Yimiao Shenzhou's IND Application for China's First CAR-T Therapy Targeting Metastatic Colorectal Cancer Receives Regulatory Acceptance

On July 18, 2024, Beijing Yimiao Shenzhou Medical Technology Co., Ltd. (referred to as "Yimiao Shenzhou") announced its next-generation anti-cancer drug for the treatment of metastatic colorectal cancer.The Investigational New Drug (IND) application for IM96 Chimeric Antigen Receptor T-Cell Injection (IM96 CAR-T Cell Injection, abbreviated as "IM96") has been accepted by the National Medical Products Administration (Acceptance No.: CXSL2400463).Benefiting from this positive development, Yimiao Shenzhou is expected to receive the sixth CAR-T new drug clinical trial approval notice in the near future, becoming one of the gene and cell drug companies with the most clinical trial approval notices in China.

It is reported that there are currently no registered clinical studies in China on CAR-T treatment for metastatic colorectal cancer. IM96 will become the first CAR-T cell therapy drug in China to enter the registered clinical stage for this indication, effectively addressing the significant unmet needs in its clinical treatment and bringing new hope and treatment options to a large number of Chinese patients with advanced metastatic colorectal cancer.

As a solid tumor CAR-T cell therapy product independently developed and owned by Yimiao Shenzhou with independent intellectual property rights, IM96 was selected twice in the form of oral presentations at international oncology academic conferences. With its groundbreaking treatment efficacy and excellent safety data, it has gained widespread attention from the industry both in China and internationally. Clinical data shows that the drug’sThe Disease Control Rate (DCR) reached 73.7%.，The best objective response rate (ORR) reached 50%, the median progression-free survival (mPFS) reached 10 months, and only 5.0% of patients experienced neurotoxicity and ≥3 grade cytokine release syndrome (CRS).This data is much better than the targeted therapeutic drugs for metastatic colorectal cancer that were most recently approved by the FDA in 2023.The latter's ORR is only 1.6~4.7%, and mPFS is merely 3.7~4.7 months.。

Colorectal cancer is one of the most common malignant tumors worldwide, with more than 1.93 million new cases and over 930,000 deaths annually. Its incidence and mortality rank 3rd and 2nd respectively among major malignant tumors globally. The treatment of colorectal cancer has always faced significant challenges, especially for patients with advanced metastatic disease, where treatment options are limited and often ineffective, making it difficult to achieve satisfactory outcomes. With the advent of IM96, this situation is expected to change, offering a more effective and safer treatment option for patients in China and around the world.