Shanghai JeYou Pharmaceutical Technology Co., Ltd. announced that the clinical trial application for its self-developed AR-NTD inhibitor, the JMN-2205 tablet project, has been approved by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). In preclinical studies, JMN-2205 demonstrated significant therapeutic potential through its novel mechanism of action.

JMN-2205 is a novel AR-NTD inhibitor independently developed by JeYou Pharmaceutical. Unlike conventional inhibitors that target AR-LBD (such as enzalutamide), this product binds to a unique site to block AR from entering the nucleus and "issuing commands" at the source, thereby inhibiting cancer cell growth. This differentiated mechanism enables it to effectively overcome resistance caused by AR gene mutations or splice variants (such as AR-V7) that limit the efficacy of traditional therapies.

In preclinical studies, JMN-2205 demonstrated outstanding efficacy: 1) In AR-positive prostate cancer models, its inhibitory effect was significantly superior to enzalutamide and competing AR-NTD inhibitors (~100-fold); 2) Its ability to regulate AR and AR-V7 downstream oncogenes was improved by ~30-fold compared to similar molecules. In vivo animal efficacy studies showed that it exhibited strong efficacy against enzalutamide-resistant models, including AR-LBD mutations, AR amplification, and AR-V7 mutants. Meanwhile, JMN-2205 demonstrated strong synergistic effects with multiple AR-LBD-targeting agents (including inhibitors, degraders, and RIPTAC molecules), further expanding its potential for first-line or second-line oral clinical development.

Prostate cancer is a common malignancy in men, with a global incidence rate of 30.7 per 100,000 and a rate of 9.7 per 100,000 in China. Current mainstream therapies are centered on androgen deprivation therapy (ADT) and novel androgen receptor signaling inhibitors (ARSI), but resistance is almost inevitable, and patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC) with poor prognosis.

JeYou Pharmaceutical focuses on unmet clinical needs and has established a portfolio of investigational drugs in the oncology field. Moving forward, JeYou Pharmaceutical will continue to adopt a clinical value-oriented approach, accelerating the development and commercialization of its pipeline in key therapeutic areas such as oncology, continuously pushing the boundaries of innovation, and providing more treatment options for patients worldwide.

Disclaimer:

1. This information is intended to share R&D progress and is for reference by healthcare professionals only, not for advertising purposes. For clinical medication, please follow the advice or guidance of physicians or other healthcare professionals and refer to the drug说明书.

2. JeYou Pharmaceutical does not recommend any drug or treatment for any specific use.

About JeYou Pharmaceutical

Shanghai JeYou Pharmaceutical Technology Co., Ltd. focuses on the "3+1" core therapeutic areas of oncology, nephrology, pain, and autoimmune diseases, specializing in the R&D, manufacturing, and commercial translation of innovative drugs. The company has built a differentiated product portfolio with international competitiveness, covering monoclonal/bispecific antibodies, TCE, ADCs, small molecule drugs, and PROTACs, among other modalities. Its current self-developed product portfolio comprises 40+ candidates, with over 10 in clinical stages. In February 2026, the company's self-developed Class 1 anti-tumor innovative drug Jielemei® (suximerex sulfate tablets) was approved for marketing by the National Medical Products Administration.