Zhongshan, November 21, 2024 – Leman Biotech Co., Ltd. (hereinafter referred to as "Leman Biotech"), a clinical-stage biotechnology company dedicated to the research, development, production, and commercialization of innovative metabolic immunotherapies, is pleased to announce the official commencement of its operations at Zhongshan Life Science Park. This milestone marks a pivotal advancement in the development of state-of-the-art, automated, and fully enclosed Chemistry, Manufacturing, and Controls (CMC) processes designed for the production of ultra-low dose Chimeric Antigen Receptor T-cell (CAR-T) therapies.
Leman Biotech's metabolically armed CD19 CAR-T therapy (Meta10-19) has demonstrated exceptional efficacy in investigator-initiated clinical trials (IITs). Administered at an ultra-low dose—just 1% of the dosage typically required for traditional CAR-T therapies—the therapy has achieved complete tumor clearance, enabling over 20 patients with relapsed or refractory leukemia or lymphoma to reach complete remission (CR) and be successfully discharged from the hospital.
In the latter half of 2024, Meta10-19 therapy made another significant clinical breakthrough. In the latest IIT trial, clinical experts further reduced the infusion dose to as low as one-thousandth (0.1%) of the conventional CAR-T dosage and remarkably, several patients once again achieved complete remission.
The ultra-low dosage requirement of metabolically armed CD19 CAR-T cells creates a unique opportunity to streamline manufacturing processes. To leverage this advantage, Leman Biotech has established a dedicated team to develop an innovative automated CAR-T cell preparation process. By commencing operations at the Zhongshan Life Science Park—equipped with state-of-the-art R&D facilities and comprehensive scientific support services—the company aims to accelerate the Meta10-19 project’s development and production implementation. Compared to the nearly one-month manufacturing timeline of traditional CAR-T cells, Leman Biotech’s novel automated manufacturing process is anticipated to reduce CAR T cell production time to less than one week.
Looking ahead, Leman Biotech aims to leverage its robust research capabilities through strategic partnerships with the Institute of Materia Medica Chinese Academy of Sciences and collaborations with XtalPi. By integrating its core Meta10 technology with cutting-edge artificial intelligence and advanced automated manufacturing processes, the company aims to drive transformative advancements in CAR-T therapy. With this strategic partner, Leman Biotech is also expected to significantly reduce production costs, enhance manufacturing efficiency, and ultimately make CAR-T therapy more accessible to patients worldwide, addressing the growing demand for affordable and effective cancer treatments.
About Zhongshan Life Science Park
The Zhongshan Life Science Park, developed and operated by Cuiheng Group, is industrial hub integrating biopharmaceutical R&D, technology commercialization, platform services, and industry incubation. As the largest single-investment biopharmaceutical industrial platform in the Guangdong-Hong Kong-Macao Greater Bay Area.
As a key hub for life science innovation in Zhongshan, the Cuiheng Science Park offers resident enterprises a world-class R&D environment and comprehensive service support to foster innovation and growth.
