氘恩扎鲁胺胶囊

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海创药业前列腺癌药物获批 首个商业化产品能带领公司扭亏吗?
Mei Ri Jing Ji Xin Wen· 2025-05-29 13:29
Core Viewpoint - Hecotech Pharmaceuticals has received approval for its core product, Deutetrabenazine capsules, marking the company's first commercialized product after years of operating with zero drug revenue [2][3]. Group 1: Product Approval and Market Potential - Deutetrabenazine capsules are approved for treating metastatic castration-resistant prostate cancer (mCRPC) in adult patients who have not previously received novel androgen receptor inhibitors [3]. - The drug is the first deuterated mechanism innovation in the prostate cancer field and the first domestic innovative drug approved for this indication [3]. - According to GLOBOCAN 2022, there were 1.467 million new prostate cancer cases globally in 2022, with 134,000 new cases reported in China [3]. Group 2: Company Financials and Historical Context - Prior to the approval of Deutetrabenazine, Hecotech Pharmaceuticals had maintained a "zero drug revenue" status, resulting in cumulative losses of 1.703 billion yuan from 2019 to 2024 [4]. - The company is accelerating its commercialization process and has established a GMP-compliant R&D production base in Chengdu, along with a professional marketing team [4]. Group 3: Competitive Landscape - Deutetrabenazine is a deuterated version of enzalutamide, which was originally developed by Astellas and Medivation and has generated over $4 billion in global sales by 2019 [5]. - Enzalutamide's sales reached $5.67 billion in 2024, making it a significant revenue source for Astellas [5]. - Several domestic companies have developed generic versions of enzalutamide, with competition expected to intensify as the patent expires in 2026 [5].