Hua Medicine Announces the Drug Manufacturing Permit Granted for Dorzagliatin
SHANGHAI, CHINA, Oct 14, 2020 - (ACN Newswire) - Hua Medicine (the "Company", Stock Code: 2552.HK) announces that, after review and on-site verification under the Marketing Authorization Holder ("MAH") system, the Company has obtained the drug manufacturing permit for dorzagliatin, its investigational first-in-class drug, issued by the Shanghai Municipal Drug Administrative Bureau.Since the beginning of this year, Hua Medicine has successfully completed two critical milestones for marketing registration, SEED (HMM0301), the Phase III clinical trial of dorzagliatin monotherapy in drug naive patients with Type 2 diabetes (T2D) and DAWN (HMM0302), the metformin combination clinical trial in T2D patients inadequately glycemic controlled with metformin. The results of the studies showed that, during the relevant treatment period, dorzagliatin has demonstrated its long-lasting efficacy and favorable safety profiles, and can improve the pancreatic beta-cell functions, promote early-phase insulin secretion and reduce insulin resistance, which is expected to fundamentally treat diabetes. On August 17, Hua Medicine and Bayer announced the establishment of their strategic partnership and conc...
