On April 24, 2024, Bio-Raid (Wuhan Boruida Biotechnology Co., Ltd.) announced that its self-developed CAR-T cell therapy drug—"BRD-03" (hereinafter referred to as "BRD-03"), a CD99-targeted chimeric antigen receptor gene-modified autologous T-cell injection., successfully obtained the clinical trial implied permission from the National Medical Products Administration (NMPA).
Figure 1: BRD-03 IND Approval Information (Source: CDE Official Website)
BRD-03 is the world's first CAR-T cell therapy product targeting the CD99 antigen, developed by Bio-Raid using proprietary intellectual property. It is mainly used to treat recurrent/refractory CD99+ bone or soft tissue sarcomas in patients aged ≥18 years.
Bone and Soft Tissue Tumors: A group of tumors originating from connective tissues such as bone or soft tissue, which can occur in various parts of the body and organs. They are most commonly found in the limbs, retroperitoneal or abdominal cavity, trunk, and head and neck regions. The overall incidence of malignant bone tumors and soft tissue sarcomas is low, accounting for approximately 1% of adult malignant tumors and 15% of pediatric malignant tumors. Bone and soft tissue tumors exhibit a wide range of clinical characteristics. Benign or low-grade malignant tumors tend to be indolent, grow slowly, and primarily manifest as localized mass-forming growths. In contrast, high-grade malignant tumors show strong local invasiveness, with infiltrative or destructive growth patterns, and are prone to local recurrence and distant metastasis. Although there have been breakthroughs in research and treatment in recent years, once chemotherapy fails, the survival period of patients generally does not exceed one year. There is an urgent clinical demand, indicating significant potential commercial value.
Preclinical studies have shown that BRD-03 has significant tumor-suppressive effects and good tolerability in mouse models, including rhabdomyosarcoma tumor cell lines. The investigator-initiated clinical trials (IIT) previously conducted for BRD-03 have also demonstrated excellent safety and efficacy results.
BRD-03 Receives Clinical Trial Implied Permission, Marking a Significant Milestone for Bio-Raid in the Field of Solid Tumor Immunotherapy and Undoubtedly Bringing New Opportunities and Treatment Options for Patients with CD99+ Bone and Soft Tissue Sarcoma.
CD99 is a highly O-glycosylated transmembrane protein encoded by the CD99 gene, and is a cell surface protein that is highly expressed in osteosarcoma (OS), Ewing's sarcoma (ES), and rhabdomyosarcoma (RMS).
CD99 CAR-T Cell Injection (BRD-03)
BRD-03 is a Class 1 therapeutic biological product independently developed by Bio-Raid over four years, with independent intellectual property rights. In earlier in vitro studies, animal experiments, and exploratory clinical trials, BRD-03 demonstrated potent targeted tumor-killing ability and favorable safety.
Relevant Links
[1] World's First CD99 CAR-T Cell Injection Accepted for Clinical Trial by NMPA[2] World's First! Bio-Raid's CD99 CAR-T Receives IND Acceptance[3] Hubei Daily: Major Breakthrough in CAR-T Cell Technology for Solid Tumor Treatment Achieved in Wuhan[4] New Breakthrough in CAR-T Therapy for Solid Tumors! Professor Zhang Tongcun's Team Successfully Treats Solid Tumor Patients with CD99 CAR-T Cell Technology[5] Bio-Raid Honored with China's Disruptive Technology Innovation Competition Outstanding Project Award, Wins Disruptive Innovation Prize for Two Consecutive Years[6] Wuhan Bio-Raid's Zhang Tongcun Team Original CART Cell Technology Treats Solid Tumor Patientshttps://smkx.wust.edu.cn/info/1311/3301.htm[7] New Target CD99 CAR-T Therapy for T-ALL Research Data Released | Medical Breakthroughhttps://mp.weixin.qq.com/s/SOLrMK1S9eFg5Kp2zcad8g[8] The School of Life Sciences Publishes Innovative Research Findings in the Field of Blood Disordershttps://smkx.wust.edu.cn/info/1392/7181.htm[9] J Hematol Oncol | Tongcun Zhang/Haichuan Zhu from the School of Life Sciences, Wuhan University of Science and Technology, Publish Innovative Research Findings in Hematological DiseasesBio-Raid is a pharmaceutical enterprise dedicated to the research, pilot production, and submission of CAR-T immunocyte drugs. Established in September 2014, it was founded by Professor Zhang Tongcun, Dean of the School of Life Sciences and Health at Wuhan University of Science and Technology, along with immunology experts, clinical medicine specialists, and cell biologists from prestigious universities and research institutions both in China and abroad.Currently, it has more than 6,000 square meters of R&D and pilot production workshops. The plant layout was designed by a professional design institute in accordance with the strict requirements for pharmaceutical R&D and production. Each workshop's space and facilities comply with GMP standards, and it has a modern R&D-pilot testing-pilot production-submission process platform as well as a quality control platform. This has resulted in a research and development system that focuses primarily on CAR-T for hematological tumors, while also advancing multiple R&D projects in parallel, including CAR-T for viral infectious diseases, CAR-T for solid tumors, and universal CAR-T.Bio-Raid has applied for more than 60 national patents and has been granted over 20 patent authorizations; its CAR-T therapies for hematological tumors, targeting leukemia, lymphoma, and multiple myeloma, have several mature targets including CD30, CD19/22, CD99, CD20, and BCMA, and have completed hundreds of clinical trial studies.For more information, please visitScan the WeChat QR code, add the editor of the Biologics Circle, and those who meet the requirements can join.
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