Shanghai Huilun Pharmaceutical’s new anti-tumor drug HTMC0435 has been approved for clinical trials

2020-04-26 Print Return

HTMC0435 tablets, a new anti-tumor Class 1.1 drug independently developed by Shanghai Huilun Pharmaceutical, was granted an implicit license for clinical trials by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on February 12, 2020, and was allowed to conduct clinical research on new drugs. The approved information is as follows:

Shanghai Huilun Pharmaceutical is one of the pioneers in the research of PARP small molecule inhibitors among domestic companies. The research and development strategy uses benzopyrazine, which was commonly used in the most cutting-edge drugs in the world at that time (such as Olaparib), as the backbone unit. Based on the pharmacophore model of PARP small molecule inhibitors, the mother core structure is appropriately configured and optimized with pharmacophore, and a large number of powerful small molecule inhibitors with independent intellectual property rights are obtained, including HTMC0435.

In June 2017, HTMC0435 entered the comprehensive IND development stage, following the requirements of the NMPA, FDA and EMA guidelines, and completed a full set of pharmacodynamic studies, non-clinical pharmacokinetic studies and pre-clinical safety evaluation studies that meet the requirements of domestic and foreign double submissions.

In December 2019, HTMC0435 API was registered and publicized by CDE, and HTMC0435 tablets were granted a CDE acceptance number.

So far, the project has applied for more than 10 invention patents at home and abroad, among which it has been authorized by China, the United States, Japan and other countries. In addition, related research has also received funding from the Shanghai Municipal Science and Technology Commission’s special fund.

As of the deadline, the Phase I clinical study of HTMC0435 tablets has been approved by the ethics committee and registered with the Office of Human Genetics. Clinical study preparations are being actively promoted, and the first patient will be enrolled in the near future. It is believed that HTMC0435 is expected to become a new anti-tumor drug targeting PARP, and Shanghai Huilun Pharmaceutical’s new drug research and development process will surely reach a new high.