On the evening of December 20, Hengrui Pharmaceutical issued an announcement that it recently received the approval of the State Food and Drug Administration to issue a "Drug Clinical Trial Approval Notice" on SHR1459 tablets, and will carry out clinical trials in the near future.
According to the announcement, SHR1459 tablets meet the relevant requirements of drug registration and agree to carry out clinical trials with rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) regimen for the treatment of diffuse large B-cell lymphoma.
According to the data, SHR1459 is a selective small molecule inhibitor of BTK. Preclinical studies have shown that SHR1459 shows strong kinase selectivity in vitro, good anti-B cell lymphoma activity in in vitro and in vivo experiments, and toxicological results also show that SHR1459 is well tolerated in animals, and it is expected to have high clinical application value for B cell lymphoma.
Up to now, SHR1459 related R&D projects have invested a total of about 116.36 million yuan in R&D expenses. (Wu Wenfeng)
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