On April 13, 2026, Fosun Kairen's autologous dual-target (targeting BCMA and CD19) CAR-T product FKC289 injection officially received clinical trial approval from the National Medical Products Administration (NMPA). The product is planned to undergo Phase I/II clinical studies in China for recurrent/refractory membranous nephropathy (R/R MN) and recurrent/refractory primary light chain amyloidosis (R/R ALA), with the application for recurrent/refractory membranous nephropathy being first-in-class. This approval marks the acceleration of FKC289's development process, potentially benefiting patients soon.

ExCell Bio extends warm congratulations to Fosun Kairen on the clinical approval of FKC289 injection! This achievement not only represents a breakthrough in autologous dual-target CAR-T applications in autoimmune diseases but also marks China's CGT innovation moving toward higher quality development. ExCell's domestically first OptiVitro® T cell serum-free medium bag (TE000-N072), with its core domestic quality, deeply empowers project development, working alongside excellent industry partners to accelerate the implementation of cutting-edge therapies.

Chen Xu, Founder and Chairman of ExCell Bio: "Fosun's FKC289 receiving clinical approval for both MN and ALA indications is an important milestone for the company's adherence to the 'core technology self-control' concept and deep cultivation in domestic cell therapy upstream. Starting from the underlying logic of cell culture, we have built a serum-free, chemically defined technology system covering multiple categories including T, NK, and MSC cells, aiming to provide safer, more efficient, and more standardized core material support for cell drug development. Over the past five years, the company's OptiVitro® product matrix has fully empowered global clinical applications, cumulatively assisting in over 30 therapy IND approvals in China and the US, and significantly improving customer R&D and industrialization efficiency through digital quality control and process optimization. In the future, we will continue to deepen innovation and iteration of key cell culture raw materials, accelerate domestic substitution and global layout, and strengthen the industrial foundation for accessible treatments for global tumor and autoimmune disease patients."