Core Viewpoint - Haichuang Pharmaceutical expects a total operating income of 19 million to 22 million yuan for the year 2025, primarily due to the approval and market entry of its first class 1 new drug, Deuteroenzalutamide soft capsule, in May 2025 [1] Group 1: Performance Forecast - The company anticipates that the sales revenue will be significantly impacted by the approval of Deuteroenzalutamide soft capsule, which will lead to a minor increase in revenue from material and intermediate sales compared to the previous year [1] - The product is expected to be included in the National Medical Insurance Catalog starting January 1, 2026, which will result in a substantial price reduction and affect the company's revenue due to inventory price adjustments and changes in marketing strategies [1] - The projected operating income for 2025 is estimated to be between 19 million and 22 million yuan, reflecting the combined effects of these factors [1] Group 2: R&D and Financials - The company plans to invest between 105 million and 125 million yuan in R&D for 2025, which is a decrease of 49.03 million to 69.03 million yuan compared to the previous year [1] - The expiration of stock incentive plans and an increase in government subsidies related to income are expected to contribute to a reduction in share-based payment expenses [1] - The company is projected to incur a net loss for 2025, although it expects a reduction in losses when excluding non-recurring gains and losses [1] Group 3: Q3 2025 Financial Results - For the first three quarters of 2025, the company's main revenue reached 23.35 million yuan, representing a year-on-year increase of 21,180.28% [2] - The net profit attributable to the parent company was -99.15 million yuan, an increase of 35.65% year-on-year, while the non-recurring net profit was -120 million yuan, up 28.35% year-on-year [2] - In Q3 2025 alone, the company reported a main revenue of 10.18 million yuan and a net profit of -37.29 million yuan, with a gross margin of 99.57% [2]

Core Viewpoint - The company is expected to report a net loss of 125 million to 150 million yuan for the year 2025 due to various factors affecting its revenue and expenses [1] Group 1: Performance Forecast - The company anticipates a net profit loss of 125 million to 150 million yuan for the full year of 2025 [1] - The expected operating revenue for 2025 is projected to be between 19 million and 22 million yuan, primarily due to limited sales from its first Class 1 new drug, HC-1119, and the impact of its inclusion in the National Medical Insurance Drug List [1] - The company plans to reduce R&D expenses to between 105 million and 125 million yuan in 2025, a decrease of 49.03 million to 69.03 million yuan compared to the previous year [1] Group 2: Q3 2025 Financial Results - For the first three quarters of 2025, the company's main revenue reached 23.35 million yuan, a significant increase of 21,180.28% year-on-year [2] - The net profit attributable to shareholders for the same period was -99.15 million yuan, reflecting a year-on-year increase of 35.65% [2] - The company reported a gross margin of 99.57% for Q3 2025, with a single-quarter main revenue of 10.18 million yuan [2]

Core Viewpoint - The company, HaiChuang Pharmaceutical, anticipates a net loss of 155 million to 185 million yuan for the year 2025 after deducting non-recurring gains and losses, primarily due to the impact of its first Class 1 new drug, Deuteroenzalutamide soft capsules, which is expected to generate limited revenue in the initial year of sales [1][2]. Group 1: Performance Forecast - The company expects its operating revenue for 2025 to be between 19 million and 22 million yuan, significantly lower than previous expectations due to the inclusion of its product in the National Medical Insurance Catalog, which will lead to a price reduction [2]. - Research and development expenses are projected to be between 105 million and 125 million yuan for 2025, a decrease of approximately 49 million to 69 million yuan compared to the previous year, reflecting a strategic optimization of the R&D pipeline [2]. Group 2: Q3 2025 Financial Results - For the first three quarters of 2025, the company's main revenue reached 23.35 million yuan, a substantial increase of 21,180.28% year-on-year [3]. - The net profit attributable to shareholders for the same period was -99.15 million yuan, showing a year-on-year increase of 35.65% in losses [3]. - The company reported a gross margin of 99.57% and a debt ratio of 19.24%, indicating strong profitability despite the net losses [3].

一、本期业绩预告情况 （一）业绩预告期间 2025 年 1 月 1 日至 2025 年 12 月 31 日。 证券代码：688302 证券简称：海创药业 公告编号：2026-001 海创药业股份有限公司 2025 年年度业绩预告 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。 （二）业绩预告情况 经海创药业股份有限公司（以下简称"公司"）财务部门初步测算： 1、公司预计 2025 年度实现利润总额-15,000.00 万元到-12,500.00 万元， 比上年同期亏损减少 4,948.35 万元到 7,448.35 万元，同比减亏 24.81%到 37.34%。 2、公司预计 2025 年度实现归属于母公司所有者的净利润-15,000.00 万元到 -12,500.00 万元，比上年同期亏损减少 4,949.57 万元到 7,449.57 万元，同比 减亏 24.81%到 37.34%。 三、本期业绩变化的主要原因 1、报告期内，公司首个 1 类新药氘恩扎鲁胺软胶囊（项目号：HC-1119）于 2025 年 5 月获批上市 ...

Core Viewpoint - The company, Haichuang Pharmaceutical, anticipates a net loss for the year 2025, with a projected net profit attributable to shareholders ranging from -125 million to -150 million yuan, reflecting a year-on-year reduction in losses of 24.81% to 37.34% [1] Financial Performance - The expected net profit excluding non-recurring gains and losses for 2025 is projected to be between -155 million and -185 million yuan, indicating a year-on-year reduction in losses of 14.95% to 28.74% [1] - The anticipated operating revenue for 2025 is estimated to be between 19 million and 22 million yuan, primarily due to limited sales from the newly approved drug and adjustments in pricing and distribution strategies [1] Key Factors Influencing Performance - The approval of the first Class 1 new drug, Deuteroenzalutamide soft capsule (Project No: HC-1119), is expected to generate minimal sales revenue in 2025, with only a slight increase in material and intermediate sales compared to the previous year [1] - The inclusion of Deuteroenzalutamide in the National Medical Insurance Drug List, effective January 1, 2026, is anticipated to lead to significant price reductions, impacting revenue due to inventory adjustments and changes in marketing strategies [1] - Research and development expenses for 2025 are projected to be between 105 million and 125 million yuan, a decrease of 49.03 million to 69.03 million yuan compared to the previous year, reflecting optimized R&D pipeline investments [1] - The company expects a reduction in share-based payment expenses due to the expiration of stock incentives and an increase in government subsidies related to earnings compared to the previous year [1]

Group 1 - The core product, Deuterated Enzalutamide soft capsule, was approved for market launch in May 2025 and included in the 2025 CSCO Prostate Cancer Diagnosis and Treatment Guidelines in June 2025. It entered the National Medical Insurance Drug List in December 2025 and was executed in January 2026 [1][3][4] - The sales strategy employs a "direct sales + agency" dual-track model, focusing on a four-wheel drive approach of "medical-market-access-sales" to build brand recognition through academic platforms and accumulate real-world data [1][3][4] - The prostate cancer market is projected to reach 50 billion yuan in China by 2030, with 146.7 million new cases globally in 2022, and 134,000 new cases in China [1][4] Group 2 - The drug HP518 is the first oral AR PROTAC in clinical stages in China, targeting metastatic castration-resistant prostate cancer (mCRPC). Phase I trials have been completed in Australia and China, with Phase II trials ongoing [2][5][6] - The company is focusing on obesity management and metabolic-associated fatty liver disease (MASH), with the weight loss market expected to grow from $282.9 billion in 2023 to $554.9 billion by 2030. The number of MASH patients in China is projected to reach 48.3 million by 2030 [2][6][7] - The core product HP515, an oral selective THR-β agonist, has shown potential in enhancing weight loss effects when combined with GLP-1, with clinical trials ongoing [2][6][8]

机构持仓方面，截止2025年9月30日，海创药业十大流通股东中，鹏华医药科技股票A（001230）位居 第二大流通股东，持股364.21万股，持股数量较上期不变。 融券方面，海创药业1月22日融券偿还0.00股，融券卖出0.00股，按当日收盘价计算，卖出金额0.00元； 融券余量0.00股，融券余额0.00元，超过近一年90%分位水平，处于高位。 责任编辑：小浪快报 1月22日，海创药业跌2.06%，成交额6605.33万元。两融数据显示，当日海创药业获融资买入额416.75 万元，融资偿还928.04万元，融资净买入-511.29万元。截至1月22日，海创药业融资融券余额合计3.70 亿元。 资料显示，海创药业股份有限公司位于四川省成都市高新区科园南路5号蓉药大厦1栋4层附2,3号，成立 日期2013年2月5日，上市日期2022年4月12日，公司主营业务涉及基于氘代技术和PROTAC靶向蛋白降 解等技术平台,以开发具有重大临床需求的Best-in-class(同类最佳)、First-in-class(国际首创)药物为目标。 主营业务收入构成为：药品99.25%，材料及研发中间体销售0.75%。 融资方面，海 ...

Group 1 - The detection industry in A-shares is experiencing growth opportunities due to increased industry concentration and the elimination of smaller, weaker institutions [1][2] - As of now, there are 23 listed companies in the detection service sector in A-shares, with several companies recently issuing positive profit forecasts for 2025 [1] - For instance, Huace Testing and Certification Group expects a net profit of 1.013 billion to 1.021 billion yuan for 2025, representing a year-on-year growth of 10% to 11% [1] - Shenzhen Tiansu Measurement Testing Co., Ltd. anticipates revenue of 865 million to 900 million yuan for 2025, with a year-on-year growth of 8.11% to 12.48% [1] - Zhongji Huanyu Certification Inspection Co., Ltd. reported a total revenue of 879 million yuan for 2025, with a year-on-year increase of 5.82% [1] Group 2 - The detection industry is transitioning from rapid expansion to a focus on existing market competition, with larger, stronger institutions gaining competitive advantages [2] - Approximately 15% of large-scale institutions contribute over 80% of the industry's revenue, indicating a trend towards concentration and intensive development [2] - Emerging fields such as AI, humanoid robots, new energy vehicles, low-altitude economy, and information security are creating new growth points for the detection industry [2] Group 3 - Policies are accelerating the detection industry's move towards strategic emerging sectors, with the National Market Supervision Administration launching a three-year action plan for quality inspection centers [3] - This plan aims to enhance the quality of national quality inspection centers and direct resources towards new energy, new materials, and low-altitude economy sectors [3] - Companies are actively laying out strategies in emerging industries, with Zhongji Huanyu stating it will accelerate strategic investments and capability building in 2025 [3] Group 4 - Guangdian Measurement Testing Group reports that its revenue from emerging businesses is steadily increasing, indicating improved development quality [4] - The company is strategically reducing its traditional low-growth businesses and reallocating resources towards strategic emerging industries such as aerospace, satellite internet, and new energy [4]

Core Insights - The first selective FAK inhibitor received FDA approval in May 2025 for treating KRAS-mutant recurrent low-grade serous ovarian cancer (LGSOC) [4] - The global market for selective FAK inhibitors is projected to grow from approximately $6.1 million in 2025 to $5,561.5 million over the next decade [4][6] - China's first selective FAK inhibitor is expected to be approved in 2026, with a market size of about $3.2 million, representing 7.48% of the global market [6] - By 2029, the Chinese market for selective FAK inhibitors is anticipated to reach $254.9 million, accounting for 58.06% of the global market [6] FAK Inhibitor Industry Definition and Classification - FAK (Focal Adhesion Kinase) is a non-receptor tyrosine kinase involved in multiple signaling pathways related to tumor cell invasion, migration, proliferation, and survival [2][3] - FAK inhibitors, also known as focal adhesion kinase inhibitors, disrupt FAK's phosphorylation, affecting downstream signaling events [2][3] - FAK inhibitors can be classified based on binding sites (kinase domain inhibitors, FERM domain inhibitors, FAT domain inhibitors, and PROTACs) and binding methods (small molecule ATP-competitive inhibitors, allosteric inhibitors, and dual-target inhibitors) [2] FAK Inhibitor Industry Development Status - The selective FAK inhibitor market is experiencing significant growth, driven by the increasing global cancer treatment market [4][6] - The industry is characterized by a limited number of approved products, with only one selective FAK inhibitor approved globally as of September 2025 [9] FAK Inhibitor Industry Competitive Landscape - Major companies in the selective FAK inhibitor space include GSK, Pfizer, Amplia Therapeutics, and Novartis, with domestic companies like HaiChuang and YingShi Biotechnology also making significant advancements [9][10] - The competitive landscape is evolving, with numerous candidates in clinical and preclinical stages, indicating a robust pipeline for future developments [9] FAK Inhibitor Industry Development Trends - The FAK inhibitor market is expected to expand rapidly, particularly in China, where the first product approval is anticipated in 2026 [12] - The ability of FAK inhibitors to reshape the tumor microenvironment positions them as a promising new option in cancer treatment, driving further research and investment in this area [12]

Group 1 - The company announced that its second board meeting was held on December 24, 2025, where two key resolutions were approved [2] - The resolutions included a proposal to waive the notification period for the meeting and a proposal to postpone certain fundraising projects related to the initial public offering [2]