Congratulations on HRAIN Biotechnology's Class 1 Innovative Drug HICARA® (Ranicabtagene Autoleucel Injection) Approval – Taimei Medical Provided IRC Services

On July 30, 2025, the National Medical Products Administration officially approved the new drug marketing application for Reni Kiohlentis Injection (trade name: Hengkailai®, English trade name: HICARA®), a Class 1 innovative biologic product developed by Shanghai Hengrun Dasheng Biotechnology Co., Ltd. (hereinafter referred to as “Hengrun Dasheng”).

As China’s first fully self-developed CD19 CAR-T product targeting relapsed or refractory large B-cell lymphoma (r/r LBCL), its approval not only fills the gap for domestically produced CAR-T in this field but also marks a new phase of autonomous control in China’s immune cell therapy technology, providing solutions for more unmet clinical needs.

Source of the image: National Medical Products Administration

The research, development, and production of Hengkaile® are fully supported by Hengrun Dasheng's proprietary intellectual property in molecular design, independently constructed process quality systems, and a closed, large-scale production platform. This has achieved the full-process localization of CAR-T cell production in China, breaking foreign technological monopolies.

As a long-term partner, Taimei Medical Technology undertook the independent imaging assessment work crucial for the approval of this drug. Relying on extensive experience in executing independent imaging assessments, a robust quality management system, an efficient digital collaboration platform, and high-quality services with rapid response, Taimei delivered the imaging review results with high quality on schedule, facilitating the product's approval and earning praise from the sponsor.

Taimei Medical Technology congratulates Shanghai Hengrun Dasheng Biotechnology Co., Ltd. on its achievements and looks forward to continuing their cooperation in the future to achieve more success!

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