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[News] Hua Medicine Initiated Phase I Clinical Trial of 2nd Gen GKA in the U.S. and Completed Enrollment of First Patient
April 26, 2024 - China, Shanghai
Hua Medicine (the "Company", HKEx: 2552.HK) announced that the Company has officially initiated its Phase I clinical trial of its 2nd generation glucokinase allosteric activator (2nd Gen GKA) in the United States, with the successful enrollment of the first patient. This milestone signifies a significant advancement in the Company's research and development of drugs for Type 2 diabetes, representing an important breakthrough in expanding the innovative concept of "repairing the sensor, restoring homeostasis" outside of the Chinese market.
Hua Medicine submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its 2nd Gen GKA in late December 2023, which was approved in January this year. The Company recently initiated the Phase Ib clinical trial and completed the enrollment of the first participant on April 25th in the United States. This is a randomized, double-blinded, placebo-controlled, single ascending dose, pharmacokinetic and pharmacodynamic Phase Ib study in 40 subjects with Type 2 diabetes mellitus (T2D) in the United States. 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, improved patient compliance, and the increase of GLP-1 secretion in intestines, thereby achieving better 24-hour blood glucose control. Moreover, the 2nd Gen GKA tablet offers the potential for combination therapy with existing approved therapeutics such as GLP-1, generating significant synergistic effects and providing multiple benefits for patients.
Dr. Li Chen, Founder and CEO of Hua Medicine, said, "After the submission of the IND application for the 2nd Gen GKA in the United States, the Company obtained approval and swiftly initiated the Phase I clinical trial, completing enrollment of the first participant in a short time period. This validates the Company's efficient execution capabilities. We look forward to obtaining crucial data on the drug's efficacy and safety from the Phase I clinical trial, which will provide a solid foundation for our global market expansion. In the future, the Company will continue to offer high-quality medical solutions for diabetes patients worldwide, relentlessly pursue innovation, expand overseas while deepening our presence in the Chinese market, and contribute to the global healthcare industry."
The 1st Gen GKA drug, dorzagliatin, developed independently by Hua Medicine, obtained approval from the China National Medical Products Administration (NMPA) for marketing in September 2022. In December 2023, it was included in the National Reimbursement Drug List (NRDL) by the National Healthcare Security Administration (NHSA), providing a more accessible and affordable treatment option for the vast number of diabetes patients in China. Hua Medicine retains all global proprietary rights to its 2nd Gen GKA. 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 (華堂寧?) (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 30th, 2022. It can be used alone or in combination with metformin hydrochloride-tolerated T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. HuaTangNing is an oral anti-diabetic 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 (華堂寧?) in China, benefiting diabetic patients and their families.
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