Clinical Trial (IND) for BioRay Pharmaceutical's BR105 Injection Receives FDA Approval

BioRay Pharmaceutical Co., Ltd. (hereinafter "BioRay") announced on October 7 that its clinical trial application for BR105 injection received approval from the Food Administration and Drugs of the United States (FDA). This marks BioRay's first project to receive IND approval from the FDA.

BR105 injection is an in-house developed humanized monoclonal antibody, specifically targeting SIRPα. It can recognize common SIRPα genotypes (V1, V2, V8) and disrupt the interaction between SIRPα and its ligand CD47, thereby abolishing the “don't eat me” signal between macrophages and tumor cells. This activation allows macrophages to carry out their tumor phagocytic function, achieving antitumor immunotherapy.

The efficacy of targeting CD47/SIRPα has been validated in several tumor models, and previous clinical studies suggest that targeting the CD47/SIRPα signaling pathway may have a broad spectrum of antitumor activity. CD47/SIRPα-targeted therapy has shown positive results in acute myeloid leukemia, lymphoma, head and neck squamous cell carcinoma, gastric cancer, and other malignancies.

Compared with CD47, SIRPα expression is more specific. By targeting SIRPα instead of CD47, BR105 exhibits an intrinsically improved safety profile. Furthermore, CD47 interacts with other proteins, such as TSP-1, SIRPγ, leading to a more complex signaling network and higher risks in corresponding targeted therapies. Therefore, the development of SIRPα antibodies to block the CD47/SIRPα signaling pathway is a more promising strategy in oncology drug development. Currently, no drugs targeting SIRPα have been approved on the global market.

The phase I clinical trial of BR105 injection is currently being carried out in China , and the preliminary result has confirmed its good clinical safety.

"Based on our global strategic design of innovative medicines, the FDA IND approval of BR105 injection as our first FDA-approved clinical trial project is an important milestone for BioRay. Currently, there is fierce competition in the global field of Innovative drug discovery and development, where innovation is indispensable. BioRay continues to invest heavily in innovation and build a rich portfolio of innovative biopharmaceutical products," said Dr. Wei Zhu, Chief Medical Officer of BioRay. "We look forward to transforming these products and BR105 into best-in-class therapies in autoimmunology and immuno-oncology, benefiting an increasing number of patients both in China and abroad."

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