Hua Medicine announced that the Company submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for the 2nd generation glucokinase allosteric activator (2nd Gen GKA) to initiate a Phase 1 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 the Company's strategy to expand its innovative approach of "repairing the sensor, restoring homeostasis, and treating the underlying caus of diabetes" beyond mainland 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 the Company's proprietary formulation platform for once daily oral administration.

The Company retains all global proprietary rights to its 2nd Gen GKA. The 2nd Gen Gka was designed as an extended release formulation 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 patients. The company believe that in combination with existing approved therapeutics, GKA candidates have the potential to achieve effective glycemic control over a continuous 24-hour period.

Specifically, the company believe GKA candidates offers the potential for huge synergies in combination with GLP-1 therapeutics especially in those patients with high fluctuations in glucose levels. Upon successful completion of the Phase I study, the Company intends to seek partners to develop the 2nd Gen GKA for the global markets.