Sinobioway STAR-T Therapeutics on Track to File 1-2 NDA Submissions for Cell Therapy Products in 2026
BriSTAR Immunotech
Cellular Immunotherapy Product Developer
Recently, a company within Zhongguan Village Life Science ParkHuaxia YingtaiCo-founder Zhao Xueqiang"When interviewed by reporters, they said: 'We have developed several autologous/universal cell therapy product pipelines, obtained two Class 1 new drug clinical trial approvals in China, received U.S. FDA Orphan Drug Designation for one product, and are currently conducting several ‘First-in-Human’ exploratory clinical trials.'"The company is expected to submit new drug marketing applications for 1-2 cell therapy drugs in 2026.", benefiting patients in China and even globally."
It is reported that the pharmaceuticals and health industry is one of the "dual engines" for Beijing's innovative development. Beijing has implemented two rounds of the Medical and Health Collaborative Innovation Action Plan, providing full-chain support for industrial development.
Among them, Huaxia Yingtai (Beijing) Biotechnology Co., Ltd., founded by renowned immunologist Professor Lin Xin, is developing a new generation of cell therapy products based on the self-innovated STAR-T technology platform using TCR-T technology, aiming to tackle solid tumors, hematologic tumors, and autoimmune diseases.
"STAR-T technology has significant advantages over CAR-T, such as high recognition sensitivity, natural dual-targeting, resistance to exhaustion, and strong tumor infiltration, which have been validated in animal studies and preliminary clinical trials," said Zhao Xueqiang. Huaxia Yingtai(Beijing)Biotechnology Co., Ltd.'s product pipeline aims at new targets for blood tumors and breakthroughs in solid tumors, utilizing dual-target or dual-function designs, with a layout ranging from autologous to universal types.
According to Zhao Xueqiang, currently, the first product of Huaxia Yingtai(Beijing)Biotechnology Co., Ltd.CD19/CD20 STAR-T Cell Injection, which was approved in September 2022 to conduct Phase I clinical research in China for relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL). AnotherSelf-developed candidate product LILRB4 STAR-T, for the treatment of acute myeloid leukemia (AML), received the U.S. FDA Orphan Drug Designation in December 2022, and was approved for IND to initiate Phase I clinical research in China in January 2024.
Since its establishment in 2018, Huaxia Yingtai(Beijing)Biotechnology Co., Ltd. has received 420 million yuan in equity financing and multiple government project supports. It is a specialized and innovative enterprise in Beijing and a key enterprise in Beijing's Medical and Health Collaborative Innovation Action Plan.
