2025.11.24 本文字数：2412，阅读时长大约4分钟 作者 |第一财经 吴斯旻 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中生 物药占比增加，"谈判药品同通用名仿制药上市自动属于目录范围"的医保政策则为生物类似药挂网入院 及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升，却 也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中 国仿制药发展报告（2025）》（下称"报告"）显示，中国仿制药市场规模多年维持在9000亿元水平，企 业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年前增 加了超过2/3，但当年增长主要由少数企业和既往过评品种的持续获批推动；而在生物类似药领域，截 至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23个药品通用 名。 此外，有业界观点认为，在中国仿制药行业市场集 ...

Core Viewpoint - The article discusses the accelerated clinical access and economic substitution of high-quality generic drugs in China due to the "volume-based procurement" policy, alongside the increasing proportion of biological drugs in national negotiations, which facilitates the listing and promotion of biosimilars in hospitals [3][4]. Group 1: Market Overview - The Chinese generic drug market has maintained a scale of approximately 900 billion yuan, with an increase in the number of companies and varieties intensifying market competition [3]. - As of 2024, the number of generic drugs that have passed consistency evaluation or are deemed equivalent has increased by over two-thirds compared to three years ago, primarily driven by a few companies and previously approved varieties [4][9]. - In the chemical generic drug sector, the top 10 companies hold a stable market share of around 22%, indicating a relatively low market concentration [7][9]. Group 2: Drug Evaluation and Approval - The number of approved generic drugs reached 914 in 2024, a significant increase from 543 in 2021, with 70% of these approvals concentrated among 33% of companies [9]. - The phenomenon of "homogenization of varieties" is becoming a defining characteristic of competition in the generic drug market, with a notable increase in the number of similar products [12][13]. Group 3: Biosimilars Market - By 2024, 87 biosimilars have been approved in China, with over 50% being antibody biosimilars, indicating a concentrated market in specific therapeutic areas [13]. - The application for biosimilars has reached a historical high, particularly in the metabolic field, with one drug alone accounting for nearly 40% of applications [13]. Group 4: Contract Manufacturing Trends - The participation of contract manufacturers in national drug procurement has significantly increased, with 31% of selected products in the tenth round of procurement being produced by contract manufacturers, up from 3% in the second round [16][19]. - The article highlights the challenges of ensuring quality control and regulatory compliance in contract manufacturing, especially as the number of B certificate enterprises increases [19][20].

品种同质化加剧，成为仿制药市场竞争的底色。 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中生物药占比增加，"谈判药品同通用名仿制药上市自动 属于目录范围"的医保政策则为生物类似药挂网入院及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升，却也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中国仿制药发展报告（2025）》（下称"报告"）显示， 中国仿制药市场规模多年维持在9000亿元水平，企业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年前增加了超过2/3，但当年增长主要由少数企业和既往过 评品种的持续获批推动；而在生物类似药领域，截至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23个药品通用 名。 此外，有业界观点认为，在中国仿制药行业市场集中度较低的背景下，不仅要审慎看待仿制研发"扎堆"现象 ...

Core Viewpoint - Zhejiang Yatai Pharmaceutical Co., Ltd. is undergoing a strategic transformation from generic drugs to innovative drug development, supported by new leadership and funding for research projects [1][2][4]. Group 1: Company Overview - Yatai Pharmaceutical is a well-established pharmaceutical company in China with a complete pharmaceutical business chain, offering a wide range of products including anti-infectives, antiviral, digestive system, and cardiovascular drugs [1]. - As of September 2025, the company holds 114 approved drug formulations, with 19 products passing consistency evaluations and 3 products entering national centralized procurement [1]. Group 2: Financial Performance - In the first three quarters, Yatai Pharmaceutical achieved revenue of approximately 228 million yuan and a net profit of about 97.2 million yuan, marking a significant year-on-year increase of 2,909.49% [1]. Group 3: Strategic Changes - The company plans to change its actual controller to Mr. Qiu Zhongxun, the chairman and founder of Yaodou Technology, and will raise 700 million yuan through a private placement to fund new drug research projects [1][3]. - This transition signifies a shift towards innovative drug development, moving away from a focus on generic drugs [2][6]. Group 4: Innovation and R&D Focus - Yatai Pharmaceutical's innovation strategy includes developing oncolytic virus drug platforms and long-acting complex formulations, targeting a market expected to reach 160 billion yuan by 2025 in China and the U.S. [2]. - The company adopts a balanced approach to R&D, focusing on specific disease areas while ensuring sustainable new drug development and efficient use of funds [2]. Group 5: Market and Policy Environment - The new leadership and strategic focus align with favorable national policies promoting biomanufacturing and innovative drug development as key economic growth areas [4][5]. - The recent launch of the national drug research major project is expected to enhance the drug innovation ecosystem in China, benefiting companies like Yatai Pharmaceutical [5]. Group 6: Market Performance - Yatai Pharmaceutical's stock has seen a significant increase, with a year-to-date rise of over 178%, reflecting investor confidence in the company's innovative transformation [3][6]. - Analysts predict that the successful implementation of the new funding projects will lead to a revaluation of the company, transitioning it from a traditional generic drug firm to an innovative drug platform company [6].

Core Viewpoint - After resuming trading on October 14, Asia-Pacific Pharmaceutical (002370.SZ) experienced a significant stock price increase of 52.38% by November 6, driven primarily by the change in its controlling shareholder to Qiu Zhongxun, chairman of the pharmaceutical internet platform Yaodou Technology, which opens new growth opportunities for the company [1] Group 1: Traditional Business and Cash Flow - Asia-Pacific Pharmaceutical's injection of cefazolin sodium is expected to generate sales revenue of 13.6965 million yuan in 2024, accounting for 3.38% of the company's total revenue [2] - The collaboration with Yaodou Technology is anticipated to enhance sales channels and market penetration, thereby increasing market share and brand influence [2] - The company holds 114 approved drug formulations, providing a solid foundation for maintaining traditional business stability while transitioning to innovation-driven operations [2] Group 2: Innovation Drug Transformation - The company plans to raise 700 million yuan through a private placement, which will be fully allocated to new drug research and development, focusing on oncolytic virus drug platforms and long-acting complex formulations [4] - A project research committee has been established to monitor cutting-edge medical technology trends and clinical value, enhancing the company's R&D capabilities and core competitiveness [4] - The new controlling shareholder has signed a research cooperation intention letter with relevant CRO companies, aiming to integrate industrial capabilities and research resources to promote the commercialization of innovative drugs [4] Group 3: Industry Environment and Future Outlook - The national "14th Five-Year Plan" suggests promoting innovative drug industries as a core component of future economic growth, benefiting from substantial capital support [5] - From 2015 to 2024, the cumulative financing scale in China's innovative drug sector has exceeded 1.23 trillion yuan, injecting strong capital support for growth [6] - The Chinese pharmaceutical market is undergoing a historic shift from generics to innovation, with Asia-Pacific Pharmaceutical leveraging a dual strategy of "capital and innovation" to navigate this transition [6]

Group 1 - The core point of the article is that Shandong Lukang Pharmaceutical Co., Ltd. has been selected for the national centralized drug procurement, which includes products like injectable cefoperazone sodium [1] - For the year 2024, the revenue composition of Lukang Pharmaceutical is as follows: human antibiotics account for 54.29%, veterinary antibiotics account for 39.72%, other products account for 4.89%, and other businesses account for 1.1% [1] - As of the report date, the market capitalization of Lukang Pharmaceutical is 9.3 billion yuan [1]

Core Viewpoint - Lu Kang Pharmaceutical (600789.SH) and its subsidiary, Shandong Lukang Pharmaceutical Group Saiter Co., Ltd., have successfully won bids for several drugs in the recent centralized procurement process, indicating a positive development for the company's market position and revenue potential [1] Group 1 - The selected products include: injectable cefazolin sodium, dapagliflozin tablets, adenosylcobalamin capsules, and mesobalamin injection [1] - The total sales revenue for the selected products in 2024 is projected to be 405 million yuan [1]

Core Viewpoint - LuKang Pharmaceutical (600789.SH) and its subsidiary, Shandong Lukang Pharmaceutical Group Sait Company, have successfully won bids for several drugs in the recent centralized procurement process, indicating a positive development for the company's market position and revenue potential [1] Group 1 - The selected products include: Cefoperazone Sodium for Injection, Dapagliflozin Tablets, Adenosylcobalamin Capsules, and Mesobam Injection [1] - The total sales revenue for the selected products in 2024 is projected to be 405 million yuan [1]

Core Viewpoint - The company reported a steady growth in net profit for the first three quarters of 2025, despite a decline in revenue, indicating resilience in its core operations and product development strategy [1] Financial Performance - The company achieved an operating revenue of approximately 1.231 billion yuan, a year-on-year decrease of 19.76% [1] - The net profit attributable to shareholders was 136 million yuan, reflecting a year-on-year increase of 4.31% [1] - Basic earnings per share stood at 0.23 yuan [1] Product Development and Pipeline - The company focuses on the fields of "anti-infection, analgesics, mental health, and chronic diseases," aiming to meet actual medication needs and enhance clinical efficacy [1] - The company has been actively pursuing consistency evaluations and independent research and development, introducing high-potential and high-value-added products [1] - A stable and mature core product lineup is being established through both internal and external growth strategies [1] Recent Product Approvals - On April 1, the company received a drug registration certificate for injectable cefoperazone sodium, enhancing its product line in the anti-infection sector [2] - On April 18, the company’s ondansetron hydrochloride tablets received approval, expanding its offerings in the gastrointestinal and metabolic fields [2] - On September 26, the company’s apremilast tablets were approved, which are recommended for the treatment of moderate to severe plaque psoriasis, further strengthening its position in the immunomodulator market [2]

Core Viewpoint - Zhejiang Apac Pharmaceutical Co., Ltd. has announced its participation in the national centralized drug procurement, with its injectable Cefoperazone Sodium (1.0g) expected to be selected in this round of procurement [1] Group 1: Procurement Announcement - The 11th batch of national drug centralized procurement includes 55 types of drugs, covering common medications in various fields such as anti-infection, anti-allergy, anti-tumor, and more [1] - A total of 46,000 medical institutions participated in the bidding, with 445 companies submitting 794 products, and 272 companies having 453 products proposed for selection [1] Group 2: Product Information - Injectable Cefoperazone Sodium is a third-generation cephalosporin antibiotic with broad-spectrum antibacterial activity, suitable for various infections [1] - This product is one of the key offerings of Apac Pharmaceutical, projected to generate sales revenue of 13.6965 million yuan in 2024, accounting for 3.38% of the company's total revenue [1] Group 3: Future Prospects - If procurement contracts are signed and implemented, it will expand sales of related products, enhance market share, and improve brand influence, positively impacting future operating performance [2] - The company reported a revenue of approximately 228 million yuan and a net profit of about 97.2 million yuan for the first three quarters, marking a significant year-on-year increase of 2,909.49% [2] - The company is undergoing a change in actual control, with the chairman of Yaodou Technology set to become the new controlling shareholder, and plans to raise 700 million yuan for new drug research and development [2] - The market anticipates that the company will continue to focus on innovation and transformation towards innovative drugs, with "industry synergy + innovation-driven" becoming a core focus for the future [2]