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Core Viewpoint - The National Medical Products Administration (NMPA) has suspended the import, sale, and use of Sun Pharmaceutical Industries Limited's (Sun Pharma) carbamazepine tartrate capsules, impacting domestic companies like Enhua Pharmaceutical [1][3] Group 1: Recall and Financial Impact - Enhua Pharmaceutical's subsidiary, Enhua Hexin, has initiated a level-three recall of the carbamazepine tartrate capsules it marketed, following the NMPA's announcement [1][3] - The sales revenue from the recalled carbamazepine tartrate capsules was approximately 40 million yuan in 2025, with the recall affecting an estimated sales amount of around 9 million yuan [2][4] - The recall is not expected to significantly impact Enhua Pharmaceutical's overall financial status, as the affected sales amount represents a small proportion of the company's total revenue [4] Group 2: Market Dynamics and Competitors - Carbamazepine tartrate is a first-line drug developed by Novartis for treating mild to moderate Alzheimer's disease, with a high therapeutic index and significant clinical efficacy [5] - Following the suspension of Sun Pharma's product, the market for carbamazepine tartrate capsules in China may be filled by other companies, including Novartis and several domestic firms with approved licenses [6] - The domestic market for carbamazepine tartrate capsules was previously dominated by Novartis, but local companies like Jingxin Pharmaceutical have begun to capture market share, with a reported market size nearing 200 million yuan [6]

Group 1 - The company, Dezhan Health, forecasts a significant loss of between 175 million to 350 million yuan for 2025, marking the largest loss in five years, compared to a loss of 20.41 million yuan in 2024 [1] - From 2021 to 2025, the company has reported losses in four out of five years, with a profit of 83 million yuan only in 2023 [1] - The company attributes the expected losses to ongoing investments in nurturing business and R&D, the impact of centralized procurement policies on revenue, and impairment provisions for long-term equity investments and goodwill [1] Group 2 - Dezhan Health, originally Tianshan Textile, is the only listed pharmaceutical and health company within the Xinjiang state-owned asset system [1] - On September 16, 2025, the company underwent a management change, appointing Wei Zheming as chairman and Liu Wei as co-chairman and general manager, along with several other executive appointments [1] - On December 13, 2025, Wang Shubin, who had been in the role for less than three months, resigned from his position as vice president due to personal reasons [2] - The company is involved in a lawsuit related to a contract dispute between its former controlling shareholder and another company, which has been filed in the Beijing Third Intermediate People's Court [2] - Dezhan Health is among over 12 pharmaceutical companies implicated in a bribery case involving a hospital's pharmacy director [2][3]

Core Insights - The Chinese generic drug industry is undergoing significant changes due to policy factors, including the implementation of the drug marketing authorization holder system and early resolution mechanisms for patent disputes, which are reshaping the competitive landscape [1][11]. Industry Overview - The number of generic drug products that have passed or are deemed to have passed evaluations in China reached 2,998 in 2024, an increase of 1,008 from 2023, representing a year-on-year growth of 50.65% [1][11]. - The proportion of contract manufacturing among these evaluated generic drug products reached 33% in 2024, up from 12% in 2020, indicating a trend towards deeper industry collaboration and resource allocation [1][11]. Generic Drug Consistency Evaluation - The consistency evaluation of generic drugs ensures that they meet the same quality and efficacy standards as original drugs, which is crucial for patient safety and effective treatment [2][3]. - The evaluation process includes determining reference formulations, conducting pharmaceutical research, and ongoing monitoring to ensure compliance with quality and safety standards [2][3]. Industry Policies - Recent policies have been introduced to enhance the quality of generic drugs and promote their market acceptance, including the 2025 guidelines for deepening drug regulation reforms [5][6]. - The establishment of a reference formulation directory is essential for conducting consistency evaluations, with 87 batches published by the National Medical Products Administration by the end of 2024 [9]. Market Dynamics - The market for chemical generic drugs in China is projected to be 868.3 billion yuan in 2024, showing a decline of 3% year-on-year, with the market share of chemical generics in the overall drug market decreasing from 60% in 2018 to 50% in 2024 [7][8]. - The competitive landscape is becoming increasingly polarized, with leading pharmaceutical companies gaining significant market share while smaller firms face challenges due to funding and research limitations [11]. Key Companies - Notable companies in the generic drug consistency evaluation sector include Tigermed Pharmaceutical Technology Co., Ltd., Huahai Pharmaceutical Co., Ltd., and Hengrui Medicine Co., Ltd., among others [1][11]. - Tigermed reported a revenue of 1.71 billion yuan in clinical trial services for the first half of 2025, reflecting a 3.07% increase year-on-year, while Hengrui Medicine achieved a revenue of 13.693 billion yuan, up 12.85% [12][14]. Future Trends - The focus of generic drug evaluations is expected to shift towards high-tech barrier products, such as controlled-release formulations and complex injectables, requiring enhanced reverse engineering and pharmaceutical research capabilities [15][16]. - The production model is transitioning from batch production to continuous manufacturing, which aims to ensure consistent quality and compliance with evaluation standards [15][16]. - Companies are encouraged to adopt a full lifecycle management approach for their products, emphasizing ongoing research and optimization post-evaluation to maintain market leadership [16].

证券代码：002020 证券简称：京新药业 公告编号：2026012 浙江京新药业股份有限公司 2026 年第一次临时股东会决议公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记 载、误导性陈述或重大遗漏。 重要提示： 网络投票：通过深圳证券交易所交易系统进行网络投票的具体时间为 2026 年 1 月 28 日 9:15—9:25,9:30—11:30 和 13:00—15:00；通过深圳证券交易所 互联网投票系统进行网络投票的具体时间为 2026 年 1 月 28 日 9:15 至 15:00 的 任意时间。 2、现场会议地点：浙江省新昌县羽林街道新昌大道东路 800 号本公司行政 楼一楼会议室。 3、会议召开方式：本次会议采取现场投票与网络投票相结合的方式。本次 股东会通过深圳证券交易所交易系统和互联网投票系统向公司股东提供网络形 式的投票平台，股东可以在网络投票时间内通过上述系统行使表决权。 4、会议召集人：浙江京新药业股份有限公司董事会。 5、会议主持人：公司董事长吕钢先生。 6、本次会议的召集、召开与表决程序符合有关法律、法规、规章和公司章 1、本次股东会无否决提案的情况； 2、 ...

法律意见书 地址：上海市浦东新区银城中路 501 号上海中心大厦 9/11/12 层 电话：021-20511000 传真：021-20511999 邮编：200120 上海市锦天城律师事务所 法律意见书 上海市锦天城律师事务所 法律意见书 上海市锦天城律师事务所 关于浙江京新药业股份有限公司 2026 年第一次临时股东会的 上海市锦天城律师事务所 关于浙江京新药业股份有限公司 2026 年第一次临时股东会的 法律意见书 致：浙江京新药业股份有限公司 上海市锦天城律师事务所（以下简称"本所"）接受浙江京新药业股份有限公 司（以下简称"公司"或"京新药业"）委托，就公司召开 2026 年第一次临时股东 会（以下简称"本次股东会"）的有关事宜，根据《中华人民共和国公司法》（以 下简称《公司法》）、《上市公司股东会规则》等法律、法规、规章和其他规范性 文件以及《浙江京新药业股份有限公司章程》（以下简称《公司章程》）的有关规 定，出具本法律意见书。 为出具本法律意见书，本所及本所律师依据《律师事务所从事证券法律业务 管理办法》和《律师事务所证券法律业务执业规则（试行）》等规定，严格履行 了法定职责，遵循了勤勉尽责和诚 ...

Core Viewpoint - The global antibacterial drug market is steadily expanding, driven by demand and technology, with an expected market size of approximately $56 billion by 2025. In contrast, the Chinese market is experiencing a slight decline due to volume-based procurement policies, with projected market sizes of 122.9 billion yuan in 2024 and about 118.9 billion yuan in 2025 [1][4]. Antibacterial Drug Industry Overview - Antibacterial drugs are commonly used for the treatment and prevention of infections caused by bacteria, mycoplasma, chlamydia, rickettsia, spirochetes, and fungi. However, misuse and over-prescription have led to significant antibiotic resistance issues [2][3]. - The Chinese antibacterial drug market has been stable but is facing a slight downward trend due to volume-based procurement policies. The total market size for systemic antibacterial drugs in Chinese medical institutions is projected to be 109.18 billion yuan in 2024, a decrease of 18.29 billion yuan from 2023 [4][5]. Antibacterial Drug Market Structure - In 2024, the sales distribution of antibacterial drugs in China is as follows: urban hospitals account for 52.2%, county hospitals 21.8%, township health centers 19.0%, and community health centers 6.9% [4][5]. - The global antibacterial drug market is expected to reach $57.1 billion by 2026, indicating continued growth in the coming years [3]. Industry Chain - The upstream of the antibacterial drug industry includes raw materials such as penicillin industrial salt, cephalosporin intermediates, quinolones, and erythromycin thiocyanate. The midstream involves the production of antibacterial drugs, while the downstream applications are in medical terminals and agricultural/animal use [5]. Industry Development Environment - The antibacterial drug sector is crucial for treating infectious diseases, but the misuse of these drugs has led to increased bacterial resistance, diminishing their effectiveness. To combat this, the government has implemented a series of regulations and policies aimed at managing and monitoring the use of antibacterial drugs [5]. Competitive Landscape - Major players in the domestic antibacterial drug market include companies like Chuaning Biological, Dongyang Sunshine Pharmaceutical, and Hansoh Pharmaceutical, focusing on antibiotic intermediates and finished drug production [6]. - Danuo Pharmaceutical, established in 2013, is nearing commercialization with innovative drug products targeting bacterial infections and related diseases. The company reported a net loss of 38 million yuan in Q1 2025, primarily due to high R&D expenditures [7]. - Chuaning Biological has established a large-scale industrial production system for antibiotic intermediates, achieving a revenue of 2.349 billion yuan in the first half of 2025, with 92.88% coming from pharmaceutical manufacturing [8]. Research and Development Trends - The focus of future antibacterial drug research will be on addressing antibiotic resistance challenges, with increased investment in innovative technologies expected to enhance R&D efficiency [8].

Investment Rating - The report assigns an investment rating of "Buy" for the company, indicating a positive outlook based on its stable generics business and growth potential in small nucleic acid drugs [5]. Core Insights - The company has a solid foundation in generics, with a stable growth phase, and is strategically positioning itself in the small nucleic acid innovation space, which is expected to drive long-term growth [7][10]. - The generics business is projected to maintain steady cash flow, while the innovative drug segment is anticipated to create a second growth curve, enhancing the company's overall valuation [8][10]. Summary by Relevant Sections Market Performance - The closing price of the company's stock is 28.82 yuan, with a market capitalization of 13,833.60 million yuan [3]. Financial Forecast and Valuation - Revenue projections for 2023 to 2027 are as follows: 3,340 million yuan (2023), 3,446 million yuan (2024), 3,472 million yuan (2025E), 3,852 million yuan (2026E), and 4,266 million yuan (2027E) [6]. - The expected growth rates for revenue are 3.07% (2023), 3.17% (2024), 0.75% (2025), 10.95% (2026), and 10.74% (2027) [6]. - The projected net profit for the same years is 489 million yuan (2023), 489 million yuan (2024), 465 million yuan (2025), 481 million yuan (2026), and 520 million yuan (2027) [6]. - The company’s price-to-earnings (P/E) ratios are estimated at 28.30 (2023), 28.31 (2024), 29.78 (2025), 28.76 (2026), and 26.61 (2027) [6]. Business Overview - The company, formerly known as Wansheng Pharmaceutical, has been in the generics business for over 20 years and has recently expanded into innovative drugs, particularly small nucleic acids [7]. - As of the first half of 2025, the company holds 209 domestic drug registration approvals, with a revenue contribution of 32.09 billion yuan from drug formulations, accounting for 93% of total revenue [7][20]. - The company’s core therapeutic areas include cardiovascular, diabetes, digestive, skin diseases, and chronic kidney disease, which collectively contribute 77% of its revenue [20]. Growth Drivers - The generics business is entering a stable growth phase, with a compound annual growth rate (CAGR) of 7.75% from 2019 to 2024 [10]. - The company is actively investing in small nucleic acid drugs, with R&D expenses increasing from 180 million yuan in 2021 to 417 million yuan in 2024 [10][49]. - The N-ER platform for nucleic acid drug delivery has been established, supporting multiple projects in clinical development [50]. Competitive Position - The company has successfully navigated the challenges posed by national drug procurement policies, with a significant portion of its core products already included in procurement programs [32][43]. - The upcoming unified procurement for previously selected products is expected to stabilize cash flow and enhance the company's competitive position in the generics market [42][43].

Core Viewpoint - The National Medical Products Administration (NMPA) of China has suspended the import, sale, and use of certain pharmaceutical products from Sun Pharmaceutical Industries Limited and Supriya Lifescience Ltd. due to quality control issues and non-compliance with regulations [1][3][5]. Group 1: Sun Pharmaceutical Industries Limited - Sun Pharmaceutical's Rivastigmine Hydrogen Tartrate Capsules have been suspended due to inadequate risk assessment of batches exceeding standards and deficiencies in quality management during production [1][3]. - The company, established in 1983, was once the highest-valued and largest pharmaceutical firm in India, with Rivastigmine being a first-line treatment for mild to moderate Alzheimer's disease [4]. - The domestic market for Rivastigmine capsules was previously dominated by Novartis until 2018, when Jingxin Pharmaceutical obtained the first generic approval, with the market size estimated at nearly 200 million yuan [4]. Group 2: Supriya Lifescience Ltd. - Supriya Lifescience's Chlorpheniramine Maleate active pharmaceutical ingredient has been suspended due to failure to ensure compliance with production and inspection regulations, as well as inadequate facility management [5][6]. - This is not the first instance of suspension; the same product was previously halted in 2020 for similar quality management issues [2][6]. - Chlorpheniramine Maleate is widely used in over 2,000 cold and allergy medications, and its production has been linked to significant price increases in the past due to market manipulation [7][8].