Hinova Pharmaceuticals (SH:688302) Shang Hai Zheng Quan Bao·2025-12-07 18:43Core Viewpoint - Haichuang Pharmaceutical's drug, Deuteroenzalutamide soft capsule, has been included in the 2025 National Medical Insurance Drug List, effective from January 1, 2026, following successful negotiations with the National Healthcare Security Administration and the Ministry of Human Resources and Social Security [2][6]. Drug Information - The drug's generic name is Deuteroenzalutamide soft capsule, marketed as Hainan An, classified as a Category B drug under the medical insurance system, with an agreement validity from January 1, 2026, to December 31, 2027 [3]. - Deuteroenzalutamide is a first-class new drug developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and is a second-generation androgen receptor (AR) inhibitor, supported by the National Major New Drug Creation Technology Major Project [3]. - Clinical data from Phase III trials showed that Deuteroenzalutamide significantly extended progression-free survival (PFS) by reducing the risk of disease progression or death by 42% compared to the control group (HR=0.58, 95% CI: 0.439-0.770; p=0.0001) [3]. - The drug is the first domestically approved innovative treatment for adult patients with mCRPC who have progressed after receiving abiraterone acetate and chemotherapy, and it demonstrates superior safety by significantly reducing the incidence of central nervous system adverse events [3]. Market Context - Prostate cancer ranks as the second most common malignancy among men globally, with 1.467 million new cases reported in 2022, and in China, the incidence reached 134,000 new cases in the same year [4]. - The market for prostate cancer treatments in China is projected to reach 50 billion yuan by 2030, with the second-generation anti-androgen drug market expected to exceed 4 billion yuan by 2024 [4]. - Endocrine therapy remains the recommended first-line treatment for metastatic castration-resistant prostate cancer [4]. Company Impact - The inclusion of Deuteroenzalutamide in the National Medical Insurance Drug List reflects the recognition of its clinical value and innovation, facilitating market promotion and reducing patient medication costs [6]. - The company plans to actively support the implementation of insurance policies and expand hospital access to meet patient needs [6].