证券日报网讯 通化金马（000766）11月26日在互动平台回答投资者提问时表示，公司研制的化学1类新 药琥珀八氢氨吖啶片，已完成各项专业审评工作，进入了综合审评环节，各项审评工作正常进行中。有 关新药的重大信息，均会在指定信息披露媒体发布，请投资者关注公司公告。 ...

（文章来源：每日经济新闻） 每经AI快讯，有投资者在投资者互动平台提问：请问，公司一类创新药已经完成各项专业审评工作进 入综合审评环节，已经处于临近审批阶段，是已经进入综合审批中，还是下一步将进入综合审批环节？ 谢谢回答。 通化金马（000766.SZ）11月19日在投资者互动平台表示，我公司研制的化学1类新药琥珀八氢氨吖啶 片，已完成各项专业审评工作，进入了综合审评环节，各项审评工作处于正常进行中。有关新药的相关 信息公司将根据有关规定和要求予以披露，请投资者关注公司公告。 ...

（记者 曾健辉） 通化金马（000766.SZ）11月18日在投资者互动平台表示，您好，我公司研制的化学1类新药琥珀八氢氨 吖啶片，已完成各项专业审评工作，进入综合审评环节，各项审评工作处于正常进行中。公司将继续深 度布局神经领域的产品管线和平台建设，有关新药的相关信息公司将根据有关规定和要求予以披露，请 投资者关注公司公告。 每经AI快讯，有投资者在投资者互动平台提问：尊敬的董秘您好！我们关注到公司的琥珀八氢氨吖啶 片是治疗阿尔茨海默病的重磅创新药。想请教，该药若成功上市，将如何具体支撑公司'中药亚洲化、 化药国际化'的战略目标？这是否意味着公司在中枢神经疾病领域的研发平台已成熟，未来该技术平台 是否会加速应用于其他管线的开发？谢谢！ ...

Core Viewpoint - Tonghua Jinma (000766) is advancing its research on a new chemical drug, Amber Dihydroaminoacridine Tablets, aimed at treating mild to moderate Alzheimer's disease, with the review process currently in the comprehensive evaluation stage [1] Group 1 - The new drug has completed all professional review work and is now in the comprehensive evaluation phase [1] - The company will disclose any information that meets the disclosure standards as per relevant regulations [1]

（记者 王晓波） 每经AI快讯，有投资者在投资者互动平台提问：公司新药发补为什么不告知投资者？ 通化金马（000766.SZ）11月14日在投资者互动平台表示，我公司研制的化学1类新药琥珀八氢氨吖啶片 主要用于治疗轻中度阿尔茨海默病。目前该新药已完成各项专业审评工作进入综合审评环节，审评工作 处于正常进行中。如公司发生达到信息披露标准的事项，公司将根据相关信息披露的规定和要求予以披 露。 ...

Group 1 - The company announced the establishment of a wholly-owned subsidiary, Guilin Jinma Innovation Investment Co., Ltd., with an investment of 70 million yuan to support its strategic planning and R&D needs [1][3] - The company operates in various fields including oncology, microbiology, cardiovascular, detoxification, digestive system, musculoskeletal system, gynecology, and neurology [1] - The R&D process is managed by the headquarters, with production bases conducting projects based on their characteristics and market layout, including both innovative and generic drug development [1] Group 2 - The company received a notice of acceptance for the market application of Amber Dihydroaminoacridine Tablets, a new drug for treating mild to moderate Alzheimer's disease, which has undergone extensive clinical trials since 2007 [2] - The company emphasizes that new drug development is a long-term, high-investment, and high-tech process, with uncertainties regarding market prospects and economic returns [2] - The establishment of the subsidiary is part of the company's strategy to transform into an innovation-driven modern pharmaceutical enterprise, enhancing its core competitiveness and ensuring sustainable development [3]

Group 1 - The company confirms that the approval process for its new drug is currently proceeding normally and is in the final stages of comprehensive review [2] - The new drug, Amber Dihydroaminoacridine Tablets, has completed all professional review work and is now in the comprehensive review phase [2] - The company will disclose any significant information as per regulatory requirements if it meets the criteria for information disclosure [2]

Core Viewpoint - The company Tonghua Golden Horse (000766.SZ) confirms that its new drug approval process is progressing normally and is nearing the final approval stage [1]. Group 1: Approval Process - The company has completed all professional review work for its new drug and has entered the comprehensive review phase [1]. - The approval work is currently proceeding normally, with the new drug, Amber Dihydroaminoacridine Tablets, in the final stages of review [1]. - The company will disclose any significant information as per the relevant disclosure regulations if necessary [1].

Core Viewpoint - The company Tonghua Golden Horse has provided an update on the approval status of its new drug, indicating that it has completed all professional review work and is now in the comprehensive review stage, nearing the approval phase [2]. Summary by Categories - **Drug Approval Progress** - The new drug, Amber Dihydroaminoacridine Tablets, has completed all necessary professional review work and is currently in the comprehensive review stage, approaching the approval phase [2]. - The company advises stakeholders to refer to the public information from the drug review center for the latest updates on the drug's review progress [2]. - The company will disclose any information that meets the disclosure standards as per relevant regulations if significant events occur [2].

Core Viewpoint - Tonghua Golden Horse (000766) reported a slight increase in revenue and a significant rise in net profit for the first half of 2025, indicating a positive trend in financial performance despite a challenging market environment [1][2]. Financial Performance - The company achieved an operating income of 650 million yuan, a year-on-year increase of 0.12% [1]. - The net profit attributable to shareholders was 16.804 million yuan, reflecting a year-on-year growth of 34.77% [1]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was 14.4073 million yuan, showing a substantial increase of 125.07% year-on-year [1]. - Basic earnings per share were reported at 0.02 yuan [1]. Business Operations - Tonghua Golden Horse is engaged in the research, production, and sales of pharmaceutical products, with a business unit cluster that includes its headquarters, Shengtai Biological, Yongkang Pharmaceutical, and Yuanshou Biological [1]. - The company’s product range covers various therapeutic areas, including oncology, microbiology, cardiovascular, detoxification, digestive system, musculoskeletal system, gynecology, and neurology [1]. Research and Development - The company is focused on enhancing professional skills and quality research levels, aiming to improve its technological innovation capabilities and market influence [2]. - A self-developed national class 1.1 new drug, Succinic Dihydroaminoacridine Tablets, has received an acceptance notice from the National Medical Products Administration (NMPA) [2]. - The drug, which has complete independent intellectual property rights, is intended for the treatment of mild to moderate Alzheimer's disease and has completed phase III clinical trials from August 2017 to September 2023 [2]. Regulatory Process - The company is actively working on the new drug's registration application in compliance with NMPA regulations and guidelines [2]. - The approval process for the drug involves several uncertainties, including review timelines and market competition dynamics [2]. - The company is maintaining communication with the NMPA during the review process, which is described as a normal state for new drug evaluations [3].