Shanghai, CHINA — September 11, 2025 — Beyang Therapeutics Co., Ltd., a clinical-stage AI-driven biotechnology company, today announced that China’s National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for BT01001, a first-in-class ophthalmic solution for the treatment of diabetic retinopathy (DR). This milestone follows the U.S. Food and Drug Administration (FDA) IND clearance for BT01001, received earlier this year. The successful IND clearances in both the U.S. and China mark significant progress in the global development strategy for BT01001 and underscore its potential as a promising therapeutic candidate.

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.

"The NMPA's approval of BT01001 IND application represents a critical breakthrough in Beyang's global R&D strategy and demonstrates the success of our research capabilities and regulatory strategy. " said Qiyue Hu, founder and CEO of Beyang Therapeutics. "Diabetic retinopathy has significant unmet clinical needs worldwide, and we will accelerate clinical development to bring breakthrough therapies to patients globally."

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.