Beyang Therapeutics Announces Successful Completion of Phase I Trial for BT01001 Ophthalmic Solution-News and Events-News & Events-Beyang Therapeutics Co., Ltd.

Beyang Therapeutics Announces Successful Completion of Phase I Trial for BT01001 Ophthalmic Solution

2026-03-24

Beyang Therapeutics announces the successful completion of the Phase I clinical trial in healthy subjects for its independently developed BT01001 ophthalmic solution project. The trial was a randomized, double-blind, placebo-controlled, single and multiple ascending dose study designed to evaluate the safety, tolerability, and pharmacokinetics of BT01001 eye drops in healthy subjects.

BT01001 ophthalmic solution demonstrated an excellent safety and tolerability profile in the Phase I clinical trial. No dose-limiting toxicities (DLTs) were observed, and no serious adverse events (SAEs) occurred. All reported adverse events (AEs) were mild or asymptomatic, with no significant differences between the treatment and placebo groups. Pharmacokinetic (PK) analysis revealed minimal systemic exposure in the blood, with no accumulation observed in the systemic circulation following continuous multiple doses, fully aligning with the expectations of the molecular design.

BT01001 is a proprietary small-molecule ophthalmic solution formulated to achieve high posterior eye tissue exposure via the trans-scleral vascular pathway. As a potent dual-inhibitor of VEGFR and FGFR kinases, BT01001 aims to provide a non-invasive, effective treatment for DR, potentially improving patient compliance and reducing the risks associated with intravitreal injections.

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About Beyang

Beyang Therapeutics is an AI-driven innovative drug R&D company, aiming to become the "DreamWorks" in the field of innovative Drug Discovery. The company focuses on the development of drugs with clear mechanisms of action (MOA) and high potential for clinical translation, in the areas with unmet medical needs. Based on its proprietary ExCEED platform (molecular design, druggability assessment, and biological research), Beyang boasts industry-leading preclinical pipeline conversion rates. The core team comprises experienced scientists from leading pharmaceutical companies such as Pfizer, Merck, and Hengrui. They have participated in the R&D of three globally-launched small molecule drugs and successfully advanced over 10 projects into clinical trials. With strict target selection standards and an "AI + experience-driven" model, the company is actively deploying in high-potential fields, accelerating the development of effective drugs to address unmet patient needs while maximizing commercial value.

Contact：

Minghui Tong, PhD

Tel：+86-13265738517

Email：tongmh@beyangtx.com

Website：Beyang Therapeutics Co., Ltd.