"A Decade in the Making": Boruida's CD30-Targeted CAR-T Therapy BRD-01 to File for Market Approval in 2025

Recently, the General Office of the Hubei Provincial People's Government released the "Hubei Province Accelerated Development Plan for Future Industries (2024-2026)", proposing to use disruptive and cutting-edge technologies to foster future industries, cultivate and strengthen new quality productive forces, inject strong new momentum into economic and social development, and create a core engine leading the future. In this "Plan", the future"Gene and Cell Therapy" (CGT) in the health sector is explicitly listed as one of the key development priorities.。

In June this year, Hubei Province released an implementation plan to accelerate the development of future industries. It particularly emphasized speeding up the research and development process of gene and cell drugs in the future health industry, while continuing to increase support in areas such as enterprise incubation, scenario application, talent cultivation, and industrial ecosystem construction. In response, Zhang Tongcun, chairman of Wuhan Bio-Raid Biotechnology Co., Ltd. (hereinafter referred to as "Bio-Raid"), stated: "The provincial government and various levels of units have provided us with comprehensive support in terms of industrial policies, R&D funding subsidies, factory discounts, major projects, and industrial transformation projects. This has greatly helped our company's development."

Since 2014, the team led by Professor Zhang Tongcun has been deeply engaged in the field of CAR-T cell therapy.Over nine years, with an investment exceeding 300 million yuan, successfully completed at Wuhan Tongji HospitalOver 1,000 Cases in Clinical Trials. The test results show that the product independently developed by Bio-RaidThe autologous T-cell injection solution modified by chimeric antigen receptor gene targeting CD30 (hereinafter referred to as "BRD-01") has shown significant efficacy in treating refractory Hodgkin's lymphoma and other diseases., which has currently entered the phase II clinical stage.

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 The 7th Symposium on Tumor Immunotherapy and Cell Treatment Technology

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CAR-T Cell Therapy is an innovative immunotherapy, and it isExtract immune cells from tumor patients, genetically engineer them, and then reintroduce them into the patient's body.These modified CAR-T cells can precisely identify and attack tumor cells, equipped with two major "weapons": one is the "bomb" capable of releasing cytokines, which can effectively dissolve tumor cells; the other is a self-amplification mechanism that ensures continuous attack until the complete elimination of tumor cells.

▲ Mechanism of CAR-T Cell Killing Tumor Cells In Vivo

▲ CAR-T Treatment Process

BRD-01 is a CAR-T cell therapy drug independently developed by Bio-Raid for patients with relapsed/refractory CD30+ hematological tumors. It is not onlyThe First CAR-T Therapy Targeting CD30 Approved for Clinical Trials in China, MoreExpected to become the world's first CAR-T new drug targeting this siteIt is reported that a leukemia patient has recently received clinical trial treatment with BRD-01 at Wuhan Tongji Hospital.

According to the press release, Bio-Raid plans to apply for the BRD-01 market launch in 2025.Its production cost is expected to be halved compared to similar drugs in China., which is expected to become the first CAR-T cell cancer drug targeting CD30 to be approved in China. According to its official website, in addition to targeting CD30, Bio-Raid has multiple pipelines laid out in the field of hematological tumors, with several CAR-T drugs targeting different mature targets currently in various stages of development.

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