来源：龙谈价值2023 大家好，我是龙哥。 2025年的创新药大行情，总体围绕创新药海外BD交易展开，市场对BD交易的预期从一个极端走向另一 个极端——从已经BD出去的要看到比较明确的临床推进才愿意给部分估值，到大多创新药公司的管线 都被拉出来用放大镜看一圈、只要有潜力BD出去的就炒一把。经过自10月份以来的多个BD交易落地或 海外资产被并购后反而股价暴跌的市场表现，3个月的行情、情绪、关注度的退潮，很多A股和H股的小 公司股价腰斩，市场情绪趋于理性，创新药行业2026年的驱动逻辑被市场重新理解和认知。 2026年行业靠什么驱动？我们此前文章已经多次讲过，淡化一过性的BD交易，后续要靠实实在在的海 外临床推进、海外商业化确定性的提升来驱动，到现在市场对该认知已经逐渐理解，创新药行业β也再 次显现，行业龙头和优质二线公司以及此前讲过的持仓比较纯粹的520880港股通创新药ETF都陆续企稳 向上。 本文我们来讨论一下2026年海外注册临床会有明确进展的公司，所谓的进展既包括新开全球多中心注册 临床，也包括临床数据的读出，我们在此抛砖引玉的列举一部分公司，也欢迎大家的补充。 1、行业影响巨大的两个肿瘤药 首先我们要 ...

同时，科伦药业公告称，公司近日获悉，公司控股子公司科伦博泰自主研发的靶向整合素β6(ITGB6)抗 体偶联药物(ADC)SKB105(亦称CR-003)的新药临床试验申请已获中国国家药品监督管理局药品审评中 心批准，用于治疗晚期实体瘤。 北京商报讯(记者丁宁)1月5日早间，科伦药业（002422）发布公告称，公司近日获悉，公司控股子公司 四川科伦博泰生物医药股份有限公司(以下简称"科伦博泰")靶向人滋养细胞表面抗原2(TROP2)的抗体偶 联药物(ADC)芦康沙妥珠单抗联合默沙东的抗程序性细胞死亡蛋白1(PD-1)单克隆抗体帕博利珠单抗一 线治疗程序性细胞死亡配体1(PD-L1)肿瘤比例分数(TPS)≥1%的表皮生长因子受体(EGFR)基因突变阴性 和间变性淋巴瘤激酶(ALK)阴性的局部晚期或转移性非小细胞肺癌(NSCLC)，已获中国国家药品监督管 理局药品评审中心授予突破性疗法认定。 ...

格隆汇1月5日丨科伦博泰生物-B(06990.HK)宣布，公司靶向人滋养细胞表面抗原2(TROP2)的抗体偶联 药物(ADC)芦康沙妥珠单抗(sac-TMT，亦称SKB264/MK-2870)(佳泰莱®)联合默沙东的抗程序性细胞死 亡蛋白1(PD-1)单克隆抗体("单抗")帕博利珠单抗(可瑞达®)一线治疗程序性细胞死亡配体1(PD-L1)肿瘤 比例分数(TPS)≥1%的表皮生长因子受体(EGFR)基因突变阴性和间变性淋巴瘤激酶(ALK)阴性的局部晚 期或转移性非小细胞肺癌(NSCLC)，已获中国国家药品监督管理局(NMPA)药品评审中心(CDE)授予突 破性疗法认定。 突破性疗法认定主要授予对于尚无有效治疗手段的，该药物可以提供有效防治手段或与现有治疗手段相 比具有明显临床优势的治疗方案。对于纳入突破性治疗药物程序的药物，在符合相关条件的情况下，可 以在申请药品上市许可时提出附条件批准申请和优先审评审批申请。 此前，公司公布了芦康沙妥珠单抗(sac-TMT)联合帕博利珠单抗一线治疗PD-L1阳性NSCLC的3期 OptiTROP-Lung05临床试验结果，其在主要终点无进展生存期(PFS)显示出统计学意义和临 ...

同时，首版商业健康保险创新药品目录也同步开始实施。北京市医保局副局长颜冰说，他们将继续 会同金融监管、卫生健康等部门，持续探索支持商业保险公司拓展覆盖商保创新药目录产品。 颜冰：对于符合条件的商保产品，要给它类似于国谈药的支持政策，进院的时候可以给它绿色挂网 通道，多部门协同做好商保产品的监管工作。 河北、江西等多地医保部门下发通知，明确要求定点医疗机构合理配备、使用目录内药品，积极推 动新版药品目录落地执行。河北医科大学第一医院药品物资部主任刘洪涛透露，他们已经完成了价格调 整。 刘洪涛：新版的药品目录价格，我们把相关药品目录进行系统上的导入，特别是一些肿瘤还有新的 一些机制药品，价格大幅下降，让患者的生命健康更有保障。 除定点医疗机构外，全国还有超过十万家定点零售药店成为患者用药的"双保险"。通过对国谈药物 的"双通道"保障，对于暂时未能进院的部分罕见病药物和创新药物，患者可以在符合条件的定点零售药 店购药，享受医保报销结算。 央广网北京1月3日消息（记者杜希萌 河南台记者冉晓晖 河北台记者魏娜）据中央广播电视总台中 国之声《新闻和报纸摘要》报道，新版《国家基本医疗保险、生育保险和工伤保险药品目录》已经正 ...

Core Viewpoint - The implementation of the new national basic medical insurance drug list and the first commercial health insurance innovative drug list in Beijing on January 1, 2026, introduces 114 new drugs into the basic insurance reimbursement scope and 19 innovative drugs into the commercial insurance list, significantly benefiting patients [1][2]. Group 1: New Drug Inclusion - The new national medical insurance directory includes a total of 3,253 drugs, with 114 new drugs added, covering critical treatment areas such as cancer, chronic diseases, and rare diseases [1]. - Notable new drugs include the anti-cancer drug Lurbinectedin for triple-negative breast cancer, the diabetes medication Tirzepatide, and treatments for rare diseases like Langerhans cell histiocytosis [1]. Group 2: Commercial Insurance Drug List - The commercial insurance list includes 19 innovative drugs, focusing on high innovation, significant clinical value, and substantial patient benefits beyond the basic insurance coverage [1]. - Included innovative treatments are CAR-T cell immunotherapy products, biological agents for Alzheimer's disease, and specific drugs for Gaucher disease and short bowel syndrome [1]. Group 3: Patient Impact - An 8-year-old boy with high-risk neuroblastoma became one of the first beneficiaries of the new policy, with his treatment costs significantly reduced from tens of thousands of yuan annually to being partially covered by commercial insurance [2]. - The inclusion of GD2 antibody therapy in the commercial insurance list allows families to shift from full out-of-pocket expenses to insurance reimbursement, alleviating financial burdens [2]. Group 4: Transition Period and Adjustments - A 6-month transition period is established for drugs removed from the old national medical insurance directory, allowing them to still be reimbursed until June 30, 2026 [3]. - The Beijing Medical Insurance Bureau has mandated timely adjustments in drug supply at medical institutions and updates to the insurance information system to ensure patient access to necessary medications [3].

来源：长江日报 长江日报记者从武汉市医保局获悉，《国家基本医疗保险、生育保险和工伤保险药品目录（2025年）》 （下称"新版国家医保药品目录"）及《商业健康保险创新药品目录（2025年）》（下称"商保创新药目 录"）于今日（2026年1月1日）起在武汉同步落地。 新版目录以"临床急需、价格亲民、保障多元"为核心，新增114种药品精准覆盖肿瘤、罕见病等关键领 域，首推的商保创新药目录与基本医保目录形成保障互补。 本次新版目录在武汉落地实施后，"双通道"目录同步扩容，武汉通过明确医疗机构配备标准、搭建院企 常态化对接平台等举措，确保谈判药品"买得到、用得上、报得了"。 50 种创新药 " 快进 " 医保 平均降价超六成 据介绍，本次新版国家医保药品目录调整后，共收录药品3253种，其中西药1857种、中成药1396种。此 次新增的114种药品中，50种为一类创新药，纳入成功率高达88%，且90%以上是近5年获批上市的新 药，实现创新药"快进"医保的加速度。 这些新药精准聚焦临床急需，涵盖肿瘤用药36种、罕见病用药10种、慢性病用药12种、儿童用药9种， 既有治疗三阴性乳腺癌的芦康沙妥珠单抗、全身型重症肌无力的艾加 ...

行 业 研 究 入 华福证券 医药生物 2025 年 12 月 28 日 医药生物 2026 年为 IO 联合 ADC 大年，有哪些关键催化？ 投资要点： 行 业 定 期 报 行情回顾：本周（2025 年 12 月 22 日- 2025 年 12 月 26 日）中信医药指数 下跌 0.2%，跑输沪深 300 指数 2.1pct，在中信一级行业分类中排名第 26 位； 2025 年初至今中信医药生物板块指数上涨 15.2%，跑输沪深 300 指数 3.1pct， 在中信行业分类中排名第 17 位。本周涨幅前五的个股为：宏源药业（+59.4%）、 鹭燕医药（+37.3%）、华康医疗（+21.1%）、康芝药业（+20.8%）、万邦德 （+15.8%）。 告 IO+ADC：26 年催化剂密集大年，中国主导二代 IO 联合 ADC 研发。免 疫疗法与 ADC 具天然互补：PD-1 激活免疫但响应有限；ADC 直接杀伤并 释放 TAA/DAMP 诱导 ICD，促进 DC 呈递，激活 CD8+与 CD4+T 细胞， 扩大受益人群。1L 膀胱癌中，KEYNOTE-361 未见 PFS/OS 显著改善；而 Padcev（Nec ...

Core Insights - Heng Rui Medicine's SHR-A1904 has been included in the list of breakthrough therapies by the National Medical Products Administration, marking a significant advancement in the ADC field [1] - The global ADC market is experiencing explosive growth, with the market size surpassing $10 billion in 2023 and projected to reach $66.2 billion by 2030 [4] Group 1: Company Developments - Heng Rui Medicine's SHR-A1904 is a targeted Claudin18.2 antibody-drug conjugate (ADC) with a payload of topoisomerase inhibitor, currently undergoing multiple clinical studies for various solid tumors [1] - The company has invested approximately 174 million yuan in the development of SHR-A1904 [1] - Heng Rui Medicine's SHR-A2102, another ADC targeting Nectin-4, has received clinical trial approval, with a total investment of about 248 million yuan in its development [2] - The company has established a proprietary technology platform for ADCs, with over 10 differentiated ADC molecules successfully approved for clinical trials [2] Group 2: Industry Trends - Other innovative pharmaceutical companies, such as CanSino Biologics, BaiLi TianHeng, and Kelun-Biotech, are also making significant progress in ADC development [3] - The ADC drug market is characterized by rapid innovation and increasing recognition of the value of Chinese ADC assets in international markets [4] - Strategic partnerships, such as the one between Kelun-Biotech and Crescent Biopharma, highlight the growing trend of Chinese ADC companies expanding their reach globally [4]

Core Viewpoint - Heng Rui Medicine's SHR-A1904 has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration, marking a significant advancement in the ADC (antibody-drug conjugate) sector, which is expected to grow substantially in the oncology treatment market [1][2]. Group 1: Company Developments - SHR-A1904 is a targeted Claudin18.2 antibody-drug conjugate developed by Heng Rui Medicine, with a cumulative R&D investment of approximately 174 million yuan [2]. - The company has also received approval for clinical trials of SHR-A2102, another ADC targeting Nectin-4, with a cumulative R&D investment of about 248 million yuan [2]. - Heng Rui Medicine has established a proprietary technology platform for ADCs, with over 5,000 patients across 15 tumor types validated globally, and more than 10 differentiated ADC molecules successfully approved for clinical use [3]. Group 2: Industry Trends - The ADC drug market is experiencing explosive growth, with the global market size surpassing $10 billion in 2023 and projected to reach $66.2 billion by 2030, according to Frost & Sullivan [6]. - Other innovative pharmaceutical companies, such as Cangzhou Jianan, Bai Li Tianheng, and Ke Lun Bo Tai, are also making significant advancements in ADC development, indicating a competitive landscape in the sector [4]. - Chinese companies are becoming key players in global ADC innovation, with increasing recognition of the value of Chinese ADC assets in international collaborations [6].

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The 2025 National Medical Insurance Negotiation results were announced, with 114 new drugs added to the medical insurance directory, achieving an overall success rate of 88%, the highest in nearly seven years, with a maximum price reduction of 94 [4][19] - The newly added drugs include monoclonal antibodies, bispecific antibodies, ADCs, siRNA, and small molecules, indicating a strong focus on innovative therapies [19][32] - The commercial insurance directory has added 19 innovative drugs, which, while not reimbursed by medical insurance, receive support for innovative drug applications, enhancing patient access and benefiting the innovative drug industry [5][24] Summary by Sections 1. National Medical Insurance Negotiation Results - The 2025 medical insurance directory added 114 new drugs, with a success rate of 88% and a maximum price reduction of 94% [4][13] - The total number of drugs in the national medical insurance directory reached 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [16][17] - The directory reflects a significant increase in the inclusion of innovative drugs, with 50 of the new additions classified as category 1 innovative drugs [19][21] 2. Commercial Insurance Directory - The commercial insurance directory added 19 innovative drugs, highlighting their clinical value and innovation [24][28] - The directory includes treatments for diseases such as Alzheimer's, rare diseases in children, and other critical conditions, showcasing a focus on addressing unmet medical needs [24][28] - The support for innovative drugs in the commercial insurance directory aims to fill gaps in patient coverage and enhance the overall healthcare system [25][28] 3. Market Performance - In the second week of December, the pharmaceutical and biotechnology sector declined by 1.04%, underperforming the CSI 300 index by 0.96 percentage points [6][34] - The medical research outsourcing sector showed the highest increase, up by 3.69%, while offline pharmacy and medical circulation sectors experienced the largest declines [6][36] 4. Recommended Companies - The report continues to favor innovative drugs and their supply chain, recommending companies such as Sanofi, Innovent Biologics, and others for investment [7][32]