Hua Medicine Announces Submission of Investigational New Drug Application with U.S. FDA

Hua Medicine
Dec 21, 2023

The application is the first step towards launching a Phase I clinical trial evaluating Hua Medicine’s 2nd generation glucokinase allosteric activator (GKA) for the treatment of Type 2 Diabetes.

December 21, 2023, Shanghai, China

Hua Medicine (HKEx:2552HK) announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for its 2nd generation glucokinase allosteric activator (2nd Gen GKA) to initiate a Phase I randomized, double-blinded, placebo-controlled, single-dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study in subjects with Type 2 diabetes mellitus (T2D) in the United States.

This IND filing is the first step in Hua Medicine's strategy to expand its innovative approach of "repairing the sensor, restoring homeostasis, and treating the underlying cause of diabetes" beyond China, where its first-generation GKA is approved and has been successfully commercialized for the treatment of Type 2 diabetes. The 2nd Gen GKA is a new molecular entity with improved physical-chemical properties and formulated using Hua Medicine's proprietary formulation platform for once daily oral administration. The 2nd Gen GKA tablet is designed to offer sustained release pharmacokinetic profile, benefits for improving patient compliance, and prolonged stimulation of GLP-1 secretion in intestines. Hua Medicine retains all global proprietary rights to its 2nd Gen GKA.

"Today's achievement is an important step towards fulfilling our mission to focus on the root cause of Type 2 diabetes by repairing patients' ability to maintain glucose homeostasis autonomously," said Dr. Li Chen, CEO and Founder of Hua Medicine.  "We have already demonstrated the scientific and medical proof-of-concept that focusing on glucokinase can advance T2D therapy in uniquely providing the potential for diabetes remission among patients treated with our only-in-class GKA dorzagliatin. In addition, our 2nd Gen GKA was designed as a novel drug to allow for once daily administration for added convenience for patients, as well as increasing the duration of the drug in the intestinal organs leading to the enhanced repair of deficient GLP-1 secretion in overweight diabetes patients and improved GLP-1 clinical efficacy.  Our GKA candidates have the potential to better combine with existing approved therapeutics to achieve effective glycemic control over a continuous 24-hour period.  Specifically, we believe our GKA candidates offers the potential for huge synergies in combination with GLP-1 therapeutics especially in those patients with high fluctuations in glucose levels."

The approval by China's National Medical Products Administration (NMPA) in September 2022 and the inclusion of dorzagliatin in the country’s National Reimbursement Drug List (NRDL) by the National Healthcare Security Administration (NHSA) in December 2023 provide regulatory and commercial validation of our approach to the treatment of Type 2 diabetes. These important milestones suggest that the glucose homeostasis approach to treat T2D patients will be made widely available through designated medical institutions and pharmacies in China at a government-reimbursed price accessible to more than 140 million T2D patients across the country.

Upon successful completion of the Phase I study, the Company intends to seek partners to develop the 2nd Gen GKA for the global markets.

About Hua Medicine
Hua Medicine is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine's cornerstone product HuaTangNing (华堂宁®) (dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30, 2022. It can be used alone or in combination with metformin on hydrochloride-tolerated T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with varying degrees of renal function impairment (including end-stage renal impairment without dialysis). Hua Medicine partnered with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing (华堂宁®) in China, benefiting diabetic patients and their families.

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