丨 2026年1月8日 星期四 丨 NO.1恒瑞创新药艾泽利获批用于晚期胃癌 近日，恒瑞医药子公司苏州盛迪亚生物医药有限公司收到国家药品监督管理局的通知，批准公司自主研 发的1类创新药瑞拉芙普α注射液（商品名：艾泽利®）上市。瑞拉芙普α注射液是全球首款获批上市的 抗PD-L1/TGF-βRII双特异性抗体融合蛋白，为晚期胃癌患者带来全新的治疗选择。 点评：恒瑞艾泽利作为全球首款PD-L1/TGF-βRII双抗融合蛋白获批用于晚期胃癌，创新机制突破免疫 抑制微环境瓶颈，填补临床治疗空白，彰显国产创新药全球竞争力。 NO.2安龙生物完成近亿元B+轮融资 安龙生物宣布完成近亿元B+轮融资，本轮融资由北京市医药健康产业投资基金与北京顺义临空产业基 金市区两级的资金投资。与此同时，安龙生物还与一家美国纳斯达克上市企业达成小核酸药物领域的国 际战略合作协议，合作规模达上亿美元，标志着安龙生物在国际BD合作方面取得重要突破。 点评：安龙生物获近亿元融资并达成上亿美元国际合作，其小核酸自主递送技术与多管线布局获认可， 契合国产创新药出海趋势，彰显本土Biotech技术输出实力。 NO.3亿帆医药：全资子公司收到易黄汤颗粒药品 ...

证券日报网讯 12月25日，华兰生物在互动平台回答投资者提问时表示，公司参股公司开展创新药和生 物类似药的研发、生产。贝伐珠单抗已于2024年11月取得药品注册证书，开始正式生产和销售；利妥昔 单抗、地舒单抗分别于2024年11月、2025年12月完成临床研究并递交药品注册上市许可申请并被受理； 阿达木单抗、曲妥珠单抗、伊匹木单抗、帕尼单抗、重组抗Claudin18.2全人源单克隆抗体注射液、重组 抗PD-L1和TGF-β双功能融合蛋白注射液、重组抗BCMA和CD3双特异性抗体注射液等已取得临床批 件，正在开展相关临床研究，为公司培育新的利润增长点，丰富公司的产品梯队。 （文章来源：证券日报） ...

智通财经APP获悉，中信证券发布研报称，IBD作为自身免疫疾病中的"硬骨头"，拥有巨大的未满足临 床需求和广阔的市场空间。尽管IBD领域的靶点不断丰富，但诱导期的临床缓解率(经安慰剂调整后)依 然非常有限，大多数药物的临床缓解率在10%-20%之间的水平，已获批药物的高剂量组临床缓解率通常 在15%以上。当前IBD的治疗新老产品更新迭代，对新机制新疗法的需求急迫，注射长效化+口服多点 开花。MNC加速IBD领域布局，中国创新药企业在差异化赛道崭露头角。该行建议关注新靶点新机制， 密切跟踪相关临床试验的开展和进度以及重点数据的读出。 中信证券主要观点如下： MNC加速IBD领域布局，中国创新药企业在差异化赛道崭露头角 作为自身免疫疾病领域中，患者人数众多且当前一年维持期疗效仍仅有30%-50%临床缓解率的适应症， IBD吸引了众多MNC布局。老玩家通过新产品巩固领先优势;慢病头部企业通过资源倾斜快速布局;肿瘤 领域核心玩家通过BD、收购等模式进入。根据过往交易规模以及MNC对产品峰值的预期，该行预计一 项临床阶段的优质IBD资产的交易对价在20亿美金以上。 中国企业紧跟全球趋势并展现出差异化创新能力：云顶新耀引 ...

Group 1: AI Empowerment in Asset Allocation - The report discusses the performance of three representative AI asset management products: AIEQ, ProPicks, and QRFT, evaluating whether AI can provide excess returns to investors [8] - AIEQ, an actively managed ETF, has underperformed SPY due to high market sentiment volatility and cost erosion from high turnover rates [8] - ProPicks has shown strong returns during favorable tech periods but is highly sensitive to execution discipline and slippage, making actual replication challenging [8] - QRFT has closely tracked the S&P 500 over the long term, showing significant phase differentiation, indicating a focus on narrow enhancements rather than stable high alpha [8] Group 2: Pharmaceutical and Biotechnology Sector - The pharmaceutical sector underperformed the overall market, with a 4.32% decline in the A-share market, and the biopharmaceutical sector fell by 6.88% [10] - The report highlights the treatment options for Hidradenitis Suppurativa (HS), noting that the prevalence in Western populations is approximately 1%, with around 320,000 diagnosed patients in the U.S. [11] - First-line therapies for HS primarily involve antibiotics, while second-line biological treatments include Adalimumab and IL-17A inhibitors, which have gained market share due to their efficacy and safety [11] Group 3: Atour (ATAT.O) Financial Performance - Atour reported a 38% year-on-year revenue growth in Q3 2025, raising its full-year revenue growth guidance from 30% to 35% [13] - The company’s retail business saw a remarkable 76% revenue growth, significantly contributing to the overall performance [13] - The number of hotels in operation increased by 27% year-on-year, with a total of 1,948 hotels by the end of Q3 2025 [14] Group 4: Hars (002615.SZ) Industry Leadership - Hars is a leading company in the cup and kettle industry, with a projected revenue compound annual growth rate (CAGR) of 25% from 2021 to 2024, reaching 3.3 billion [17] - The company operates both OEM/ODM and proprietary brand businesses, maintaining stable partnerships with international brands like YETI and PMI [17] - The domestic market for insulated cups is expected to replicate overseas trends, with significant growth potential driven by IP collaborations and social media marketing [18]

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [5] Core Insights - The pharmaceutical sector has underperformed the overall market, with a significant decline in various sub-sectors, including a 6.88% drop in the biotechnology sector [1][32] - Hidradenitis Suppurativa (HS) is identified as a chronic, recurrent inflammatory skin disease with a low prevalence in China and the U.S., highlighting the potential market for treatment options [2][10] - The report emphasizes the increasing market share of new biologics targeting IL-17A and IL-17A/F, which are expected to outperform traditional therapies like Adalimumab [17][18][22] Summary by Sections Market Performance - The overall A-share market declined by 4.32%, with the biotechnology sector falling by 6.88%, indicating a weaker performance compared to the broader market [1][32] - Specific declines were noted in chemical pharmaceuticals (7.02%), biological products (7.46%), and medical services (6.90%) [1][32] Hidradenitis Suppurativa (HS) Overview - HS affects approximately 0.03% of the population in China, with around 400,000 cases, and has been included in the rare disease directory [2][10] - The disease's complex pathogenesis involves multiple immune pathways, making it a target for various therapeutic approaches [11][27] Investment Strategy - The report suggests focusing on undervalued stocks in the medical device and pharmacy sectors, which have already priced in risks from policy changes [42][43] - It highlights the potential for growth in the CXO sector, particularly in CDMO and clinical CRO segments, as they continue to show strong performance despite market challenges [42][43] Recommended Stocks - The report lists several companies with strong growth potential, including Mindray Medical, WuXi AppTec, and Aier Eye Hospital, all rated as "Outperform" [4][44] - Mindray Medical is noted for its robust R&D and international expansion, while WuXi AppTec is recognized for its comprehensive drug development services [44]

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [5][4]. Core Insights - The pharmaceutical sector has underperformed the overall market, with a significant decline in various sub-sectors, including a 6.88% drop in the biotechnology sector [1][32]. - Hidradenitis Suppurativa (HS) is identified as a chronic, recurrent inflammatory skin disease with a low prevalence in China and the U.S., highlighting the potential market for treatment options [2][10]. - The report emphasizes the increasing market share of new biologics targeting IL-17A and IL-17A/F, which are expected to outperform traditional therapies like Adalimumab [2][18]. Summary by Sections Market Performance - The overall A-share market declined by 4.32%, with the biotechnology sector falling by 6.88%, indicating a weaker performance compared to the broader market [1][32]. - Specific declines were noted in chemical pharmaceuticals (7.02%), biological products (7.46%), and medical services (6.90%) [1][32]. Hidradenitis Suppurativa Treatment Overview - HS affects approximately 0.03% of the population in China, with around 400,000 cases, and has been included in the rare disease directory [2][10]. - First-line treatments primarily involve antibiotics, while second-line therapies include biologics such as Adalimumab and newer agents targeting IL-17A and IL-17A/F [2][10]. Company Earnings Forecast and Investment Ratings - Key companies such as Mindray Medical, WuXi AppTec, and Aier Eye Hospital are rated as "Outperform," with projected net profits for 2024 ranging from 1.4 billion to 116.7 billion CNY [4][42]. - The report highlights the strong growth potential in the CXO sector, particularly in CDMO and clinical CRO services, driven by new orders and emerging business lines [42][43]. Investment Strategy - The report suggests focusing on undervalued stocks in the medical device and pharmacy sectors, which have already priced in various policy risks [42]. - It also emphasizes the importance of monitoring the clinical progress of innovative drugs in overseas markets, as this can significantly impact their commercialization potential [43][42]. Recommended Stocks - Mindray Medical is noted for its strong R&D and sales capabilities, benefiting from domestic healthcare infrastructure development [44]. - WuXi AppTec is recognized for its comprehensive service capabilities across the new drug development chain, poised to benefit from the global outsourcing market [44]. - Aier Eye Hospital is highlighted for its scale and commitment to introducing international standards in eye care [44].

Group 1: Core Insights - The current wave of innovative drugs is driven by China's participation in new technologies, with advancements in ADC, bispecific antibodies, second-generation IO, and GLP-1 [1] - The global pharmaceutical transaction volume has steadily increased, with total transaction amounts rising from $56.9 billion to $187.4 billion over the past decade, while China's transaction amounts surged from $3.1 billion to $57.1 billion [1] - By 2024, China's transaction volume is expected to account for approximately 30% of global pharmaceutical transactions [1] Group 2: Sector Analysis - In oncology, the combination of IO and ADC therapies remains strong, with significant transactions in the PD-1 bispecific antibody space; the sales of Pembrolizumab are projected to reach $29.482 billion in 2024 [2] - The autoimmune disease sector is witnessing a shift as older drugs face patent expirations, with new opportunities emerging in Th2 and Th17 pathways; Dupilumab is expected to lead with $14.1 billion in sales in 2024 [2] - The cardiovascular and metabolic disease market continues to grow, with GLP-1 receptor agonists projected to exceed $50 billion in global sales in 2024 [3] Group 3: Future Technologies - New technologies such as next-generation ADCs, TCE therapies, universal/in vivo CART technologies, gene therapy, and small nucleic acid technologies are anticipated to lead future disease treatments [4]

Core Viewpoint - 百奥泰 reported a revenue of 684 million yuan for the first three quarters of 2025, representing a year-on-year growth of 17.57%, while the net loss narrowed to 224 million yuan, indicating improved financial performance [1] Group 1: Financial Performance - The company achieved a revenue of 684 million yuan in the first three quarters, marking a 17.57% increase year-on-year [1] - The net loss for the same period was 224 million yuan, showing a reduction in losses compared to the previous year [1] Group 2: Product Development and Approvals - Several products have been approved for sale, including Adalimumab and Tocilizumab in China and other regions, and Bevacizumab in multiple countries [1] - BAT1806 (Tocilizumab) and BAT2206 (Ustekinumab) have been approved in Europe, with sales managed by partners [2][3] - The company is advancing its innovative drug pipeline, with BAT5906 and BAT4406F expected to submit applications for market approval soon [2][3] Group 3: Market Expansion and Strategy - The company is preparing for participation in centralized procurement, optimizing production capacity and supply chain to enhance competitiveness [2] - New guidelines in the EU and the US for biosimilars are expected to lower R&D costs, providing a competitive advantage for the company [2] Group 4: Clinical Trials and Research - BAT6026 is currently in Phase II clinical trials for atopic dermatitis, while BAT8008 is set to begin Phase III trials for cervical cancer and HER2-negative breast cancer in mid-2026 [3] - Ongoing clinical research for BAT8008 in combination with BAT1308 has shown positive efficacy signals, leading to an expansion of the sample size [3] - BAT7111 is in Phase I dose escalation studies, progressing smoothly with three doses explored [3]

Core Insights - The article discusses the impact of the "volume-based procurement" policy on the Chinese generic drug industry, highlighting increased competition and challenges such as product homogeneity and cost-cutting in production [2][3][11] 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 products intensifying market competition [2] - As of 2024, the number of generic drugs that have passed consistency evaluations or are considered equivalent has increased by over two-thirds compared to three years prior, primarily driven by a few companies and previously approved products [2][7] Regulatory Environment - The Chinese government has emphasized improving the quality of generic drugs as a key reform goal since 2015, with consistency evaluations becoming a prerequisite for participation in centralized procurement [4][5] - Despite the increase in evaluated products, a significant proportion of generic drugs have yet to meet the evaluation standards, indicating a low market concentration [5][7] Product Trends - In 2024, the number of evaluated or equivalent generic drug varieties reached 914, a significant increase from 543 in 2021, with 70% of these concentrated in 33% of companies [7] - The report indicates that the market for biosimilars is also experiencing similar trends, with over 50% of the 87 approved biosimilars being antibody biosimilars [11] Production Dynamics - The report notes a significant increase in the participation of contract manufacturing in centralized procurement, with 31% of selected products in the tenth round being produced by contract manufacturers, up from 3% in the second round [13][15] - The need for effective quality management and regulatory oversight in contract manufacturing has become increasingly critical as the industry faces pressures from policy changes and market competition [15][16]

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].