RemeGen Secures NMPA Approval for Phase I/IIa Trial of Bispecific ADC RC288 Targeting PSMA and B7H3 in Solid Tumors
RemeGen Ltd (HKG: 9995) announced it has received approval from China’s National Medical Products Administration...
Clinical trial approval / initiation
Fosun Pharma Secures NMPA Approval for Phase I Trial of HLX319, Biosimilar to Roche’s Phesgo for HER2-Positive Breast Cancer
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced it has received approval...
Sichuan Biokin Receives NMPA Approval for Phase II/III Trials of First-in-Class Bispecific ADC Iza-bren in Prostate and Ovarian Cancers
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced it has received approval from China’s National...
Fosun Pharma Secures NMPA Clearance for Two Novel Therapeutics: PD-1/IL-2 Fusion FXB0871 and Recombinant Hyaluronidase HLXTE-HAase02
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced it has received clearance...
Rui Therapeutics Secures NMPA Approval for KN5501 CAR-NK Therapy in Autoimmune Diseases
Rui Therapeutics, a China-based cell therapy developer, announced it has received approval from the National...
Fosun Pharma Secures NMPA Approval for Phase I Trial of ATTENUKINE™ Therapy FXB0871 in Solid Tumors
Fosun Pharma (SHA: 600196, HKG: 2196) has announced NMPA approval to initiate a Phase I...
Abbisko Therapeutics Secures FDA Clearance for ABSK061 Pediatric Achondroplasia Trial, Advancing Oral FGFR2/3 Inhibitor
Abbisko Therapeutics Co., Ltd. (HKG: 2256) has announced FDA clinical trial approval for its investigational...
ImmuneOnco Doses First Patient in Phase III Trial of World’s First CD47/CD20 Bispecific for Follicular Lymphoma
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) has announced the first patient dosing in a...
Kexing Biopharma Secures FDA Clearance for GB19 Clinical Trial in Lupus, Targeting Novel BDCA2 Pathway
Kexing Biopharma (SHA: 688136) announced it has received approval from the U.S. Food and Drug...
Clover Biopharmaceuticals Completes Enrollment in Phase II Trial of Trimer-Tag Respiratory Combination Vaccines for Older Adults
Clover Biopharmaceuticals Ltd. (HKG: 2197) announced the completion of subject enrollment in a Phase II...
Hengrui Pharma’s HRS9531 Wins NMPA Approval for Cardiovascular Outcomes Trial – Dual GIPR/GLP-1R Agonist Targets MACE Reduction
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) received National Medical Products Administration (NMPA)...
Chengdu Kanghong’s KHN922 Wins NMPA Approval – Dual-Payload HER3 ADC Targets Advanced Solid Tumors with Anti-Resistance Mechanism
Chengdu Kanghong Pharmaceutical Group Co., Ltd. (SHE: 002773) announced clinical trial approval from China’s National...
Huadong Medicine’s HDM2024 Wins NMPA Approval – EGFR/HER3 Bispecific ADC Targets Advanced Solid Tumors
Huadong Medicine Co., Ltd. (SHE: 000963) announced clinical trial approval from China’s National Medical Products...
Biocytogen’s NEOK002 Wins FDA Approval for Phase I – EGFR/MUC1 Bispecific ADC Targets Solid Tumors
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (SHA: 688796, HKG: 2315) announced that NEOK Bio, Inc., its...
Joincare Pharma’s JKN2404 Wins NMPA Approval for Asthma Trial – Next-Gen Inhaled Corticosteroid Targets Improved Safety Profile
Joincare Pharmaceutical Group Industry Co., Ltd. (SHA: 600380) announced that JKN2404 inhalation suspension, a Category...
Zhifei Bio Initiates Phase I Study for DTaP-Hib Quadrivalent Vaccine – Component Combination Targets Pediatric Immunization Compliance
Chongqing Zhifei Biological Co., Ltd. (SHE: 300122) announced the initiation of a Phase I clinical...
Gan & Lee’s Bonfaglutide Wins NMPA Approval for OSA Study – Biweekly GLP‑1 Expands to Sleep Apnea Indication
Gan & Lee Pharmaceuticals (SHA: 603087) announced NMPA clinical trial approval to initiate a study...
Haixi Pharma Advances HXP056 to Phase II – Oral Multi‑Selective Therapy for Wet AMD and Hemorrhagic Retinal Diseases
Fujian Haixi Pharmaceuticals Co., Ltd. (HKG: 2637) announced the initiation of a Phase II clinical...
IASO Bio Wins Japan PMDA Approval for Fucaso CAR‑T – BCMA Therapy Enters Phase III in Relapsed/Refractory Multiple Myeloma
IASO Biotherapeutics announced receiving tacit clinical approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)...
Hope Medicine Doses First Patient in HMI-115 Phase III – First-in-Class Non-Hormonal Endometriosis Therapy Advances in China
Hope Medicine Inc. announced first patient dosing in a Phase III clinical study evaluating HMI-115,...