在获批新药的治疗领域方面，肿瘤是占比最大的治疗领域，涵盖了多种实体瘤和血液瘤；其他治疗领域 也涉及到呼吸系统、内分泌与代谢、心血管等领域。其中，多达34 款新药的审评审批涉及特殊审评。 国外MNC 大型药企获批新药领先，国内药企同样有新药获批 事件 2025 年，FDA 药品评价与研究中心（CDER）共批准了46 款新药，虽然获批数量相较于2024 年及2023 年均有所下降，但是获批新药的类型丰富且创新性较高。 2025 年FDA 批准新药的类型丰富且创新性较高 2025 年FDA 共批准了46 款新药，获批新药的创新性较高，"first-in-class"疗法占比过半；获批新药类型 丰富，以小分子化药为主，其他包括单克隆抗体、ADC、siRNA、ASO、融合蛋白和双特异性T 细胞接 合器等。 2025 年FDA 批准新药的治疗领域以肿瘤治疗为主 智通财经APP获悉，万联证券发布研报称，2025 年FDA 批准新药的创新"质量"提升和技术平台多元 化，国内药企崭露头角。建议聚焦前沿技术平台，重点关注拥有ADC、siRNA、细胞基因治疗（CGT） 等前沿技术平台的公司；建议布局具有"出海"潜力的中国创新，重点 ...

市 场 研 究 [Table_MeetReportDate] 2026 年 01 月 08 日 星期四 [Table_Summary] 概览 核心观点 3028 【市场回顾】 周三 A 股震荡上涨，上证指数收涨 0.05%报 4085.77 点，深证成指涨 0.06%，创业板指涨 0.31%；沪深两市成交额 2.85 万亿元。申万行业 方面，煤炭、电子、通信等领涨；石油石化、非银、美容护理等领跌。 概念板块方面，光刻胶、科创次新股、存储芯片等上涨，DRG、互联 网保险、脑机接口等下跌。港股方面，恒生指数收跌 0.94%报 26458.95 点；恒生科技指数跌 1.49%；美国三大股指收盘涨跌不一，道指跌 0.94%报 48996.08 点，标普 500 指数跌 0.34%报 6920.93 点，纳指涨 0.16%报 23584.27 点；欧洲三大股指收盘涨跌不一，亚太主要股指收 盘涨跌互现。 【重要新闻】 [Table_Title] 万联晨会 【工信部等八部门印发《"人工智能+制造"专项行动实施意见》】工 信部等八部门印发《"人工智能+制造"专项行动实施意见》，目标是 到 2027 年，我国人工智能关键核心技 ...

第一上海发布研报称，康方生物-B（09926）在核心产品管线方面取得多项进展。卡度尼利已获批宫颈 癌和胃癌适应症并纳入医保，多个新适应症进入III期临床；依沃西在非小细胞肺癌领域数据积极，海外 上市申请推进中；派安普利单抗成功获得FDA批准上市。此外，多款产品纳入医保或处于临床后期阶 段。以DCF估值法，得出目标价144.9港元，较现价有23.4%上升空间，买入评级。 第一上海主要观点如下： 财务表现 2025年上半年，康方生物产品收入同比增长49.2%至14.0亿元，加上许可费收入，公司录得总收入14.1 亿元，毛利率为79.4%，研发开支增长23.0%至7.3亿元。2025年8月底，公司以每股149.54港元的价格配 售23.55亿股，获得净融资额34.93亿港元，预计配售后公司在手净现金为58亿元。 产品管线进展 （1）卡度尼利AK104（PD-1/CTLA-4）：已获批用于1-3线宫颈癌和一线胃癌，并纳入医保；PD-（L） 1进展后胃癌、肝细胞癌术后辅助治疗、中晚期不可切除肝细胞癌、一线PD-L1表达阴性非小细胞肺癌 和同步/序贯放化疗后非小细胞肺癌处于III期临床阶段。其中，IO耐药鳞状非小细胞肺癌 ...

Core Insights - The 2025 National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory were announced, marking a significant development in the pharmaceutical industry [1][3][10] - A total of 114 new drugs were added to the National Medical Insurance Directory, including 50 innovative drugs, which is expected to enhance patient access and support sustainable investment in drug development [1][2][3] National Medical Insurance Directory - The 2025 National Medical Insurance Directory includes 114 new drugs, with 50 classified as innovative drugs, such as Tislelizumab and domestic ADC drugs [1][3] - Companies like Kelun-Biotech and Kangnuo have successfully included their innovative drugs in the directory, reflecting strong government support for domestic innovation [3][4] - The total number of drugs in the National Medical Insurance Directory has increased to 3,253, with significant improvements in coverage for critical areas like oncology and chronic diseases [5][6] Commercial Health Insurance Innovative Drug Directory - The newly introduced Commercial Health Insurance Innovative Drug Directory includes five CAR-T cell therapies and several high-cost drugs for rare diseases, enhancing accessibility for patients [1][6][8] - The directory allows innovative drug companies to explore new payment channels outside of traditional medical insurance, potentially increasing patient access to high-value therapies [11][12] - The pricing for drugs in the Commercial Health Insurance Directory is expected to be more flexible, allowing for negotiations between companies and insurers, which could lead to better affordability for patients [8][12] Industry Impact - The introduction of the Commercial Health Insurance Innovative Drug Directory is seen as a milestone for improving drug accessibility and affordability, particularly for high-cost therapies [7][9][12] - The past decade has witnessed significant growth in China's innovative drug sector, with the new directory marking a pivotal moment in the industry's evolution [10][11] - The dual-track payment framework established by the National Medical Insurance and Commercial Health Insurance is expected to foster a more robust ecosystem for drug research and application in China [12]

Group 1 - The report emphasizes the rapid development of China's innovative pharmaceuticals, highlighting that the number of clinical trials has reached a global leading position, with a significant increase in new drug approvals [3][5][7] - Chinese pharmaceutical companies are transitioning from a "fast follower" to an "innovation leader" model, actively engaging in cutting-edge fields such as ADC, bispecific antibodies, and mRNA vaccines, with a notable increase in the number of products in late-stage development [8][11][18] - The report identifies two main investment directions: the transformation of biotech companies into biopharma and the revaluation of traditional pharmaceutical companies during their innovation transition, suggesting specific companies to watch in both categories [3][4] Group 2 - China's integration into the global innovative drug value chain is deepening, with a growing number of global multi-center clinical trials led by Chinese companies, indicating a shift in the global drug development landscape [3][24] - The report notes that the contribution of Chinese companies to global clinical trials has significantly increased, with a projection of 1,903 innovative drug clinical trials registered in China by 2024 [7][24] - The report highlights the increasing competitiveness of Chinese companies in high-potential therapeutic areas, particularly in oncology, metabolic diseases, and autoimmune diseases, with substantial market shares in these segments [18][19] Group 3 - The report discusses the rising trend of BD (business development) transactions involving Chinese assets, with a notable increase in transaction amounts and numbers, indicating China's growing influence in the global pharmaceutical innovation landscape [33][44] - It highlights that the majority of license-out projects are now in early stages, reflecting the international interest in early-stage Chinese innovations, particularly in oncology and metabolic therapies [39][44] - The report points out that major multinational corporations (MNCs) are increasingly seeking next-generation blockbuster products from China to fill revenue gaps due to impending patent expirations [62][66]

Group 1 - The report highlights the focus on innovative drugs and the opportunities within the pharmaceutical industry chain, indicating a positive outlook for the Hong Kong pharmaceutical sector by 2026 [1][3] - Multiple policies are supporting the development of the innovative drug industry, with record highs in both transaction amounts and numbers for domestic innovative drugs going overseas [3][6] - The report notes a rebound in valuations for the sector, with leading companies achieving profitability through increased commercialization and licensing revenues [3][6] Group 2 - Key companies such as BeiGene and Innovent Biologics are experiencing significant sales growth, with BeiGene's global sales exceeding $1 billion in Q3 2025, marking a 51% year-on-year increase [3][4] - Innovent Biologics is expanding its pipeline and is expected to achieve positive non-IFRS net profit and EBITDA in 2024, with continued growth projected for 2025 [3][4] - The report emphasizes the strong performance of the CXO sector, driven by a recovery in investment and demand for early-stage research, particularly in emerging fields like peptides and ADCs [3][6] Group 3 - The report provides a detailed earnings forecast and valuation for key companies, indicating significant revenue growth for companies like BeiGene and Innovent Biologics, with projected revenues of $5.1 billion and $2.7 billion respectively for 2025 [4][6] - The pharmaceutical sector is noted for its robust performance, with companies like Sihuan Pharmaceutical and Hengrui Medicine showing strong revenue contributions from innovative products [4][6] - The report also highlights the increasing competitiveness of domestic innovative drugs on a global scale, with successful international collaborations and licensing agreements [3][6] Group 4 - The report indicates that the Hong Kong pharmaceutical market has shown impressive performance year-to-date, with the Hang Seng Healthcare Index significantly outperforming other markets, achieving an approximate 82% increase [15][16] - Valuations for Hong Kong pharmaceuticals are noted to be lower than those in A-shares and overseas markets, with a median PE of 17x for 2025 [15][16] - The report mentions a notable increase in the number of IPOs in the Hong Kong pharmaceutical sector, with over 20 new companies listed in 2025, raising substantial capital [40][41]

Core Insights - The 7th Guangdong-Hong Kong-Macao Greater Bay Area Biopharmaceutical Innovation Conference emphasizes the theme "Bay Area Innovation Navigates New Journey," focusing on discussions around innovative drug development, technology transfer, global compliance, and AI empowerment in new drug development [1][5] Group 1: Industry Trends - China's pharmaceutical industry is transitioning from a focus on generic drugs to early-stage innovation represented by Me too drugs and biosimilars, facing challenges such as insufficient payment systems, difficulties in international expansion, and limited capital patience [2] - The Guangdong province has reduced drug approval times from 200 working days to 60, supporting innovative drug projects with comprehensive policy assistance, resulting in 27 approved national Class 1 innovative drugs, ranking third in the country [2] - The Greater Bay Area has seen 14 overseas authorizations by Guangdong biopharmaceutical companies in 2024, accounting for nearly 16% of the national total, indicating initial success in internationalization [2] Group 2: Company Innovations - Dongyang Sunshine Pharmaceutical has developed multiple technology platforms and is transitioning from "following" to "leading" in the market, exemplified by a $1 billion licensing deal with UK-based Apollo for HEC88473 [3] - Kangfang Biopharma has achieved breakthroughs in tumor immunotherapy and set records for international licensing, including a $5 billion deal for its drug with Summit in the U.S., marking a significant milestone for Chinese innovative drugs [3] - Micron Biotech highlights that over 50% of IND approvals from the FDA in 2024 are from China, with 30% of global license-outs originating from the country, showcasing a shift from "following" to "reshaping the global landscape" [4] Group 3: Technological Advancements - AI is evolving from a supportive tool to a core engine in drug development, with companies like Baidu Biotech achieving significant improvements in research efficiency through AI collaborations [4] - The FDA's approval process for gene therapies reflects the balance between unmet clinical needs and safety concerns, emphasizing the importance of maintaining scientific rigor and patient safety in innovation [4] - The conference illustrates the confidence and capability of China's pharmaceutical innovation to transition from local to global markets, driven by policy support, technological breakthroughs, and corporate practices [5]

Core Viewpoint - The announcement of a 100% tariff on all branded or patented pharmaceuticals imported into the U.S. starting October 1 has caused significant turmoil in the global pharmaceutical market, particularly affecting major European and Asian pharmaceutical companies [1][3][5]. Tariff Policy Details - The tariff specifically targets branded or patented pharmaceuticals, exempting generics, biosimilars, and raw materials [5][6]. - The policy follows a series of investigations and threats from the U.S. government regarding drug imports, with the final tariff being less severe than initially proposed [3][5]. - Major pharmaceutical stocks, particularly in Europe and Asia, experienced notable declines following the announcement, with companies like Novo Nordisk and GlaxoSmithKline seeing drops of 3.1% and 1.1% respectively [3][5]. Impact on Global Pharmaceutical Companies - U.S. pharmaceutical companies, such as Pfizer and Merck, are expected to benefit from the tariff as it may enhance their market share domestically [5][6]. - Companies are responding by increasing investments in U.S. production capabilities, with Johnson & Johnson planning to invest $55 billion over five years to bolster local manufacturing [6][7]. - The cost implications of the tariff are significant, potentially doubling the cost of imported drugs, which could lead to increased healthcare costs in the U.S. [5][6]. Response from Chinese Pharmaceutical Companies - Chinese pharmaceutical companies are likely to be less affected due to their focus on generic drugs and raw materials, which are not subject to the new tariffs [2][9]. - The majority of Chinese exports to the U.S. consist of generics (over 60%) and raw materials (approximately 25%), with patented drugs making up less than 15% [9][10]. - Chinese companies like Huahai Pharmaceutical and Haisco Pharmaceutical are positioned to avoid tariff impacts by focusing on generics and utilizing licensing agreements for any innovative drugs [10][11]. Opportunities for Chinese Pharmaceutical Industry - The tariff situation may create unexpected growth opportunities for Chinese pharmaceutical companies as Western firms are forced to relocate production to the U.S., potentially diminishing their competitiveness in other markets [11][12]. - The restructuring of the global pharmaceutical supply chain could lead to increased demand for outsourcing services, benefiting Chinese contract research organizations (CROs) [11][12]. - Analysts suggest that the actual impact of the tariff on Chinese pharmaceutical stocks is minimal, with upcoming healthcare negotiations and data releases potentially serving as catalysts for recovery [11][12].

Core Viewpoint - The significant stock price increases of Kangfang Biopharma and Pop Mart, which rose over 150% and 450% respectively, reflect the accurate predictions of the "Phoenix Star Listed Company Awards" regarding high-quality investment targets [1][4][18]. Group 1: Performance and Growth - Kangfang Biopharma achieved a revenue of 1.412 billion yuan in the first half of 2025, marking a year-on-year growth of 33.7%, driven by the commercialization of core products [5]. - Pop Mart reported a revenue of 13.88 billion yuan during the same period, with a remarkable year-on-year growth of 204.4%, showcasing the strong monetization capability of cultural IP operations [8]. - Both companies' growth is attributed to stable revenue contributions from their core businesses, with Kangfang Biopharma focusing on dual-antibody drug matrices and Pop Mart leveraging its leading IP series [8]. Group 2: Globalization Strategy - Kangfang Biopharma is actively pursuing a global strategy, with key products like Cardunili and Yivosi being central to its international expansion. The company has authorized Summit to commercialize Yivosi globally under a deal worth up to $5 billion [9]. - Pop Mart adopts a localized international strategy, signing artists globally to cater to diverse consumer needs and launching region-specific products, such as Thai-themed LABUBU products and collaborations with famous artworks in Paris [9]. Group 3: Industry Trends - The innovative pharmaceutical sector, where Kangfang Biopharma operates, is experiencing structural changes, with improved healthcare systems and accelerated drug approvals driving the growth of Chinese innovative drugs [12]. - Pop Mart is capitalizing on the rise of the IP economy, fueled by the increasing demand for emotional value consumption among Generation Z and the global popularity of "Guzi" culture [12]. Group 4: Evaluation Criteria - The "Phoenix Star Listed Company Awards" emphasizes long-term growth potential over short-term financial metrics, utilizing data analysis, expert reviews, and public voting to identify companies with sustainable value [13][14]. - The awards recognize Kangfang Biopharma's comprehensive layout from R&D to industrialization and Pop Mart's innovative capabilities in IP operations and global expansion potential [14].

Core Insights - The significant stock price increases of Kangfang Biopharma and Pop Mart, exceeding 150% and 450% respectively, reflect the accurate predictions of the "2024 Phoenix Star Listed Company Awards" regarding high-quality companies [1][3][14] Company Performance - Kangfang Biopharma achieved a revenue of 1.412 billion yuan in the first half of 2025, marking a year-on-year growth of 33.7%, driven by the commercialization of core products [3][5] - Pop Mart reported a revenue of 13.88 billion yuan during the same period, with a remarkable year-on-year growth of 204.4%, showcasing its strong monetization capabilities in cultural IP operations [5][9] Strategic Initiatives - Both companies are actively pursuing globalization strategies to tap into overseas market potential, which is crucial for their scale expansion [5][6] - Kangfang Biopharma's key products, such as Cardunili and Yivosi, are being commercialized globally, with significant licensing agreements and clinical trials underway in the U.S. [5][9] - Pop Mart is adapting its international strategy by signing local artists and creating products tailored to regional consumer preferences, enhancing its global appeal [6][9] Industry Trends - The innovative pharmaceutical sector, where Kangfang Biopharma operates, is experiencing structural changes, including improved healthcare systems and accelerated drug approvals, contributing to the growth of Chinese innovative drug companies [9][10] - Pop Mart is capitalizing on the rise of the IP economy, driven by the increasing demand for emotional value consumption among Generation Z and the global popularity of "Guzi" culture [9][10] Evaluation Criteria - The "Phoenix Star" awards focus on companies' core competitiveness and long-term industry impact rather than short-term financial metrics, highlighting the potential for sustained growth [10][12] - The evaluation process includes data analysis, expert reviews, and public voting, ensuring a comprehensive assessment of companies' long-term value [10][12]