特别提示 微信机制调整，点击顶部"仪器信息网" → 右上方"…" → 设为 ★ 星标，否则很可能无法看到我们的推送。 第十二届药典委员会执委 中国工程院院士 王军志： 新版药典首次收载了曲妥珠（单抗）、利妥昔（单抗）等8个单抗 抗体的品种 。 这些品种都是我们国家自主研发的，也是在国际上首次纳入药典的品种。 北京大学第三医院药学部主任药师 杨毅恒：最多的就是抗肿瘤药物，共有5个药物，比如说注射用三氧化二砷，是治 疗急性早幼粒细胞白血病，还有一类就是治疗自身免疫性疾病的，比如像阿达木单抗。同时这一次也关注了儿童的用 药，比如说生长激素，专门是治疗儿童早期生长发育缓慢的。 北京大学肿瘤医院乳腺癌预防治疗中心主任医师 范照青：曲妥珠单抗在我们乳腺癌领域是治疗HER2（人表皮生长因 子受体-2）阳性乳腺癌，在晚期乳腺癌（治疗）中有非常广泛的应用。 此外， 中国药典还注重收载国际研发热点，规范、指导相关药物研发，加快我国这类创新药研发上市 。国家药典委员 会秘书长 舒融：2025年版的中国药典填补了19项国内外空白，主要涉及药物研发、质量控制等方面的技术指导原则 和通用技术要求。 2025年版《中国药典》已于2025年 ...

（来源：研报虎） 创新药周专题：炎性肠病(Inflammatory Bowel Disease,IBD)包括溃疡性结肠炎(Ulcerative Colitis,UC)和克 罗恩病(Crohn Disease,CD)，美国和欧美高发，超过300万患者。发病机制仍不清晰，腹泻、腹痛、发热 的症状严重到肠穿孔等致命并发症。IBD目前没有治愈疗法，轻-中度CD患者仍以糖皮质激素或传统免 疫抑制剂为一线诱导，中-重度活动期的一线生物制剂则以抗-TNF(英夫利西单抗、阿达木单抗)最具优 势，因其起效快、黏膜愈合证据充分且长期数据最完整。当抗-TNF疗效不佳、失应答或出现副作用 时，临床主要转向维得利珠单抗、乌司奴单抗、利生奇珠单抗或JAK1抑制剂作为二线及后线方案。虽 然生物靶向疗法对许多患者有效，但依然有高达30%的患者对初始治疗没有反应，高达40%的患者随着 时间的推移反应消失。对新机制新疗法的需求急迫，可延长IBD患者治疗时间和寿命。 IBD全球药物市场规模预计2030年有望达到370亿美金，艾伯维、强生、礼来、武田、默沙东、辉瑞、 赛诺菲等TOPMNC均有布局IBD领域。在目前已获批靶向药物治疗中，TNF单抗销售 ...

此外，RINVOQ在治疗多种自身免疫性疾病方面有着广泛的应用，并于2025年4月获得欧盟和美国FDA 批准用于治疗巨细胞动脉炎的新适应症。这一批准不仅扩大了药物的市场潜力，也进一步加强了艾伯维 在免疫学领域的领导地位。 2013年，艾伯维从雅培分拆独立，带着阿达木单抗进入市场，开创了全球第一款全人员肿瘤坏死因子抑 制剂。阿达木单抗的成功为艾伯维创造了巨额收入，从而支持其长期研发和业务扩展。这种稳定的现金 流促使艾伯维在免疫、肿瘤和神经科学等领域持续投资和扩展，通过自主研发和并购扩大业务版图。 艾伯维的布局不仅限于单一领域，其通过并购艾尔建进入医美与眼科市场，通过收购非美思进入血液肿 瘤领域，并与多家生物科技公司合作，加速高潜力药物的研发与上市。这种策略确保了艾伯维即使在核 心产品面临市场挑战时，仍能保持竞争力和稳定的营收。 对于投资者来说，艾伯维的发展路径展示了一个成功企业的必要条件——不仅依赖短期的风口或爆款产 品，而是具备将稳定的现金流持续投入到创新中，并不断拓宽业务护城河的能力。这样的企业能够在时 间的沉淀中释放出持久的力量，是长期投资的理想选择。 来源：市场资讯 （来源：美股情报站） 9月11日，艾伯 ...

Core Insights - The company reported a total operating revenue of 1.798 billion yuan for H1 2025, representing an 8.8% year-on-year increase, and a net profit attributable to shareholders of 516 million yuan, up 17.19% [1] - The blood products segment showed steady growth with revenue of 1.737 billion yuan in H1 2025, a 7.57% increase, and a gross margin of 51.69% [1][2] - The vaccine segment achieved significant growth with a revenue of 57 million yuan, a 92.63% increase, despite challenges from price reductions and fluctuating vaccination rates [2] - The company demonstrated improved profitability with a net profit margin of 28.69%, up 2.06 percentage points year-on-year, and announced a mid-year dividend plan of 5 yuan per 10 shares, totaling approximately 914 million yuan [3] Financial Performance - H1 2025 total operating revenue: 1.798 billion yuan, up 8.8% [1] - H1 2025 net profit attributable to shareholders: 516 million yuan, up 17.19% [1] - H1 2025 gross margin for blood products: 51.69%, up 1.59 percentage points [1] - H1 2025 net profit margin: 28.69%, up 2.06 percentage points [3] Segment Performance - Blood products revenue: 1.737 billion yuan in H1 2025, up 7.57% [1] - Vaccine revenue: 57 million yuan in H1 2025, up 92.63% [2] - Clinical progress in vaccines includes completion of Phase III for certain products and ongoing clinical trials for others [2] Future Outlook - The company expects steady growth in plasma collection due to the operational commencement of the Fengdu plasma collection station and the upcoming peak collection season [1] - Earnings per share (EPS) projections for 2025-2027 are 0.71 yuan, 0.76 yuan, and 0.80 yuan respectively [4]

Core Viewpoint - The chairman of Maiwei Biotech, Liu Datao, has been penalized for short-term trading of the company's stock, violating securities laws, and must return related profits to the company [2][6]. Company Overview - Liu Datao has served as the general manager and director of Maiwei Biotech since June 1, 2020, and became chairman on June 1, 2023, earning a total salary of 7.4 million yuan over the past three years [5]. - Under Liu's leadership, Maiwei Biotech has made significant progress in product research and development, focusing on innovative drugs and biosimilars, with a portfolio that includes antibodies, ADC drugs, and recombinant proteins [6]. Financial Performance - Since its establishment in 2017, Maiwei Biotech has consistently reported losses, with a cumulative net loss exceeding 6 billion yuan as of the first quarter of 2025, primarily due to substantial R&D investments totaling over 4.425 billion yuan [8]. - The company has faced cash flow challenges, with 1.119 billion yuan in cash on hand against 1.073 billion yuan in short-term loans and 210 million yuan in current non-current liabilities, alongside 962 million yuan in long-term debt [8]. Product Pipeline and Market Strategy - As of the first quarter of this year, Maiwei Biotech has 16 core products in various stages of development, including 12 innovative drugs and 4 biosimilars, with 3 products already on the market [6]. - The company is rapidly advancing its international strategy, having secured formal agreements for its products in multiple countries, including submissions for market approval in Pakistan and Indonesia [6].

Core Viewpoint - The chairman and general manager of Maiwei Biotech, Liu Datao, has been penalized for short-term trading violations, receiving a warning and a fine of 600,000 yuan due to his trading activities during the company's initial public offering period [1][2]. Company Overview - Maiwei Biotech specializes in the research, production, and sales of innovative drugs and biosimilars, with key products including antibodies, ADC drugs, recombinant proteins, and small molecule chemical drugs [5]. - As of the first quarter of 2025, the company has 16 core products in various stages of development, including 12 innovative drugs and 4 biosimilars, with 3 products already on the market [5]. Financial Performance - Since its establishment in 2017, Maiwei Biotech has reported cumulative losses exceeding 6 billion yuan, primarily due to substantial investments in research and development totaling over 4.43 billion yuan [6]. - As of the first quarter of 2025, the company has cash and cash equivalents of 1.12 billion yuan, but also faces short-term borrowings of 1.07 billion yuan and long-term borrowings of 962 million yuan, indicating significant financial pressure [6]. Management Background - Liu Datao has served as the general manager and director of Maiwei Biotech since June 1, 2020, and became chairman on June 1, 2023, earning a total compensation of 7.4 million yuan over the past three years [4].

Core Viewpoint - The article discusses the extension of centralized procurement to biosimilars in China, highlighting the implications for market dynamics and pricing strategies in the pharmaceutical industry [4][6]. Group 1: Centralized Procurement of Biosimilars - The Anhui Provincial Medical Procurement Platform has initiated information reporting for eight monoclonal antibody products, marking the beginning of centralized procurement for biosimilars [4]. - Biosimilars are large molecule biological products that are similar in quality, safety, and efficacy to already approved reference drugs, and their development is typically more costly and time-consuming than small molecule drugs [4][8]. - The centralized procurement process for biosimilars is expected to take longer than previous chemical drug procurements due to the need for comprehensive data collection and rule formulation [6]. Group 2: Market Impact and Dynamics - The total sales of the eight involved biosimilar products are projected to approach 30 billion yuan in 2024, with specific products like Bevacizumab exceeding 10 billion yuan in sales [9]. - The article emphasizes that the centralized procurement of biosimilars will not drastically disrupt existing market structures but will lead to adjustments within the current competitive landscape [9][10]. - The involvement of multiple companies in the production of these biosimilars indicates a competitive environment, with several products having three or more approved manufacturers [8][9]. Group 3: Characteristics of Biosimilar Procurement - Compared to chemical drug procurement, biosimilar procurement is characterized by smaller price reductions, comprehensive reporting requirements, and a focus on high-quality products [13][14]. - The procurement process aims to clarify market demand and supply, allowing companies to better predict future business conditions and adjust their product pipelines accordingly [6][10]. - The article suggests that the pricing adjustments in biosimilar procurement will be more moderate than those seen in previous chemical drug procurements, reflecting the unique nature of biological products [14][15].

Core Viewpoint - The introduction of centralized procurement for biosimilars in China marks a significant shift in the pharmaceutical industry, aiming to enhance drug accessibility and affordability while maintaining quality standards [1][3][6]. Group 1: Centralized Procurement Overview - The centralized procurement initiative has officially extended to biosimilars, with the Anhui Provincial Medical Procurement Platform issuing a notification for companies to report pricing, sales volume, and production capacity for specific monoclonal antibody products [1][3]. - This marks the first instance of centralized procurement for biosimilars in mainland China, with expectations for a longer timeline for information organization and rule formulation compared to previous chemical drug procurements [1][2]. Group 2: Market Impact and Dynamics - The market for the eight involved biosimilar products is projected to reach nearly 30 billion yuan, with specific products like Bevacizumab exceeding 10 billion yuan in sales [4][6]. - The competitive landscape is expected to be influenced but not drastically altered, as the procurement process aims to provide a clearer understanding of market volumes and guide companies in their operational strategies [2][4]. Group 3: Characteristics of Biosimilar Procurement - Compared to chemical drug procurement, biosimilar procurement is characterized by smaller price reductions, comprehensive reporting requirements, and a focus on high-quality products [7][8]. - The procurement process emphasizes a data-driven approach, requiring companies to report detailed sales figures and product specifications to ensure a thorough understanding of the market [7][9]. Group 4: Future Expectations - The impact of the biosimilar procurement is anticipated to manifest in the performance of related companies and product sales starting from 2026, with ongoing adjustments to market dynamics expected [1][2]. - The overall goal of the procurement initiative is to optimize resource allocation in the pharmaceutical market while ensuring that patient interests remain a priority [5][9].

Group 1 - The stock price of Baiotai closed at 31.00 yuan on August 4, 2025, down by 0.43 yuan, a decrease of 1.37% from the previous trading day [1] - Baiotai is a biopharmaceutical company focused on the research and development of innovative drugs and biosimilars, with key products including Adalimumab and Bevacizumab [1] - The national alliance for biopharmaceuticals has initiated information collection for centralized procurement, involving 8 monoclonal antibody biological agents, with Baiotai having 3 related products in this category [1] Group 2 - The market sales for the 8 biological drugs involved in the procurement have exceeded 28 billion yuan [1] - On August 4, Baiotai experienced a net outflow of main funds amounting to 15.25 million yuan, with a cumulative net outflow of 15.01 million yuan over the past five days [1]

Core Viewpoint - The Anhui Provincial Medical Price and Centralized Procurement Center has initiated information collection for eight monoclonal antibody biological agents, indicating the commencement of a national centralized procurement alliance for biological drugs in China [1][5]. Group 1: Market Overview - The eight biological drugs targeted for information collection have a combined market sales exceeding 28 billion yuan [2]. - The original manufacturers of these drugs include AbbVie, Amgen, and Johnson & Johnson, with Roche holding the original drugs for several others [2]. - The competitive landscape is intense, particularly for Bevacizumab, which has 13 approved products in the domestic market, with sales reaching 10.576 billion yuan in 2023 [2]. Group 2: Sales Trends - Sales of Adalimumab in sample hospitals increased from 1.257 billion yuan in 2022 to 1.488 billion yuan in 2024, while sales in urban pharmacies rose from 743 million yuan to 931 million yuan [3]. - The market share of original drugs is declining due to the introduction of biosimilars, with the original Adalimumab being surpassed in market share by a biosimilar in 2023 [3]. Group 3: Impact of Centralized Procurement - Centralized procurement is expected to intensify market competition, leading to a redistribution of market shares, with original drugs facing greater pressure from price competition [3][7]. - The procurement process is anticipated to enhance drug accessibility for patients, potentially lowering prices and ensuring quality [4]. - Companies must improve production capacity and flexibility to meet the demands of centralized procurement [4]. Group 4: Regulatory Environment - The development of biosimilars in China has accelerated, with a record 104 registration applications for therapeutic biological products submitted in 2024 [5]. - The centralized procurement of biological drugs is not prohibited, and the National Healthcare Security Administration has indicated that it will consider various factors before implementing such measures [5][6]. Group 5: Future Industry Trends - The initiation of national centralized procurement for biological drugs may shorten the profit period for low-quality products, prompting companies to focus on enhancing product quality and R&D capabilities [7]. - Companies may also shift their R&D focus towards more valuable innovative fields and increase investments in overseas markets to mitigate the impact of localized procurement [7].