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华领医药第二代GKA在美国启动一期临床试验并完成首例受试者入组

Hualing Pharmaceutical's second-generation GKA launches phase 1 clinical trial in the US and completes the enrollment of the first patient

Gelonghui Finance ·  Apr 26 13:01
Glonghui, April 26 | Hualing Pharmaceutical (2552.HK) announced that the first phase clinical trial of a second-generation glucokinase activator (second-generation GKA) has officially started in the US, and the first case was enrolled on April 25, local time in the US. The trial was a randomized, double-blind, placebo-controlled, single-dose escalation pharmacokinetics and pharmacodynamics study in 40 US patients with type 2 diabetes (T2D). The second-generation GKA is a new molecular entity with optimized physico-chemical properties. Using Hualing Pharmaceutical's proprietary formulation technology, it is designed for oral administration once a day. Second-generation GKA tablets are designed to prolong the action time of the drug in the body, improve patient compliance, and prolong the effect of stimulating GLP-1 secretion in the intestines; at the same time, second-generation GKA tablets have the potential to be used in combination with existing approved therapeutic drugs to effectively control blood sugar within 24 hours, especially for patients with high fluctuations in blood sugar levels. When used in combination with GLP-1 treatment, they are expected to have huge synergistic effects, bringing multiple benefits to patients. The first-generation GKA drug doglitidine, independently developed by Hualing Pharmaceutical, was approved for marketing by China's State Drug Administration in September 2022, and included in the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue” by the National Medical Security Administration in December 2023. Hualing Pharmaceutical reserves the global patent for second-generation GKA. After successful completion of the first phase clinical trial, the company plans to seek partners to promote the development of second-generation GKA in the global market.

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