登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：688302 证券简称：海创药业 公告编号：2025-051 药品通用名：氘恩扎鲁胺软胶囊 中文商品名：海纳安■ 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 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 公司的具体产品销售情况会受到渠道拓宽、市场环境等诸多因素的影响，敬请广大投资者谨慎决策，注 意防范投资风险。公司将按有关规定及时对后续进展情况履行信息披露义务。 特此公告。 海创药业股份有限公司 董事会 剂型：胶囊 医保分类：乙类 协议有效期：2026年1 ...

公告还显示，氘恩扎鲁胺软胶囊被纳入2025年国家医保药品目录，体现了国家医保局对该药物临床价 值、患者获益及创新程度等方面的认可。氘恩扎鲁胺软胶囊进入医保目录后，有利于该药物的市场推 广，将进一步减轻患者用药负担，提升药品可及性。海创药业将积极配合推动医保政策落地，持续推进 医院准入与核心市场覆盖，以期更大范围满足患者的用药需求。 氘恩扎鲁胺软胶囊(曾用名：HC-1119软胶囊)是海创药业自主研发的、用于治疗转移性去势抵抗性前列 腺癌(mCRPC)的1类新药，是第二代雄激素受体(AR)抑制剂，获得国家重大新药创制科技重大专项支 持。 作为国内首款获批上市治疗接受醋酸阿比特龙及化疗后出现疾病进展，且既往未接受新型雄激素受体抑 制剂的转移性去势抵抗性前列腺癌成人患者的国产创新药物，相较于其他新型内分泌药物，氘恩扎鲁胺 软胶囊在安全性方面表现优异，可显著降低中枢神经系统不良事件(如癫痫、跌倒等)发生率，且无皮疹 相关不良反应，同时减少老年患者常见并发症风险。2025版中国临床肿瘤学会(CSCO)前列腺癌诊疗指 南已将其纳入mCRPC的推荐治疗方案。 本报讯(记者蒙婷婷)12月7日晚间，海创药业股份有限公司(以下简称 ...

氘恩扎鲁胺软胶囊被纳入2025年国家医保药品目录，体现了国家医保局对对该药物临床价值、患者获益 及创新程度等方面的认可。药品进入医保目录后，有利于该药物的市场推广，将进一步减轻患者用药负 担，提升药品可及性。国家医保目录将自2026年1月1日起正式实施，公司将积极配合推动医保政策落 地，持续推进医院准入与核心市场覆盖，以期更大范围满足患者的用药需求。具体医保支付标准、医保 报销细则等相关信息，需以国家医保局等相关政府部门公示信息为准。 格隆汇12月7日丨海创药业(688302.SH)公告，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。 ...

氘恩扎鲁胺软胶囊(曾用名：HC-1119软胶囊)是公司自主研发的、用于治疗转移性去势抵抗性前列腺癌 (mCRPC)的1类新药，是第二代雄激素受体(AR)抑制剂，获得国家重大新药创制科技重大专项支持。 海创药业(688302.SH)发布公告，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")，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。 ...

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]

Core Insights - Rui Jian Pharmaceutical has achieved significant milestones in the development of its Parkinson's disease cell therapy product NouvNeu001, becoming the first globally to receive Fast Track designation from the FDA and entering Phase II clinical trials in China [1][4] - Chengdu High-tech Zone is emerging as a key player in the biopharmaceutical industry, with a focus on innovative drug development and a robust ecosystem supporting various companies [3][12] Company Developments - Rui Jian Pharmaceutical's NouvNeu001 is the first iPSC-derived universal cell therapy for Parkinson's disease to gain Fast Track status from the FDA, while also progressing in clinical trials in China [1] - The company is also advancing other products, such as NouvNeu004 for multiple system atrophy, which has received approval for full-cycle clinical trials in China [4] - Recent funding of over 300 million yuan for Rui Jian Pharmaceutical will accelerate the development of its Parkinson's and ophthalmic treatment products [14] Industry Trends - Chengdu High-tech Zone has been recognized as a leading biopharmaceutical hub, ranking alongside other major innovation districts in China [3] - The region is witnessing a surge in innovative products, with multiple companies achieving significant breakthroughs in various therapeutic areas, including diabetes and cancer [7][5] - The biopharmaceutical industry in Chengdu is projected to exceed 128 billion yuan in scale by 2024, with over 3,000 companies contributing to this growth [7] Ecosystem and Collaboration - The development of Rui Jian Pharmaceutical is closely tied to the supportive ecosystem in Chengdu High-tech Zone, which includes a network of suppliers and clinical resources [8][10] - The establishment of the "Global New Drug Discovery Center" aims to integrate resources from over 3,000 biopharmaceutical companies in the region, enhancing collaboration and innovation [11] - The collaboration between enterprises and institutions, such as Sichuan University West China Hospital, is fostering a comprehensive innovation chain from research to commercialization [12][18] Policy and Financial Support - Chengdu High-tech Zone has implemented supportive policies and established a substantial investment fund to facilitate the growth of the biopharmaceutical sector [16][17] - The "Wutong Plan" provides a comprehensive service framework for biopharmaceutical companies, covering all stages from drug development to market entry [17] - The region's proactive approach in policy-making and capital investment is crucial in overcoming challenges in the biopharmaceutical innovation landscape [16][14]

Core Insights - Haichuang Pharmaceutical achieved significant revenue growth in the first three quarters of 2025, with a reported revenue of 23.35 million yuan, representing a year-on-year increase of 21,180.28% [1] - The company reported a net loss attributable to shareholders of 99.15 million yuan, a substantial reduction from a loss of 154 million yuan in the same period last year [1] - The approval and commercialization of the first-class new drug, Dihenzalutamide, in May 2025 marked a pivotal moment for the company, indicating a successful transition from the investment phase to the return phase [1][2] Revenue Growth and Market Strategy - The significant revenue increase is attributed to the successful market launch of Dihenzalutamide, which has become a key revenue driver for the company [1] - Haichuang Pharmaceutical employs a dual-track model of "self-operated + CSO (Contract Sales Organization)" and a four-wheel drive strategy encompassing "medical-market-access-sales" to rapidly capture market opportunities [2] - The company has established an efficient sales network covering over 500 hospitals and 240 DTP pharmacies across 30 provinces, laying a solid foundation for the rapid growth of new drug sales [2] Product Development and Clinical Trials - Dihenzalutamide has been included in the 2025 edition of the CSCO Prostate Cancer Diagnosis and Treatment Guidelines, enhancing its market recognition [2] - The product is undergoing preliminary review for inclusion in the national medical insurance directory, which, if successful, will significantly improve drug accessibility and accelerate market penetration [2] - In the metabolic disease sector, the company is advancing its key product HP515, which targets obesity and metabolic-associated fatty liver disease (MASH), with promising results from Phase I clinical trials [3] Future Prospects - The development path for HP515 focuses on three main areas: combination therapy with GLP-1 for MASH, combination therapy for obesity, and exploring its use with the company's own oral small molecule GLP-1 receptor agonist [3] - The company is expected to continue expanding its revenue scale and gradually reduce net profit losses as new drugs progress through commercialization [3] - With its innovative technology and forward-looking pipeline, Haichuang Pharmaceutical is positioned to secure a significant place in the biopharmaceutical sector [3]

Core Viewpoint - Haichuang Pharmaceutical's first innovative drug, Deuteroenzalutamide soft capsule, reported a revenue of 10.18 million yuan for the quarter, a 22.65% decrease from the previous quarter, and a net loss of 37.29 million yuan, down 25.35% quarter-on-quarter but narrowed by 30% year-on-year [2][3][4]. Financial Performance - Revenue for the quarter was 10.18 million yuan, a significant drop from 13.16 million yuan in June, indicating a failure to maintain growth [4]. - The total profit for the period was -37.29 million yuan, with a basic earnings per share of -0.38 yuan [5][8]. - Cash flow from operating activities showed a net outflow of 32.28 million yuan, primarily due to employee payments and market promotion expenses [8]. Cost Structure - Sales expenses reached 15.19 million yuan, a 218.68% increase year-on-year, leading to a high expense ratio of 606.44% [6]. - Despite a decrease in R&D expenses, the overall cost structure remains burdensome, impacting profitability [6]. Market and Product Pipeline - The company has strategically adjusted its pipeline, halting further development of the HP501 project due to intense competition in the URAT1 target market [10][11]. - The ongoing clinical trial for HP515 is expected to face significant market challenges, similar to those encountered by the abandoned HP501 project [11]. - The competitive landscape for Deuteroenzalutamide is intense, with the prostate cancer treatment market in China valued at 8.1 billion yuan in 2022, dominated by other established drugs [12][13]. Future Outlook - Analysts predict that Haichuang Pharmaceutical may not achieve profitability until 2027, with a consensus net loss forecast of 219 million yuan for 2025 [13].

Core Viewpoint - Haichuang Pharmaceutical (688302) reported significant revenue growth in Q3 2025, driven by the launch of its first Class 1 new drug, HC-1119, for prostate cancer treatment, marking its entry into commercialization [1] Group 1: Financial Performance - For the first nine months of 2025, the company achieved revenue of 23.35 million yuan, a year-on-year increase of 21,180% [1] - The net loss narrowed to 99 million yuan from a loss of 154 million yuan in the same period last year [1] Group 2: Product Development and Market Entry - The drug HC-1119 was approved for sale in late May 2025, generating its first sales revenue [1] - HC-1119 has been included in the 2025 edition of the CSCO Prostate Cancer Diagnosis and Treatment Guidelines, gaining clinical recommendation status [1] - The product has passed the initial review for inclusion in the national medical insurance directory, which could enhance drug accessibility and market penetration [1] Group 3: Market Potential - Prostate cancer is a prevalent cancer among men in China, with 134,000 new cases reported in 2022, indicating a large and growing patient base [1] - The domestic market for second-generation anti-androgens is projected to exceed 4 billion yuan by 2024, with an estimated overall market size of 50 billion yuan by 2030 [1] Group 4: Sales Strategy - The company employs an innovative "self-operated + CSO" dual-track model, supported by a "medical-market-access-sales" four-wheel drive strategy [2] - A robust sales network has been established, covering over 500 hospitals and 240 DTP pharmacies across 30 provinces and cities in China [2] Group 5: Clinical Trials - The Phase I clinical trial for HP515, aimed at treating metabolic-associated fatty liver disease (MASH), has met its expected goals [2] - Initial results show significant improvements in multiple blood lipid indicators, with LDL-C reduction of 39%, TC reduction of 28%, and ApoB reduction of 41% at an 80 mg dosage [2] Group 6: Future Development Plans - The company is advancing to Phase IIa clinical trials for HP515, focusing on three main directions: combination therapy with GLP-1 for MASH, obesity treatment, and exploring combinations with its own oral small molecule GLP-1 receptor agonist [3]

Core Viewpoint - The report outlines the ongoing supervision and financial performance of Hai Chuang Pharmaceutical Co., Ltd., highlighting its focus on innovative drug development in oncology and metabolic diseases, while also addressing the associated risks and challenges in achieving profitability and market acceptance [1][2][3]. Group 1: Continuous Supervision and Financial Performance - The continuous supervision by CITIC Securities has not revealed any major issues within the company during the reporting period [2]. - The company reported a revenue of 13.17 million yuan for the first half of 2025, with a net loss of 61.85 million yuan, indicating ongoing financial challenges [2][11]. - Research and development expenses for the period amounted to 56.97 million yuan, reflecting a significant investment in drug development [8][20]. Group 2: Risks and Challenges - The company faces risks related to its lack of profitability, as it is heavily invested in R&D with long timelines for product commercialization [2][3]. - There is a risk of significant revenue decline or losses due to ongoing R&D expenditures and the uncertain approval timelines for new drugs [2][3]. - The company’s core product, Deuterated Enzalutamide soft capsules, was approved for sale in May 2025, but the commercial success remains uncertain due to competition and market acceptance challenges [5][11]. Group 3: R&D and Product Pipeline - The company has established four core technology platforms, including PROTAC and deuterated drug development, which are crucial for its innovative drug pipeline [13][19]. - The Deuterated Enzalutamide soft capsule is the first domestically approved drug for treating metastatic castration-resistant prostate cancer, marking a significant milestone for the company [13][21]. - The company is actively pursuing clinical trials for multiple products, including HP518, which has received fast-track designation from the FDA for treating AR-positive triple-negative breast cancer [15][22]. Group 4: Fundraising and Financial Management - The total amount raised through public offerings was approximately 1.06 billion yuan, with a significant portion already utilized for R&D and operational expenses [26]. - As of June 30, 2025, the company had a remaining balance of 117.24 million yuan in its fundraising account, indicating ongoing financial management efforts [26][27]. - The company has implemented a structured approach to manage and utilize the raised funds effectively, ensuring compliance with regulatory requirements [26].