BioRay Biopharmaceutical Co., Ltd.

SHANGHAI, Feb. 10, 2025 /PRNewswire/ -- On December 19, 2024, BioRay Pharmaceutical Co., Ltd. ("BioRay") announced that the National Medical Products Administration (NMPA) has accepted the clinical trial application for its self-developed Class 1 innovative therapeutic biological product, BR111 for injection. BR111 is an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, intended for the treatment of ROR1-positive hematological malignancies and solid tumors. ROR1 is a transmembrane receptor tyrosine kinase protein that is either not expressed or expressed at low levels in normal tissues, but is highly expressed in various hematological malignancies and solid tumors, such as lymphoma, breast cancer, ovarian cancer, and lung cancer. ROR1 is involved in the non-canonical Wnt signaling pathway mediated by Wnt5a, regulating the growth and invasion of tumor cells. It is closely associated with tumorigenesis and drug resistance, making it a potential target for oncology drug development. To date, no ROR1-targeting drugs have been marketed. BR111 utilizes BioRay's next-generation CysX™ irreversible site-specific conjugation technology platform to conjugate an antibody targeting dual epitopes of ROR1 with the small-molecule toxin eribulin. It is the world's first anti-ROR1 Bi-paratopic ADC to enter clinical trials. BR111 can recognize two non-overlapping epitopes of ROR1 on the surface of tumor cells, and dual-epitope recognition brings stronger affinity and endocytosis. Once endocytosed into ROR1-positive tumor cells, BR111 releases the small-molecule toxin in the lysosome, effectively killing tumor cells. Developed using the CysX™ platform, BR111 has higher homogeneity and circulating stability, significantly reducing toxin release in circulation, which enhances safety and optimizes the therapeutic window. In preclinical studies, BR111 demonstrated superior in vivo anti-tumor efficacy compared to its clinical counterparts in multiple animal models and exhibited better safety. Additionally, BR111 can induce a bystander effect and activate immune response in the tumor microenvironment, showing potential for combination therapy with various drugs, including targeted therapies and immunotherapies. The acceptance of this project application is a testament to BioRay's R&D capabilities and a validation of the CysX™ platform technology. Moving forward, BioRay will continue to focus on clinical needs, drive innovative research, and advance biopharmaceutical technology, with the goal of delivering more effective and safer treatment options to patients through innovative drugs. SOURCE BioRay Pharmaceutical Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI, Nov. 7, 2023 /PRNewswire/ -- BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as BioRay) announced that the first patient has been dosed in the Phase I Clinical trial of BRY812, a third-generation antibody-drug conjugate (ADC) targeting LIV-1 for the treatment of advanced malignant tumors. The leading institution of this clinical trial is Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and the principal investigators are academician Song Erwei and Professor Yao Herui. LIV-1, also known as SLC39A6 or ZIP6, is a multipass transmembrane protein belonging to the ZIP superfamily of zinc transporters, possesses zinc transporter and metalloproteinase activities. LIV-1 directly participates in the homeostasis metabolism of intracellular zinc ions, facilitating the transport of zinc ions from the extracellular space or intracellular organelles to the cytoplasm, influencing cell growth. To date, there are no approved drugs worldwide that target LIV-1, making BioRay's BRY812 the first LIV-1 ADC in China and the second to enter clinical trials globally. BRY812 uses the proprietary CysLink™ irreversible chemical conjugation technology platform and highly stable linker to conjugate the antibody with the toxin. BRY812 has shown significant tumor growth inhibition in preclinical studies, and demonstrated excellent anti-tumor activity that is potentially superior to similar drugs. Compared to other drugs of the same class, it exhibits higher circulation stability, effective release of the payload within the tumor while significantly reducing toxin shedding and exchange in serum. This provides BRY812 with a great safety profile and an improved therapeutic window. Furthermore, BRY812 can also induce immunogenic cell death (ICD) and enhance the anti-tumor effects of immunotherapies such as anti-PD-(L)1. Dr. Zhu Wei, CMO of BioRay, stated, " The significant market potential of ADCs requires differentiation in the market competition and expanding coverage to a broader patient population. As the first domestic ADC targeting LIV-1 to enter clinical trials, BRY812 is expected to treat various advanced malignant tumors, meet more clinical medication needs, and provide more treatment options for patients." About BioRay BioRay is a pioneer in China's biopharmaceutical industry focusing on immune-mediated diseases. Its extensive autoimmune and oncology portfolio includes six marketed products and over 10 clinical-stage drug candidates. Operating a fully integrated platform with end-to-end capabilities across drug discovery, clinical development, manufacturing, and commercialization, BioRay has over 1,500 employees globally, with main sites in Taizhou, Hangzhou, Shanghai, and San Diego. SOURCE BioRay Pharmaceutical Co., Ltd

SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") announced on October 7th that its clinical trial application for BR105 Injection has received approval from the United States Food and Drug Administration (FDA). This marks BioRay's first project to receive FDA IND approval. BR105 Injection is a humanized monoclonal antibody developed in-house, specifically targeting SIRPα. It can recognize common genotypes of SIRPα (V1, V2, V8) and disrupt the interaction between SIRPα and its ligand CD47, thereby abolishing the "don't eat me" signal between macrophage and tumor cell. This activation enables macrophages to perform their tumor-phagocytosing function, achieving anti-tumor immunotherapy. The efficacy of targeting CD47/SIRPα has been validated in various tumor models, and previous clinical studies suggest that targeting the CD47/SIRPα signaling pathway may have a broad spectrum of anti-tumor 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 to CD47, the expression of SIRPα is more specific. By targeting SIRPα instead of CD47, BR105 exhibits enhanced safety profile intrinsically. Additionally, CD47 interacts with other proteins, such as TSP-1, SIRPγ, leading to a more complex signaling network and increased risks in corresponding targeted therapies. Therefore, developing SIRPα antibodies to block the CD47/SIRPα signaling pathway is a more promising strategy in oncology drug development. Currently, no medicine targeting SIRPα has been approved in the global market. Phase I clinical trial of BR105 Injection is currently on-going in China, and preliminary result has confirmed its good clinical safety. "Based on our global strategic layout of innovative drugs, the FDA IND approval of BR105 Injection as our first FDA approved clinical trial project is a significant milestone for BioRay. Currently, fierce competition exists in the global innovative drug discovery and development arena, where innovation is indispensable. BioRay continues to invest heavily in innovation and build a rich pipeline of innovative biopharmaceuticals," said by Dr. Wei Zhu, Chief Medical Officer of BioRay. "We look forward to transforming these pipelines and BR105 into best-in-class therapies in autoimmunology and immuno-oncology, benefiting an increasing number of patients both in China and overseas." SOURCE BioRay Pharmaceutical Co., Ltd