Hinova Pharmaceuticals (688302)
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海创药业股份有限公司自愿披露关于氘恩扎鲁胺软胶囊纳入2025年国家医保药品目录的公告
Shang Hai Zheng Quan Bao· 2025-12-07 18:43
Core 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].
海创药业新药氘恩扎鲁胺软胶囊首次纳入国家医保目录
Zheng Quan Ri Bao Wang· 2025-12-07 12:33
Core Viewpoint - Haichuang Pharmaceutical's self-developed drug, Deuteroenzalutamide soft capsule, has been included in the national medical insurance drug list, effective from January 1, 2026, marking a significant milestone for the company and the treatment of metastatic castration-resistant prostate cancer (mCRPC) [1][2] Group 1 - Deuteroenzalutamide soft capsule is a first-class new drug developed by Haichuang Pharmaceutical, specifically for treating mCRPC, and is recognized as a second-generation androgen receptor inhibitor [1] - The drug is the first domestically approved innovative medication for adult patients with mCRPC who have progressed after treatment with abiraterone acetate and chemotherapy, and have not previously received new androgen receptor inhibitors [1] - The drug demonstrates superior safety compared to other new endocrine therapies, significantly reducing the incidence of central nervous system adverse events and avoiding rash-related side effects, while also lowering the risk of common complications in elderly patients [1] Group 2 - The inclusion of Deuteroenzalutamide soft capsule in the national medical insurance drug list reflects the recognition of its clinical value, patient benefits, and innovation by the National Healthcare Security Administration [2] - This inclusion is expected to facilitate market promotion of the drug, reduce the financial burden on patients, and enhance drug accessibility [2] - Haichuang Pharmaceutical plans to actively support the implementation of medical insurance policies and continue to promote hospital access and core market coverage to meet patient medication needs more broadly [2]
海创药业氘恩扎鲁胺软胶囊纳入2025年国家医保药品目录
Ge Long Hui· 2025-12-07 08:41
Core Viewpoint - Haichuang Pharmaceutical's self-developed drug, Deutetrabenazine soft capsules, has been included in the National Medical Insurance Drug List for 2025, marking a significant recognition of its clinical value and innovation by the National Healthcare Security Administration [1] Group 1 - The inclusion of Deutetrabenazine soft capsules in the National Medical Insurance Drug List will facilitate market promotion and reduce the financial burden on patients, enhancing drug accessibility [1] - The National Medical Insurance Drug List will be officially implemented starting January 1, 2026, and the company will actively cooperate to promote the implementation of insurance policies [1] - The company aims to expand hospital access and core market coverage to better meet patient medication needs [1]
海创药业:氘恩扎鲁胺软胶囊被纳入2025年国家医保药品目录
Zhi Tong Cai Jing· 2025-12-07 08:19
Core Viewpoint - Haichuang Pharmaceutical (688302.SH) announced that its self-developed drug, Deuteroenzalutamide soft capsule, has been included in the National Medical Insurance Drug List after negotiations, effective from January 1, 2026 [1] Group 1 - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security published the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List for 2025 [1] - Deuteroenzalutamide soft capsule is a first-class new drug developed by the company for the treatment of metastatic castration-resistant prostate cancer (mCRPC) [1] - The drug is a second-generation androgen receptor (AR) inhibitor and has received support from the National Major New Drug Creation Science and Technology Major Project [1]
海创药业(688302.SH):氘恩扎鲁胺软胶囊被纳入2025年国家医保药品目录
智通财经网· 2025-12-07 08:17
Core Viewpoint - Haichuang Pharmaceutical (688302.SH) announced that its self-developed drug, Deuteroenzalutamide soft capsule, has been included in the National Medical Insurance Drug List after negotiations, effective from January 1, 2026 [1] Group 1 - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security published the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List for 2025 [1] - Deuteroenzalutamide soft capsule is a first-class new drug developed by the company for the treatment of metastatic castration-resistant prostate cancer (mCRPC) [1] - The drug is a second-generation androgen receptor (AR) inhibitor and has received support from the National Major New Drug Creation Science and Technology Major Project [1]
海创药业(688302) - 自愿披露关于氘恩扎鲁胺软胶囊纳入2025年国家医保药品目录的公告
2025-12-07 07:45
证券代码:688302 证券简称:海创药业 公告编号:2025-051 自愿披露关于氘恩扎鲁胺软胶囊纳入 2025 年 国家医保药品目录的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 2025 年 12 月 7 日,国家医保局、人力资源社会保障部公布了《国家基本医 疗保险、生育保险和工伤保险药品目录(2025 年)》(以下简称"国家医保药品 目录"),海创药业股份有限公司(以下简称"公司")自主研发的氘恩扎鲁胺 软胶囊通过国家医保谈判,首次被纳入国家医保药品目录,该目录将于 2026 年 1 月 1 日起执行。 现将相关情况公告如下: 一、药品相关情况 药品通用名:氘恩扎鲁胺软胶囊 中文商品名:海纳安® 剂型:胶囊 医保分类:乙类 海创药业股份有限公司 激素受体(AR)抑制剂,获得国家重大新药创制科技重大专项支持。氘恩扎鲁胺 (HC-1119)在中国开展的Ⅲ期临床数据入选2023年6月美国临床肿瘤学会(ASCO) 年会,氘恩扎鲁胺的 HC-1119-04 注册研究纳入了 2023 版 CSCO 前列 ...
海创药业:氘恩扎鲁胺软胶囊纳入2025年国家医保药品目录
Xin Lang Cai Jing· 2025-12-07 07:39
Core Viewpoint - Haichuang Pharmaceutical announced that its self-developed drug, Deutetrabenazine soft capsules (brand name: Hainan'an®), has been included in the National Medical Insurance Directory for 2025, effective from January 1, 2026, with an agreement valid until December 31, 2027 [1] Group 1 - The drug is a first-class new medication for the treatment of metastatic castration-resistant prostate cancer, demonstrating excellent safety [1] - Inclusion in the medical insurance directory will facilitate market promotion and reduce the financial burden on patients [1] - The company will actively promote the implementation of the medical insurance policy [1]
122亿!国药控股大合作来了
Xin Lang Cai Jing· 2025-12-04 11:36
Core Insights - China National Pharmaceutical Group (Sinopharm) has renewed its distribution partnership with Fuhong Hanlin, which will last from January 1, 2026, to December 31, 2028, focusing on the commercialization of innovative biopharmaceutical products [1][10]. Group 1: Partnership with Fuhong Hanlin - Fuhong Hanlin, a biopharmaceutical company, has a strong product matrix and approximately 50 molecules in development, ensuring a stable supply of new products for Sinopharm [3][5]. - The sales cap for the renewed partnership is set at 12.224 billion RMB over three years, with expected sales growth driven by new product launches and existing product demand [5][17]. - Specific sales growth expectations include a 0.8% increase in 2027 and a 14.2% increase in 2028, attributed to new indications and innovative products [5][17]. Group 2: Strategic Collaborations - Sinopharm is accelerating collaborations with upstream industrial partners, including a recent strategic partnership with Pierre Fabre, a French pharmaceutical company [5][19]. - The company is also engaging with other multinational pharmaceutical giants like AstraZeneca and Bristol-Myers Squibb to explore strategic synergies and innovative business models [19][20]. - Domestic collaborations are also progressing, with Sinopharm partnering with Tianjin Pharmaceutical Group to enhance channel integration and product offerings [21][22]. Group 3: Retail and Operational Performance - Sinopharm's retail arm, Guoda Pharmacy, is transforming its procurement system and has seen a 11.3% year-on-year sales growth in core products from industrial partners in the first half of 2025 [23]. - The company reported a revenue of 431.5 billion RMB in the first three quarters of 2025, with a reduced year-on-year decline of 2.47% [23]. - Recent leadership changes, including the resignation of Chairman Zhao Bingxiang, signal a potential shift in strategic direction for Sinopharm [24].
复星医药:控股子公司地舒单抗生物类似药HLX14获国家药监局受理
Hua Er Jie Jian Wen· 2025-12-02 15:17
Core Points - The subsidiary of Fosun Pharma, Fuhong Hanlin, has received acceptance for the drug registration application of the biosimilar HLX14, a drug similar to Dexamethasone, by the National Medical Products Administration [1] - The application is classified as a Class 3.3 therapeutic biological product, with indications based on all approved indications of the reference drug Prolia in China [1] Product Information - HLX14 has been approved for marketing in the United States, European Union, and the United Kingdom, covering all indications of the original product [1] - The application for marketing registration was accepted by Health Canada in September 2024 [1] - Cumulative R&D investment is approximately 320 million yuan (unaudited) as of October 2025 [1] Market Outlook - According to IQVIA data, the global sales of Dexamethasone products are projected to be approximately 7.463 billion USD in 2024 [1]
西高院:关于变更持续督导保荐代表人的公告



Zheng Quan Ri Bao Zhi Sheng· 2025-11-26 13:39
Core Points - The Xi'an High Voltage Electrical Research Institute Co., Ltd. has received a notice from its sponsor, China International Capital Corporation (CICC), regarding a change in the representative responsible for ongoing supervision of its initial public offering (IPO) project [1] - The original supervising representatives were Ms. Tong Yan and Mr. Jia Yizhen, but due to Ms. Tong's job change, she will no longer serve in this role [1] - Mr. Zhan Zhengjie has been appointed to replace Ms. Tong and will continue to fulfill the duties of ongoing supervision [1]