关于召开 2025 年第三季度业绩说明会的公告 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、准确性和完整性承担法律责任。 重要内容提示： 投资者可于投资者可于 2025 年 11 月 07 日（星期五）至 11 月 13 日（星期四）16:00 前登录上证路演中心网站首页点击"提问预征集" 栏目或通过公司邮箱 ir@hinovapharma.com 进行提问。公司将在说明 会上对投资者普遍关注的问题进行回答。 海创药业股份有限公司（以下简称"公司"）已于 2025 年 10 月 31 日发布公司 2025 年第三季度报告，为便于广大投资者更全面深入 地了解公司 2025 年第三季度经营成果、财务状况，公司计划于 2025 年 11 月 14 日（星期五）14:00-15:000 举行 2025 年第三季度业绩说 明会，就投资者关心的问题进行交流。 证券代码：688302 证券简称：海创药业 公告编号：2025-049 海创药业股份有限公司 一、说明会类型 本次投资者说明会以网络文字互动形式召开，公司将针对 2025 年第三季度的经营成果及财务指标的具体 ...

Core Viewpoint - The company, Haichuang Pharmaceutical, has participated in the medical insurance negotiation for its product, Deutetrabenazine, which has passed the review for inclusion in the National Basic Medical Insurance Drug List by 2025 [1] Group 1 - The company confirmed its participation in the medical insurance negotiation process [1] - The outcome of the negotiation will be announced by the National Healthcare Security Administration [1]

Macroeconomic News - The State Council announced the holiday schedule for 2026, including a 3-day break for New Year's, a 9-day break for Spring Festival, and a 5-day break for Labor Day [2] - The Ministry of Commerce responded to questions regarding ASML, stating that the Dutch government interfered with the company's internal affairs and that ASML (Netherlands) announced on October 26 to stop supplying wafers to ASML (China), causing disruptions in the global semiconductor supply chain [2] - The People's Bank of China will conduct a 700 billion yuan reverse repurchase operation on November 5, 2025, to maintain liquidity in the banking system [3] - In October, the central bank resumed trading of government bonds, with a net injection of 20 billion yuan [3] - The U.S. Senate failed to pass a temporary funding bill again, leading to a record government shutdown [3] Company News - Fuyao Glass announced a change in its legal representative from Cao Dewang to his son, Cao Hui [8] - Industrial Fulian reported a cumulative repurchase of 0.04% of its shares, amounting to 147 million yuan as of October 31 [9] - True Love Home announced plans for a change in control, leading to a stock suspension [10] - ST Wanfang disclosed that its stock price volatility was mainly due to market speculation regarding a change in control [11] - Siwei Liekong announced the dismissal of Deputy General Manager Zhao Jianzhou, who is under investigation [12] - Haichuang Pharmaceutical completed the enrollment of the first batch of participants in the Phase II clinical trial for its drug HP515, targeting metabolic-associated fatty liver disease [13] - Midea Group has repurchased a total of 9.575 billion yuan of its A-shares [14] - Tianpu Co. completed the transfer of shares with its controlling shareholder and a related party [15] - Baili Tianheng's innovative biopharmaceutical T-Bren (HER2ADC) has been included in the list of breakthrough therapy varieties [16] - Redik announced plans to acquire a 20.41% stake in robotics and brain-computer interface company Aoyi Technology for 160 million yuan [17] Global Market - U.S. stock indices collectively fell, with the Nasdaq down 2.04%, S&P 500 down 1.17%, and Dow Jones down 0.53% [18] - Major technology stocks declined, with Intel dropping over 6%, Tesla over 5%, and Nvidia nearly 4% [18] - Cryptocurrency stocks saw significant declines, with Bakkt down nearly 20% and Galaxy Digital down over 10% [18] - European major indices mostly closed lower, with Germany's DAX30 down 0.6% [18] Investment Opportunities - The robot industry in China saw a revenue increase of 29.5% year-on-year in the first three quarters of this year, with industrial robot production reaching 595,000 units and service robot production reaching 13.5 million units, surpassing the total production for 2024 [23] - Dongfang Securities believes that the industry is expected to enter a mass production phase next year, benefiting component manufacturers with excellent manufacturing and management capabilities [24] - SK Hynix announced the development of new storage products, including AI-DRAM and AI-NAND, and is deepening partnerships to advance AI manufacturing technology [25] - Guotai Junan Securities noted that the storage industry has entered a new upcycle, driven by the increasing demand for memory capacity due to AI model training and inference [25]

Core Viewpoint - Haichuang Pharmaceutical has completed the enrollment of the first participants in the Phase II clinical trial of HP515, a drug for treating Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH), with no similar products approved in the domestic market as of the announcement date [2][4]. Group 1: Drug Information - HP515 is an orally administered, highly selective THR-β agonist developed by the company, aimed at enhancing lipid metabolism in liver cells to improve MASH [3]. - The drug received approval from the National Medical Products Administration of China in August 2024 and from the U.S. Food and Drug Administration in September 2024 for the treatment of MASH [3]. Group 2: Clinical Trial Results - The Phase I clinical trial of HP515 showed expected results in safety, tolerability, pharmacokinetics, and pharmacodynamics, with a significant dose-dependent increase in SHBG (Sex Hormone Binding Globulin) observed [4]. - At the 80 mg dosage, SHBG increased by 176% after 14 days of treatment, indicating the pharmacological effect of HP515 through THR-β receptor activation [4]. - Multiple lipid indicators showed significant improvements, with LDL-C (Low-Density Lipoprotein Cholesterol) decreasing by 39%, TC (Total Cholesterol) by 28%, and ApoB (Apolipoprotein B) by 41% at the 80 mg dosage [4]. Group 3: Market Potential - The global MASH market is projected to reach $10.7 billion by 2025 and $32.2 billion by 2030, with a compound annual growth rate (CAGR) of 24.6% [8]. - The Chinese MASH drug market is expected to reach 3.2 billion RMB by 2025 and 35.5 billion RMB by 2030, with a CAGR of 61.4% [8]. Group 4: Related Research - The company is also conducting research on HP515 in combination with GLP-1R agonists for obesity, showing promising potential to enhance weight loss effects while preserving muscle mass [5].

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]

证券代码：688302 证券简称：海创药业 公告编号：2025-048 近日，公司已完成 HP515 的 I 期临床试验,初步数据显示，HP515 在安全性、 耐受性、药代动力学及药效动力学方面均达到预期。在 40 mg、60 mg 及 80 mg 每日一次、连续给药 14 天的条件下，SHBG（性激素结合球蛋白）较基线呈现显 著剂量依赖性上升。在80mg剂量下，给药14天后SHBG增幅达176%，表明HP515 1 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： 一、 药品基本情况 HP515 片 ...

Group 1 - Jinguang Electric won a bid for a State Grid procurement project with a total amount of 21.7976 million yuan, accounting for approximately 2.93% of the company's expected revenue for 2024 [1] - Shen Gong Co. plans to reduce its shareholding by up to 2%, equating to 340.61 million shares [2] - Guomai Culture received a government subsidy of 3.78 million yuan, representing 24.90% of its audited net profit for 2024 [2] Group 2 - Guomai Culture focuses on the development and provision of digital content operation platforms [3] - Shentong Technology's two directors plan to collectively reduce their shareholding by no more than 0.0473% [4] - Ruihua Tai intends to reduce its shareholding by up to 1%, amounting to 1.8 million shares [5] Group 3 - Guoji Automobile's wholly-owned subsidiary won a total contract project worth 809 million yuan [7] - Changcheng Technology's stock is expected to remain suspended due to potential changes in control [9] - Huabei Pharmaceutical's subsidiary received approval for a chemical raw material drug listing application [11] Group 4 - Fuyao Glass has changed its legal representative to Cao Hui [13] - Huaxi Biological plans to reduce its shareholding by up to 2%, totaling 9.6336 million shares [14] - Hopu Co. signed a procurement contract for a storage system worth 500 million yuan [15] Group 5 - ST Songfa's subsidiary plans to invest 458 million yuan in a mooring dock project [18] - Zhonghong Medical's subsidiary is expected to be selected for several centralized procurement projects [19] - Huakai Yibai's vice chairman plans to increase his shareholding by no less than 30 million yuan [20] Group 6 - Haichuang Pharmaceutical completed the first participant enrollment for a clinical trial of a drug for metabolic-associated fatty liver disease [21] - Dongfang Biological's subsidiary obtained medical device product registration certificates for multiple products [22] - Lepu Medical's rechargeable implantable deep brain stimulation system received NMPA registration approval [23] Group 7 - Changyuan Power's power generation in October decreased by 32.25% year-on-year [24] - Jinshi Yaya's diclofenac sodium sustained-release tablets passed the consistency evaluation for generic drugs [26] - Yutong Bus sold 3,040 buses in October, a decrease of 5.62% year-on-year [27] Group 8 - Far East Co. signed contracts worth 1.062 billion yuan in October [28] - Tianya Pharmaceutical's subsidiary passed the consistency evaluation for a drug [29] - Yuheng Pharmaceutical plans to resolve a debt dispute through a share transfer agreement [30] Group 9 - Hailanxin's subsidiary won a bid for a marine observation network project worth 1.097 billion yuan [31] - Huasheng Lithium plans to reduce its shareholding by up to 0.37% [33] - Maike Biological obtained product registration certificates for five new in vitro diagnostic products [34] Group 10 - Huayuan New Materials signed a strategic cooperation agreement with Taiblue New Energy [37] - Greebo's actual controller and some directors plan to collectively increase their shareholding by no less than 11.5 million yuan [39] - Yian Technology received a government subsidy of 1.1643 million yuan [41] Group 11 - Kangtai Biological's quadrivalent influenza virus vaccine has commenced Phase I clinical trials [43] - Spring Airlines received a commitment letter for a stock repurchase loan of up to 450 million yuan [45] - Foton Motor sold 8,006 new energy vehicles in October, a year-on-year increase of 98.83% [46] Group 12 - Greebo plans to transfer 100% equity of its subsidiary for 280 million yuan [48] - Siwei Liekong's director is under investigation [49] - Dingyang Technology launched a new generation of multi-channel microwave signal generator products [50] Group 13 - Jiangling Motors reported a year-on-year increase of 8.06% in vehicle sales for October [51] - Shengyi Technology plans to reduce its shareholding by up to 1.03% [52] - Dongshan Precision completed the acquisition of 100% equity of France's GMD Group for approximately 814 million yuan [53] Group 14 - Tianyang Technology plans to acquire 7.5% of Baoland's shares for 155 million yuan [54] - Alter plans to establish a joint venture company with a total investment of 672 million yuan [54] - Changchun High-tech's clinical trial application for a drug was approved [55] Group 15 - Beibu Gulf Port's cargo throughput in October increased by 22.73% year-on-year [56] - ST Zhangjiajie was ruled by the court to undergo reorganization [57] - Teda Co.'s subsidiary was selected as a supplier for an energy project in Indonesia [58]

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 Viewpoint - Haichuang Pharmaceutical has completed the enrollment of the first participants in the Phase II clinical trial for its drug HP515, aimed at treating Metabolic Associated Steatotic Hepatitis (MASH), with no similar products approved in the domestic market [1] Group 1: Clinical Trial Progress - The Phase II clinical trial for HP515, a highly selective THR-β agonist, has recently completed the enrollment of its first participants [1] - The study aims to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of HP515 in participants with MASH [1] Group 2: Product Development and Market Position - HP515 is an oral medication developed by the company, and it is currently the only product targeting this specific mechanism that has not been approved in the domestic market [1] - The company is also conducting research on HP515 in combination with GLP-1R agonists for obesity, with related preclinical data presented at international conferences [1] Group 3: Business Impact and Industry Characteristics - The completion of this research is not expected to have a significant impact on the company's recent operating performance [1] - The pharmaceutical products in this sector are characterized by high technology, high risk, and high added value, with uncertainties surrounding clinical trial progress, results, and future market competition [1]