胰岛素专题：出海正当时 20260106 摘要 国内胰岛素市场规模约 220 亿人民币，预计行业增速 5%-8%，头部企 业通过以价换量策略，有望实现 10%-20%的更高增速，主要驱动力包 括三代胰岛素替代、国产替代进口及基层医疗渗透率提升。 国内药企积极布局海外市场，如甘李药业预计 2025 年 1 月获欧洲行政 批件，2024 年底获巴西大单，并通过授权进入拉美、印度等市场，有 望在未来两三年内转化为订单和利润。 中国药企具备产能优势，甘李药业、通化东宝和联邦制药分别拥有 6 亿 支、3 亿支以上和 1 亿支制剂产能，可通过性价比优势抢占全球市场份 额。 欧美发达国家市场策略侧重与当地头部企业合作，实现利润最大化，如 美国长效甘精胰岛素价格是国内 3 倍。亚非拉发展中国家则通过提供更 低价格提高渗透率，如出口原液进行当地灌装。 通过灌装业务，企业可显著提升市场份额，原料毛利率达 50%，净利润 约 25%。建议投资者关注企业拓展海外市场，以实现更大的增量。 Q&A 在当前市场环境下，企业如何通过灌装业务获取更大的市场份额？ 国内胰岛素市场目前主要集中在甘李药业、通化东宝和联邦制药这几家企业。 整体来看， ...

近日，上海英捷信医疗科技有限公司（以下简称"英捷信医疗"）宣布成功完成数千万元人民币A+轮融 资，本轮融资由毅达资本独家投资，浩悦资本担任独家财务顾问。本轮资金将用于进一步扩大全球高质 量标准的产能体系建设，拓展全球营销与注册团队。 英捷信医疗作为国家高新技术企业，始终聚焦自主创新，以精密制造工艺突破技术瓶颈，逐步构建起完 整的自主知识产权体系。公司目前已为数十家国内外大型生物制药公司提供配套服务，产品覆盖GLP-1 类药物、胰岛素、生长激素等多领域，不仅在国内GLP-1领域客户覆盖度领先，还成功开拓多国海外市 场，全球化布局效果显著。 ...

法国企业则掀起"中国中心"建设热潮。制药巨头赛诺菲创下在华最大单笔投资纪录，10亿欧元在北京亦庄新建胰岛素生产基地，实 现从原料药到成品药的全产业链布局，这也是跨国药企首次在华布局生物制剂原料药生产 。工业巨头施耐德电气密集落地重大项 目，上海金山创新实验园区二期、厦门中压生产基地相继动工，将中国打造成服务全球的研发与供应链核心 。美妆巨头欧莱雅更是 启用全球首家自建智能运营中心，用实际行动印证"下一个中国，还是中国"的判断 。 近两年欧洲扎堆迁华的企业有哪些？ "在中国投资，来对了！"瑞士医沛生总经理斐雷杜用略显生涩的中文坚定表态。这位外企高管的心声，正是近两年来欧洲企业集 体"向东看"的真实写照。从德国汽车巨头到法国制药龙头，从瑞士医疗先锋到法国工业翘楚，一批欧洲知名企业纷纷加码对华投 资，迁徙浪潮背后，是中国市场无可替代的独特魅力。 巨头云集：百亿级投资密集落地，覆盖全产业链 近两年来，欧洲企业对华投资不再是简单的产能布局，而是升级为全产业链的深度扎根，超大规模投资项目接踵而至。 德国作为欧洲对华投资的"领头羊"，表现尤为抢眼。大众汽车豪掷25亿欧元扩建合肥生产及创新中心，宝马更是连续加码沈阳基 地，在 ...

国家组织药品集中采购1-8批接续采购正式进入报量阶段。 12月18日，山西发布《关于组织医疗机构填报国家组织药品集中采购接续相关药品需求量的通知》，明 确12月19日正式启动医疗机构报量，医疗机构须按要求填报相关药品采购需求量，并于12月29日前提交 数据。 本次接续共涉及前八批集采的317个品种（不含第六批集采胰岛素）。据风云药谈创始人张廷杰统计， 这次涉及4943个标的，按投标主体的数量是1185家企业。医疗机构需要根据系统内的药品清单填报采购 需求量，每个采购品种可在过评规格中自主选择按厂牌进行报量，未过评规格的历史用量由医疗机构自 行折算至过评规格，并上报附件及相关说明。 需要指出的是，本次接续中选规则发生了较大变化。据此前业内流传的《国家组织集采药品协议期满接 续采购方案（征求意见稿）》，本次接续采购总体实行询价方式。自然药论创始人张自然认为，询价理 论上所有企业都可中选。竞价是企业之间拼杀，为了不被淘汰出局，报价没有最低只有更低。询价不是 企业间拼价格，而是和基准价比，只要不高于基准价都可中选。所以询价降幅要比竞价温和得多。 随着报量工作的推进以及询价机制的落地，医药市场的竞争格局也将迎来新一轮重 ...

Core Insights - Algeria's pharmaceutical industry has developed significantly, with over 200 production units meeting approximately 80% of the national drug demand, including 10 factories dedicated to cancer medications [1] - The African Ministerial Conference on Pharmaceutical Production held in Algeria resulted in positive outcomes, gathering representatives from 29 African countries and various international organizations, highlighting the strategic importance of ensuring drug accessibility in Africa [1] - Algeria has signed five export contracts totaling $10 million with countries like Mauritania, Libya, and Senegal during the conference, showcasing its capability in local drug production and medical supplies [1] Industry Developments - Algeria is not only meeting domestic market needs but is also capable of supplying to markets outside Africa, having already exported drugs, particularly insulin, to Middle Eastern countries such as Oman and Saudi Arabia [2] - The country is increasing investments in medical supplies, focusing on digitalizing processes, simplifying approval procedures, and creating precise industrial planning to enhance local production capacity and reduce import costs [2]

Investment Rating - The report maintains a "Positive" investment rating for the healthcare sector [14] Core Insights - The non-pharmaceutical sector is facing performance pressure in 2025 due to price reductions from centralized procurement, medical insurance cost control, and the closure of retail pharmacies. However, companies are leveraging overseas expansion and innovation to achieve growth [4][9] - For 2026, the domestic fundamentals are expected to improve, with companies seeking new growth points primarily through overseas expansion and innovation, particularly in insulin and medical devices [9] - The report highlights that the insulin market is stabilizing post-centralized procurement, with significant overseas opportunities for leading companies like Mindray Medical and Ganli Pharmaceutical [10][24] - The focus on innovation in traditional Chinese medicine and medical devices is expected to create alpha opportunities for individual stocks [9][11] Summary by Sections Non-Pharmaceutical Sector - The non-pharmaceutical sector is under pressure but has opportunities through overseas expansion and innovation. Insulin and medical devices are key areas for long-term growth [4][9] - Companies like Mindray Medical and Ganli Pharmaceutical are beginning to realize overseas revenue, indicating a significant long-term market potential [9] Biopharmaceuticals - The report prioritizes insulin, with ongoing attention to blood products and vaccines. The insulin market is stabilizing, and companies are focusing on innovation and business development [10][24] - The report notes that the insulin market in developed countries is valued at $13.2 billion, with significant growth potential in emerging markets [24] Traditional Chinese Medicine - The focus is on innovation and the basic drug catalog, which is crucial for accelerating drug sales and enhancing market presence [11][12] - The report anticipates a recovery in performance due to early flu outbreaks and emphasizes the importance of retail pharmacy sales [11] Medical Devices - The report indicates that the medical device sector is at a turning point, with overseas revenue for leading companies expected to exceed 50% in 2025 [12] - The report suggests focusing on low-value consumables and in vitro diagnostics as key growth areas [12] Vaccines - The vaccine sector is currently facing challenges, with price reductions and low demand impacting sales. However, there are ongoing developments in innovative vaccines that warrant attention [39][40] - The report highlights the importance of tracking clinical progress and market performance of major vaccine candidates [40]

据阿尔及利亚Algérie360网站12月3日报道，阿正持续推进医药自主战略，在胰岛素、抗 癌药物及激素类药物等关键领域取得重要成绩，并逐步向多个非洲国家出口国产药 品。阿的医药产业正迈向"主权化"和国际化的双重轨道。 （原标题：阿尔及利亚构建医药自主体系） 阿目前已拥有超过230家制药企业和780条生产线。这是该国医药产业增长的关键 指标，也体现了阿方希望成为非洲与地中海地区重要制药中心的战略意图。 阿医药工业部监察总长介绍了国家医药产业的发展方向。阿正大规模扩大本地生产能 力、吸引全球药企技术，并将卫生主权建设作为产业政策核心之一。阿方正与多家国 际领先实验室建立战略性合作伙伴关系，目标是获取最新的国际医药创新技术。他宣 布，国家已批准 100 个新的医药生产项目，这些项目将显著加强本土生产能力，并提 高国产药品的质量水平。 ...

Summary of Key Points from Conference Call Records Industry Overview - The pharmaceutical sector experienced a correction in 2025 but rebounded towards the end of the year, with the innovative drug market expected to continue its momentum into 2026, presenting investment opportunities [1][6][10]. - Current industry hotspots include the flu epidemic, policy support, and breakthroughs in innovative fields such as small nucleic acid drugs, GLP-1, and BCL-2 inhibitors [1][7][8]. Core Insights and Arguments - The overall performance of the pharmaceutical sector in November 2025 was weak, with a decline of 3.6%, underperforming the CSI 300 index by approximately 1.16 percentage points [3]. - The application of AI technology in healthcare, including AI medicine and brain-computer interfaces, is gaining attention and is expected to present opportunities in 2026 [4][12]. - The release of the medical insurance negotiation directory and commercial insurance innovation directory will significantly impact the sales of related products once they enter the insurance system [10]. - Investment recommendations for 2026 include focusing on cutting-edge technologies such as dual antibodies, multi-antibodies, ADC, PROTAC, small nucleic acids, and GLP-1, as well as large companies with strong R&D capabilities and biotech firms with best/first-in-class potential [9][11]. Notable Developments - The flu data has reached new highs, driving up the stock prices of related testing drugs and vaccines [7]. - The third-party laboratory sector is expected to see performance bottoming out in Q4 2025, with a recovery starting in Q1 2026, aided by accelerated payment collection from companies like KingMed and Dian Diagnostics [4][19]. - The PROTAC technology is highlighted for its ability to degrade target proteins, addressing issues of drug resistance, with leading companies like Pfizer, BMS, and BeiGene making significant progress [4][16][17]. Investment Opportunities - Companies such as KingMed and Dian Diagnostics are recommended for investment due to their improving cash flow and potential recovery in the IVD industry [19][20]. - Jichuan Pharmaceutical is included in the December portfolio due to its expected performance rebound driven by flu season demand and low inventory levels [21]. - The CRO industry is poised for growth, with expectations of increased outsourcing rates and improved margins due to a decrease in new entrants [22][23]. Future Trends - The medical device sector is showing positive trends, with expectations for improvement in the consumer healthcare segment in 2026 [2][11]. - The potential for significant growth in the insulin business of companies like Lianbang Pharmaceutical is anticipated, with a projected revenue of 20 billion yuan in 2025 [32][35]. - The upcoming KMR data in December is expected to act as a catalyst for the global PROTAC market, with a focus on companies with substantial technology platforms [18]. Conclusion - The pharmaceutical and healthcare sectors are navigating through a period of adjustment, with various innovative technologies and market dynamics presenting both opportunities and challenges. Investors are advised to keep a close watch on regulatory developments, clinical trial outcomes, and emerging technologies that could shape the future landscape of the industry [1][6][10].

Core Insights - The biopharmaceutical sector is one of the fastest-growing areas in the pharmaceutical industry, driven by an aging population and increased public health awareness [1][5] - China's biopharmaceutical market is projected to grow from CNY 312 billion in 2019 to CNY 587.1 billion in 2024, and is expected to reach CNY 675.2 billion by 2025, with a potential to hit CNY 1.149 trillion in the next five years [1][5][6] - Innovation remains the core driver of growth in the biopharmaceutical industry, which is capital-intensive and requires significant R&D investment [1][6] Industry Definition and Classification - Biopharmaceuticals are medical products manufactured using biological methods, aimed at replicating the activity of natural substances [2][4] - They can be categorized into vaccines, blood products, biopharmaceutical drugs, diagnostic reagents, and others, with further subdivisions based on source or mechanism of action [2] Current Industry Status - The global biopharmaceutical market is expected to grow from USD 286.4 billion in 2019 to USD 461.6 billion in 2024, with the original biopharmaceutical market projected to increase from USD 268.9 billion to USD 427.9 billion in the same period [5] - China plays a significant role in the global biopharmaceutical market, with rapid growth driven by favorable policies, increased R&D investment, and advancements in biotechnology [5][6] Industry Development Environment - Policies - The Chinese government has implemented various laws and policies to encourage biopharmaceutical R&D, including the Drug Registration Management Measures and regulations for clinical research and application of biomedical technologies [7] Competitive Landscape - The biopharmaceutical sector is recognized as a "new frontier" in the pharmaceutical industry, with major global players actively entering the market [9] - Key companies in China's biopharmaceutical industry include WuXi AppTec, Hengrui Medicine, ZhiFei Biological, BeiGene, and others, with a competitive landscape characterized by differentiated strategies [9] Future Development Trends - Market demand for biopharmaceuticals is expected to continue growing, supported by policy backing, technological advancements, and increased health awareness [10] - Domestic companies are transitioning from biosimilars to First-in-Class drugs, with examples like Hengrui Medicine's ADC drug showing superior efficacy [10][11] - Personalized medicine based on genetic testing is anticipated to become a trend, with increasing international recognition of Chinese innovative drugs [11]

Core Viewpoint - Tonghua Dongbao is focusing on expanding its product pipeline in diabetes and endocrine metabolic diseases, achieving significant revenue growth and international market expansion in 2025 [2][3][4]. Financial Performance - In the first three quarters of 2025, the company reported revenue of 2.18 billion yuan, a year-on-year increase of 50.55%, and a net profit of 1.202 billion yuan, compared to a loss of 66.37 million yuan in the same period last year [2]. - In Q3 2025, the company achieved revenue of 806 million yuan, a year-on-year growth of 13.9%, and a net profit of 984 million yuan, representing a staggering increase of 499.86% [2]. Product Development and Market Expansion - The sales volume of insulin analogs doubled year-on-year in the first three quarters of 2025, with revenue from these products surpassing human insulin, becoming the largest revenue contributor for the company [2]. - The company is expanding its research pipeline to include indications beyond diabetes, such as obesity and non-alcoholic steatohepatitis (NASH), as well as other endocrine metabolic diseases like gout and hyperuricemia [2]. International Strategy - In H1 2025, overseas revenue reached 110 million yuan, a year-on-year increase of approximately 187%, surpassing the total revenue for the previous year, indicating the effectiveness of the internationalization strategy [3]. - The company has made significant progress in international registrations, with insulin products approved in five emerging markets and ongoing BLA submissions for insulin products in the U.S. [4]. - The company is focusing on the U.S. market due to the large patient base and significant market opportunities, collaborating with Jianyou Co. to share risks and leverage expertise [5][6]. Future Outlook - The company aims to drive growth through a dual strategy of "innovation + internationalization," solidifying its leadership in diabetes treatment while expanding its product registrations in both developed and emerging markets [6].