Hengruida's Self-developed HICARA (Renilicelogene) Receives CSCO Guidelines Class II Recommendation and the 'Clinical Application Guideline of Renilicelogene Injection (2026 Edition)' Officially Released

On April 25, 2026, during the grand convening of the 2026 CSCO Guidelines Update Conference in Harbin, the drug Raniky Orelacept Injection(Product name: Hengkailai^®, English Product Name: HICARA^®）Included for the first time in the 2026 edition of the CSCO Lymphoma Diagnosis and Treatment Guidelines, for relapsed/refractory diffuse large B-cell lymphoma（R/R DLBCL）Level Ⅱ recommendation; Meanwhile, "Clinical Application Guidelines for Reni Kioleucel Injection (2026 Edition)"("Guiding Principles" hereinafter)Official Release. Experts in the field of hematological oncology in China jointly witnessed this moment, marking that after achieving "product innovation," Reni Kiohlensai Injection has officially entered a new phase of "standard leadership."

Release Ceremony of "Lenkior Cell Injection Guidelines"

The Birth of the Ranikio Cell Therapy Guidelines: A Key Step for China's Self-Developed CAR-T Therapy from "Accessible Products" to "Replicable Standards"

Under the chairmanship of Professor Bai Ou, the Guideline Release Conference officially commenced. Members of the presidium, Professors Ma Jun, Zhu Jun, Wu Depei, and Shen Zhixiang, delivered enthusiastic opening speeches, jointly witnessing this milestone moment. Subsequently, Professor Liu Peng, Director of the Hematology Department at Fudan University's Zhongshan Hospital, provided a systematic introduction to the development process and core clinical data of Reni Kiorance.

Professor Peng Liu Delivers Specialized Sharing

Professor Liu Peng pointed out that relapsed/refractory diffuse large B-cell lymphoma（R/R DLBCL）2-Year Overall Survival of Patients with Traditional Salvage Therapy（OS）The rate is only 27%, facing an extremely severe survival dilemma. ^[1,2]CAR-T therapy, though recommended by guidelines, has long been plagued by insufficient accessibility.^[3-5]The successful development of Raniky Orencell has achieved the independent research and development and scaled production of key raw materials such as stable virus vectors, with an annual production capacity that can meet the demand of tens of thousands of cases, allowing Chinese patients to truly access and afford advanced therapies that are synchronized with the world.

Renecabtagene Autoleucel CAR-T Cell Infusion Shows Kinetic Advantage for Rapid and Deep Remission with Expansion Initiated at Day 3 and Peaking at Day 10. In terms of the much-anticipated efficacy and safety data, Renecabtagene Autoleucel presents a "dual advantage" result: in the pivotal Phase II study of 81 refractory patients, the best objective response rate（ORR）Up to 75.3%, Best Complete Remission（CR）Reaching 56.8%, with a 2-year OS rate of 64.9%. More notably, its safety advantage — ≥3 grade neurotoxicity.（NT）The incidence rate is as low as 0, with no ≥3 grade ICANS or CRS-related deaths reported.^[6]This "potent and safer" characteristic has laid a solid foundation for its subsequent exploration in second-line and even more front-line treatments.

Professor Donglu Zhao Delivers Special Topic Sharing

In the second half of the meeting, Professor Zhao Donglu from Harbin First Hospital provided an in-depth interpretation of the guiding principles. The unique structural design of Ranikio Rensai adopts the "golden combination" of the CD28 co-stimulatory domain and the CD8α hinge region. This design significantly enhances the metabolic activity and in vivo expansion ability of CAR-T cells while effectively reducing the level of inflammatory cytokine release, truly achieving the treatment goal of being "safer and more durable." Its peripheral blood mononuclear cells can be stably cryopreserved for up to 24 months, providing clinicians with ample time to collect and store cells in advance, greatly enhancing the flexibility and continuity of treatment strategies.

In the whole-process management, from patient screening to infusion at every step, to the ASTCT standard 1-4 grade classification management of cytokine release syndrome, as well as the dual-track system for infection prevention and control, relevant guidelines provide clear and structured norms. In the intermediate stage post-infusion, regular monitoring of blood routine and immunoglobulin levels is required to evaluate immune reconstitution progress, while long-term follow-up needs to cover multiple dimensions including disease assessment, immune reconstitution, infection markers, CAR-T cell persistence, and long-term functionality.^[7], this "whole life cycle" management concept fully reflects the profound consideration for the long-term benefits of patients.

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