Novartis Submits AR-Targeting PROTAC JSB462 for Clinical Trial in China; Nearly 20 Domestic Biopharma Companies Advance Their Own AR PROTAC Programs

On June 6, the CDE official website showed,NovartisClinical Trial Application for JSB462 Tablets Accepted.JSB462 is a targetedAndrogen Receptor（AR）OfProtein Degradation Targeting Chimera（PROTAC）, currently conducting overseas studies on castration-resistant prostate cancer（mCRPC）Phase III clinical trial.

Source: CDE Official Website

JSB462（ARV766）It is a product developed by Arvinas.Novel, Potent Oral AR PROTAC, which can target wild-type AR and clinically relevant ARLigand Binding Domain（LBD）Mutants, including L702H, H875Y, T878A.

In April 2024, Novartis$1.16 billionThe price fromArvinas has introducedGlobal development and commercialization rights for JSB462, as well as all rights to the preclinical project AR-V7.

Arvinas at the 2024 ASCAnnounced at the O ConferenceLatest I/II Phase Clinical Data of JSB462 for the Treatment of mCRPC(Registration No.:NCT05067140）As of April 15, 2024, the study had enrolled a total of 123 subjects, including 53 subjects carrying AR LBD mutations.

The results showed that, in 47 patients with prostate-specific antigen（PSA）LevelEvaluatableofIn AR LBD mutation subjects,PSA50 response rate was 43%In terms of safety, it was well-tolerated, with no DLTs occurring.

Insight database shows that currently globally there are30 ItemsAR PROTAC Under Research, among whichJSB462 and BMS DevelopmentGridegalutamide is the fastest progressing globally, with all in Phase III clinical trials.

In ChinaAR PROTAC under researchThere are 17 products, of which 6 have entered the clinical stage, includingHRS-5041 (Hengrui),GT20029 (Kintor Pharmaceuticals), HP518 (Hinova Pharmaceuticals), SHR3591 (Hengrui Medicine), AH-001 (Anhongsheng), and RG6537 (Jemincare).

Source: Insight Database

It is worth mentioning that,Global Development and Commercialization Rights of RG6537 Successfully ObtainedIn August 2022, it was exclusively licensed to Genentech, a subsidiary of Roche, with an upfront payment of $60 million and milestone payments of $590 million.

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