Genscript Supports Imviva Biotech’s CTA313 in Securing FDA IND Clearance, Reinforcing Leadership in Global Cell Therapy

June 9, 2026,Nanjing Bioheng Biotech Co., Ltd. officially announced that its independently developed dual-target allogeneic CAR-T cell therapy, CTA313 (targeting CD19/BCMA), has successfully received approval for its Investigational New Drug (IND) application from the U.S. FDA.A Phase 1b basket registration clinical trial targeting B cell-mediated autoimmune diseases, including systemic lupus erythematosus, progressive multiple sclerosis, and autoimmune encephalitis, is即将 to be initiated.

CTA313 is an allogeneic CAR-T cell therapy targeting CD19 and BCMA, currently in the clinical research stage., derived from PBMCs of healthy donors, is designed to treat B cell-mediated autoimmune diseases. This product utilizes Bioheng Biotech’s proprietary ANSWER™ inhibitory ligand and gene-editing technology to enhance its resistance to host immune rejection, thereby improving treatment durability.

CTA313 can be manufactured and stored in advance, with a single production batch suitable for treating multiple patients, providing an “off-the-shelf” therapeutic solution for patients requiring CAR-T cell therapy.CTA313 has been evaluated in investigator-initiated trials (IITs) conducted in China, covering multiple autoimmune-related indications, including disease areas such as nephrology, rheumatology, endocrinology, gastroenterology, and hematology.

Nanjing Bioheng Biotech Co., Ltd. is a clinical-stage biotechnology company dedicated to developing innovative allogeneic CAR-T cell therapies for patients with cancer and autoimmune diseases. The company’s proprietary platform integrates advanced cell engineering technologies to create off-the-shelf cellular immunotherapy products. Bioheng’s R&D pipeline spans two major therapeutic areas: oncology and autoimmune diseases. For more information, please visit Bioheng’s official website: https://www.imvivabio.com/

Leveraging extensive experience in regulatory submissions and a specialized regulatory affairs team, GenScript excels in preparing submission dossiers for both China and the United States, providing strategic solutions to address deficiency letters. Furthermore, GenScript’s GMP-grade sgRNA products are supported by an FDA Drug Master File (DMF) filing, which can expedite the regulatory review process. Driven by the dual engines of superior product quality and expert regulatory support, GenScript’s GMP-grade sgRNA has become the ideal choice for accelerating cell therapy development.

GenScript offers GMP-grade sgRNA up to 170 nt in length, supporting the development of cell therapies based on various cell types—including T cells, NK cells, and hematopoietic stem cells—and utilizing diverse editing platforms such as Cas9, Cas12, base editing, and prime editing.As of June 2026, GenScript has successfully delivered over 210 batches of GMP-grade sgRNA and gene knock-in templates, supported regulatory filings for more than 50 projects, passed over 60 audits, and enabled global clients to secure 27 IND approvals. Standing at the forefront of the GMP gene-editing nucleic acid raw material industry, GenScript is empowering the optimization, iteration, and globalization of cell therapy products.

The GenScript Zhenjiang GMP facility was constructed in compliance with the GMP requirements of major regulatory authorities, including the FDA, EMA, PMDA, and NMPA. It features advanced environmental control systems, optimized sterile product manufacturing equipment, and standardized personnel and material flow management.GenScript will support rapid delivery with ample production capacity, accelerate regulatory filings and clinical trial progress, facilitate the efficient development and commercialization of GCT companies’ pipelines, and contribute to making gene and cell therapies accessible to more patients.

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GenScript Biotech Corporation (HK.1548), founded in New Jersey in 2002, accelerates innovation in biotechnology and healthcare by providing researchers and enterprises with essential research and development services needed to develop breakthrough therapies and products. As a widely recognized biotechnology company, GenScript is committed to its mission of “making humans and nature healthier through biotechnology.” With approximately 6,165 employees worldwide, the company delivers high-quality services to over 200,000 customers across more than 100 countries and regions.

For more information, please visit the GenScript official website https://www.genscript.com

For detailed inquiries regarding GenScript’s GMP-grade sgRNA and HDR gene knock-in template services, please contact your local GenScript sales representative or GenScript Technical Support.

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