HIGHTIDE-B(02511): HTD1801 randomized controlled clinical trial received positive evaluation.

HIGHTIDE-B (02511) announced recently that after the Phase III clinical trial results of its core product HTD1801 in combination with metformin for treating type 2 diabetes (SYMPHONY-2) was published in the international renowned medical journal "New England Journal of Medicine" (NEJM) Clinical Evidence Sub-Journal, a further editorial titled "Berberine-Ursodeoxycholate Bringing Traditional Chinese Medicine to Our World" was published in "NEJM Evidence". The editorial positively evaluated the rigorous design and continuous accumulation of clinical evidence of the randomized controlled clinical trial of HTD1801, and pointed out that the research of HTD1801 provides a reference for promoting innovative drugs based on traditional Chinese medicine wisdom to the world through high-quality clinical research. The publication of the research results and editorial further demonstrates that the clinical achievements of HTD1801 have received widespread attention and recognition from the international academic community. Currently, the company is actively advancing the listing and commercialization of HTD1801, and is in discussions with several potential partners regarding potential authorization and commercial cooperation for the first indication market of HTD1801 in China. Under the potential cooperation, the company may receive potential upfront payments, potential development milestone payments, potential sales milestone payments, and sales royalties. The company will release further announcements in a timely manner as progress is made. HTD1801 is a globally pioneering new molecular entity aimed at addressing unmet clinical needs in the cardio-kidney-metabolic system (CKM) diseases. As a single molecule, HTD1801 is an oral anti-inflammatory and metabolism regulator (AIMM) with a unique dual mechanism, exerting its biological activity by activating AMPK and inhibiting NLRP3 inflammasome; this complementary synergistic dual mechanism can effectively address metabolic issues. Global clinical results validate that HTD1801 can bring comprehensive benefits to patients, including improving insulin sensitivity, blood glucose control, lowering blood lipids, kidney protection, weight loss, liver benefits, and anti-inflammatory effects. Based on this, HTD1801 has the potential to become a foundational therapeutic drug in the CKM field.