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...
Drug
Sichuan Huiyu’s HY05350 Achieves First Patient Dosing in Phase I Trial for MSLN-Positive Tumors
China-based Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) announced that its wholly-owned subsidiary, Huiyu Haiyue,...
Zhaoke Ophthalmology’s TONO-i Gains NMPA Approval for Glaucoma Management in China
China-based Zhaoke Ophthalmology Limited (HKG: 6622) announced that its innovative product, TONO-i, has received a...
Innovent Biologics’ IBI3032 Receives IND Approval From FDA and NMPA for GLP-1RA Clinical Trials
China-based Innovent Biologics (HKG: 1801) announced that its self-developed oral small molecule GLP-1 receptor agonist...
FDA Clears Elevidys Gene Therapy After Investigating 8-Year-Old Boy’s Death
The U.S. Food and Drug Administration (FDA) has completed its investigation into the death of...
Mabwell’s CDH17-Targeted ADC 7MW4911 Receives Clinical Trial Approval in China and IND Clearance in the US
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that its self-developed CDH17-targeted antibody-drug conjugate...
Cutia Therapeutics’ CU-40102 Approved in Hong Kong for Androgenetic Alopecia Treatment
China-based dermatology specialist Cutia Therapeutics (HKG: 2487) announced today that its CU-40102 (finasteride topical spray)...
UTC Therapeutics Gains FDA Clearance for CAR-T Therapy UCLM805 in MSLN-Positive Solid Tumors
China-based cell therapy biotech UTC Therapeutics announced receiving clearance from the US Food and Drug...
FDA Mandates Safety Labeling Changes for Opioid Pain Medications and Targets 7-OH Products
The U.S. Food and Drug Administration (FDA) is implementing new safety measures for opioid pain...
Luye Pharma’s LY03021 Completes Enrollment of First Healthy Subject in Phase I Trial
China-based Luye Pharma Group (HKG: 2186) announced on August 3, 2025, that its self-developed Class...
Lee’s Pharma’s Socazolimab Approved by NMPA for ES-SCLC First-Line Treatment
Lee’s Pharmaceutical Holdings Ltd. (HKG: 0950) announced that its in-licensed programmed-death ligand 1 (PD-L1) monoclonal...
BeOne Medicines’ BGB-16673 Granted PRIME Designation by EMA for Waldenström’s Macroglobulinemia
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced on July 31, 2025,...
Neurodawn’s Subsidiary Receives NMPA Approval for First LHI Treatment RK-4 Injection
China-based Neurodawn Pharmaceutical Co., Ltd.’s wholly-owned subsidiary, Fuzhou Ningdan Rongkang Biomedical Technology Co., Ltd. (Ningdan...
Haisco’s Ciprofol NDA Accepted by FDA: A Milestone for Chinese Anesthesia Innovation
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that the New Drug Application (NDA)...
AstraZeneca’s Ultomiris Gains NMPA Approval for Neuromyelitis Optica Spectrum Disorder
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced that China’s National Medical Products Administration (NMPA)...
Chipscreen’s Next-Gen Brain-Penetrant Aurora B Inhibitor CS231295 Gains FDA Clearance for Advanced Solid Tumors
On July 31, 2025, the investigational new drug (IND) application for Shenzhen Chipscreen Biosciences Co.,...
Hengrui Receives Clinical Clearance for HRS-5041 in Prostate Cancer Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received clinical clearance from...
Sanofi’s SAR446523 Gains FDA Orphan Drug Status for Relapsed or Refractory Multiple Myeloma
French pharmaceutical major Sanofi (NASDAQ: SNY) reported that the U.S. Food and Drug Administration (FDA)...
Zhaoke Ophthalmology’s Melphalan Granted FDA Orphan Drug Designation for Pediatric Retinoblastoma
China-based Zhaoke Ophthalmology Ltd (HKG: 6622), a leader in ophthalmic solutions, today announced that its...
HRAIN Biotech’s HICARA Approved by NMPA for Relapsed/Refractory LBCL
The National Medical Products Administration (NMPA) officially approved the New Drug Application (NDA) for lenecabtagene...