January 23, 2019 - Shanghai
Hua Medicine (HKEX: 2552), a Shanghai-based drug development company focused on developing a global first-in-class oral drug for the treatment of Type 2 diabetes, announced today that the China National Intellectual Property Administration (CNIPA) has issued a patent on a controlled release formulation of dorzagliatin.
“Hua Medicine continues to expand its intellectual property portfolio,” said Dr. Li Chen, Chief Executive Officer of Hua Medicine. “Given dorzagliatin’s potential to serve as a cornerstone therapy for Type 2 Diabetes, this particular formulation patent creates significant value to the Company and its shareholders by extending the exclusivity of dorzagliatin from 2029 to 2037 in China. The issuance of this patent from CNIPA is consistent with the Chinese government’s strong support for innovation in China and represents one of the fastest approval yet.”
Our Phase III trial enrollment remains on schedule. As of December 31, 2018, we have enrolled 377 patients in our Phase III monotherapy trial (301) and 375 patients in our Phase III combination with metformin trial (302). This represents good progress since our last reported enrollment figures (September 14, 2018), of 246 patients for 301 and 220 patients for 302. The controlled release formulation of dorzagliatin are studied in these trials.
Dorzagliatin is a first-in-class glucokinase activator, or GKA, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in Type 2 diabetics. By addressing the defect of the glucose sensor function of glucokinase, or GK, dorzagliatin has the potential to repair the impaired glucose homeostasis state of Type 2 diabetics and serve as a first-line standard of care therapy for the treatment of Type 2 diabetes, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs.
About Hua Medicine
Hua is a leading, clinical stage innovative drug development company in China focused on novel therapies for the treatment of diabetes. Founded by an experienced group of entrepreneurs and international investment firms, Hua advanced a first-in-class oral drug for the treatment of Type 2 Diabetes into NDA enabling stage and started 2 Phase III trials in China. The Company has also initiated product life-cycle management studies of this novel diabetes drug, and advanced its use in personalized diabetes care. Hua's strategy is to leverage the cost-efficient and high-quality drug development capabilities available in China, while working very closely with disease experts and regulatory agencies in China and rest of the world to advance diabetes care solutions for global patients.
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