Zhongguancun-Backed Qinghui Lianuo Receives CDE IND Approval for QH104A, a First-in-Class Allogeneic CAR-γδ T Cell Therapy Targeting B7H3 for CNS Malignancies

(Source:ZhongguancunDevelopment Group）

Source: Zhongguan Village Development Group

Recently, QH104A, the world's first off-the-shelf CAR-γδ T cell injection targeting B7H3, independently developed by Beijing Qinghui Lienal Biotechnology Co., Ltd. ("Qinghui Lienal"), an investee company of Zhongguancun Development Group, has officially received the clinical trial implied permission from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). It is intended for the treatment of recurrent or progressive central nervous system malignant tumors.

QH104A is the first allogeneic cell drug for solid tumors to achieve dual submissions and dual approvals in both China and the United States. It is also one of the fastest-progressing products globally among cell therapies targeting the same indication. In May 2025, it received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). The product demonstrated favorable safety and efficacy in earlier IIT studies, and preparations for Phase I clinical research are nearly complete.

Qinghui Lianuo, located in the Zhongguan Village Life Science Park and founded under the leadership of Professor Yonghui Zhang from Tsinghua University's School of Pharmaceutical Sciences, is a company based on a new type of immune cell --A biotechnology company developing innovative immunotherapeutics based on γδ T cells, committed to fully exploringγδ TThe therapeutic potential of Cell/BTN immune mechanisms in cancer, infectious diseases, and autoimmune disorders. The company is a national high-tech enterprise that has built an immunological innovative drug R&D platform in compliance with GMP standards. Its ongoing projects have received support from the National Key R&D Program and Beijing Science and Technology Program.

In 2021, Zhongguancun Capital led the PRE-A round financing of Qinghui Lianuo, simultaneously driving market-oriented institutions to participate in this RMB 100 million round. In 2024, it continued to increase its investment. Meanwhile, it provided comprehensive post-investment services for the company, assisting it in settling into the Zhongguancun Life Science Park, successfully completing the setup of a 1,400-square-meter proprietary laboratory, and offering services such as financing matchmaking and support for clinical research.

In recent years, Zhongguan Village Development Group has focused on high-end projects in the fields of artificial intelligence, integrated circuits, pharmaceuticals and healthcare, new energy, and new materials. It has built a full life-cycle industrial fund system covering everything from angel investment, venture capital to mergers and acquisitions, including high-end precision funds, scientist funds, golden seed funds, IPO support funds, and S funds. To date, the group's fund system has invested in over 4,000 technology projects, supported more than 200 national strategic science and technology projects, nurtured over 1,000 national high-tech enterprises, nearly 800 specialized and sophisticated companies, 96 unicorn companies, and more than 160 listed companies.