新版医保目录已进入实质性落地阶段。1月8日，北京商报记者注意到，包括替妥尤单抗N01注射液、夫 那奇珠单抗注射液在内的多款新增创新药，已在多地医院纷纷开出医保首方。这标志着患者使用这些高 价创新药的实际门槛正在快速降低，新版目录的惠民效应开始显现。 倒逼药企研发策略转向真创新 本次医保目录调整不仅新增了114种药品，更首次同步推出《商业健康保险创新药品目录（2025 年）》，通过"基本医保+商保"的双重保障，为肿瘤、罕见病等领域19种高值药品开辟了可及的支付通 路，医保支付体系向多层次保障的实质性转型迈出关键一步，创新药企也迎来了加速商业化放量的重要 节点。 不到一年开出医保首方 创新药迅速落地医保，是新版医保目录对具有高临床价值"真创新"支持力度加大的直接体现。本次调整 中，新版医保目录与商保创新药目录共纳入独家品种124个。 其中，备受关注的替妥尤单抗N01注射液是国内首款用于治疗甲状腺眼病的靶向药物，从2025年3月上 市，到开出医保首方，用时不到一年，填补了我国该领域近70年的治疗空白。 夫那奇珠单抗注射液则是用于治疗银屑病的生物制剂1类创新药，由恒瑞医药自主研发。恒瑞医药在本 次医保目录调整中被视为 ...

从全球研发的追随者，到新治疗格局的开创者，中国创新药正在完成一场深刻的蜕变。如今，中国创新 药管线与上市新药数量已占据全球总量的三分之一。巨变背后，是一批以长期主义为信仰、坚持创新的 本土生物医药企业。 康方生物正是这样的企业代表。它的故事，记录的不仅是一家企业的成长，更是中国创新药如何以技术 定力、战略耐性与全球视野，最终在全球前沿刻下中国坐标。在其不断向上攀登的历程中，广州不仅是 一个站点，更是支撑其快速产业化、链接临床资源、贯通创新链条的关键土壤。 01/ 双抗锋芒十年亮剑 2012年，夏瑜与几位同样拥有海外工作经历的好友，共同在广东中山创立了康方生物。当时，中国的创 新药产业正处于萌芽阶段。 两年之后，全球首个PD-1抑制剂上市。也正是在这一时期前后，海内外大量生物医药企业将研发力量 投入到PD-1领域。然而，初来乍到的康方生物却将目光聚焦在了当时少有人涉足的肿瘤免疫下一代产 品赛道——双抗，并在公司成立初期，就投入了巨大资源打造端对端全方位的药物开发平台（ACE）和 双特异性抗体开发技术平台（TETRABODY）技术。 这是一个技术上充满挑战的决定。与单靶点的PD-1不同的是，双抗药物是"一药双靶" ...

康方生物科学家正在进行细胞工艺实验。 受访者供图 从全球研发的追随者，到新治疗格局的开创者，中国创新药正在完成一场深刻的蝶变。如今，管线与上 市新药数量已占据全球总量的三分之一。巨变背后，是一批以长期主义为信仰、坚持创新的本土生物医 药企业。 康方生物正是这样的企业代表。它的故事，记录的不仅是一家企业的成长，更是中国创新药如何以技术 定力、战略耐性与全球视野，最终在全球前沿刻下中国坐标。在其不断向上攀登的历程中，广州不仅是 一个站点，更是支撑其快速产业化、连接临床资源、贯通创新链条的关键土壤。 战略 双抗锋芒 十年亮剑 2012年，夏瑜与几位同样拥有海外工作经历的好友，共同在广东中山创立了康方生物。当时，中国的创 新药产业正处于萌芽阶段。 两年之后，全球首个PD-1抑制剂上市。初来乍到的康方生物却将目光聚焦在了当时少有人涉足的肿瘤 免疫下一代产品赛道——双抗，并在公司成立初期，就投入了巨大资源打造端对端全方位的药物开发平 台(ACE)和双特异性抗体开发技术平台(TETRABODY)技术。 这是一个技术上充满挑战的决定。与单靶点的PD-1不同的是，双抗药物是"一药双靶"，在分子设计、稳 定性和生产工艺上的复杂度 ...

Core Insights - The biopharmaceutical sector in Guangzhou, particularly in the Huangpu District, is rapidly developing, with a focus on innovation in areas such as gene therapy, diagnostics, and medical devices [1][5][21] - Guangzhou has established itself as a hub for unicorn companies, with 210 enterprises listed, 60 of which are in Huangpu, representing 29% of the city's total [1][5] - The "Strategic Entrepreneur Cultivation Plan" initiated by the Guangzhou Development Zone aims to enhance the competitiveness of biopharmaceutical companies through resource integration and systematic training [1][5] Biopharmaceutical Industry Development - Huangpu District has over 4,800 biopharmaceutical companies, including 528 high-tech firms and 21 listed companies, accounting for 72% of the city's total [7][21] - The district's industrial output value reached 35.1 billion yuan, positioning it among the top tiers of China's biopharmaceutical industry [7] - The area has seen a significant increase in clinical trial approvals, with 115 new approvals in 2024, including 99 for innovative drugs [7][21] Key Companies and Innovations - Yunzhou Biotech has become the world's largest CRO service provider for research-grade gene vectors, delivering over one million gene vectors globally by 2024 [2][17] - The company has achieved a compound annual growth rate of over 20% in revenue over the past three years, with a valuation exceeding 70 billion yuan, making it the first biopharmaceutical unicorn in Guangzhou [17] - Other notable companies in the region include Akeso, BeiGene, and Hengrui Medicine, contributing to a diverse and innovative biopharmaceutical landscape [5][18] Strategic Initiatives and Collaborations - The Guangzhou International Bio-Island initiative aims to create a comprehensive biopharmaceutical ecosystem through the establishment of pilot parks that enhance collaboration among companies [9][10] - The Huangpu District has implemented multiple policies to support the biopharmaceutical industry, including the "Biopharmaceutical 3.0" policy, which focuses on technology innovation, product commercialization, and talent support [25][30] - Recent investments from global healthcare giants, such as the establishment of a production base by Medtronic, highlight the area's attractiveness for foreign investment [28][30]

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 ...

Investment Rating - The report assigns a "Buy" rating to several companies in the pharmaceutical sector, indicating a potential upside of over 15% in their stock prices over the next 12 months [2][29]. Core Insights - The release of the 2025 version of the basic medical insurance directory continues to support innovation, with 114 new drugs added, including 50 first-class innovative drugs, while 29 drugs were removed due to lack of supply or better alternatives [3]. - The MSCI China Healthcare Index has seen a cumulative increase of 60.9% since the beginning of 2025, outperforming the MSCI China Index by 29.2% [1]. - Despite a recent 9% pullback in the healthcare sector, undervalued stocks present attractive investment opportunities [1][3]. - The trend of innovative drugs going overseas is expected to continue, with a focus on the progress of these products in international markets [1]. - The demand for innovative drug research and development in China is showing signs of recovery, supported by a resurgence in capital market financing and an increase in the scale of overseas transactions [1]. Summary by Sections Industry Research - The report highlights that the adjustment of the medical insurance directory emphasizes support for "true innovation" and "differentiated innovation" [3]. - The first version of the commercial insurance directory includes 19 innovative drugs, which may pave the way for the expansion of commercial medical insurance in China [3]. - The report recommends a more cautious investment approach, focusing on undervalued stocks in the sector [3]. Company Ratings - Recommended companies include: - 三生制药 (Sangfor) with a target price of 37.58 and a potential upside of 29% [2]. - 固生堂 (Gushengtang) with a target price of 44.95 and a potential upside of 58% [2]. - 药明合联 (WuXi AppTec) with a target price of 74.00 and a potential upside of 10% [2]. - 巨子生物 (Giant Biotech) with a target price of 53.89 and a potential upside of 48% [2]. - 信达生物 (Innovent Biologics) with a target price of 110.62 and a potential upside of 29% [2]. - 中国生物制药 (China National Pharmaceutical Group) with a target price of 9.40 and a potential upside of 39% [2].

每经AI快讯，12月7日，据康方生物微信公众号，其5个自研新药参与本轮国家医保谈判的所有适应 证，全部谈判成功进入国家医保目录，包括双抗新药卡度尼利和依沃西新增多个一线大适应证，以及3 个首次参与谈判药物的全部适应症。截至目前，康方生物5个自主商业化自研新药的全部获批适应证， 均已纳入国家医保目录。 （文章来源：每日经济新闻） ...

生物医药ETF（512290）连续3日迎净流入，制药行业表现较好。 中信建投指出，制药行业表现较好，恒瑞医药艾速达（JAK1）提交了新的适应症上市申请；信达生物 首个中国原研IL-23p19单抗获批上市；百济神州索托克拉上市申请已获美国FDA受理并授予优先审评资 格；康方生物卡度尼利方案一线治疗晚期宫颈癌被作为全人群治疗的"首选方案"写入NCCN指南中国版 推荐；诺和诺德Amycretin糖尿病二期临床数据公布，司美格鲁肽阿尔茨海默症三期临床失败；美国第 二轮IRA谈判结果出炉；BioNTech更新PD-L1/VEGFTNBC临床数据。 生物医药ETF（512290）跟踪的是CS生医指数（930726），该指数从沪深市场中选取涉及生物技术、制 药、医疗设备等业务的上市公司证券作为指数样本，以反映生物科技与医药健康相关上市公司证券的整 体表现。该指数成分股具有较高的成长性和创新性，侧重于展示生物医药行业的综合发展水平。 （文章来源：每日经济新闻） ...

Core Insights - The Chinese pharmaceutical industry is at a significant "structural turning point," involving a systemic reconstruction of technology, market dynamics, value logic, and global roles [1] - The trend of Chinese pharmaceutical companies increasingly engaging in overseas licensing agreements is notable, with a total of nearly $66 billion in licensing deals in the first half of 2025 [2][4] - China's innovation in pharmaceuticals is gaining global recognition, with a substantial increase in the number of approved innovative drugs and clinical trial registrations surpassing those in the U.S. for two consecutive years [4][5] Group 1 - Chinese pharmaceutical companies are transitioning from generic drugs to innovative drugs, focusing on original drugs with new mechanisms and targets, as evidenced by significant licensing agreements with global pharmaceutical giants [2][3] - The quality of Chinese pharmaceutical innovation is improving, with research and development speeds 30% to 40% faster than global benchmarks, while asset valuations remain lower at 60% to 70% of global levels [4][6] - The number of approved innovative drugs in China reached 43 in the first half of the year, marking a 59% increase year-on-year, alongside a 87% increase in innovative medical devices [5][6] Group 2 - Challenges remain in the industry, including low concentration, poor accessibility of new drugs, and insufficient original innovation, necessitating strategies like internationalization and industrial transformation [6] - The industry is still positioned at the lower end of the value chain, with calls for building international innovation platforms to capture a larger share of global innovation benefits [6] - The integration of basic research with industrial transformation is crucial for achieving a turning point in China's innovative drug sector, focusing on unmet clinical needs rather than competing in existing markets [6]

Investment Rating - The report maintains a positive outlook on the overseas pharmaceutical sector, particularly focusing on innovative drugs and industry chain opportunities, with an investment rating of "Overweight" [1][6]. Core Insights - Multiple policies are supporting the development of the innovative drug industry, with domestic innovative drug transactions reaching historical highs in both value and quantity. The sector's valuation has rebounded from a low point, and leading companies are achieving profitability through increased commercial sales and licensing income [6][8]. - Companies like BeiGene are experiencing significant growth, with global sales exceeding $1 billion in Q3 2025, marking a 51% year-on-year increase. The company anticipates a positive GAAP operating profit for the full year 2025, raising its revenue guidance to $5.1-5.3 billion [1][6]. - Innovent Biologics is expanding its pipeline with a dual focus on oncology and non-oncology products, expecting to achieve positive non-IFRS net profit and EBITDA in 2024, with continued growth projected for 2025 [2][6]. - The report highlights the increasing R&D investments by leading pharmaceutical companies, which are enhancing their innovative pipelines and accelerating their transformation towards innovation [3][7]. Summary by Sections Section 1: Overseas Pharmaceuticals - The report emphasizes the focus on innovative drugs and the opportunities within the industry chain for 2026, noting the historical highs in transaction amounts and numbers for domestic innovative drugs going overseas [6][8]. - BeiGene's overseas sales are highlighted, with Q3 2025 global sales surpassing $1 billion and a significant year-on-year profit turnaround [1][6]. - Innovent Biologics is noted for its strategic partnerships and expected profitability in the coming years [2][6]. Section 2: Pharma Sector - Leading companies are rapidly increasing their R&D investments, which is expected to strengthen their innovative pipelines and global competitiveness [3][7]. - Companies like Hansoh Pharmaceutical and China Biologic Products are projected to see substantial growth in their innovative product revenues, with significant contributions expected in the coming years [3][7]. Section 3: CXO Sector - The report indicates a recovery in investment and financing for innovative drugs, which is likely to drive early-stage R&D investments and boost demand [8]. - Emerging fields such as peptides and ADCs are expected to open new growth opportunities, with a recommendation to focus on companies like WuXi AppTec and WuXi Biologics [8].