National Category-1 New Medicine Developed by HNU Approved for Clinical Trials

Recently, TM471-1 capsules, a National Category-1 new medicine independently developed by Professor Jiang Yuqin and his pharmaceutical research and development innovation team from School of Chemistry and Chemical Engineering at HNU, officially received approval from the National Medical Products Administration to conduct clinical trials for the indication of “Multiple Sclerosis (MS).” This marks a significant breakthrough in the research and development of the medicine in the field of autoimmune diseases and signifies a solid step forward in overcoming the global challenge of multiple sclerosis.

The medicine research and development innovation team, with over 40 years of development history, focuses on advanced new medicinal research and the technological upgrade of established major pharmaceutical varieties. Under the strategic guidance of Dr. Ding Qingjie and Professor Li Wei, and after nearly a decade of dedicated research, the team successfully designed and developed a series of BTK inhibitors with novel frameworks, screening two candidate medicines. Compared to existing marketed products, TM471-1 capsules demonstrate higher activity, selectivity, and bioavailability, with lower toxicity, longer half-life, and a broader therapeutic window, as well as significant advantages in crossing the blood-brain barrier. In November 2023, TM471-1 capsules were approved to proceed with clinical trials for B-cell Non-Hodgkin Lymphoma and are currently undergoing Phase I clinical trials. During the research period, the team secured three international new medicine patents, which have entered over ten countries and regions, including the United States, Europe, and Canada. They successfully transferred these rights to Zhiwei Biomedicine (Xinxiang) Co., Ltd. and have published a series of research findings in journals such as Journal of Medicinal Chemistry and European Journal of Medicinal Chemistry.

Multiple Sclerosis is an immune-mediated inflammatory demyelinating disease of the central nervous system characterized by episodes of lesions in both time and space. Currently, there are no medicines available that can completely cure this disease. The emergence of TM471-1 capsules offers hope in meeting unmet clinical needs. In the future, the medicinal research and development innovation team at HNU will continue to collaborate with Zhiwei Biomedicine (Xinxiang) Co., Ltd. to conduct high-quality clinical trials, contributing to the establishment of the university’s “Double First-Class” initiative.

(School of Chemistry and Chemical Engineering, Wang Manman, Zhang Dandan)