑Based Immunotherapy Deal
Bristol-Myers Squibb (BMS, NYSE: BMY) announced today that it will acquire Orbital Therapeutics (“Orbital”), a...
Takeda Shuts Down Cell‑Therapy Program, Eyes External Collaboration for γδ T‑Cell Platform
Takeda Pharmaceutical Co., Ltd. (TYO: 4502, NYSE: TAK) announced today that it is discontinuing all...
Simnova Secures FDA IND for CAR‑NK Therapy in SLE
Shanghai Simnova Biotech Co., Ltd. (Simnova) announced that its CD19‑targeted chimeric antigen receptor gene‑modified natural...
Beijing Unicet’s QH104A Receives Chinese NMPA Approval for CNS Solid‑Tumor Clinical Trials
Beijing Unicet Biotechnology Co., Ltd. announced that its pioneering QH104A—the world’s first B7H3‑targeted, off‑the‑shelf allogeneic...
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...
Lion TCR Secures FDA Approval for LioCyx‑M004, Launching Phase Ib/II Trial in Chronic Hepatitis B
In a landmark announcement, Lion TCR disclosed that the U.S. Food and Drug Administration (FDA)...
FibroX Therapeutics Secures IND Approval for FibroCell in Lumbar Disc Degeneration
Shanghai‑based FibroX Therapeutics announced that its investigational new drug (IND) application for FibroCell, an allogeneic...
IASO Biotherapeutics & Cellbri Sign Global Cell‑Therapy Alliance
China‑based IASO Biotherapeutics and Shenzhen Cellbri Bio‑Innovation Technology Co., Ltd. announced a global strategic cooperation...
Regenelead Secures NMPA Approval for RGL‑305 Cell Therapy in Advanced Malignant Tumors
On September 2, 2025, Shanghai‑based Regenelead announced that its internally developed cell‑therapy product RGL‑305 Injection received...
Gilead Terminates $2.3 B Collaboration With Kite Pharma Over Off‑the‑Shelf Cell Therapies
US-based Gilead Sciences’ (NASDAQ: GILD) subsidiary Kite Pharma has officially ended its $2.3 billion collaboration with Shoreline...
Bioheng Therapeutics Receives FDA RPDD for Off‑The‑Shelf CAR‑T CTD402
Bioheng Therapeutics (China) announced that the U.S. Food and Drug Administration (FDA) has granted Rare...
Suzhou HemaCell Receives NMPA IND Approval for First‑In‑Class Megakaryocyte Injection – Thrombocytopenia Treatment
Suzhou HemaCell Therapeutics, a platelet‑regeneration‑focused cell‑therapy developer, announced that the Center for Drug Evaluation (CDE)...
Chengdu Ucello’s UC101 CAR‑T Gains NMPA Approval
China‑based Chengdu Ucello Biotechnology Co., Ltd. announced that its Investigational New Drug (IND) application for...
Kite Pharma Acquires Interius BioTherapeutics for $350 Million to Boost CAR Therapy Platform
On August 22, 2025, Kite Pharma, Inc., a subsidiary of Gilead Sciences (NASDAQ: GILD), announced...
3D Medicines and CATUG Biotech Forge Strategic Alliance in mRNA-LNP Innovation
China-based 3D Medicines (HKG: 1244) has entered into a strategic cooperation framework agreement with CATUG Biotechnology....
Genentech to End $2B Collaboration With Adaptive Biotechnologies on T-Cell Therapies
Genentech, a member of the Roche Group (SWX: ROG, OTCMKTS: RHHBY), will terminate its strategic...
iRegene Therapeutics’ NouvNeu001 Receives FDA Fast Track Designation for Parkinson’s Therapy
China-based iRegene Therapeutics announced on August 15, 2025, that its self-developed injectable product, NouvNeu001, has...
Qihan Biotech’s QT-019B Gains FDA IND Approval for Autoimmune Diseases
Hangzhou Qihan Biotech Co., Ltd. announced that its self-developed universal dual-target CAR-T cell product, QT-019B,...
Hebei Senlang’s SENL103 CAR-T Therapy Approved for Refractory Generalized Myasthenia Gravis in China
Hebei Senlang Biotechnology Co., Ltd. announced that its SENL103 autologous T-cell infusion has received clinical...