氘恩扎鲁胺软胶囊于2025年12月纳入国家医保目录，自2026年1月1日起执行，有望通过"直营+招商"双 轨模式提升患者可及性；该产品此前已于2025年5月获批上市，并纳入《CSCO前列腺癌诊疗指南》。 产品研发进展 公司重点布局前列腺癌和代谢疾病领域，口服AR PROTAC药物HP518已完成Ⅰ期临床，中国Ⅱ期及联 合用药试验正在进行；治疗代谢性脂肪性肝炎(MASH)的HP515已进入Ⅱ期临床，其与GLP-1联用的临 床前数据多次在国际会议发布。 经济观察网海创药业-U(688302)近期在商业化生产、医保准入及研发管线方面取得关键进展，同时业绩 预告显示营收增长且亏损收窄。 公司项目推进 公司于2026年2月1日公告通过药品GMP符合性检查，软胶囊剂(抗肿瘤药)生产线获认证，标志着核心产 品氘恩扎鲁胺软胶囊具备规模化生产能力，补齐了"研发-生产-销售"全产业链闭环。 业务进展情况 2025年业绩预告显示，公司预计营业收入1900万元至2200万元，同比大幅增长，亏损同比收窄24.81% 至37.34%，主要得益于氘恩扎鲁胺上市销售。 机构调研 2026年1月，公司接待淡水泉投资、西部证券（002673）等 ...

Core Insights - Haichuang Pharmaceutical's innovative drug, Deutetrabenazine (brand name: Hainan'an®), has successfully passed GMP compliance inspection, enabling large-scale commercial production [1] - The drug has been included in the 2025 National Medical Insurance Directory, providing a solid payment foundation for market expansion [1] - The combination of GMP certification and insurance inclusion creates a synergistic effect, completing the company's full industry chain from R&D to production and sales [1] Group 1: Product and Market Potential - Deutetrabenazine is the first domestic AR inhibitor approved for metastatic castration-resistant prostate cancer (mCRPC), filling a clinical gap in this area [2] - The domestic AR inhibitor market is rapidly growing, expected to reach 23.9 billion yuan by 2030, with the overall prostate cancer market exceeding 50 billion yuan [2] - The current market is dominated by foreign products, which hold 75% of the market share, indicating significant potential for domestic alternatives [2] Group 2: Pipeline Development - The activation of commercial production capacity will support not only the core product but also the pipeline reserves, ensuring scalable implementation [3] - The oral ARPROTAC drug HP518 is in clinical trials, showing potential for synergy with Deutetrabenazine in treating resistant prostate cancer [3] Group 3: Metabolic Disease Research - The drug HP515 for treating MASH has completed Phase I clinical trials, with Phase II trials ongoing, showcasing promising preclinical data in combination with GLP-1 drugs [4] - The combination therapy addresses the core issue of muscle loss associated with traditional weight loss drugs, catering to the needs of over 400 million overweight/obese individuals in China [5] - The global weight loss market is projected to reach $554.9 billion by 2030, indicating substantial growth potential in this sector [5] Group 4: Strategic Positioning - The dual breakthroughs of GMP certification and core product insurance inclusion signify the company's comprehensive capabilities in innovative R&D, large-scale production, and market promotion [5] - The company aims to leverage its mature production management system and full industry chain layout to enhance market penetration of core products and clinical transformation of pipeline products [5]

Company Overview - The company specializes in the development of new drugs, including HC-1119, HP518, HP568, HP501, HP515, HP537, and HP560 [8] - The first class new drug, HC-1119, is expected to be approved for sale in May 2025, leading to a modest increase in sales revenue from material and intermediate sales [8] Financial Performance - The company anticipates total revenue for 2025 to be between 19 million and 22 million yuan, influenced by the inclusion of HC-1119 in the National Medical Insurance Drug List, which will result in a significant price reduction [8] - Research and development expenses for 2025 are projected to be between 105 million and 125 million yuan, a decrease of 4.903 million to 6.903 million yuan compared to the previous year [8] - The company expects to report a net loss for 2025, although the loss will be reduced compared to the previous year when excluding non-recurring gains and losses [9] Historical Revenue and Profit Trends - Historical total revenue and net profit data indicate fluctuations, with total revenue expected to show a growth rate of -1,000% to 6,000% from 2020 to 2025 [10] - The company has experienced varying growth rates in total revenue and net profit over the years, with specific projections for 2025 indicating a continued trend of net losses [10] Valuation Metrics - The company’s valuation metrics include price-to-earnings (P/E) ratio, price-to-book (P/B) ratio, and price-to-sales (P/S) ratio, with P/E being negative during loss periods, making P/B and P/S more relevant for valuation [13]

2026年1月29日，海创药业披露接待调研公告，公司于12月1日至1月29日接待淡水泉投资、西部证券、 泰康资产、诺鼎资产、信达澳亚、嘉实基金等29家机构调研。 Q2：HP518 单药的临床进展以及联合用药的进展？ 调研情况显示，海创药业核心产品氘恩扎鲁胺软胶囊于2025年5月获批上市，同年6月纳入《2025版 CSCO前列腺癌诊疗指南》，12月首次进入国家医保药品目录并于2026年1月执行。其销售采用"直营＋ 招商"双轨模式，围绕"医学－市场－准入－销售"四轮驱动，通过学术平台塑造品牌，积累真实世界数 据探索全病程疗效；营销团队核心成员具备跨国药企及国内创新药商业化经验，多有泌尿肿瘤背景。前 列腺癌市场潜力较大，2022年全球新发病例146．7万，中国13．4万，预计2030年国内市场规模达500 亿，2024年中国二代抗雄药物市场超40亿元。 公司在研药物HP518为国内首个进入临床阶段的口服AR PROTAC，用于治疗转移性去势抵抗性前列腺 癌，已完成澳大利亚和中国Ⅰ期临床，中国Ⅱ期临床正在进行中，2025年11月获批联合抗肿瘤药物开展 Ⅰb／Ⅱ期临床试验。公司在AR PROTAC的分子设计、成药性研究 ...

Core Viewpoint - Haichuang Pharmaceutical announced the completion of the first batch of participant enrollment for its self-developed HP515 clinical phase II trial aimed at treating Metabolic Associated Steatotic Liver Disease (MASH), previously known as Non-Alcoholic Steatohepatitis (NASH) [2] Company Summary - The clinical phase II trial for HP515 has recently completed its first batch of participant enrollment [2] - As of the announcement date, there are no similar targeted products approved for market in China [2]

Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has announced the completion of the first participant enrollment in the Phase II clinical trial of HP515, a drug developed for the treatment of Metabolic Associated Steatotic Liver Disease (MASH) [2][3] Group 1: Clinical Trial Progress - The Phase II clinical trial of HP515 has recently completed the enrollment of its first participants [2] - HP515 is an orally administered, highly selective THR-β agonist that enhances lipid metabolism in liver cells, aiming to improve conditions related to MASH [2] - The drug received approval for clinical trials in China in August 2024 and in the United States in September 2024 [2] Group 2: Phase I Clinical Trial Results - Haichuang Pharmaceutical has completed the Phase I clinical trial of HP515, showing expected results in safety, tolerability, pharmacokinetics, and pharmacodynamics [3] - In the trial, SHBG levels increased significantly in a dose-dependent manner, with an increase of 176% at the 80mg dose after 14 days [3] - Key lipid indicators showed significant improvement, with LDL-C decreasing by 39%, TC by 28%, and ApoB by 41% at the 80mg dose [3] Group 3: Future Research Directions - The company is also conducting research on HP515 in combination with GLP-1R agonists for obesity treatment [4] - Preclinical studies indicate that HP515 may enhance weight loss effects while preserving muscle mass, potentially improving the efficacy of GLP-1R agonists [4] - Data from the combination study is set to be presented at the 32nd European Congress on Obesity in May 2025 and will be featured at the 3rd Obesity & Weight Loss Drug Development Summit in June 2025 [4]

Group 1 - The State Council issued a notice regarding the holiday arrangements for 2026 [1] - The People's Bank of China will conduct a 700 billion yuan reverse repurchase operation on November 5 [1] - Public fund performance benchmark elements library and operational instructions have been distributed to industry institutions [1] Group 2 - Trina Solar signed a memorandum of understanding for a 5GWh grid-level battery energy storage system with Pacific Green [1] - ST Lingnan has been prosecuted for alleged collusion in bidding [1] - Haichuang Pharmaceutical completed the enrollment of the first batch of participants in the Phase II clinical trial of HP515, with no similar targeted products approved for market in China [1] Group 3 - Founder Securities reported that China Cinda plans to reduce its stake by no more than 1% [1] - The ChiNext Index fell nearly 2%, with the total trading volume of the Shanghai and Shenzhen markets below 2 trillion yuan [1] - The Hong Kong Hang Seng Index declined by 0.79%, and the Hang Seng Technology Index dropped by 1.76% [1]

Core Viewpoint - Haichuang Pharmaceutical has announced the completion of the first batch of participant enrollment for its clinical phase II trial of HP515, a drug developed for the treatment of Metabolic Associated Steatotic Liver Disease (MASH), previously known as Non-Alcoholic Steatohepatitis (NASH) [1] Company Summary - The clinical phase II trial for HP515 has recently completed its first batch of participant enrollment [1] - As of the announcement date, there are no similar targeted products approved for market in China [1]

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].