Yimiao Shenzhou Presents Pivotal Phase II Clinical Data of CAR-T Therapy SaiboHua® (Bokijilunsa) for Advanced Lymphoma at the 6th UISLM
Imunopharm
Developer of Gene and Cell Therapy Technologies
October 24, 2025, Tianjin, China, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. (referred to as "Yimiao Shenzhou", "Yimiao Bio" or "the Company")Independently Developed CAR-T Cell Therapy Product – Saipuwa®(Pokimagene)，The Phase II pivotal clinical data led by Professor Song Yuxin, Vice President of Peking University Cancer Hospital, made a brilliant appearance at the 6th Xiehe International Lymphoma Symposium (UISLM). During the conference,NorthProfessor Xie Yan, Deputy Director of the Lymphoma Department at Beijing University Cancer Hospital, shared a keynote report titled "Phase II Pivotal Clinical Study of Saibo Hua® (Pegylated Olaratumab) in the Treatment of Aggressive Non-Hodgkin's Lymphoma.", Saibo Hua® (Boji Aolun Sai)"With a 'unique CAR molecular protective peptide design, excellent efficacy data, and outstanding product safety,' it has garnered high praise from the industry!"
Professor Xie Yan Sharing Session
It is worth mentioning that, as the first self-developed autologous CAR-T cell product targeting CD19 for the treatment of r/r NHL by Beijing Yimiaoshenzhou Medical Technology Co., Ltd., Saibo Hua...®(Key Data from Phase II Study of Borkiolumab) was officially presented at the CSCO Leukemia, Lymphoma, and Myeloma Expert Committee Working Conference and the 2025 CSCO Hematological Oncology Academic Conference held in Haikou this January, as well as at the 28th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) held in September. The data received widespread attention from experts and industry professionals in attendance.
Unique Product Features
Add to the scFv endUnique protective peptide design, therebyEnhance cell killing efficiency and reduce immunogenicity.
Memory T cell enrichment technology increases the proportion of memory T cells to >80%.A high proportion of memory T cells leads to a gentle and sustained expansion curve, enhancing safety with mild adverse reactions.
Excellent efficacy and optimal safety
Excellent Clinical Efficacy:Phase II pivotal clinical trial included 100 patients with aggressive NHL who failed second-line treatment in the efficacy analysis set, representing the largest pre-market NHL CAR-T pivotal clinical study in China.The ORR at 3 months, the primary efficacy endpoint, was 57% (95% CI: 46.7%–66.9%). The median progression-free survival (mPFS) reached 5.95 months, and the median duration of response (mDOR) was 8.02 months. The mPFS for patients who achieved a response at 3 months post-infusion was 11.9 months, and the mPFS for patients with a complete response (CR) has not yet been reached.
Excellent Safety:The incidence of Grade 3 CRS was only 0.9%, with no ≥Grade 3 ICANS, lower than that of similar products already on the market.，This may be related to the higher proportion of memory T cells in this product. Other adverse reactions were mainly hematological toxicities, all of which were within expectations and manageable.
Reliable Robustness
A domestically developed one-stop platform ensures efficient delivery capabilities.Success rate in the preparation of Phase II pivotal clinical trials reached 99%.，Ensure patients receive medication in a timely manner.
Saibohua®(Pokizolecleucel) is the first self-developed autologous CAR-T cell product targeting CD19 by Beijing Yimiaoshenzhou Medical Technology Co., Ltd. It has successively received clinical trial approval notices for three indications from the National Medical Products Administration, namely, relapsed/refractory aggressive non-Hodgkin lymphoma, acute B lymphoblastic leukemia, and mantle cell lymphoma. Among them, the clinical trial for the first indication, end-line treatment of aggressive non-Hodgkin lymphoma, has been completed, demonstrating excellent clinical efficacy and optimal safety. In November 2024, the company submitted a marketing application for the product, which was accepted, and it is expected to be approved for marketing as early as the beginning of next year. This will make it the first CAR-T cell therapy product in Beijing, bringing hope of rebirth to hundreds of thousands of lymphoma patients in China.
In August 2024, Beijing Yimiaoshenzhou Medical Techology Co., Ltd. on Saibo Hua®(Pokarcell) has reached a commercial authorization cooperation agreement with Huadong Medicine in mainland China, with a total amount of 1.075 billion yuan.
