证券代码：688302 证券简称：海创药业 公告编号：2025- 048 海创药业股份有限公司 自愿披露关于治疗代谢相关脂肪性肝炎（MASH）药物 HP515 临床 II 期试验完成首批参与者入组的公告 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： 海创药业股份有限公司（以下简称"公司"）自主研发的拟用于治疗代谢相 关脂肪性肝炎（MASH，曾用名非酒精性脂肪性肝炎（NASH））的 HP515 临床 II 期试验（以下简称"该研究"）于近日完成首批参与者入组。截至本公告披露日， 国内无同类靶点产品获批上市。 现将相关情况公告如下： HP515 通过激活人体内 THR-β受体发挥药理作用。同时，经 HP515 治疗后多项 血脂指标获得显著改善：LDL-C（低密度脂蛋白胆固醇）、TC（总胆固醇）、ApoB （载脂蛋白 B）较基线呈现显著剂量依赖性下降。在 80mg 剂量下，LDL-C 降幅 达到 39%、TC 降幅达 28%、ApoB 降幅达 41%。 该研究是一项评估 HP515 在代谢相关脂肪性肝病（MAS ...

Core Viewpoint - Haichuang Pharmaceutical (688302.SH) has completed the enrollment of the first batch of participants in the Phase II clinical trial for HP515, a drug aimed at treating Metabolic Associated Steatotic Hepatitis (MASH), with no similar targeted products approved in China as of the announcement date [1] Group 1: Product Development - HP515 is an orally administered, highly selective THR-β (thyroid hormone receptor beta subtype) agonist developed by the company [1] - The drug works by activating downstream gene transcription through THR-β, enhancing lipid metabolism in liver cells, improving liver fat metabolism, and reducing lipotoxicity to alleviate MASH [1] Group 2: Regulatory Approvals - HP515 received approval from the National Medical Products Administration of China for MASH treatment in August 2024 [1] - The drug also obtained approval from the U.S. Food and Drug Administration for MASH treatment in September 2024 [1]

Core Viewpoint - The company has completed the enrollment of the first participants in the Phase II clinical trial of HP515, a drug developed for the treatment of Metabolic Associated Steatotic Liver Disease (MASH) [1] Group 1: Product Development - HP515 is an orally administered, highly selective THR-β agonist developed by the company [1] - The drug works by directly activating THR-β, which enhances downstream gene transcription [1] - HP515 aims to improve MASH by increasing lipid metabolism activity in liver cells, enhancing liver fat metabolism, and reducing lipotoxicity [1]

Group 1 - The 2025 International Lung Cancer Frontier and Innovation Forum was held in Shanghai, focusing on key topics such as clinical prevention and control of lung cancer, breakthroughs in non-small cell lung cancer (NSCLC), and new advancements in immunotherapy for small cell lung cancer (SCLC) [1] - The rise of targeted and immunotherapy has fundamentally reshaped the treatment landscape for lung cancer, with new therapies like antibody-drug conjugates (ADC), bispecific antibodies, T-cell engagers (TCE), and tumor vaccines emerging rapidly [1] - The global incidence of lung cancer remains the highest among malignant tumors, with the company having launched 9 products that benefit over 900,000 patients worldwide, including the first approved PD-1 monoclonal antibody for first-line treatment of SCLC [1] Group 2 - The company's R&D strategy focuses on antibodies and their derivatives, including monoclonal antibodies, bispecific antibodies, multi-specific antibodies, and ADCs, supported by three core technology engines [2] - High-value projects such as HLX3901 and HLX48 are prioritized for future development, while the company continues to build a robust pipeline [2] - Local innovative enterprises have made significant progress over the past decade, providing effective "Chinese solutions" for clinical challenges, emphasizing the need for international collaboration and continuous innovation in tackling lung cancer [2]

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].

Group 1 - HaiChuang Pharmaceutical (688302.SH) reported its Q3 2025 results on October 31, 2025, with 11 institutional investors holding a total of 34.54% of the company's shares, amounting to 34.2005 million shares [1] - The top ten institutional investors collectively hold 34.42% of the shares, with a decrease of 2.15 percentage points compared to the previous quarter [1] Group 2 - In the public fund sector, one fund, Penghua Innovation Growth One-Year Holding Mixed A, reported a slight decrease in holdings compared to the previous quarter [2] - A total of 78 public funds did not disclose their holdings this quarter, including notable funds such as Yinhua Digital Economy Stock Initiation A and CITIC Construction Investment Medical Reform A [2]

Core Viewpoint - The company, Xi'an High Voltage Electrical Research Institute Co., Ltd., has shown significant growth in revenue and net profit for the first nine months of 2025, indicating a strong performance in the electrical inspection and testing services sector [2]. Financial Performance - For the period from January to September 2025, the company achieved a revenue of 651 million yuan, representing a year-on-year growth of 15.05% [2]. - The net profit attributable to the parent company for the same period was 198 million yuan, reflecting a year-on-year increase of 21.28% [2]. Shareholder Information - As of September 30, 2025, the number of shareholders decreased by 8.45% to 11,200, while the average circulating shares per person increased by 9.23% to 14,019 shares [2]. - The company has distributed a total of 280 million yuan in dividends since its A-share listing [3]. Financing and Trading Activity - On October 30, the company's stock price fell by 1.97%, with a trading volume of 92.23 million yuan [1]. - The financing buy-in amount for the company on the same day was 12.38 million yuan, with a net financing buy of 1.49 million yuan, indicating active trading [1]. - The total financing and securities lending balance reached 138 million yuan, accounting for 4.20% of the circulating market value, which is above the 80th percentile of the past year [1].

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]

证券代码：688302 证券简称：海创药业 公告编号：2025-046 海创药业股份有限公司 2025年第一次临时股东大会决议公告 本公司董事会及全体董事保证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： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2025 年 10 月 30 日 （二） 股东大会召开的地点：四川省成都市高新区科园南路 5 号蓉药大厦 1 栋 4 层公司会议室 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 86 | | --- | --- | | 普通股股东人数 | 86 | | 2、出席会议的股东所持有的表决权数量 | 33,086,681 | | 普通股股东所持有表决权数量 | 33,086,681 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比 | 33.4156 | | 例（%） | | | 普通股股东所持有表决权数量占公司表决权数量的比例（%） | 33.415 ...