浙江九洲药业股份有限公司 证券代码：603456 证券简称：九洲药业 公告编号：2026-002 关于公司收到化学原料药上市申请批准通知书 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。 近日，浙江九洲药业股份有限公司（以下简称"公司"）收到国家药品监督 管理局（以下简称"国家药监局"）颁发的关于枸橼酸坦度螺酮的《化学原料药 上市申请批准通知书》（通知书编号：2026YS00030），具体情况如下： 一、药品的基本情况 申请事项：境内生产化学原料药上市申请 生产企业：浙江九洲药业股份有限公司，浙江省台州市椒江区外沙路工业区 （外沙路 99 号） 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准注册。质量标准、标签及生产工艺照所附执行。 二、药品其他相关情况 枸橼酸坦度螺酮是一种抗焦虑药，主要用于各种神经症所致的焦虑状态，如 广泛性焦虑症；原发性高血压、消化性溃疡等躯体疾病伴发的焦虑状态。公司于 2024 年 7 月向国家药品监督管理局药品审评中心（以下简称"CDE"）提交 ...

Core Viewpoint - Jiuzhou Pharmaceutical (603456.SH) has received approval from the National Medical Products Administration for the marketing application of Citric Acid Tianeptine, an anti-anxiety medication used for various anxiety states caused by neuroses, such as generalized anxiety disorder, and anxiety states associated with primary hypertension and peptic ulcers [1]. Group 1 - The company has been granted a marketing approval notice for Citric Acid Tianeptine, with the notification number 2026YS00030 [1]. - Citric Acid Tianeptine is primarily indicated for treating anxiety states resulting from various neuroses [1]. - The medication is also applicable for anxiety states associated with physical conditions such as primary hypertension and peptic ulcers [1].

Core Viewpoint - The approval of the citric acid tianeptine raw material drug by the National Medical Products Administration will enhance the company's product portfolio and competitiveness, although it will not have a significant short-term impact on performance [1] Group 1: Product Approval - The company has received the approval notice for the citric acid tianeptine raw material drug from the National Medical Products Administration [1] - The drug is classified as an anti-anxiety medication [1] Group 2: Research and Development Investment - The company submitted the listing application in July 2024 and has invested approximately 6.23 million yuan in research and development [1] Group 3: Market Potential - The global market sales for the drug are projected to reach 390 million USD in 2024 and 750 million USD by 2031 [1] Group 4: Impact on Company Performance - The approval will enrich the company's product structure and enhance competitiveness, but it is noted that there will be no significant short-term impact on performance [1] - There are uncertainties associated with drug production and sales [1]

Group 1 - The core viewpoint of the news is that Jiuzhou Pharmaceutical has shown positive financial performance with a notable increase in revenue and net profit, alongside significant trading activity in its stock [1][2][3] Group 2 - As of January 15, Jiuzhou Pharmaceutical's stock price increased by 0.66%, with a trading volume of 366 million yuan. The financing buy-in amount for the day was 53.27 million yuan, while the financing repayment was 45.71 million yuan, resulting in a net financing buy of 7.56 million yuan [1] - The total balance of margin trading for Jiuzhou Pharmaceutical reached 513 million yuan, with the financing balance accounting for 2.92% of the circulating market value, indicating a high level compared to the past year [1] - The company reported a revenue of 4.16 billion yuan for the period from January to September 2025, reflecting a year-on-year growth of 4.92%, and a net profit attributable to shareholders of 748 million yuan, which is an 18.51% increase year-on-year [2] - Jiuzhou Pharmaceutical has distributed a total of 2.183 billion yuan in dividends since its A-share listing, with 1.245 billion yuan distributed in the last three years [3] - As of September 30, 2025, the number of shareholders for Jiuzhou Pharmaceutical increased to 59,200, a rise of 10.22%, while the average circulating shares per person decreased by 9.27% to 15,035 shares [2][3]

Core Viewpoint - Jiuzhou Pharmaceutical is focused on the development of its core business and aims to create long-term value for shareholders through steady operations [2] Group 1 - The company responded to investor inquiries on January 15, indicating its commitment to its main business [2] - Jiuzhou Pharmaceutical will disclose relevant announcements regarding its 2025 performance on the Shanghai Stock Exchange website [2]

Group 1 - WuXi AppTec (药明康德) is a leading global pharmaceutical R&D outsourcing company with a comprehensive layout in AI healthcare, integrating AI technology throughout the drug development process [1] - The AI drug discovery platform developed by WuXi AppTec utilizes machine learning to analyze vast compound data, significantly shortening the early development cycle of small molecules and biologics [1] - The platform has been applied in new drug development projects for oncology and neurodegenerative diseases [1] Group 2 - Aier Eye Hospital (爱尔眼科) is a leading domestic eye care chain focusing on the intelligent upgrade of the entire eye diagnosis and treatment process through AI [2] - The AI fundus screening system developed by Aier can accurately identify common eye diseases with an accuracy rate exceeding 95%, implemented in over a thousand grassroots eye clinics and health check centers nationwide [2] - The company also utilizes AI technology to create personalized correction plans for myopia patients and enhance the precision and safety of surgeries [2] Group 3 - Kanglong Chemical (康龙化成) is a core player in the domestic pharmaceutical R&D outsourcing sector, leveraging AI technology to enhance R&D service efficiency [3] - The AI drug development platform integrates molecular simulation and machine learning, reducing compound screening cycles from months to weeks [3] - AI is also used to construct disease models and simulate drug metabolism processes, improving data accuracy and reducing animal usage [3] Group 4 - Tigermed (泰格医药) is a leading clinical trial CRO in China, focusing on the intelligent transformation of the entire clinical trial process through AI [4] - The AI clinical trial management system enables intelligent project initiation, patient recruitment, and data management, improving recruitment efficiency by over 30% [4] - AI algorithms are employed for real-time monitoring of clinical trial data, providing precise risk warnings and decision-making support for pharmaceutical companies [4] Group 5 - Kelaiying (凯莱英) is a global leader in the pharmaceutical CDMO sector, applying AI technology to enhance drug production and R&D [5] - AI algorithms are used to design optimal chemical synthesis pathways, reducing production costs and enhancing safety and yield [5] - The company has developed an AI drug R&D platform to predict the physicochemical properties and biological activity of compounds, aiding in the rapid selection of candidate drug molecules [5] Group 6 - Meinian Health (美年健康) is a leading health checkup company in China, with AI healthcare as a core driver for upgrading its services [6] - The AI intelligent health check system covers the entire process from appointment scheduling to health report interpretation, with AI imaging diagnosis achieving accuracy close to that of professional doctors [6] - The company integrates national health check big data to conduct chronic disease trend research, supporting public health decision-making [6] Group 7 - Zhaoyan New Drug (昭衍新药) is a leader in non-clinical safety evaluation of drugs, focusing on the intelligent upgrade of drug safety evaluation through AI [7] - The AI drug safety prediction platform integrates vast toxicology data and machine learning algorithms to predict potential toxicity of new drugs early [7] - AI technology is also used for intelligent monitoring of experimental animals, enhancing data accuracy and reliability [7] Group 8 - BGI Genomics (华大基因) is a leading global player in the field of gene sequencing, deeply integrating AI technology with gene sequencing [8] - AI algorithms are applied to analyze gene sequencing data, significantly improving the efficiency and accuracy of genetic disease diagnosis [8] - The company has developed a big data platform to support precision medicine and drug development through AI analysis of vast genetic data [8] Group 9 - Tongce Medical (通策医疗) is a leading domestic dental care chain focusing on the intelligent upgrade of dental diagnosis and treatment through AI [9] - The AI dental imaging diagnosis system can automatically analyze dental CT and panoramic images, assisting dentists in making accurate diagnoses [9] - The company also utilizes AI technology to optimize patient appointment and triage systems, enhancing patient flow and reducing wait times [9] Group 10 - Haoyuan Pharmaceutical (皓元医药) is a core player in the domestic pharmaceutical reagents and raw materials sector, focusing on intelligent upgrades in drug and reagent development through AI [10] - The AI molecular design platform significantly shortens the discovery cycle of lead compounds in drug development [10] - AI technology is also used to optimize inventory management, reducing costs and improving supply chain efficiency [10] Group 11 - Jiuzhou Pharmaceutical (九洲药业) is an important player in the domestic CDMO sector, focusing on the intelligent upgrade of drug production and R&D through AI [11] - AI algorithms are utilized to design optimal chemical synthesis pathways, enhancing yield and reducing production costs [11] - The company has developed an AI drug R&D platform to predict the biological activity and pharmacokinetic properties of compounds [11] Group 12 - KingMed Diagnostics (金域医学) is a leading third-party medical testing company in China, with AI healthcare applications throughout the testing process [12] - The AI data analysis system can automatically analyze vast testing data, quickly identifying abnormal indicators and generating reports [12] - The company also integrates national testing big data to conduct epidemiological research, supporting public health prevention efforts [12] Group 13 - Dian Diagnostics (迪安诊断) is a leading third-party medical diagnostic service provider, with AI healthcare as a core driver for enhancing diagnostic capabilities [13] - The AI diagnostic platform covers multiple fields, achieving over 90% accuracy in identifying tumor cells and infectious lesions [13] - AI technology is also used to optimize testing processes, improving laboratory throughput and efficiency [13] Group 14 - Chengdu XianDao (成都先导) is a leading new drug development company, deeply integrating AI technology with its core DNA-encoded compound library business [14] - AI algorithms are used to design DNA-encoded compound libraries, significantly improving screening efficiency and hit rates [14] - The company has developed a cloud computing platform for AI drug R&D, providing intelligent services to global pharmaceutical companies [14] Group 15 - Sanbo Brain Science (三博脑科) is a specialized medical service institution in the field of neurosurgery, with AI applications in both healthcare and brain-computer interface technology [15] - The AI neuroimaging diagnosis system can automatically analyze brain CT and MRI images, assisting in diagnosing neurological diseases [15] - The company collaborates with research institutions to conduct clinical studies on brain-computer interfaces, helping patients regain motor function [15] Group 16 - Innovation Medical (创新医疗) is a comprehensive medical service enterprise focusing on intelligent upgrades in rehabilitation and orthopedic diagnosis through AI [16] - The AI rehabilitation assessment system collects patient movement data to automatically evaluate rehabilitation effectiveness and adjust training plans [16] - AI technology is also used to analyze X-ray and CT images for orthopedic diagnosis, enhancing the precision of surgical planning [16]

Group 1 - The core viewpoint of the news is that Jiuzhou Pharmaceutical has shown significant trading activity and financial performance, with a notable increase in stock price and trading volume on January 9, 2025 [1] - On January 9, Jiuzhou Pharmaceutical's stock price increased by 3.18%, with a trading volume of 465 million yuan. The net financing purchase was 5.38 million yuan, indicating strong investor interest [1] - As of January 9, the total margin balance for Jiuzhou Pharmaceutical was 489 million yuan, with financing accounting for 2.82% of the circulating market value, which is above the 60th percentile of the past year [1] Group 2 - As of September 30, 2025, Jiuzhou Pharmaceutical reported a total revenue of 4.16 billion yuan, representing a year-on-year growth of 4.92%, and a net profit attributable to shareholders of 748 million yuan, up 18.51% year-on-year [2] - The company has distributed a total of 2.18 billion yuan in dividends since its A-share listing, with 1.25 billion yuan distributed in the last three years [3] - The number of shareholders increased to 59,200, with an average of 15,035 circulating shares per person, a decrease of 9.27% from the previous period [2]

Core Viewpoint - Jiuzhou Pharmaceutical announced that its wholly-owned subsidiary, Zhejiang Ruibo Pharmaceutical Co., Ltd., has been recognized as a high-tech enterprise, which may enhance its competitive position and innovation capabilities in the pharmaceutical industry [2]. Group 1 - The announcement was made on January 9, indicating the company's proactive approach to innovation and technology [2]. - The certification was issued by the National High-tech Enterprise Recognition Management Work Leading Group Office, highlighting the credibility of the recognition process [2]. - The certificate number is GR202533010708, with an issuance date of December 19, 2025, and a validity period of three years [2].

Core Viewpoint - Jiuzhou Pharmaceutical (603456.SH) announced that its wholly-owned subsidiary, Zhejiang Ruibo Pharmaceutical Co., Ltd., has been recognized as a high-tech enterprise, which will allow the company to benefit from tax incentives for the next three years [1] Group 1 - Zhejiang Ruibo Pharmaceutical has received the high-tech enterprise certification with certificate number GR202533010708, issued on December 19, 2025, and valid for three years [1] - The company will enjoy a reduced corporate income tax rate of 15% from 2025 to 2027 due to its high-tech enterprise status [1]

Core Viewpoint - Jiuzhou Pharmaceutical (603456.SH) announced that its wholly-owned subsidiary, Zhejiang Ruibo Pharmaceutical Co., Ltd., has been recognized as a high-tech enterprise, which will allow the company to benefit from tax incentives for the next three years [1] Group 1 - Zhejiang Ruibo Pharmaceutical Co., Ltd. received the high-tech enterprise certification with certificate number GR202533010708, issued on December 19, 2025, and valid for three years [1] - The company will enjoy a reduced corporate income tax rate of 15% from 2025 to 2027 due to its high-tech enterprise status [1]