GenCRISPR cGMP gRNA

On November 14, 2024, Base Therapeutics Co., Ltd. announced that its independently developed, world-first base-edited universal NK cell product, NK510 Cell Injection, received Investigational New Drug (IND) application approval from the U.S. Food and Drug Administration (FDA) for the clinical treatment of advanced solid tumors. On October 22, NK510 Cell Injection received the IND approval form NMPA.

GenScript is proud to have supported the development of this groundbreaking therapy with our cGMP sgRNA. Our cGMP guide RNA supports various editing systems including Cas9, Cas12a, base editing, and prime editing, facilitating the diversified advancement of cell therapies.

On November 5, 2024, BRL Medicine Inc. announced that its developed "Targeted CD19 Non-Viral PD1 Site-Specific Integration CAR-T Cell Injection" (BRL-203) has officially received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) for the clinical treatment of "moderate to severe refractory systemic lupus erythematosus (SLE).“

GenScript provided core materials, GMP sgRNA, and gene knock-in templates (dsDNA) for this approved non-viral CAR-T therapy. This contributes to the development of safer, more efficient, and cost-effective cell therapies based on CRISPR technology and supports the treatment of a more diverse range of diseases.

In July of 2024, ST Phi Therapeutics obtained an IND approval for the allogeneic cell therapy product CNK-UT002 for solid tumors from the NMPA.

This is the 10^th global gene and cell therapy IND approval supported by GenScript’s cGMP sgRNA. We are proud to be the collaborator of choice for leading gene and cell therapy companies, continually exploring and innovating to benefit more patients globally.

April 2024, CorrectSequence Therapeutics Co., Ltd. (Correctseq), using innovative transformer Base Editing (tBE) technology to help people with severe diseases, announced that its base editing drug "CS-101 Injection" targeting transfusion-dependent β-thalassemia has obtained IND approval from the NMPA.

GenScript is honored to provide Correctseq's base editing therapy with cGMP sgRNA for IND application and resupply for phase I clinical study, supporting the therapeutic application of high-quality gene therapy products.

 “We are delighted to establish a strategic cooperation with GenScript. T-MAXIMUM focuses on recurrent high-grade gliomas without effective standard therapies and is committed to the development of universal CAR-T cell therapies. Gene editing reagents are crucial raw materials for the quality and efficacy of our products. We are confident that this collaboration will accelerate the regulatory processes in China and the United States, expediting T-MAXIMUM’s first product pipeline to benefit patients in need as soon as possible.”

Related reading: GenScript’s cGMP sgRNA reagent services enabled FDA-certified orphan drug designation (ODD) for T-MAXIMUM Biotech's MT207 CAR-T cell therapy

By integrating GenScript’s cGMP single-guide RNA services into their R&D workflows, BRL Medicine tap GenScript’s expertise to accelerate their go-to-market pathways for non-viral cell and gene therapies. And BRL Medicine was recently granted an investigational new drug (IND) application for its BRL-201 in relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL) by the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA).

Related reading: Cell and Gene Therapy Companies Leverage GenScript’s cGMP sgRNA Capability to Accelerate Speed to Market