Search Results

China Medical System Holdings Limited is pleased to announce that on 11 June 2024, the New Drug Application of the Group’s innovative drug methylthioninium chloride enteric-coated sustained-release tablets has been approved by the National Medical Products Administration of China.

On June 25, China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) announced the completion of dosing for the first subject in the phase III bridging trial of ruxolitinib cream (the “Product”) in atopic dermatitis (“AD”) in China.

Recently, Professor Jianping Weng of the University of Science and Technology of China and President of Anhui Medical University and his team of researchers from USTC, Southern Medical University and Peking University published the results of their latest research on the effects of early insulin therapy on cardiovascular health in adults with Type 2 Diabetes Mellitus in the journal Signal Transduction and Targeted Therapy.

China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 22 April 2024, the New Drug Application (NDA) of Desidustat Tablets (“Desidustat Tablets” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA).

Gyre Therapeutics today announced that the Center for Drug Evaluation (“CDE”) of China’s National Medical Products Administration (“NMPA”) has approved Gyre Pharmaceuticals’ (Gyre’s indirectly controlled subsidiary) Investigational New Drug (“IND”) application for F230 tablets.

Well-financed startup Tome is winding down operations just as two new companies, Borealis Biosciences and GondolaBio, are launching. Meanwhile, in the midst of already tense relations with China, House lawmakers raise the alarm about U.S. companies working with the country’s military on trials.

BioArctic AB’s partner Eisai announced today that Leqembi® has been launched in China. Leqembi received approval in January 2024 as a treatment of mild cognitive impairment due to Alzheimer’s disease and mild AD dementia.

The BIOSECURE Act’s prohibition on doing business with China-based companies may have implications for biotech and biopharma markets on both sides of the Pacific.

AriBio Co., Ltd. (AriBio) announces approval of the Investigational New Drug (IND) application by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the initiation of the Phase 3 Polaris-AD trial in China of AR1001 in early Alzheimer’s Disease (AD) on May 11th, 2024.

Innovent Biologics’ dual GLP-1/glucagon receptor agonist mazdutide is also being developed for chronic weight management. China’s regulator accepted Innovent’s drug application for this indication in February 2024.