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海思科(002653.SZ)获得创新药HSK46575片新增适应症IND申请受理
智通财经网· 2025-12-22 09:45
智通财经APP讯,海思科(002653.SZ)发布公告,公司子公司辽宁海思科制药有限公司于近日收到国家药 品监督管理局下发的《受理通书》,涉及药品:"HSK46575"。本次获得受理的为本品联合奥拉帕利片 或联合多西他赛和泼尼松片用于前列腺癌的治疗适应症的临床试验申请。 HSK46575片是公司自主研发的一种口服、强效和高选择性的小分子抑制剂,拟用于前列腺癌的治疗。 临床前研究结果表明,本品靶点明确、疗效确切、安全性好,是一款极具开发潜力的小分子药物,临床 应用的效益/风险比高,具有广阔的临床应用前景,有望成为前列腺癌的有效治疗药物并解决目前临床 用药匮乏的难题。根据国家药品监督管理局关于发布《化学药品注册分类及申报资料要求》的通告 (2020年第44号)中化学药品注册分类的规定,本品属于化学药品1类。 ...
海思科获得创新药HSK46575片新增适应症IND申请受理
Zhi Tong Cai Jing· 2025-12-22 09:42
HSK46575片是公司自主研发的一种口服、强效和高选择性的小分子抑制剂,拟用于前列腺癌的治疗。 临床前研究结果表明,本品靶点明确、疗效确切、安全性好,是一款极具开发潜力的小分子药物,临床 应用的效益/风险比高,具有广阔的临床应用前景,有望成为前列腺癌的有效治疗药物并解决目前临床 用药匮乏的难题。根据国家药品监督管理局关于发布《化学药品注册分类及申报资料要求》的通告 (2020年第44号)中化学药品注册分类的规定,本品属于化学药品1类。 海思科(002653)(002653.SZ)发布公告,公司子公司辽宁海思科制药有限公司于近日收到国家药品监 督管理局下发的《受理通书》,涉及药品:"HSK46575"。本次获得受理的为本品联合奥拉帕利片或联 合多西他赛和泼尼松片用于前列腺癌的治疗适应症的临床试验申请。 ...
海思科:子公司HSK46575片新增适应症IND申请获受理
Ge Long Hui A P P· 2025-12-22 09:08
格隆汇12月22日|海思科公告,子公司辽宁海思科制药有限公司于近日收到国家药品监督管理局下发的 《受理通知书》,HSK46575片联合奥拉帕利片或联合多西他赛和泼尼松片用于前列腺癌的治疗适应症 的临床试验申请获受理。HSK46575片是公司自主研发的一种口服、强效和高选择性的小分子抑制剂, 拟用于前列腺癌的治疗。临床前研究结果表明,本品靶点明确、疗效确切、安全性好,具有广阔的临床 应用前景。 ...
市场简报:知名演员患癌离世,警惕沉默的“妇癌之王”卵巢癌?-20250811
Tou Bao Yan Jiu Yuan· 2025-08-11 14:52
Investment Rating - The report does not explicitly state an investment rating for the oncology drug industry in China, particularly focusing on ovarian cancer treatments. Core Insights - Ovarian cancer is one of the most common malignant tumors in the female reproductive system in China, ranking third in incidence among gynecological malignancies and first in mortality [6] - The early symptoms of ovarian cancer are often non-specific, leading to late-stage diagnosis and low five-year survival rates, hence it is referred to as the "silent killer" [6] - The report highlights the importance of identifying early symptoms such as abdominal discomfort, loss of appetite, and urinary changes [6] Summary by Sections Ovarian Cancer Overview - Ovarian cancer is a significant health threat to women, with a high mortality rate among gynecological cancers [6] - The most common type is epithelial ovarian cancer, which is prevalent in postmenopausal women [6][11] Treatment Pathways - The standard treatment for ovarian cancer includes surgical intervention and chemotherapy, with specific protocols based on FIGO staging [10][11] - Initial treatment options vary from comprehensive staging surgery to neoadjuvant chemotherapy, depending on the cancer stage [11] Key Drugs in Ovarian Cancer Treatment - The report lists several key drugs used in the treatment of ovarian cancer, including Carboplatin, Paclitaxel, and Bevacizumab, with varying insurance coverage and price ranges [15] - The market for first-line chemotherapy drugs is mature, while alternative treatment options still show growth potential [20] Market Dynamics - As of June 2025, the report indicates that Paclitaxel has the highest market presence among approved ovarian cancer drugs in China, followed closely by Bevacizumab [20] - The report notes that while some drugs have saturated the market, others like liposomal doxorubicin are gradually penetrating due to safety advantages [20] Genetic Risk and Prevention - For high-risk populations, genetic counseling and regular screenings are recommended, particularly for those with a family history of ovarian cancer [24][26] - The report emphasizes the importance of identifying high-risk individuals for early intervention and management [26]