Hengrui Medicine's second-generation AR antagonist plans to be included in breakthrough treatment products

Text|Pharmaceutical Mission Hills

On August 26, the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China announced that Hengrui Medicine's new generation of AR antagonist SHR3680 was included in the proposed breakthrough therapy, and it was planned to develop metastatic hormone sensitivity for the treatment of high tumor burden.
Patients with prostate cancer
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It is worth mentioning that in July this year, Hengrui Medicine just announced that SHR3680 has reached the primary end point in a phase 3 clinical trial, and it is about to submit a pre-market communication application to CDE

Screenshot source: CDE official website

The growth of prostate cancer cells is characterized by androgen dependence, so newly diagnosed patients with metastatic prostate cancer are sensitive to androgen deprivation therapy (ADT) treatment (ie mHSPC)
.

Recent studies have shown that a new type of androgen receptor (AR) antagonist combined with ADT in the treatment of mHSPC can effectively reduce the risk of disease progression or death and prolong the overall survival (OS) of patients

SHR3680 is a new type of AR antagonist developed by Hengrui Medicine, which belongs to a class 1 new drug
.

According to a press release issued by Hengrui Medicine earlier, compared with the first generation of AR inhibitors, SHR3680 has a stronger AR inhibitory effect and no agonistic effect

On July 15, Hengrui Medicine announced that SHR3680 had reached the primary research endpoint in a phase 3 clinical trial for the treatment of prostate cancer
.

This is a multi-center, randomized, controlled Phase 3 clinical study (study number: SHR-3680-III-HSPC), which aims to evaluate the effect of SHR3680 combined with ADT in the treatment of patients with high tumor burden mHSPC compared with the standard treatment combined with ADT

The data judged by the Independent Data Monitoring Committee (IDMC) showed that the results of the interim analysis of the primary endpoint of the imaging progression-free survival reached the pre-specified superiority standard.
SHR3680 can significantly reduce the disease progression or death of mHSPC patients with high tumor burden Risk
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Public information shows that in addition to the positive results of the rPFS phase analysis, SHR3680 has multiple phase 2 clinical studies for metastatic castration-resistant prostate cancer, such as a single agent and combined docetaxel
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I look forward to the smooth progress of the follow-up clinical study of SHR3680 and bring new treatment options to patients as soon as possible

Reference materials:

[1] Center for Drug Evaluation (CDE) of China National Medical Products Administration.