Breaking the Deadlock in 'Untreatable' T-cell Malignancies: Biosyngen's CD7 CAR-T Therapy Enters Pivotal Phase II Clinical Trial

September 17, 2025, Hefei, China —— A leading cell therapy company in ChinaBo Sheng JiAnke Cell Technology Co., Ltd. announced that its globally innovative self-developed CD7-targeted autologous CAR-T cell product, PA3-17 Injection, has successfully completed the review process with the Center for Drug Evaluation of the National Medical Products Administration.（CDE）The formal communication meeting was held, and the company received clear support opinions from the CDE. The company plans to officially launch the pivotal Phase II clinical trial of this product in the near future.

This milestone progress marks a significant advancement in the extremely challenging area of adult relapsed/refractory T lymphoblastic leukemia/lymphoma.（R/R T-ALL/LBL）In the field of treatment, China's innovative drugs are expected to achieve significant breakthroughs, filling a critical gap in the global CAR-T treatment landscape for T-cell malignancies.

Currently, all CAR-T cell therapies approved for marketing worldwide focus on B-cell malignancies or myeloma.(such as targeting CD19 or BCMA)，For T-cell malignancies, which are equally aggressive, especially for adult R/R T-ALL/LBL, patients face the dilemma of very limited treatment options and extremely poor prognosis. The emergence of PA3-17 injection is a strong response to this unmet clinical need. Its unique mechanism of action - precisely targeting the CD7 antigen on the surface of T cells - makes it a highly promising new star in the global field of T-cell tumor treatment. In the completed Phase I clinical trial, PA3-17 demonstrated encouraging efficacy, with the best overall response rate.（ORR）Up to 85.00%, bringing a new dawn of cure for the deeply troubled patient population.

The rapid advancement of PA3-17 Injection is not only a success for a single product but also represents a significant expansion for the global CAR-T therapy industry. Compared to B-cell tumors, the development of CAR-T therapies for T-cell tumors faces unprecedented scientific and technological challenges, including:

•   Fratricide Effect:CAR-T cells may attack or kill each other due to their own expression of CD7.

•   High Risk of Tumor Cell Contamination:Autologous T-cell products are susceptible to contamination by malignant T cells.

•   Healthy T Cell Exhaustion Risk:Treatment may cause severe T-cell immunodeficiency.

•  The complexity of the preparation process is extremely high.

As the earliest strategic shareholder of Bo Sheng Ji Medicine, from the first batch of companies listed on the Growth Enterprise Market ——Dr. Song Lihua, Chairman of Anke Biotechnology Group, pointed out:The breakthrough progress of PA3-17 injection has set a benchmark for the global development of CAR-T therapy for T-cell tumors, demonstrating the feasibility of this treatment pathway and will greatly encourage and drive the development of the entire industry in this field. Anke Biotechnology is very pleased to be able to support the development of Bo sheng ji medicine science and technology (suzhou) co., LTD and Bo sheng ji Anke in this process.

The successful advancement of PA3-17 Injection is inseparable from the outstanding leadership and selfless dedication of China's top clinical research expert team in hematology oncology. The project has been carried out across multiple authoritative research centers in China, under the guidance of Academician Huang Xiaojun.(Peking University Institute of Hematology)、Professor Zhang Mingzhi(The First Affiliated Hospital of Zhengzhou University), Professor Mei Heng(Xiehe Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology）, Professor Zou Dehui(Blood Diseases Hospital, Chinese Academy of Medical Sciences)Led by multiple leading experts in various disciplines, the clinical research is conducted with their profound academic attainments, extensive clinical experience, and keen insight into breakthrough therapies. They provide crucial scientific guidance and clinical assurance for the design, implementation, and patient safety management of Phase I clinical trials, ensuring high-quality completion of the research and data reliability. This has laid a solid clinical foundation for PA3-17 to gain recognition from the CDE.

Dr. Lin Yang, founder and chairman of Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD, stated:"The entry of this project into the pivotal Phase II clinical trial demonstrates the scientific value, clinical potential, and the company’s development strategy of PA3-17 Injection have received multiple levels of affirmation. Behind this achievement lies the relentless efforts of the Bo Sheng Ji team in continuously exploring and overcoming challenges in an extremely difficult technical field. This progress would not have been possible without the outstanding contributions and steadfast support of the clinical PI teams led by Academician Huang Xiaojun, Professor Zhang Mingzhi, Professor Mei Heng, and Professor Zou Dehui. We are deeply encouraged and will place patient needs at the core, accelerate the advancement of the Phase II clinical trial, while simultaneously refining the commercial production layout. We are fully committed to driving this innovative cell therapy product, originating from China, to market as soon as possible—benefiting not only Chinese patients but also contributing Chinese wisdom and solutions to address treatment challenges for T-cell tumor patients worldwide."

PA3-17 Injection is a globally leading autologous CAR-T cell therapy product independently developed by Bo Shengji Medicine Science and Technology (Suzhou) Co., LTD, targeting CD7 for the treatment of adult relapsed/refractory T lymphoblastic leukemia/lymphoma.（R/R T-ALL/LBL）. This product utilizes advanced genetic engineering technology to modify patients' own T cells, enabling them to specifically recognize and kill malignant tumor cells expressing CD7. Its Phase I clinical data demonstrated a high remission rate and manageable safety, showing great potential to become a breakthrough therapy for this refractory disease. The product has been designated as a breakthrough therapy by the Center for Drug Evaluation of the National Medical Products Administration, according to the "Procedure for the Review of Breakthrough Therapies."(Trial)》, For varieties included in the breakthrough therapy drug program, applicants who meet relevant conditions after evaluation may submit applications for conditional approval and priority review and approval when applying for drug marketing authorization. Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD plans to evaluate the clinical trial results during the pivotal Phase II clinical trial period. If the requirements for conditional approval are met, they will apply for conditional approval and priority review and approval to shorten the product’s time to market.

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