Hengrunda's First-in-Class CD19 CAR-T Therapy HICARA® Successfully Enters Commercialization, Highlighting the Value of Homegrown Innovation

In July this year, the National Medical Products Administration officially approved Shanghai Hengrun Dasheng Biotechnology Co., Ltd.(hereinafter referred to as "Hengrun Dasheng")Class I Innovative Biological Product - Raniky Orencia Injection(CommercialProductName: Heng Kailai^®，English Product Name: HICARA^®）The new drug marketing application, as the first domestically produced self-developed treatment for relapsed or refractory large B-cell lymphoma（r/r LBCL）CAR-T products,Heng Kai Lai^®Not only fills the gap of domestically produced CAR-T in this field, but also marks that China's immune cell therapy technology has entered a new stage of independent control.`, providing solutions for more unmet clinical needs.`

Heng Kai Lai^®The entire process of R&D and production is based on Hengrun Dasheng's proprietary intellectual property in molecular design, independently constructed process quality system, and a closed, scaled production platform. This has achieved the full-process localization of CAR-T cell production in China, breaking the foreign technology monopoly. Hengkailai^®It is the first China-produced CAR-T product approved to adopt a stable cell line virus process. The results of Hengrun Dasheng's proprietary viral vector platform passed the acceptance of a high-quality research project by the Ministry of Industry and Information Technology in 2023. The platform's annual production capacity can meet the CAR-T cell preparation needs of more than 10,000 patients.

Department of Hematology, Zhongshan Hospital, Fudan University as Hengkailai^®The leading unit of the registered clinical trial,全程主导并深度参与了恒凯莱^®Clinical trials have also witnessed Hengkailai^®On the path of fulfilling the mission of "healing the sick and saving lives," every key milestone from clinical research to commercialization.

Relying on its proprietary virus vector platform and scaled production capabilities, Shanghai Hengrun Dasheng Biotechnology Co., Ltd.'s CD19 CAR-T product has brought new hope to more than a hundred patients from clinical trials to commercialization. In the future, the company will take the approval of its first CAR-T product as an opportunity to accelerate the innovative research and clinical transformation of other immune cell therapy products, allowing China's self-innovated achievements to benefit more patients.

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