Hengrui Medicine's new generation AR inhibitor listing application plans to be reviewed first!

Article source: Medical Rubik's Cube Info

Author: Shi Bei

On October 28, the CDE official website showed that the listing application of Hengrui SHR3680 tablets was planned to be included in the priority review and started to be publicized for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden
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SHR3680 is a new type of AR (androgen receptor) antagonist with independent intellectual property rights developed by Hengrui Medicine.
It can effectively inhibit androgen-induced AR nuclear translocation and transcription activity, thereby significantly inhibiting the proliferation of AR-positive prostate cancer cells
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Compared with the first generation of AR inhibitors, SHR3680 has a stronger AR inhibitory effect and no agonistic effect

Phase III international multi-center study reached the primary endpoint and qualified for breakthrough therapy in CDE

Phase III international multi-center study reached the primary endpoint and qualified for breakthrough therapy in CDE

On July 16, Hengrui Medicine announced that the multi-center, randomized, controlled phase III SHR-3680-III-HSPC study of SHR3680 for the treatment of high tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC) reached the primary endpoint
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This study aims to evaluate the efficacy and safety of SHR3680 combined with androgen deprivation therapy (ADT) compared with standard therapy combined with ADT in the treatment of high tumor burden

The study was launched in June 2018 and was randomly enrolled at a ratio of 1:1, enrolling a total of 654 subjects
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The primary endpoints include progression-free survival (rPFS, based on an independent review committee's assessment) and overall survival (OS), and secondary endpoints include rPFS (based on the investigator's assessment), time to prostate specific antigen progression, safety, etc.

The results showed that the intermediate analysis results of SHR3680's primary endpoint of imaging progression-free survival (rPFS) reached the pre-specified superiority standard of the protocol, and it could significantly reduce the risk of disease progression or death in mHSPC patients with high tumor burden
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On September 2, SHR3680 was certified as a breakthrough therapy by CDE.

At present, 6 AR inhibitors including bicalutamide and enzalutamide have been marketed globally
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In China, bicalutamide, enzalutamide, apatamide and dalotamide have been approved for marketing

Innovative drugs continue to develop, 8 approved and 4 declared for listing

Innovative drugs continue to develop, 8 approved and 4 declared for listing

According to Hengrui’s October 15 R&D Open Day report, as of now, Hengrui has 8 original innovative drugs approved for marketing, namely Irecoxib, Apatinib, Thiopefilgrastim, Pirotinib, Carrelizumab, Remazolam, Fluzoparib, Hetrobopaethanolamine
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Four innovative drugs in the Hengrui pipeline have been declared and listed, namely DDP-4 inhibitor repagliptin, SGLT2 inhibitor Henggliflozin, CKD4/6 inhibitor SHR6390 and AR antagonist SHR3680
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Just yesterday, Hengrui announced the randomized, double-blind, placebo-controlled, multi-center phase III of its research PD-L1 monoclonal antibody SHR-1316 (Adbelizumab) combined with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer The main research endpoint of the study (SHR-1316-III-301) reached the pre-specified superiority standard
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It shows that Hengrui will submit another innovative drug to market in the near future

According to the R&D Open Day report, Hengrui has obtained 23 clinical approvals for new molecules in 2021 (tumor: 9; non-tumor: 14)
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It is expected that 30+ new drug IND applications and 15+ indications will be submitted in 2021Q4-2022