HaiChuang Pharma's Class 1 New Drug Deuratumide Soft Capsules Approved for Market Launch: A Breakthrough in Domestic Treatment for Prostate Cancer in China!

On May 29, 2025, information obtained from the website of the National Medical Products Administration (hereinafter referred to as “NMPA”) revealed that Hinova Pharmaceuticals (688302.SH) had independently developed the Class I new drug Haina’an^®(Generic name: Deuterated Enzalutamide Soft Capsules) has been approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have experienced disease progression after treatment with abiraterone acetate and chemotherapy, and who have not previously received novel androgen receptor inhibitors. As a project supported by the National Major Science and Technology Project for Significant New Drugs Development, Deuterated Enzalutamide Soft Capsules is the first domestically developed innovative drug approved in China for this indication.

According to GLOBOCAN 2022 data, prostate cancer is a common malignant tumor of the urinary system, ranking second in global male cancer incidence and fifth in cancer mortality. In 2022, the number of new prostate cancer cases worldwide reached 1.467 million. In recent years, the incidence of prostate cancer in China has shown an upward trend, with 134,000 new cases reported in 2022. For metastatic castration-resistant prostate cancer, endocrine therapy remains the recommended first-line treatment.

Deuterated Enzalutamide Soft Capsules (formerly known as HC-1119 Soft Capsules) are a Class 1 new drug independently developed by the company for the treatment of metastatic castration-resistant prostate cancer (mCRPC). As a second-generation androgen receptor (AR) inhibitor, it has received support from the National Major Science and Technology Special Project for Significant New Drug Development. The Phase III clinical study of Deuterated Enzalutamide (HC-1119) in China has met its primary endpoint. Data show that, compared with the control group, Deuterated Enzalutamide significantly prolonged progression-free survival (PFS) in patients and reduced the risk of disease progression or death by 42% (HR=0.58, 95% CI: 0.439–0.770; p=0.0001).

The Phase III clinical data of dezalutamide (HC-1119) conducted in China were selected for presentation at the June 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO). The HC-1119-04 registration study of dezalutamide was included in the 2023 edition of the CSCO Guidelines for the Diagnosis and Treatment of Prostate Cancer. Dezalutamide soft capsules are the first domestically developed innovative drug approved in China for this indication. Compared with other novel endocrine therapies, dezalutamide soft capsules demonstrate a superior safety profile, significantly reducing the incidence of central nervous system adverse events (such as seizures and falls), causing no rash-related adverse reactions, and lowering the risk of common complications in elderly patients.

With the approval of deuterated enzalutamide, Hinova Pharmaceuticals is accelerating its commercialization efforts. The company has established a research and production base in Chengdu that complies with international GMP standards and has assembled a professional marketing team to ensure full readiness for the product’s market launch.

Dr. Chen Yuanwei, Founder and Chairman of Hinova Pharmaceuticals Inc., stated, “Deuterated Enzalutamide is the ‘debut masterpiece’ that Hinova has honed over a decade. Its ten-year R&D journey demonstrates Hinova Pharmaceuticals’ unwavering commitment to innovation. We look forward to this innovative drug, representing ‘Intelligent Manufacturing in China,’ providing patients with safer and more effective treatment options. Deuterated Enzalutamide marks only the beginning of Hinova Pharmaceuticals’ innovation journey; in the future, we will drive the commercialization of more products. Guided by our mission of ‘Creating Quality Medicines to Benefit the World,’ Hinova Pharmaceuticals will continue to invest in building cutting-edge technology platforms and develop innovative drugs with global rights, bringing Chinese wisdom to benefit patients worldwide.”