Jiangsu Hengrui Medicine Gets NMPA Approval for HRS-4357 Clinical Study in Prostate Cancer

Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 radiotherapeutic drug, HRS-4357. This novel molecule is under development for the treatment of prostate specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) in patients who have previously received androgen receptor (AR) pathway inhibitor and taxane therapy.

HRS-4357: A Unique Approach to Prostate Cancer Treatment
Hengrui highlights that HRS-4357 has no similar product approved globally, making it a pioneering drug candidate in the field of radiotherapeutics for prostate cancer. The company has invested significantly in the research and development of HRS-4357, with a total outlay of RMB 29.18 million (USD 4 million) to date. This investment underscores Hengrui’s commitment to innovation in cancer treatment and the development of targeted therapies for hard-to-treat cancers like mCRPC.

The Clinical Study and Its Significance
The upcoming clinical study for HRS-4357 is a crucial step towards bringing a potentially groundbreaking treatment to patients with PSMA positive mCRPC. The study will evaluate the safety, tolerability, and efficacy of the drug, which could offer a new therapeutic option for patients who have exhausted standard treatments and are in need of more targeted and effective care.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry