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 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 announced the suspension of the HP501 project due to intense market competition and the presence of multiple competing products targeting the same URAT1 pathway [2][3][5]. Drug Development Pipeline - HP501, a small molecule chemical innovation drug developed by Haichuang, is a URAT1 inhibitor aimed at treating hyperuricemia and gout, with clinical trials initiated in 2018 [4]. - The project had received a clinical trial notification from the National Medical Products Administration (NMPA) in November 2018 and entered Phase II clinical trials in September 2020 [4][5]. - Despite initial optimism, the project fell behind competitors, leading to its suspension in August 2025 after an investment of 81.1125 million yuan [2][5]. Market Competition - The market for URAT1 inhibitors has become increasingly competitive, with several domestic companies having received approvals for similar products and others in advanced clinical stages [5]. - Notable competitors include Fuji Yakuhin Co Ltd and Hengrui Medicine, which have launched or are in the process of launching their own URAT1 inhibitors [5]. Strategic Focus - Following the suspension of HP501, Haichuang plans to focus on advancing the development of other projects, particularly HP518 and HP537 [6][7]. - HP518 is the first oral AR PROTAC drug in clinical trials in China, targeting metastatic castration-resistant prostate cancer (mCRPC), with ongoing clinical trials and positive safety and efficacy signals reported [7][8]. - The company aims to leverage its expertise in PROTAC drug development to enhance the progress of its pipeline projects [8].

Core Viewpoint - Haichuang Pharmaceutical has decided to suspend the development of its self-developed drug HP501 due to intense market competition and the presence of similar products already approved for the URAT1 target [2][6]. Group 1: Project Development and Market Competition - HP501, a small molecule chemical innovation drug, is a URAT1 inhibitor that showed superior biological activity compared to similar drugs in preclinical studies [3]. - The project has faced significant delays, with its clinical progress lagging behind competitors, leading to the decision to halt its development [5][6]. - As of the announcement, several domestic companies have launched products targeting the URAT1 pathway, increasing competitive pressure on HP501 [6][7]. Group 2: Financial and Strategic Adjustments - The company has invested approximately 81.11 million yuan (about 11.5 million USD) into the HP501 project before deciding to suspend it [2]. - Following the suspension, Haichuang Pharmaceutical plans to redirect the remaining funds, approximately 122 million yuan (about 17.3 million USD), towards the development of other projects, specifically HP518 and HP537 [7][8]. - HP518 is the first oral AR PROTAC drug in clinical trials in China, with ongoing studies showing promising safety and efficacy signals in treating metastatic castration-resistant prostate cancer (mCRPC) [7][8].

Investment Rating - The investment rating for the company is "Accumulate" (maintained) [2] Core Views - The company has made significant progress in innovative drug development, with the successful launch of Deutetrabenazine soft capsules, which are approved for treating metastatic castration-resistant prostate cancer (mCRPC) [9] - The company is expected to achieve revenue of 0.8 billion, 3.0 billion, and 5.0 billion RMB in 2025, 2026, and 2027 respectively, indicating a strong growth trajectory [9] Financial Performance - For the first half of 2025, the company reported total revenue of 0.13 million RMB and a net profit of -0.62 billion RMB, showing a reduction in losses compared to the same period last year [9] - Revenue growth rates are projected to be 21,708.1% in 2025, 275.0% in 2026, and 66.7% in 2027 [7][10] - The company is expected to continue incurring losses, with net profits projected at -221 million RMB in 2025, -85 million RMB in 2026, and -9 million RMB in 2027 [7][10] Research and Development Progress - The company has developed HP518, the first oral AR PROTAC drug in clinical trials in China, with clinical trial applications approved by both the NMPA and FDA [9] - HP515, another drug for treating MASH, has also progressed well, with clinical trial applications approved and ongoing patient enrollment [9] Market Performance - The company's stock has shown a performance of -7% over the last 12 months, compared to a 25% increase in the chemical pharmaceutical sector [4]

Core Viewpoint - Haichuang Pharmaceutical reported significant revenue growth in the first half of 2025, with a revenue of 13.17 million yuan, marking a year-on-year increase of 11,899.08% [1] Financial Performance - The company recorded a net profit attributable to shareholders of -61.85 million yuan, an improvement from -100 million yuan in the same period last year [1] - Previous years (2020-2023) showed zero revenue, with only 366,800 yuan in revenue for 2024 [1] Product Development - The company achieved a breakthrough with its core product, Deuteroenzalutamide soft capsule, which was approved for market release in May 2025 for the treatment of metastatic castration-resistant prostate cancer [1] - The product is a first-class new drug developed independently by the company and supported by a national major new drug creation technology project [1] Market Strategy - During the reporting period, the company initiated commercialization preparations and established a four-wheel drive strategy [1] - In June, the product was first shipped nationwide, and the first prescription was issued, with ongoing efforts for market access and medical insurance inclusion planned for 2025 [1] Research and Development Progress - The company disclosed progress on multiple drugs in development, including HP518, which has commenced Phase I/II clinical trials in China and completed Phase I trials in Australia [1] - HP515 tablets have completed Phase I clinical trials in China, with preliminary data indicating good safety [1] - The company has adopted a global synchronized development strategy, establishing global branches and clinical teams, with a product pipeline that includes 334 patent applications, of which 129 have been authorized [1] Investment and Market Performance - The company acknowledged the high costs and long cycles associated with innovative drug development, expecting R&D expenses to remain elevated, and the unprofitable status may continue, potentially increasing cumulative unrecouped losses [1] - The innovative drug sector has been favored this year, with Haichuang Pharmaceutical's stock price increasing by over 100% [1] - As of June 30, three institutions entered the top ten circulating shareholders, while the top two shareholders slightly reduced their holdings in the second quarter [1]

Core Viewpoint - Haichuang Pharmaceutical-U reported significant revenue growth in the first half of 2025, primarily driven by the launch of its first new drug, but still faces challenges in achieving profitability due to competition and ongoing R&D costs [1][2]. Financial Performance - The company achieved revenue of 13.167 million yuan, a year-on-year increase of 11,899.08% [2][3]. - The net profit attributable to shareholders was -61.853 million yuan, a reduction in losses by 38.40% compared to the same period last year [3]. - The company reported a decrease in R&D expenses by 30.96 million yuan, contributing to the reduction in losses [3]. Product Development - The newly launched drug, Dihenzalutamide soft capsule, generated over 10 million yuan in revenue within a month of its approval [1][2]. - The company plans to include Dihenzalutamide in the national medical insurance by 2025 to enhance product accessibility [4]. - Haichuang Pharmaceutical announced the suspension of the HP501 project, which had already invested over 80 million yuan, due to increased competition in the market [5][6]. Market Competition - The Dihenzalutamide soft capsule faces competition from similar androgen receptor inhibitors and generic drugs, with several competitors already in advanced clinical stages [4][7]. - The company noted that the HP501 project was lagging behind competitors, prompting the decision to halt further investment [6][7]. Future Outlook - The company aims to continue advancing other projects, such as HP518, which is in the clinical trial phase for treating metastatic castration-resistant prostate cancer [8].