-
Abbisko Therapeutics Gets NMPA Approval for Phase I Study of ABSK112 in NSCLC
•
Shanghai-based biotechnology firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, ABSK112. This next-generation EGFR inhibitor, which targets the Exon20ins mutation, is set to be evaluated as…
-
Zhejiang Jianfeng Receives FDA Approval for JFAN-1001 Clinical Trial in NSCLC
•
Zhejiang Jianfeng Group Co., Ltd (SHA: 600668), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, JFAN-1001. The drug is indicated for the treatment of locally advanced or metastatic…
-
MicroPort CardioFlow Medtech Completes Clinical Implantations of Second-Generation TAVI Device
•
MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of China-based MicroPort Scientific Corp (HKG: 0853), has announced the successful completion of seven clinical implantations of its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty. The surgeries were performed in Denmark and Ireland, with all patients recovering well post-operation.…
-
CSPC Pharmaceutical Gains NMPA Approval for Clinical Study of Bispecific Antibody NBL-028
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its investigational bispecific antibody (BsAb) NBL-028. The drug targets CLDN6 and CD137, focusing initially on advanced tumors with CLDN6 expression, such as testicular…
-
Shanghai Henlius Initiates Global Phase III Study for HanSiZhuang in LS-SCLC
•
China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the milestone of the first patient dosing in the global multi-center Phase III clinical study for its anti-PD-1 monoclonal antibody (mAb) HanSiZhuang (serplulimab). The study is evaluating the drug in combination with chemotherapy and concurrent radiotherapy for patients with limited-stage small…
-
Fosun Pharma Gains NMPA Approval for Phase I Trial of XS-03 in Advanced Solid Tumors
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a leading healthcare conglomerate in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, XS-03. This study will focus on evaluating the drug’s efficacy in…
-
Cutia Therapeutics’ CU-20401 Completes Phase I Study for Obesity Treatment
•
China-based dermatology specialist Cutia Therapeutics (HKG: 2487) has announced the last subject out (LSO) in a Phase I study for its potential Category 1 drug, CU-20401. This recombinant mutant collagenase is being developed for the treatment of obesity and other metabolic diseases related to local fat accumulation, marking a significant…
-
China Grand Pharma Initiates Phase III Trial for GPN00833 in Cataract Surgery Recovery
•
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced a significant milestone in the clinical development of GPN00833, with the first patient enrolled and dosed in a Phase III study. This multi-center, randomized, double-blinded, placebo-controlled, parallel group study is designed to assess the efficacy and safety of…
-
Sihuan Pharmaceutical Gains NMPA Approval for Innovative Type 2 Diabetes Treatment
•
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its insulin degludec, liraglutide to treat type 2 diabetes. This marks a significant step forward in the development of novel treatments for diabetes in China.…
-
Yiling Pharmaceutical Gains NMPA Approval for XY0206 in AML Trial
•
China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, XY0206. The drug is intended for use in treating acute myeloid leukemia (AML) with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal…
-
Chengdu Kanghong Receives FDA Nod for Clinical Trial of Novel Depression Therapy KH607
•
China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced that it has received approval from the US FDA for a clinical trial of its novel depression therapy, KH607. This marks a significant milestone for the company as it advances its innovative treatment through the regulatory pipeline in the…
-
Blue Sail Medical Enrolls First Patient in Study for Rapamycin-Coated Balloon Catheter
•
China’s Blue Sail Medical Co., Ltd (SHE: 002382) has announced a significant milestone with the enrollment of the first patient in a prospective, multi-center, randomized controlled clinical study. The study is designed to assess the efficacy and safety of Blue Sail Medical’s rapamycin-coated balloon dilation catheter for arteriovenous fistula in…
-
Vcanbio Receives NMPA Approval for Clinical Study of VUM02 in SR-aGvHD Treatment
•
China-based biotechnology firm Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its VUM02, a Category 1 therapeutic biologic product. This human umbilical cord-derived mesenchymal stem cell therapy is intended…
-
Skyline Therapeutics Gains NMPA Approval for SKG0106 in Neovascular AMD Treatment
•
Skyline Therapeutics has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug SKG0106, an intraocular injection solution for the treatment of neovascular age-related macular degeneration (nAMD). Innovative Gene Therapy MechanismSKG0106 is a recombinant adeno-associated virus (rAAV) gene therapy drug, utilizing…
-
Boehringer Ingelheim’s Vitiligo Drug EI-001 Approved for Clinical Trials by NMPA
•
Germany’s Boehringer Ingelheim (BI) has announced that the National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) filing for EI-001, a Category 1 vitiligo drug co-developed by Elixiron Immunotherapeutics. This approval marks a significant milestone in the development of new treatment options for vitiligo, a condition that…
-
MicuRx Pharmaceuticals Initiates Phase I Study for MRX-5 in Australia
•
Sino-US firm MicuRx Pharmaceuticals Inc. has announced the approval to conduct a Phase I clinical study in Australia to evaluate the safety, tolerability, and pharmacokinetics of its in-house developed antibiotic, MRX-5. The study will also explore the effects of food on the drug’s pharmacokinetics and is expected to conclude in…
-
Simcere’s SIM0237 Receives NMPA Approval for Bladder Cancer Trial
•
China-based pharmaceutical innovator Simcere Pharmaceutical Group (HKG: 2096) has announced the receipt of an additional clinical trial approval from the National Medical Products Administration (NMPA) for its investigational bispecific antibody (BsAb), SIM0237. This molecule, targeting both PD-L1 and IL-15, is set to be evaluated as a novel treatment for non-muscular…
-
MicroPort CardioFlow Medtech’s Third-Generation TAVI Product Achieves Initial Clinical Success
•
MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off from China-based MicroPort Scientific Corp (HKG: 0853), has announced the successful completion of the first two clinical applications of its third-generation transcatheter aortic valve implantation (TAVI) product. This advanced medical device features a recyclable and controllable bend delivery system, which was…
-
Fosun Pharma Initiates Phase III Trial for ET-26 Anesthetic in China
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a leading healthcare conglomerate in China, has announced the commencement of a Phase III clinical study for its drug ET-26 (methoxyethyl etomidate). This marks a significant milestone in the development of new anesthetic solutions, with ET-26 being evaluated as an induction therapy…
