Biyang Pharma's BT01001 Ophthalmic Solution for Diabetic Retinopathy Receives IND Approval in Both China and the U.S.

(Source: Arterial New Medicine)

On September 10, Beyang Therapeutics Co., Ltd. announced that the National Medical Products Administration (NMPA) had officially approved the Investigational New Drug (IND) application for its self-developed BT01001 eye drops. Previously, the drug had received IND approval from the U.S. Food and Drug Administration (FDA). The successful dual IND approvals in China and the United States further confirm the global development value and international R&D standards of BT01001 in the field of diabetic retinopathy.

BT01001 is a small-molecule eye drop that selectively targets the VEGFR and FGFR dual pathways, aiming to provide a safe, effective, and convenient treatment option for patients with diabetic retinopathy.Compared with traditional intravitreal injection therapy, this eye drop significantly improves patient medication adherence and reduces potential risks associated with intravitreal injections through a non-invasive administration method. It also has the potential to enhance real-world treatment outcomes.

BT01001 Eye Drops Feature a Unique Design That Cleverly Achieves High Exposure in Posterior Ocular Tissues, Ensuring Therapeutic Efficacy While Reducing the Risk of Systemic Absorption, Providing Strong Assurance for Long-Term Safety of Use.

Hu Qiyue, founder and CEO of the company, stated, "The NMPA's approval of the BT01001 eye drop IND application marks a key breakthrough in Beyang Therapeutics' global R&D strategy, successfully reflecting the company's R&D capabilities and registration strategy. Diabetic retinopathy represents a significant unmet clinical need worldwide, and we will accelerate the advancement of clinical research to bring breakthrough therapies to patients globally."

According to the plan, Beyang Therapeutics will initiate Phase I clinical trials in China in the fourth quarter of 2025 and continue to advance its global development process.

About Beyang Therapeutics

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