Yimiao Shenzhou's Investigational GUCY2C-Targeting CAR-T Therapy IM96 Receives FDA IND Approval for Gastric and Colorectal Cancers, Achieving Dual Clinical Clearance in China and the U.S.
Imunopharm
Developer of Gene and Cell Therapy Technologies
In April 2025, Beijing, China, Beijing Yimiaoshenzhou Medical Techology Co., Ltd. ("Yimiaoshenzhou") announced,Its independently developed CAR-T cell therapy candidate for solid tumors — IM96 Chimeric Antigen Receptor T-cell Injection targeting GUCY2C(IM96 CAR-T Cell Injection, abbreviated as "IM96"), officially obtainedFDA's IND Approval for New Drug Indications: Gastric Cancer and Colorectal Cancer, this is what Beijing Yimiaoshenzhou Medical Techology Co., Ltd. has obtainedFirst FDA Clinical Trial Approval in the United States, which is also the company's approval obtained globally.Approval for the Eighth Drug Clinical Trial.
This approval makes IM96 the world's only CAR-T cell candidate drug targeting GUCY2C to have received clinical trial authorization in both China and the United States. Previously, IM96 was approved in China in October 2024 for the treatment of colorectal cancer, becoming the first CAR-T cell candidate drug in China for this indication. The FDA’s approval not only demonstrates the global innovative value of IM96 but also initiates a new model of synchronized advancement of CAR-T clinical trials for solid tumors in China and the United States, highlighting that China's innovative pharmaceutical companies are leading new breakthroughs in global solid tumor cell therapy.
Urgent Clinical Needs: Gastrointestinal Tumors in Dire Need of Breakthrough Therapies
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Gastric cancer and colorectal cancer are among the most common and deadliest types of malignant tumors globally. According to the 2022 global cancer statistics, there were 970,000 new cases of gastric cancer and 660,000 deaths, ranking it 5th in incidence and 4th in mortality among all cancers worldwide. Colorectal cancer had 1.93 million new cases and over 900,000 deaths, placing it 3rd in incidence and 2nd in mortality. Patients with advanced stages generally have a survival period of less than one year due to the lack of effective treatment options, creating an urgent clinical need for better therapeutic solutions.
Dual Breakthrough in Efficacy and Safety: IM96 Demonstrates Globally Leading Potential
IM96 targets the GUCY2C antigen highly expressed in gastrointestinal malignancies, with a positivity rate of 80% in colorectal cancer and over 60% in gastric cancer. Early clinical research data shows promising results:
Significant efficacy:Disease Control Rate (DCR) 74%, Best Objective Response Rate (ORR) 50%, Median Progression-Free Survival (mPFS) reached 10 months, Median Overall Survival (OS) greater than 17 months, far exceeding the current third-line standard treatment drugs for colorectal cancer;
Excellent Safety:Only 5.0% of patients experienced neurotoxicity (ICANS) or ≥3 grade cytokine release syndrome (CRS), indicating high safety;
Academic Recognition:The research findings were selected for oral presentation at the 2023 ESMO Annual Meeting and the 2024 ASCO Annual Meeting, with preclinical studies published in the "Journal for ImmunoTherapy of Cancer."
He TingPh.D.
CEO of Yimiao Shenzhou
Dr. He Ting, CEO of Beijing Yimiaoshenzhou Medical Techology Co., Ltd., said:IM96 Receives FDA Approval, Marking a Significant Milestone in Yimiao Shenzhou's International Strategy. Clinical data from China has demonstrated its remarkable efficacy and safety. We will accelerate clinical trials in both China and the United States to expedite its global market launch, providing a breakthrough treatment option for patients with gastric and colorectal cancer worldwide as soon as possible. Moving forward, we will continue to focus on the field of solid tumors, enabling more CAR-T cell therapies independently developed in China to benefit patients globally.
// About Yimiao Shenzhou //
Founded in 2015 and headquartered in Beijing, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. is a leading innovative pharmaceutical company with the mission of "making cancer no longer an incurable disease." It focuses on applying proprietary gene-cell drug technology to treat major diseases such as cancer and autoimmune disorders. To date, the company has completed 10 rounds of strategic financing and owns a one-stop, self-developed gene-cell drug research and industrialization platform. It possesses several core technologies, won the top prize in the finals of China's Disruptive Technology Innovation Competition, obtained seven CAR-T clinical trial approvals in China and one in the U.S., and received Beijing’s first-ever Drug Manufacturing License for gene-cell drugs. Its R&D pipeline covers hematological cancers including lymphoma, leukemia, and multiple myeloma, as well as solid tumors like liver cancer, gastric cancer, colorectal cancer, and melanoma. Among its products, IM19, a CAR-T therapy for relapsed or refractory diffuse large B-cell lymphoma, has submitted a New Drug Application (NDA) in China and gained acceptance, while IM96, a CAR-T product for solid tumors, has received clinical trial approval from both China’s NMPA and the U.S. FDA.
The company has undertaken more than 10 national and provincial research projects, including the key R&D program of the Ministry of Science and Technology, the National Major Science and Technology Special Project of the National Health Commission, the "Challenge Leader" technical project for cell therapy by the National Innovation Center, and the Beijing Municipal Science and Technology Major Special Project. It has obtained important qualifications such as a National High-tech Enterprise, a Beijing Specialized,精细化, and Innovative Enterprise, a Zhongguancun High-tech Enterprise, and a Postdoctoral Research Workstation. The team has been honored with awards such as Beijing Science and Technology Nova, Zhongguancun High-end Leading Talent, Beijing Outstanding Engineer, Beijing Youth Role Model, Beijing Haidian District Haiying Talent, Beijing Daxing District New Gateway Leading Talent, the Gold Award (First Place) in Tsinghua University President’s Cup Innovation Challenge, MIT's 35 Innovators Under 35, and Fortune Magazine's 40 Under 40 Business Elites.