Shanghai, China–February 21, 2025—Beyang Therapeutics, a clinical-stage biotechnology company dedicated to developing innovative treatments for retinal diseases, has announced today the submission of an Investigational New Drug (IND) application of BT01001, a novel ophthalmic solution for the treatment of diabetic retinopathy (DR), to the U.S. Food and Drug Administration (FDA).

“This IND submission marks a major milestone for Beyang Therapeutics as we advance BT01001 toward clinical development.”

 BT01001 is a first-in-class small molecule inhibitor targeting VEGFR and FGFR pathways, formulated as a topical ophthalmic solution. Designed to shift the treatment paradigm for DR, BT01001 offer a non-invasive alternative to traditional intravitreal injections, aiming to enhance patient compliance, reduce the risk of injection-related side effects, and provide a cost-effective alternative to current monoclonal antibody treatments. This submission marks an important milestone toward initiating a Phase I clinical trial for the treatment of diabetic retinopathy (DR), a leading cause of preventable blindness.

“This IND submission marks a major milestone for Beyang Therapeutics as we advance BT01001 toward clinical development,” said Qiyue Hu, Founder and CEO of Beyang Therapeutics. “We believe BT01001 has the potential to significantly improve treatment accessibility and outcomes for patients with diabetic retinopathy, a leading cause of vision loss worldwide.”

Pending FDA clearance of the IND application, Beyang Therapeutics plans to initiate a Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of BT01001 in healthy volunteers. The trial will include single and multiple ascending dose cohorts to determine the optimal dosing regimen for further clinical development.

About BT01001

BT01001 Ophthalmic Solution is a therapeutic product containing a small molecule inhibitor targeting both VEGFR and FGFR kinase families, developed for the treatment of diabetic retinopathy (DR). Designed to shift the treatment approach for DR from standard observation in NPDR to a proactive strategy using small molecule ophthalmic solutions. The goal is to slow the progression of DR and prevent vision-threatening complications, offering a potential breakthrough in the management of this blinding disease. Preclinical studies have demonstrated its potent efficacy in addressing DR phenotypes, including vascular leakage, neurophysiological dysfunction, inflammation, and neovascularization, with a favorable safety profile in toxicology studies.

About Beyang

Beyang Therapeutics is revolutionizing drug discovery by leveraging its proprietary AI-driven platform, ExCEED, to accelerate the identification of Best-in-Class drug candidates. This approach significantly expands the chemical space explored and optimize the potential drug molecules. The company’s experienced founding team is boasting on average over 20 years of experience at major pharmaceutical companies (Pfizer, Merck, AstraZeneca and Hengrui) with extensive experience in target selection, CADD/AIDD, biological screening and druggability optimization. Beyang has a proven track record, contributing to the development of over 20 clinical candidates, including five FDA/NMPA-approved drugs (Sunitinib, Crizotinib, Axitinib, Adebrelimab, Recaticimab). Focusing on ophthalmology and oncology, Beyang’s lead ophthalmic candidate, BT01001, has completed IND filing with US FDA and awaits clinical trial approval. The oncology program, BY002, is advancing through IND-enabling studies.

For more information about Beyang Therapeutics and its innovative pipeline, please visit https://www.beyangtx.com.

Media contact:

Eric Liu, PhD

Email: liuc@beyangtx.com

www.beyangtx.com