Hengruida's Fully Indigenous CAR-T Therapy HICARA® (Ranicabtagene Autoleucel) Offers New Hope for Long-Term Survival in Relapsed/Refractory Large B-Cell Lymphoma Patients

In January 2026, during the 2026 CSCO Hematological Oncology Academic Conference, Reny CART Injection, a CAR-T product for lymphoma indications independently developed by Shanghai Hengrun Dasheng Biotechnology Co., Ltd., was officially launched, and the compilation of clinical guidelines commenced. At the "Dialogue on the Future" special session hosted by CR Double-Crane, a panel of experts in the field of hematological oncology in China delivered keynote speeches, participated in roundtable discussions, and conducted case studies to jointly promote the deep integration of clinical practice and scientific research innovation in this field.

Opening Ceremony of the Conference

Experts at the meeting engaged in in-depth discussions on the core clinical data of Reni Kiohlensai Injection and the breakthrough role of Teniposide Injection in central nervous system lymphoma, aiming to build consensus and provide direction for the systematic improvement of hematological tumor diagnosis and treatment in China.

At the conference, a milestone moment was reached in China's hematology and oncology field: Reni Kiorlence Injection, a CAR-T cell therapy product for lymphoma indications that was independently developed in China and achieved full-chain localization, was officially launched. The "Guiding Principles for Clinical Application of Reni Kiorlence Injection" were simultaneously initiated. Professor Peng Liu from Zhongshan Hospital, Fudan University, as the reporter of the core data of this product, systematically elaborated on its background, breakthrough significance, and outstanding clinical value.

Professor Peng Liu from Zhongshan Hospital Affiliated to Fudan University Delivers Special Topic Sharing

Professor Peng Liu first pointed out that 30%-40% of patients with diffuse large B-cell lymphoma (DLBCL) will develop recurrent or refractory disease (R/R DLBCL). The emergence of Reni Kioleucel marks a key transition in China's lymphoma cell therapy field, achieving "from following to self-reliance." Professor Liu emphasized its core advantage of full-chain domestic production—

1. Technical Independence: The product has successfully achieved independent R&D and scaled production of key raw materials such as stable lentiviral vectors, establishing a robust manufacturing process with an annual production capacity planned to meet demand at the ten-thousand-case level.

2. Stable quality and rapid onset: This product uses a stable transfection library method to produce viral vectors, ensuring the uniformity and stability of CAR-T cell preparation quality from the source. In addition, the CAR-T cells after infusion exhibit excellent in vivo expansion ability, initiating within 3 days and peaking at around 10 days, providing a key kinetic advantage for achieving rapid and deep therapeutic responses.

Professor Peng Liu shared the core data of the pivotal Phase II study of this product: In relapsed/refractory patients, including pathological subtypes such as diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and high-grade B-cell lymphoma (HGBCL), the best overall response rate (ORR) of Reni Kiohlencel reached 75.3%, with the best complete response rate (CRR) reaching 56.8%. Its efficacy demonstrated good durability, with over 44% of patients still in sustained response at 18 months post-treatment. With a median follow-up of nearly 21 months, the median progression-free survival (mPFS) was 8.4 months, and 74% of CR patients maintained long-term CR, with a 2-year overall survival (OS) rate of 64.9%. Additionally, the CR conversion rate for patients who initially achieved PR/SD was 28.4%, and among those who converted from PR to CR, the response maintenance rate was as high as 95.0%. These impressive data bring hope of survival to patients with R/R large B-cell lymphoma.

In addition, the safety of Raniky Orencel Injection is good, with an incidence rate of ≥3 grade cytokine release syndrome (CRS) at 3.7%, comparable to similar products; the incidence rate of ≥3 grade neurotoxicity (NT) is as low as 0, showing superior performance among similar products; no ≥3 grade ICANS or CRS-related deaths occurred, demonstrating an excellent risk-benefit ratio.

Finally, Professor Liu Peng concluded that the launch of Raniky Orencel not only marks the debut of a new drug but also symbolizes the maturity of China's independent innovation capabilities in the field of tumor cell immunotherapy, opening a new chapter in lymphoma treatment. He stated that, based on the current excellent data, future efforts will further explore the application of this product in earlier stages, such as second-line treatment, with the aim of benefiting a broader patient population.

During the peak dialogue session, Professors Zhou Hui, Yu Wenjuan, Li Wenyu, Su Liping, and Deng Qi spoke highly of the efficacy of Reni Kiohlensai Injection and pointed out that CAR-T still holds unique value in achieving deep and lasting remission, especially in pursuing long-term survival or even functional cure. In the future, its application will not be limited to later-line treatments but also has broad exploration space in frontline/second-line treatment for high-risk patients, as well as in combination with autologous stem cell transplantation strategies.

Experts unanimously believe that the significantly reduced price is one of the most core advantages of this new product, truly breaking the "economic threshold" of CAR-T therapy. This is a key step in promoting innovative therapies from clinical trials to widespread real-world applications. Finally, the experts also emphasized that after the new product is launched, clinicians will continue to primarily focus on its long-term safety in the real world. They will actively explore the optimal combination modes and sequential timing with other treatment methods, aiming to develop better personalized treatment plans for lymphoma patients with different characteristics.