The NMPA official website shows that the Class 1 innovative biological product independently developed by Hengrun Dasheng, Renikiolunsai Injection (trade name: Hengkailai), has been approved for marketing in China .

As China's first fully independently developed CD19 CAR-T product for relapsed or refractory large B-cell lymphoma (r/r LBCL), its approval not only fills the gap in China's CAR-T field, but also marks that China's immune cell therapy technology has entered a new stage of independent control.
The approval of Renykiolencil Injection was based on its excellent performance in clinical trials. In the Phase II HRAIN01-NHL01-II study, the drug enrolled 81 patients with relapsed/refractory non-Hodgkin's lymphoma (R/R NHL) who had received at least two lines of therapy (including an anthracycline and a CD20-targeted drug) or autologous hematopoietic stem cell transplantation.

Study results showed that Renykiolensay injection not only demonstrated a durable remission effect in patients with relapsed or refractory large B-cell lymphoma, but also demonstrated excellent overall safety. This achievement not only provides a new treatment option for patients, but also provides clinicians with a more powerful treatment tool.

What is particularly noteworthy is that the research and development and production of Renikiolunsai Injection rely entirely on Hengrun Dasheng's molecular design with independent intellectual property rights, independently constructed process quality system and closed large-scale production platform.

From molecular design to production technology to quality control, every step reflects Hrain Biopharm's spirit of independent innovation. This complete process of localization in China not only breaks the monopoly of foreign technology but also provides strong support for the development of immune cell therapy in China.

It is worth mentioning that Renikiorencel is the first Chinese CAR-T product approved to use a stably transfected cell line virus process. The results of Hengrun Dasheng's independent viral vector platform passed the high-quality research project acceptance of the Ministry of Industry and Information Technology in 2023. The platform's annual production capacity can cover the CAR-T cell preparation needs of more than 10,000 patients.

The launch of Renykiolunsai injection is just the beginning.

Hrain Biopharmaceuticals stated that it will continue to advance the drug's research and development for other indications. Furthermore, Hrain Biopharmaceuticals is actively developing its pipeline, including CAR-NK cell therapy products, to expand its solid tumor treatment offerings. These initiatives will not only bring new hope to more patients but will also further solidify Hrain Biopharmaceuticals' leading position in immune cell therapy.

Conclusion: The approval of Renikiorencel Injection for marketing is a major breakthrough in China's biopharmaceutical industry and a new starting point for the development of immune cell therapy technology in China . It not only provides a new treatment option for patients with relapsed or refractory large B-cell lymphoma, but also sets a precedent for independent innovation among Chinese biopharmaceutical companies.

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