截至去年9月，鼓励仿制药品目录内药品仅有40个品种获批上市。 1月4日，国家卫健委、工信部、国家药监局和国家知识产权局联合发布《关于印发第四批鼓励仿制药品 目录的通知》（下称《通知》）。针对"国内专利即将到期尚未提出注册申请及临床供应短缺（竞争不 充分）"的药品，第四批目录共计收录21个药品品种，涉及47个药品品规。 相较于前三批目录，今年最新发布的第四批目录除了持续关注肿瘤、罕见病等重大疾病领域，也同样关 注到慢病、精神疾病以及辅助生殖等领域的治疗用药短缺问题，回应了老龄少子化趋势下的人口疾病负 担变化和临床需求。 国家卫健委药物政策与基本药物制度司在《通知》解读文件中提出，第四批目录继续以患者治疗需求为 导向，补短板、强弱项。"综合考虑临床指南推荐和国内在研情况等药品信息，经专业科别咨询、剂型 规格逐一讨论和专家独立投票等多种形式，充分听取临床、药学、药品审评、知识产权等方面专家意 见，收录药品涉及抗肿瘤、神经系统、辅助生殖、放射性诊断等领域用药。" 具体来说，针对国内企业研发薄弱环节，第四批目录收录了多个新靶点、新作用机制产品。比如，今年 新增纳入了缓解血液透析患者慢性肾病治疗中重度瘙痒的地非法林，此外 ...

2025-011 | 回复： | | --- | | 公司有专业的 BD 团队，在针对中药产品进行深入研究，目 | | 标是找到与公司发展方向相符合的产品。 | | 问题 7：公司合作推广品种佩玛贝特片计划上市时间？ | | 回复： | | 该产品预计明年实现上市销售。 | | 问题 8：公司产品出口情况及未来计划？ | | 回复： | | 公司出口业务占整体营业收入比例较低，为注射用磷酸肌酸 | | 钠出口至乌兹别克斯坦；未来公司如果开展现有产品的出口业务， | | 也将主要围绕一带一路国家开展。 | | 问题 9：目前公司处于无实际控制人状态的原因？未来第一 | | 大股东是否会持续增持？ | | 回复： | | 公司原控股股东因破产导致其持有的公司股份于 2023 年被司 | | 法拍卖，导致公司处于无实际控制人状态。 | | 公司第一大股东通过司法拍卖方式获得了公司股份，后续因 | | 认可经理层团队及公司长期投资价值，进行了多次增持。 | | 未来是否会继续增持，将结合公司发展及市场情况而定。 | | 问题 10：公司多年未进行分红的原因，以及公司进行股份回 | | 购的原因？ | | 回复： | ...

Core Viewpoint - The company, Anglikang (002940), announced on October 30 that its current R&D team is primarily focused on generic drug development, while it is in the process of establishing a clinical medicine team to enhance its capabilities in innovative drug development in the short term [1] Group 1 - The company is currently building its R&D team based on generic drug development [1] - A clinical medicine team is being initiated to support innovative drug development [1] - The company plans to continuously optimize its R&D team structure as investment in innovative drugs increases in the future [1]

Core Viewpoint - Haixi New Drug officially listed on the Hong Kong Stock Exchange on October 20, 2023, with an issue price of HKD 86.4 per share, opening 18.06% higher on its first day, and achieving a market capitalization of HKD 8.5 billion [1][4]. Company Overview - Founded 13 years ago by a couple with strong academic backgrounds, Kang Xinshan and Feng Yan, who returned to Fujian to establish Haixi New Drug with support from local state-owned enterprises [1][2]. - The company has a dual-track business model focusing on both generic and innovative drug development, having successfully commercialized multiple products [5][4]. Financial Performance - Haixi New Drug reported revenues of RMB 212.5 million, RMB 316.6 million, RMB 466.7 million, and RMB 249.2 million for the years 2022, 2023, 2024, and the first five months of 2025, respectively [7][5]. - The company achieved profits of RMB 68.98 million, RMB 117.45 million, RMB 136.08 million, and RMB 90.21 million for the same periods [7][5]. Product Pipeline - The company has established a pipeline of four innovative drugs under development, targeting cancer, ophthalmology, and respiratory diseases, with one drug expected to be a breakthrough therapy for osteosarcoma [4][5]. Industry Context - The biopharmaceutical industry in Fujian has been strategically supported by government initiatives since 2009, aiming to cultivate a robust pharmaceutical sector [12][14]. - Fujian's biopharmaceutical industry is rapidly growing, with Xiamen and Fuzhou emerging as key hubs, and the province aims to achieve RMB 120 billion in pharmaceutical industrial revenue by 2025 [13][14].

Core Viewpoint - Fujian Haixi New Drug Creation Co., Ltd. (Haixi New Drug) officially listed on the Hong Kong Stock Exchange on October 20, 2023, with an initial price of 86.4 HKD per share, opening 18.06% higher, and currently has a market capitalization of 8.5 billion HKD [5][10]. Company Overview - Haixi New Drug was founded 13 years ago by a couple with strong academic backgrounds, Kang Xinshan and Feng Yan, who returned to Fujian with extensive experience in the pharmaceutical industry [7][8]. - The company has received significant support from local government and venture capital, which has been crucial for its growth and development [8][14]. Business Model - The company operates on a dual-track model focusing on both generic and innovative drug development, which has allowed it to achieve profitability [12]. - As of October 2025, Haixi New Drug has 15 generic drugs approved by the National Medical Products Administration, with products targeting various disease areas including digestive, cardiovascular, endocrine, and neurological systems [8][12]. Financial Performance - Revenue figures for Haixi New Drug are as follows: 212.5 million RMB in 2022, projected to reach 3.16 billion RMB in 2023, and 4.67 billion RMB in 2024, with profits of 68.98 million RMB in 2022 and 117.45 million RMB in 2023 [12][13]. - The majority of the company's revenue comes from generic drugs, with key products contributing over 90% of total income [13]. Industry Context - The rise of Haixi New Drug reflects the broader growth of the biopharmaceutical industry in Fujian, which has been strategically supported by government initiatives since 2009 [17][18]. - Fujian aims to develop five biopharmaceutical industry clusters by 2025, with a target revenue of 120 billion RMB for the pharmaceutical industry [18].

Core Viewpoint - Fudan Zhangjiang's application for the listing of Obeticholic Acid Tablets was not approved by the National Medical Products Administration, resulting in a loss of approximately 125 million yuan in R&D investment and highlighting systemic risks in product structure, R&D strategy, and external policy environment [1] Group 1: R&D Risks - The application for Obeticholic Acid Tablets, a Class 3 chemical generic drug, faced obstacles due to the original drug's withdrawal from markets in Europe and the U.S. due to safety concerns, which disrupted the registration path for domestic generic drugs [1] - The withdrawal of the original drug by Intercept Pharmaceuticals has led to multiple rejections of generic drug applications from various companies, including Fudan Zhangjiang [1] Group 2: Revenue Structure Challenges - Fudan Zhangjiang has four commercialized products, with Revlimid and Ella contributing approximately 70% of revenue, while the anti-tumor drug Liposomal Doxorubicin accounts for about 29.04% [3] - The core product Liposomal Doxorubicin is expected to see a price reduction of at least 35% starting May 2025, potentially leading to a more than 50% year-on-year decline in sales revenue [3] - The sales revenue of Revlimid decreased by 7% year-on-year in the first half of this year, while Ella saw a slight increase of 2%, indicating weak growth overall [3] Group 3: High R&D Investment and Uncertain Returns - Despite emphasizing that the failure of the Obeticholic Acid project will not alter the overall R&D strategy, the incident underscores the high investment, long cycle, and high risk associated with pharmaceutical R&D [4] - The company is increasing its focus on the ADC (Antibody-Drug Conjugate) platform to build a differentiated advantage, but competition in this field is intensifying [4] Group 4: Regulatory Environment - The National Medical Products Administration has tightened regulations on the entire lifecycle of drugs, making it increasingly difficult for generic drugs to find reference products if the original drug is withdrawn due to safety or efficacy issues [5] - Domestic pharmaceutical companies are advised to consider global regulatory dynamics and real-world data when selecting generic drug projects, rather than solely focusing on patent expiration and unlisted drugs in the domestic market [5] Conclusion - Fudan Zhangjiang faces multiple challenges, including aging product structures, missteps in generic drug projects, and impacts from centralized procurement policies, which complicate the path to maintaining stable existing business while accelerating the development of competitive innovative drug pipelines [6][7]

Core Viewpoint - Fudan Zhangjiang Biopharmaceutical Co., Ltd. announced that its subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration stating that its application for the drug Ocaliva (Obeticholic Acid Tablets) for the treatment of Primary Biliary Cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1][2]. Group 1: Drug Development and Approval - The application for Ocaliva is a Class 3 generic drug, with the first target indication being PBC. Fudan Zhangjiang has made breakthroughs in patent restrictions and obtained relevant patent authorization in mainland China [2]. - The drug was included in the second batch of encouraged generic drugs in China in 2021, but no generic versions have been approved domestically yet [4]. - Other companies, including Chengdu Kanghong Pharmaceutical Group and Jiangsu Hengrui Medicine, are also involved in the development of Ocaliva [4]. Group 2: Financial Impact and R&D Investment - Fudan Zhangjiang has invested approximately 125 million yuan in the development of Ocaliva, which will not significantly impact the company's current financial status [3]. - The company has experienced a continuous decline in revenue and net profit over the past three and a half years, with revenues of 1.031 billion yuan, 851 million yuan, and 709 million yuan from 2022 to 2024, representing year-on-year declines of 9.57%, 17.5%, and 16.61% respectively [7]. - R&D expenses have been increasing, reaching 314 million yuan in 2024, accounting for 44% of revenue [8]. Group 3: Market Context and Competitors - The original drug for Ocaliva was conditionally approved in foreign markets but has faced significant safety and efficacy controversies, leading to its withdrawal from the U.S. market by Intercept Pharmaceuticals [3]. - Other companies, including Zhengda Tianqing Pharmaceutical Group, have also faced setbacks with their applications for Ocaliva [5][6].

Core Points - The application for the generic drug developed by Fudan Zhangjiang, which cost 125 million yuan, was rejected due to safety concerns related to its reference drug, which has been withdrawn from the European and American markets [1][2] - The original drug, Ocaliva, has faced multiple safety warnings since 2017, leading to its withdrawal from the market and suspension of all related clinical trials [3][4] - The domestic market for the generic version of Ocaliva is now highly uncertain due to the original drug's safety issues and market withdrawal [4][5] Company Summary - Fudan Zhangjiang's subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., received a notice from the National Medical Products Administration stating that the application for Obechol acid tablets was not approved due to non-compliance with drug registration requirements [1][5] - The company has invested approximately 125 million yuan in the development of Obechol acid tablets, but the rejection of the application is not expected to have a significant impact on its current financial status [1][5] - Other domestic companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obechol acid generics, with several applications still pending approval [5] Industry Summary - Obechol acid, originally developed by Intercept Pharmaceuticals, was first approved in 2016 for treating primary biliary cholangitis (PBC) but has since faced serious safety concerns leading to its market withdrawal [2][3] - The prevalence of PBC in China has been increasing, reaching 21.05 per 100,000 in 2022, indicating a potential market for treatments despite the current setbacks [2] - The domestic market for Obechol acid generics is now fraught with uncertainty, as the original drug's safety risks have raised doubts about the viability of its generic counterparts [4][5]

Core Viewpoint - Fudan Zhangjiang (688505.SH) announced that its subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notice from the National Medical Products Administration stating that the application for the marketing authorization of Ocaliva (Obeticholic Acid Tablets) for the treatment of primary biliary cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1] Group 1: Drug Approval and Market Impact - The primary reason for the rejection of the marketing application is the safety issues associated with the original drug, which led to its withdrawal from the European and American markets [1][2] - Fudan Zhangjiang has invested approximately 125 million yuan in the development of Obeticholic Acid Tablets, but the company stated that the rejection will not have a significant impact on its current financial status [1][3] Group 2: Original Drug Background - The original drug, Ocaliva, developed by Intercept Pharmaceuticals, was first approved by the FDA in May 2016 and received conditional approval in Europe in December 2016 [2] - The global sales of Ocaliva showed steady growth from 2016 to 2021, reaching approximately 363 million USD in 2021, but stabilized around 300 million USD in subsequent years [2] Group 3: Safety Concerns and Regulatory Actions - Since 2017, there have been multiple safety alerts regarding Ocaliva, including reports of severe liver damage and even death, leading to the FDA placing a "black box warning" on the drug [3] - In October 2023, the European Medicines Agency recommended the withdrawal of Ocaliva's marketing authorization, which was officially revoked in September 2024 [3] Group 4: Domestic Generic Drug Landscape - Currently, there are no approved domestic versions of Obeticholic Acid, and the safety risks associated with the original drug have created significant uncertainty for its generic prospects in China [4][5] - Several domestic pharmaceutical companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obeticholic Acid generics [5][6]

Core Points - Fudan Zhangjiang (688505.SH) announced that its subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notice from the National Medical Products Administration stating that the drug application for Obeticholic Acid Tablets was not approved due to non-compliance with drug registration requirements [1] - The original drug for Obeticholic Acid faced safety issues and was withdrawn from the European and American markets, which was a significant reason for the rejection of the application [1] - The company has invested approximately 125 million yuan in the development of Obeticholic Acid Tablets, but the rejection will not have a significant impact on its current financial status [1] Industry Overview - Obeticholic Acid was first approved by the FDA in May 2016 for treating primary biliary cholangitis (PBC) and received conditional approval in Europe in December 2016 [2] - The prevalence of PBC in China has been increasing, reaching 21.05 per 100,000 in 2022 [2] - Global sales of Obeticholic Acid grew steadily from approximately $250 million in 2019 to $363 million in 2021, stabilizing around $300 million in subsequent years [2] - Safety concerns have led to multiple warnings from the FDA, including a "black box warning" and restrictions on its use in patients with liver cirrhosis [2] - In October 2023, the European Medicines Agency recommended the withdrawal of Obeticholic Acid's market authorization, and Intercept Pharmaceuticals voluntarily withdrew the drug from the U.S. market [3] - Several domestic pharmaceutical companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obeticholic Acid generics due to the original drug's safety risks [4][5]