Class I Innovative Drug — Deuterated Enzalutamide Soft Capsules Approved for Market Launch!A Breakthrough in China’s Prostate Cancer Treatment with a Homegrown Innovation!
According to information obtained from the official website of Hong Kong DengYue Medicine, the Class I innovative drug Haina’an® (generic name: Deuterated Enzalutamide Soft Capsules) has been approved for marketing in China.
This therapy is indicated for adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after treatment with abiraterone acetate and chemotherapy, and who have not previously received a novel androgen receptor inhibitor.
Supported by the National Major New Drug Innovation Program, Deuterated Enzalutamide Soft Capsules represent the first domestically developed innovative drug approved in China for this specific indication.
According to GLOBOCAN 2022 data, prostate cancer is among the most common urological malignancies—ranking second in global incidence and fifth in cancer-related mortality among men—with 1.467 million new cases worldwide in 2022.
In China, prostate cancer incidence has been rising steadily, 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 second-generation androgen receptor (AR) inhibitor, developed under the support of the National Major Scientific and Technological Special Project for Significant New Drug Development.
The Phase III clinical trial conducted in China met its primary endpoint, showing that, compared with the control group, Deuterated Enzalutamide significantly prolonged progression-free survival (PFS) 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 Deuterated Enzalutamide (HC-1119) were presented at the 2023 ASCO Annual Meeting and have been included in the 2023 edition of the CSCO Prostate Cancer Clinical Guidelines.
Compared with other novel endocrine therapies, Deuterated Enzalutamide Soft Capsules demonstrate superior safety, significantly lowering the incidence of central nervous system-related adverse events (such as seizures and falls), showing no rash-related side effects, and reducing the risk of common comorbidities in elderly patients.
As one of China’s leading pharmaceutical exporters and distributors, Hong Kong DengYue Medicine is accelerating its global expansion and actively building a stronger international presence.
Guided by the mission of “Connecting Chinese Innovation, Serving Global Health,” DengYue Medicine is committed to bringing high-quality Chinese pharmaceuticals to the world, ensuring safe, reliable, and accessible therapeutic solutions for patients worldwide.
Looking ahead, DengYue Medicine will continue optimizing its global supply chain, strengthening international partnerships, and deepening strategic collaboration with leading pharmaceutical enterprises.
The company will invest in brand development and market expansion, advancing more Chinese-made quality medicines into mainstream global markets.
To become a globally recognized benchmark in Chinese pharmaceutical distribution, DengYue Medicine will continue to earn the world’s trust and respect through the excellence and strength of Chinese manufacturing.
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