Beijing's First CAR-T Cell Therapy Drug Manufacturing License Granted to Imunopharma
On July 27, 2022, Beijing Imunopharm Biotechnology Co., Ltd. (hereinafter referred to as “Imunopharm”) successfully passed the comprehensive review by the Beijing Medical Products Administration and obtained the Drug Manufacturing License for its CAR-T cell therapy product, becoming the first gene and cell therapy company in Beijing and one of the few in China to be granted a Drug Manufacturing License for a CAR-T cell therapy product.
The approval of this license is not only a milestone for iCAR Therapeutics ahead of the market launch of its proprietary CAR-T product, but also signifies that the company’s various production facility systems have met the quality regulatory requirements for the manufacturing of CAR-T cell therapy products. This will further accelerate the New Drug Application (NDA) process for IM19, iCAR Therapeutics’ first proprietary CAR-T product, and lay a solid foundation for commercial-scale production following the drug’s market approval.
Dr. He Ting, CEO of ImmunoChina“The honor of receiving Beijing’s first Drug Production License for a CAR-T cell therapy product is deeply felt, and we extend our sincere gratitude to the municipal drug regulatory authorities for their unwavering support and guidance. We will continue to forge ahead with determination and strive for excellence. Taking this as a new starting point, we are committed to rapidly commercializing our independently developed CAR-T products, aiming to provide cancer patients with more advanced, reliable, and cost-effective CAR-T cell therapies at the earliest possible date, thereby contributing Yimiao’s strength to the advancement of China’s gene and cell therapy industry!”
As the first independently developed CAR-T product of Imunopharm, IM19 CAR-T Cell Injection has successively obtained three Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for the treatment of relapsed/refractory aggressive non-Hodgkin lymphoma (r/r NHL), relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and relapsed/refractory mantle cell lymphoma (r/r MCL). All indications have entered the registration clinical trial stage. Notably, the study for r/r NHL has advanced to the confirmatory (Phase II) clinical stage, positioning it to potentially become the first domestically developed and marketed CD19 CAR-T therapy in China. Upon market launch, this product will effectively fill the gap in the domestic market for indigenous CAR-T cell therapies, bringing new hope to hundreds of thousands of lymphoma patients in China.
Immunochina Therapeutics, founded in 2015 and headquartered in Beijing, is driven by the mission to “make cancer no longer a terminal illness.” The company is dedicated to applying innovative gene and cell therapy technologies to the treatment of malignant tumors. Immunochina Therapeutics boasts a one-stop, independent R&D and industrialization platform for gene and cell therapies, mastering core technologies such as large-scale plasmid preparation, lentiviral vector production, and primary immune cell processing. Its R&D pipeline comprehensively covers hematologic malignancies—including lymphoma, leukemia, and myeloma—as well as solid tumors such as liver cancer, colorectal cancer, gastric cancer, and pancreatic cancer, establishing it as a leading innovative platform in China’s independently developed gene and cell therapy sector. The company has been approved to establish a Postdoctoral Research Station and has received recognition and support as a National High-Tech Enterprise, a beneficiary of Beijing’s Major Science and Technology Special Projects, and a Zhongguancun Frontier Technology Enterprise. Members of its management team have been honored with government distinctions such as Beijing Science and Technology New Star, Zhongguancun High-End Leading Talent, and Beijing Haiying Talent.