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 ...

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]

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].

Market Overview - In November, the U.S. private sector employment unexpectedly decreased by 32,000, marking the largest decline since early 2023[9] - The Hang Seng Index closed at 25,761, down 1.28% for the day and up 28.42% year-to-date[3] - The S&P 500 index closed at 6,850, up 0.30% for the day and up 16.46% year-to-date[3] Sector Performance - Major technology stocks in Hong Kong fell, with Bilibili down 3% and Alibaba down over 2%[9] - The financial sector also declined, with China Pacific Insurance down 4% and China Life down over 3%[9] - In contrast, precious metals and non-ferrous metals stocks rose, with China Molybdenum up over 2%[9] Global Economic Indicators - The ISM index showed that the U.S. services sector growth reached a nine-month high in November, while the prices paid index fell to a seven-month low[13] - The ADP report indicated a significant drop in employment, leading traders to bet on a 90% probability of a 25 basis point rate cut next week[13] Notable Stock Movements - Nvidia fell 1.03% and Apple dropped 0.71%, while Tesla rose 4.08% amid speculation about U.S. government support for the robotics industry[9] - Marvell Technology's stock rose 7.87% following the announcement of a $3.25 billion acquisition of Celestial AI[9] Investment Insights - Analysts suggest maintaining an overweight position in gold due to its rapid price increase since the beginning of the year, despite potential future volatility[9] - The market sentiment remains cautious due to weak labor market data and concerns over AI product sales forecasts from Microsoft[9]

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]

11月26日，香港新界大埔宏福苑多栋住宅楼发生火灾。上海复星公益基金会联合复星国际，以及复星医 药、复地香港、复宏汉霖、复星财富、鼎睿再保险等生态企业，周深等爱心人士和机构捐赠1000万港 币，用于紧急救援和灾后重建等工作。 ...

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]

Group 1 - The core viewpoint of the articles highlights the target price increases for several listed companies, particularly in the semiconductor and consumer electronics sectors, as recommended by various brokerages on November 25 [1][2]. Group 2 - The companies with the highest target price increases include: - **豪威集团 (OmniVision Technologies)**: Target price increased by 35.83% to 159.00 CNY, rated "Buy" by Huaxing Securities [2]. - **北方华创 (North Huachuang)**: Target price increased by 25.12% to 523.00 CNY, rated "Buy" by CITIC Securities [2]. - **立讯精密 (Luxshare Precision)**: Target price increased by 22.17% to 68.05 CNY, rated "Buy" by Huaxing Securities [2]. Group 3 - On November 25, a total of 14 listed companies received brokerage recommendations, with companies like 梅花生物 (Meihua Biological), 维力医疗 (Weili Medical), and 东航物流 (China Eastern Logistics) receiving one recommendation each [2]. Group 4 - In terms of initial coverage, three companies received new ratings on November 25: - **维力医疗 (Weili Medical)**: Rated "Buy" by CITIC Jian Investment [3]. - **东航物流 (China Eastern Logistics)**: Rated "Buy" by Zhongtai Securities [3]. - **爱博医疗 (Aibo Medical)**: Rated "Recommended" by Ping An Securities [3].

Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration of China for its new generation androgen receptor (AR) targeted protein degrader HP518 tablets, which will be used in a Phase Ib/II clinical trial for advanced prostate cancer treatment [1] Group 1: Product Development - HP518 tablets offer a more efficient mechanism to block the AR pathway compared to traditional AR inhibitors, providing a core solution for next-generation treatment options for prostate cancer patients [1] - The Phase I clinical studies for HP518 have been completed in Australia and China, and the Phase II clinical trial in China has successfully enrolled all participants [1] Group 2: Market Positioning - HP518 tablets are positioned alongside Haichuang's commercially successful second-generation AR inhibitor, Dihydrotestosterone Enzalutamide (Hainan An), creating a differentiated combination matrix where HP518 focuses on AR degradation while Hainan An targets AR signal blockade [1] - Dihydrotestosterone Enzalutamide soft capsules are the first domestically approved innovative drug for this indication, demonstrating superior safety by significantly reducing the incidence of central nervous system adverse events and common complications in elderly patients [1] Group 3: Market Potential - The drug is expected to benefit more prostate cancer patients once it enters the medical insurance system, with projections indicating that the prostate cancer market in China could reach 50 billion yuan by 2030 [1]

Policy Developments - Shanghai government issued measures to promote high-quality development in the pharmaceutical industry, focusing on key areas such as cell and gene therapy, rare diseases, high-quality first generic drugs, and AI medical devices [2] Drug Approvals - Yipinhong received a drug registration certificate for Levodopa oral solution, aimed at treating mild to moderate Alzheimer's symptoms, with an estimated sales scale of approximately 100.21 million RMB in 2024 [4] - Prolo Pharma obtained a drug registration certificate for Cefdinir dry suspension, which is the first generic drug approved in China for this formulation, with a projected market size of 760 million RMB in 2024 [5] - Haichuang Pharma's HP518 tablet, a PROTAC drug for advanced prostate cancer, received clinical trial approval, with no similar products currently approved in the market [6] Market Activity - Dae Oriental announced plans to transfer 80% of its subsidiary Jinhua Lianji's equity for 1 RMB and related debts for approximately 5.8 million RMB [8] - Jichuan Pharma plans to repurchase shares worth between 25 million and 50 million RMB, with a maximum repurchase price of 38 RMB per share [9] Industry Trends - JD's data indicated a 22-fold year-on-year increase in sales of flu medications during the current flu season, with significant spikes in demand for specific drugs like Oseltamivir and Sufentanil [11] - The respiratory virus testing orders on JD's platform increased by 66%, with a positivity rate of 68.2% [11] Tax Compliance - Shenqi Pharma's subsidiary paid approximately 16.67 million RMB in overdue corporate income tax and penalties [13] Regulatory Issues - Former deputy director of the National Medical Products Administration, Chen Shifei, was arrested for bribery, highlighting ongoing regulatory scrutiny in the pharmaceutical sector [15]