格隆汇9月29日丨康弘药业(002773.SZ)公布，公司于近日收到国家药品监督管理局签发的依帕司他片的 《药品注册证书》(证书编号：2025S02992)，批准注册。 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，发给药品注册证书。 规格：50mg 适应症：糖尿病性神经病变。 注册分类：化学药品 3 类 批准文号：国药准字 H20255572 依帕司他是一种可逆性的醛糖还原酶非竞争性抑制剂，对醛糖还原酶具有选择性抑制作用。临床研究显 示，依帕司他能抑制糖尿病性外周神经病变患者红细胞中山梨醇的积累，与对照组比较能改善患者的自 觉症状和神经功能障碍。 药品名称：依帕司他片 剂型：片剂 ...

关于公司收到药品注册证书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整， 没有虚假记载、误导性陈述或重大遗漏。 证券代码：002773 证券简称：康弘药业 公告编号：2025-052 成都康弘药业集团股份有限公司 1 / 2 二、产品简介 成都康弘药业集团股份有限公司（以下简称"公司"）于近日收 到国家药品监督管理局签发的依帕司他片的《药品注册证书》（证书 编号：2025S02992），批准注册。现将相关情况公告如下： 一、药品基本信息 药品名称：依帕司他片 剂型：片剂 规格：50mg 适应症：糖尿病性神经病变。 注册分类：化学药品 3 类 批准文号：国药准字 H20255572 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，发 给药品注册证书。 依帕司他是一种可逆性的醛糖还原酶非竞争性抑制剂，对醛糖还 原酶具有选择性抑制作用。临床研究显示，依帕司他能抑制糖尿病性 外周神经病变患者红细胞中山梨醇的积累，与对照组比较能改善患者 的自觉症状和神经功能障碍。 三、对公司的影响 本次依帕司他片获批上市，丰富了公司的产品管线。 由于医药产品的生产 ...

证券日报网讯康弘药业（002773）9月25日在互动平台回答投资者提问时表示，截至2025年9月19日，公 司股东户数为24909户。 ...

Market Overview - The biopharmaceutical sector experienced a decline of 0.21% on September 25, with Nossland leading the drop [1] - The Shanghai Composite Index closed at 3853.3, down 0.01%, while the Shenzhen Component Index closed at 13445.9, up 0.67% [1] Stock Performance - Notable gainers in the biopharmaceutical sector included: - Aopu Mai (688293) with a closing price of 62.85, up 7.42% and a trading volume of 30,600 [1] - Rongchang Biotech (688331) closed at 108.50, up 3.43% with a trading volume of 89,200 [1] - Baipusais (301080) closed at 62.16, up 3.43% with a trading volume of 43,500 [1] - Major decliners included: - Nossland (430047) closed at 22.99, down 3.69% with a trading volume of 57,000 [2] - Wufan Biotech (301393) closed at 53.12, down 3.42% with a trading volume of 24,600 [2] - Kexing Pharmaceutical (688136) closed at 38.75, down 3.34% with a trading volume of 53,500 [2] Capital Flow - The biopharmaceutical sector saw a net outflow of 207 million yuan from institutional investors, while retail investors contributed a net inflow of 45.07 million yuan [2] - Notable capital flows included: - Rongchang Biotech (688331) with a net inflow of 1.021 billion yuan from institutional investors [3] - Junshi Biosciences (688180) with a net inflow of 35.36 million yuan from institutional investors [3] - Aopu Mai (688293) with a net inflow of 9.41 million yuan from institutional investors [3]

Core Viewpoint - Kanghong Pharmaceutical's stock has shown significant volatility, with a year-to-date increase of 96.63% but a recent decline in the last five and twenty trading days [1][2]. Group 1: Stock Performance - As of September 24, Kanghong Pharmaceutical's stock price was 37.36 CNY per share, with a market capitalization of 34.42 billion CNY [1]. - The stock experienced a net inflow of 5.30 million CNY from main funds, with large orders accounting for 13.33% of purchases [1]. - The stock has seen a 5.70% decline over the last five trading days and an 8.27% decline over the last twenty trading days [1]. Group 2: Financial Performance - For the first half of 2025, Kanghong Pharmaceutical reported a revenue of 2.45 billion CNY, representing a year-on-year growth of 6.95%, and a net profit of 730 million CNY, up 5.41% year-on-year [2]. - The company has distributed a total of 2.04 billion CNY in dividends since its A-share listing, with 1.04 billion CNY distributed in the last three years [3]. Group 3: Shareholder Information - As of September 10, the number of shareholders for Kanghong Pharmaceutical was 24,700, a decrease of 1.19% from the previous period [2]. - The average number of circulating shares per shareholder increased by 1.21% to 27,778 shares [2]. - The top ten circulating shareholders include Hong Kong Central Clearing Limited and several mutual funds, with notable changes in their holdings [3].

Core Viewpoint - 康弘药业 has made significant progress during the "14th Five-Year Plan" period, focusing on core technologies and expanding its product matrix in ophthalmology, psychiatry/neuroscience, and oncology, leading to a steady increase in performance and high-quality development [1] Financial Performance - The company's operating revenue increased from 3.605 billion yuan in 2021 to 4.453 billion yuan in 2024, while the non-net profit rose from 301 million yuan to 1.184 billion yuan during the same period [1] - In the first half of 2025, the operating revenue was 2.453 billion yuan, a year-on-year increase of 6.95%, and the non-net profit was 723 million yuan, up 6.51% [1] Development Philosophy - The company adheres to a development philosophy centered on market orientation, innovation, quality, and talent, aiming to create innovative products and services that benefit the public [2] Risk Management and Innovation - 康弘药业 balances innovation and risk management by conducting thorough research and making accurate judgments, focusing on policy risk assessment, market demand validation, and a well-structured R&D pipeline [3] Product Strategy - 康弘药业 aims to develop long-lifecycle blockbuster products, with 康柏西普 being a prime example, generating 1.345 billion yuan in revenue in the first half of 2025, accounting for 54.83% of total revenue [3] - The company has launched 利非司特滴眼液, the first of its kind in China, targeting the large dry eye patient population [4] Market Potential - The dry eye medication market in China is projected to reach 4.79 billion yuan in 2024, with a compound annual growth rate of 16% from 2020 to 2024, providing 康弘药业 with significant growth opportunities [5] Technological Advancements - 康弘药业 is investing in cutting-edge technologies such as gene therapy, antibody-drug conjugates, and synthetic biology, with ongoing clinical trials for various innovative products [6][7]

Core Viewpoint - 康弘药业 has made significant progress during the "14th Five-Year Plan" period, focusing on core technologies in ophthalmology, psychiatry/neuroscience, and oncology, leading to a robust product matrix and steady revenue growth [1][2] Financial Performance - The company's revenue increased from 3.605 billion yuan in 2021 to 4.453 billion yuan in 2024, while the net profit attributable to shareholders rose from 301 million yuan to 1.184 billion yuan during the same period [1] - In the first half of 2025, 康弘药业 reported a revenue of 2.453 billion yuan, a year-on-year increase of 6.95%, and a net profit of 723 million yuan, up 6.51% [1] Development Philosophy - The company adheres to a development philosophy centered on market orientation, innovation, quality, and talent, aiming to create innovative products and services that benefit the public [2] - 康弘药业 emphasizes a balance between innovation and risk management, focusing on deep research and accurate judgment to ensure sustainable development [2] Product Strategy - 康弘药业's flagship product, 康柏西普, has generated 1.345 billion yuan in revenue in the first half of 2025, accounting for 54.83% of total revenue, showcasing the company's strategy of building a competitive edge through cost-effectiveness and treatment convenience [2] - The company is actively seeking to develop more "super products" to mitigate risks associated with over-reliance on a single product [2] Market Opportunities - 康弘药业's newly approved 利非司特滴眼液 addresses a significant market need for dry eye treatment, with the dry eye medication market in China projected to reach 4.79 billion yuan by 2024, growing at a compound annual growth rate of 16% from 2020 to 2024 [3] - The company is investing in cutting-edge technologies such as gene therapy and synthetic biology, with ongoing clinical trials for its gene therapy products and a focus on expanding its market presence [4] Technological Advancements - 康弘药业 is advancing in gene therapy, with its product KH631 entering clinical phase II in China and KH658 progressing in both Chinese and U.S. clinical trials [4] - The company has also made strides in synthetic biology, with KH617 being the first domestically developed I-type new drug from synthetic biology to enter clinical trials, and it has received orphan drug designation from the FDA [4]

Market Overview - The biopharmaceutical sector experienced a decline of 1.9% on September 19, with Kanghong Pharmaceutical leading the drop [1] - The Shanghai Composite Index closed at 3820.09, down 0.3%, while the Shenzhen Component Index closed at 13070.86, down 0.04% [1] Stock Performance - Notable gainers included: - Aopumai (688293) with a closing price of 53.41, up 1.71% on a trading volume of 34,700 shares and a turnover of 189 million yuan [1] - Kexing Pharmaceutical (688136) closed at 41.88, up 1.70% with a trading volume of 45,300 shares and a turnover of 189 million yuan [1] - Significant decliners included: - Kanghong Pharmaceutical (002773) which fell 6.09% to a closing price of 37.00, with a trading volume of 94,100 shares and a turnover of 355 million yuan [2] - Changchun High-tech (000661) decreased by 3.91% to 125.22, with a turnover of 1.674 billion yuan [2] Capital Flow - The biopharmaceutical sector saw a net outflow of 999.7 million yuan from institutional investors, while retail investors had a net inflow of 914 million yuan [2] - The table of capital flow indicates that: - Changchun High-tech had a net inflow of 67.986 million yuan from institutional investors [3] - Kanghua Biological (300841) experienced a net inflow of 11.825 million yuan from institutional investors [3]

Core Viewpoint - 康弘药业 has made significant progress in its core therapeutic areas, particularly with its flagship product 康柏西普, which now accounts for a substantial portion of the company's revenue. The company aims to achieve international market presence and continuous innovation over the next decade [1][4]. Group 1: Financial Performance - The company's revenue increased from 36.05 billion in 2021 to 44.53 billion in 2024, while the net profit rose from 3.01 billion to 11.84 billion during the same period [1]. - In the first half of 2025, 康弘药业 reported a revenue of 24.53 billion, a year-on-year growth of 6.95%, and a net profit of 7.23 billion, reflecting a 6.51% increase [2]. Group 2: R&D and Innovation Strategy - 康弘药业 has invested a total of 25.21 billion in R&D over the past few years, emphasizing the importance of innovation and market-driven development [1][2]. - The company maintains a balanced approach to innovation and risk management, focusing on "controllable risks under innovative breakthroughs" [3]. Group 3: Product Development and Market Position - 康柏西普 has generated 13.45 billion in revenue in the first half of 2025, representing 54.83% of the company's total revenue, and has maintained a leading market share in the hospital sector [4][5]. - The company has introduced a new product, 利非司特滴眼液, which is expected to tap into a market with a projected size of 47.9 billion by 2024, indicating a significant growth opportunity [5]. Group 4: Future Growth and Technological Advancements - 康弘药业 is focusing on cutting-edge technologies such as gene therapy and synthetic biology, with ongoing clinical trials for its gene therapy products [6][7]. - The company aims to establish a strong position in the next-generation antibody-drug conjugates (ADC) market, with its product KH815 being the first of its kind to enter clinical trials [8].

Investment Rating - The report maintains a rating of "Overweight" for the pharmaceutical and biotechnology industry [2] Core Insights - Geopolitical disturbances and fluctuations in innovative drugs have limited impact on the innovation theme, while opportunities in medical devices are becoming apparent [9] - The report highlights the ongoing optimization of centralized procurement rules for medical consumables, indicating a shift from a "lowest price" approach to a "preventing excessive competition" strategy [10] - The approval process for innovative drugs is accelerating, with a new 30-day review channel established for eligible innovative drug applications [9][10] Summary by Sections Industry Overview - The pharmaceutical sector has shown a return of 26.80% since the beginning of 2025, outperforming the Shanghai Composite Index by 11.88 percentage points [14] - The report notes a mixed performance among sub-sectors, with medical devices and medical services showing positive growth while biopharmaceuticals and chemical drugs faced declines [9][14] Market Dynamics - The report indicates that the medical device sector is experiencing a recovery, with significant movements in stocks related to CRO/CDMO and medical devices [22] - Recent geopolitical news has caused short-term volatility in the innovative drug sector, but the market has quickly stabilized [9] Key Company Performance - The report recommends several companies for investment, including WuXi AppTec, WuXi Biologics, and others, which are expected to perform well in the current market environment [6][25] - The average performance of recommended stocks has shown a 6.64% increase this month, outperforming the broader pharmaceutical industry [24] Regulatory Developments - The National Medical Products Administration has announced measures to streamline the clinical trial approval process for innovative drugs, enhancing efficiency and transparency [9][12] - New procurement rules for coronary intervention balloon medical consumables have been introduced, emphasizing the need for reasonable pricing and cost commitments from bidding companies [10][12]