The clinical trial of Hengrui Medicine's BTK inhibitor SHR1459 tablets was approved by the State Food and Drug Administration

On April 25, Hengrui Medicine issued an announcement stating that the company had received the "Notice of Drug Clinical Trial Approval" for SHR1459 tablets approved by the State Food and Drug Administration, and clinical trials will be launched soon.

According to the announcement, SHR1459 is a selective small_molecule inhibitor of BTK. Preclinical studies have shown that SHR1459 shows strong kinase selectivity in vitro, and has shown good anti-B-cell lymphoma activity in both in vitro and in vivo experiments. The results also show that SHR1459 is well tolerated in animals and is expected to have a high clinical application value for B-cell lymphoma.

Currently, four BTK inhibitors have been approved globally, namely Imbruvica (Ibrutinib), Calquence (Acalabrutinib), Brukinsa (Zanubrutinib), and Velexbru (Tirabrutinib). At present, BTK inhibitors under research in China include obritinib developed by Beijing Nuocheng Jianhua, avitinib developed by Hangzhou Aisen Pharmaceutical, and Zebutinib developed by BeiGene, all of which have been submitted to the State Food and Drug Administration for listing. The application is currently under review and approval. After querying the EvaluatePharma database, the global sales of Ibrutinib, Acalabrutinib, and Zanubrutinib in 2020 are approximately US$7.176 billion.

Up to now, SHR1459 related research and development projects have invested about 92.69 million yuan in research and development expenses.