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 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：600056 证券简称：中国医药 公告编号：临2025-086号 中国医药健康产业股份有限公司 关于公司涉及诉讼事项的进展公告 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。 重要内容提示: ● 案件所处的诉讼阶段：二审 ● 上市公司所处的当事人地位：上诉人 ● 涉案的金额：13,940.41万元 公司已在法定期限内就北京市第二中级人民法院（"一审法院"）作出的（2024）京02民初1131号民事判 决书（"一审判决"）依法提起上诉，西藏天晟亦就一审判决提起上诉。 三、本次诉讼案件对公司的影响 截至本公告披露日，本次诉讼二审尚未开庭审理，最终审理结果存在不确定性。公司将根据上述诉讼事 项进展情况履行相关信息披露义务，敬请广大投资者注意投资风险。 特此公告。 中国医药健康产业股份有限公司董事会 2025年11月22日 证券代码：600056 证券简称：中国医药 公告编号：临2025-087号 ● 是否会对上市公司损益产生负面影响：截至本公告披露日，本次诉讼二审尚未开庭审 ...

Core Viewpoint - Asia-Pacific Pharmaceutical received a notification from the National Medical Products Administration regarding the rejection of its application for the consistency evaluation of Diltiazem Hydrochloride Tablets, which may impact the company's recent strategic shift towards innovation following a change in control [2][6]. Company Overview - Asia-Pacific Pharmaceutical, established in 1989 and listed in 2010, primarily produces chemical generic drugs, with over 60% of its products being antibiotics [4]. - The company has faced a continuous decline in performance over the past six years, accumulating a net loss of over 2.5 billion yuan [4]. Financial Performance - From 2019 to 2024, the company's net profit excluding non-recurring items showed significant losses: 1.94 billion yuan, 143 million yuan, 239 million yuan, 117 million yuan, 68.94 million yuan, and 28.13 million yuan respectively [4]. - In the first half of 2025, the company reported revenue of 152 million yuan, a year-on-year decline of 31.48%, while the net profit attributable to shareholders increased by 1820.97% due to the sale of a subsidiary [4]. - The third quarter of 2025 showed a net profit of 97.2 million yuan, a year-on-year increase of 2909.49%, but the net profit excluding non-recurring items was a loss of 56.6 million yuan, indicating a worsening trend [5]. Product and Market Challenges - The company's product structure, heavily reliant on chemical generics, faces intense market competition and challenges due to delays in the consistency evaluation of generics, leading to weakened competitiveness [5]. - Currently, only 19 of the company's products have passed the consistency evaluation, and the ongoing pressures from centralized procurement and slowing demand for antibiotics have resulted in declining sales and prices [5]. Strategic Shift - In October 2023, Starry Holdings acquired a 14.62% stake in Asia-Pacific Pharmaceutical for 900 million yuan, marking a strategic shift from generic to innovative drug development, with plans to invest 700 million yuan in new research platforms [6]. - The recent failure of the consistency evaluation for Diltiazem Hydrochloride Tablets poses a setback to this transformation strategy [6].

Core Viewpoint - Asia-Pacific Pharmaceutical (亚太药业) faced a setback as its application for the consistency evaluation of Diltiazem Hydrochloride Tablets was rejected by the National Medical Products Administration (NMPA) just a month after a significant change in its controlling shareholder and a capital increase plan [1][2][4]. Group 1: Company Overview - Asia-Pacific Pharmaceutical was established in 1989 and primarily produces chemical generic drugs, with over 60% of its products being antibiotics [3]. - The company has been experiencing a decline in performance for six consecutive years, with a cumulative loss exceeding 2.5 billion yuan in net profit excluding non-recurring items from 2019 to 2024 [3][4]. Group 2: Financial Performance - In the first half of 2025, the company reported revenue of 152 million yuan, a year-on-year decrease of 31.48%, while the net profit attributable to shareholders increased by 1820.97% due to the sale of a subsidiary [3]. - The third-quarter report for 2025 indicated a net profit of 97.2 million yuan, a year-on-year increase of 2909.49%, but the net profit excluding non-recurring items showed a loss of 56.6 million yuan, reflecting a 150.47% increase in loss [4]. Group 3: Market Challenges - The company’s product structure, heavily reliant on chemical generics, faces intense market competition and challenges due to delays in the consistency evaluation of generics, leading to weakened competitiveness [4]. - As of now, only 19 of the company's products have passed the consistency evaluation, and the ongoing pressures from normalized centralized procurement and slowing demand for antibiotics have resulted in declining sales and prices [4]. Group 4: Strategic Shift - In October 2023, Starry Holdings acquired 14.62% of Asia-Pacific Pharmaceutical for 900 million yuan, marking a 45.68% premium, and initiated a 700 million yuan capital increase plan aimed at transitioning the company from generic to innovative drug development [4]. - The recent failure of the consistency evaluation for Diltiazem Hydrochloride Tablets poses a significant challenge to this strategic shift towards innovation [4].

Core Viewpoint - The concept of generic drug consistency evaluation has seen a significant increase, with a rise of 3.31% as of the market close on October 31, ranking it seventh among concept sectors [1]. Group 1: Market Performance - Within the generic drug consistency evaluation sector, 135 stocks experienced gains, with notable performers including Zhongsheng Pharmaceutical, Lianhuan Pharmaceutical, and Haishike, all reaching their daily limit up [1]. - The top gainers in this sector were Kangzhi Pharmaceutical, Deyuan Pharmaceutical, and Yuandong Biological, with increases of 17.47%, 13.09%, and 11.45% respectively [1]. - Conversely, Shanghai Pharmaceuticals, *ST Suwu, and Jianfeng Group were among the top decliners, with decreases of 2.07%, 1.98%, and 1.81% respectively [1]. Group 2: Capital Inflow - The generic drug consistency evaluation sector attracted a net inflow of 2.434 billion yuan, with 72 stocks receiving net inflows, and 8 stocks exceeding 100 million yuan in net inflow [2]. - The leading stock in terms of net capital inflow was Yongtai Technology, which saw a net inflow of 397 million yuan, followed by Lianhuan Pharmaceutical and Zhongsheng Pharmaceutical with net inflows of 349 million yuan and 305 million yuan respectively [2]. Group 3: Capital Flow Ratios - Lianhuan Pharmaceutical, Anglikang, and Yatai Pharmaceutical had the highest capital inflow ratios, with net inflow rates of 41.17%, 33.00%, and 21.24% respectively [3]. - The top stocks in the generic drug consistency evaluation sector based on capital inflow included Yongtai Technology, Lianhuan Pharmaceutical, and Zhongsheng Pharmaceutical, with respective daily gains of 6.16%, 10.01%, and 10.02% [3].

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 - Shanghai Modern Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., has received approval for its product, Lincomycin Hydrochloride Injection, to pass the consistency evaluation for generic drugs, which is expected to enhance market expansion and sales potential for the product [1][3]. Group 1: Drug Information - The drug Lincomycin Hydrochloride Injection is an antibiotic used for treating severe infections caused by sensitive strains of bacteria such as Streptococcus, Pneumococcus, and Staphylococcus [2]. - The product's sales in public medical institutions in China are projected to be approximately RMB 77.29 million in 2024 [2]. - The cumulative R&D investment for the consistency evaluation of Lincomycin Hydrochloride Injection by China National Pharmaceutical Group Rongsheng is about RMB 3.61 million (unaudited) [2]. Group 2: Company Impact - The approval of Lincomycin Hydrochloride Injection for consistency evaluation is anticipated to positively influence the product's future market expansion and sales [3]. - The current operational performance of the company is not expected to be significantly impacted by this development [3].

Core Viewpoint - The article discusses the complexities of China's healthcare system, particularly the challenges of balancing quality, cost, and accessibility in the context of imported and domestic pharmaceuticals [6][19]. Group 1: Drug Registration and Market Dynamics - The National Medical Products Administration (NMPA) recently announced the cancellation of 80 drug registration certificates, with over 55% being products from foreign or joint venture companies, indicating a trend of imported drugs exiting the Chinese market [8][9]. - The cancellation of these drugs was initiated by the companies themselves, suggesting a strategic business decision rather than regulatory enforcement [8]. Group 2: Quality and Efficacy of Pharmaceuticals - Both original and generic drugs have identical active ingredients, but differences in formulation and manufacturing processes can lead to variations in clinical effectiveness [11][12]. - The quality of domestic generic drugs has improved significantly due to stricter regulations, but there remains a gap in bioequivalence standards compared to international benchmarks [15][19]. Group 3: Healthcare Financing and Policy - China's healthcare system faces the "impossible triangle" of quality, cost, and accessibility, necessitating the use of low-cost generic drugs to meet the basic healthcare needs of a large population [19][20]. - The government prioritizes the reimbursement of generic drugs over original drugs to ensure the sustainability of the healthcare system, which can lead to limitations on the availability of higher-priced original medications [20][24]. Group 4: Innovation and Future Directions - The introduction of innovative drugs into the healthcare reimbursement system has become more efficient, with the average time from market entry to reimbursement reduced to less than two years [22][24]. - The savings from using generic drugs are being redirected to subsidize the costs of innovative drugs, highlighting a strategic approach to healthcare funding [24][27]. Group 5: Patient Choices and Market Dynamics - There is a call for more flexibility in the healthcare system to allow wealthier patients to access original drugs, suggesting a need for a multi-tiered healthcare financing model [26][27]. - The article emphasizes the importance of maintaining a balance between cost control and individual patient needs, advocating for a system that supports both generic and innovative drug development [26][27].

Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary Tianfang Pharmaceutical received approval from the National Medical Products Administration for the Vitamin B6 injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Product Approval and Market Impact - The Vitamin B6 injection is primarily used for the prevention and treatment of Vitamin B6 deficiency, as well as for conditions such as isoniazid poisoning, pregnancy-related issues, radiation sickness, and vomiting caused by anticancer drugs [1] - The original product was developed by Fujisawa Pharmaceutical Co., Ltd. in June 1957 and received FDA approval for the U.S. market in August 1972, with a specification of 1ml:0.1g [1] - Currently, the original product is not imported or available in the domestic market [1] Group 2: Policy and Competitive Advantage - According to national policies, drugs that pass the consistency evaluation will receive greater support in areas such as medical insurance payments and procurement by medical institutions [1] - The approval of Tianfang Pharmaceutical's Vitamin B6 injection enhances the product's market competitiveness and is expected to further expand its market share [1]

Core Viewpoint - China National Pharmaceutical Group Modern (600420.SH) announced that its wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the supplementary application of Famotidine injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approval allows Famotidine injection to be used for treating upper gastrointestinal bleeding caused by peptic ulcers and other non-tumor related conditions [1] - Famotidine is classified as a histamine H2 receptor antagonist [1] - The drug is indicated for various causes of gastric and duodenal mucosal erosion bleeding, excluding those related to tumors and esophageal or gastric varices [1]