Recently, news released from the State Drug Administration (SFDA) that the innovative small molecule drug with new mechanism, leonurine sulfate tablets (referred to as “SCM-198”) which was previously transferred to Zhongzhu Medical, has been approved by the SFDA for clinical trial. The Approval (No. 2018L02655) is a one-time approval for all Phase I, II and III clinical trials, which is a major reform of SFDA to approve Phase I to III clinical trials to the excellent original new drug. Clinical trials of SCM-198 tablets are about to begin based on the approval.
The preclinical study of SCM-198 has been finished after over 10 years of research by the team led by Prof. Yizhun Zhu. Prof. Zhu, the former Dean of the School of Pharmacy at Fudan University, is the winner of the National Outstanding Youth Fund, the Distinguished Professor of the Ministry of Education, the Chief Scientist of the National Major Research Program, and the head of the National Major New Drug Platform.
In December of 2016, Zhongzhu Medical and Fudan University signed a contract to successfully obtain the exclusive development and industrialization rights of SCM-198 worldwide with RMB 150 million. In September 2017, SCM-198 was submitted as a new drug registration IND application with the joint efforts and further improvement of both parties. In February 2018, SCM-198 entered the CDE green channel for rapid review process as a major drug supported by the “National Major New Drug Creation” technology, and was approved for clinical approval after completing the technical review in June. Currently, SCM-198 has been filed as an IND for US clinical research at FDA and is expected to conduct clinical research in the United States soon.
As reported by the National Health and Family Planning Commission, more than 160 million people in China are suffering from hyperlipidemia and the anti-hyperlipidemia drugs are in great need. It has been estimated that the anti-hyperlipidemia products in China should exceed 30 billion on sales in 2019. As a hypolipidemic innovative drug, SCM-198 will simultaneously declare IND in China and the United States, which will gradually enter the clinical trials in both countries. It is expected to become one of the few original drugs in China.