12月7日，新版国家医保药品目录及首版商保创新药目录正式发布，此次调整纳入上百种创新药，降糖 药新"网红"、全新靶点"三兄弟"、百万元一针的抗癌药等悉数入选，目录将于明年1月1日起正式实施。 "四不改"是指不改主成分、不改适应证、不改给药途径、不改临床价值的药品。"四不改"药品所在同治 疗领域内目录药品已保障比较充分且具备价格优势，创新性低的药品不再考虑纳入。 "能够填补目录空白，有较大临床价值获益的药品，是我们认为的'真创新'药。"天津大学医学部药学院 教授吴晶表示，例如某靶点第三代药物在医保目录中已有多个，同靶点药物如果还想进入目录，就要证 明其能够给患者带来额外获益，否则就是同质化。 "药篮子"全面上新备受关注。面对近年来逐步成熟的靶向药物、免疫药物等，参保人不必再"望药兴 叹"。哪些药品填补空白？首版商保创新药如何落地临床？12月9日，相关专家在国家医保局举办的2025 年医保药品目录解读活动上就上述问题答疑。 第一问：哪些新药入选医保目录？ "98%的医保入选药品是5年内获批新药，其中50种是一类新药，数量创历史新高。"国家医保局医药服 务管理司司长黄心宇介绍，今年新增药品中，肿瘤药、慢性病药、罕见 ...

2025.12. 12 本文字数：3973，阅读时长大约6.5分钟 作者 | 第一财经 郭晋晖 从一年只需2针的超长效降脂针，到填补医保目录空白的治疗三阴性乳腺癌和KRAS非小细胞肺癌的 最新靶向药物，再到千元一针"鼻炎网红药"，国家基本医保药品目录又一次上新了114种新药好药。 与过去七年不同的是，今年国家医保局还同步发布了我国首版商业健康保险创新药品目录（以下简 称"商保创新药目录"），纳入了"百万抗癌药"CAR-T，以及治疗阿尔茨海默病、戈谢病等的19款药 品。 明年1月1日医保商保双目录落地，对大家的"药箱子"和"钱袋子"有何影响？商保创新药目录又和普通 人有什么关系？在近日举行的全国创新药高质量发展大会和国家医保局举办的解读会上，政策制定 者、专家学者、业内人士就民众关心的十个问题给出答案。 脂）、司普奇拜单抗（特异性皮炎）。 在乳腺癌领域，三阴性乳腺癌（TNBC）因缺乏明确的治疗靶点，长期面临治疗选择匮乏、预后较差 的困境。中国自主研发的TROP2 ADC——芦康沙妥珠单抗进入新版医保目录之后填补了这项空白， 更多三阴性乳腺癌患者将受益。 国家医保局医保药品目录解读会现场/郭晋晖摄 50种1类新药 ...

在2025年国家基本药品目录调整中，谈判成功率达到88%，较上一年的76%有明显提升，创近七年新 高。与此同时，在新晋"国谈药"中，有111种为5年内新上市品种，50种为1类新药，无论是比例还是数 量也均创下历年新高。 而与此同时，仍有近百种（98种）药品在形式审查阶段，就被"国谈"拒之门外。近六成目录外药品在专 家评审阶段未过评，过评率连续两年不足50%。15种药在过评后最终谈判/竞价失败。 "一进一拒"，从正反两个维度体现了国家医保局价值购买的方向——在基本医保的保障边界内，支持真 创新，支持差异化创新。 部分业界观点认为，这一方面是因为在申报和形式审查环节，药企申报意愿持续提升，对规则的认知也 更加清晰，形式审查通过数量和通过率不断提升；另一方面，也与目录内药品涵盖适应证不断丰富，创 新药市场上同靶点、同机制、同适应证药品竞争激烈，医保基金紧平衡等多重原因下，国家医保局对创 新要求不断拔高有关。 182种药未过评背后："四不改"、价格与价值不匹配 国家基本药品目录谈判走进第八个年头，已形成了一套成熟的谈判流程：药企自主申报，专家综合评 审，价格谈判/竞价，最终公布谈判结果。 在今年"国谈"中，国家医保局 ...

目录外药品在专家评审环节的通过率创近四年新低。 在2025年国家基本药品目录调整中，谈判成功率达到88%，较上一年的76%有明显提升，创近七年新 高。与此同时，在新晋"国谈药"中，有111种为5年内新上市品种，50种为1类新药，无论是比例还是数 量也均创下历年新高。 而与此同时，仍有近百种（98种）药品在形式审查阶段，就被"国谈"拒之门外。近六成目录外药品在专 家评审阶段未过评，过评率连续两年不足50%。15种药在过评后最终谈判/竞价失败。 "一进一拒"，从正反两个维度体现了国家医保局价值购买的方向——在基本医保的保障边界内，支持真 创新，支持差异化创新。 182种药未过评背后："四不改"、价格与价值不匹配 国家基本药品目录谈判走进第八个年头，已形成了一套成熟的谈判流程：药企自主申报，专家综合评 审，价格谈判/竞价，最终公布谈判结果。 在今年"国谈"中，国家医保局共计收到718份基本医保目录申报信息，涉及药品通用名633种，最终， 535种通过形式审查，包含311种目录外药品；在专家评审阶段，则有超半数药品被筛出，最终129种药 品通过(含2种直接调入)评审，通过率为41.48%；在此之后，127种目录外药品 ...

Core Viewpoint - The company, He Yu-B (02256), has seen a significant stock price increase following the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, Goresan, for treating KRAS G12C mutated NSCLC in China, marking a progression to Phase II clinical trials. Additionally, the company has been included in the MSCI Global Small Cap Index, which is expected to enhance its global funding visibility and liquidity [1]. Group 1 - The stock price of He Yu-B increased by over 6% in early trading, currently up 4.92% at HKD 17.93, with a trading volume of HKD 39.0714 million [1]. - The IND application for the combination treatment of ABSK043 and Goresan has been approved in China, allowing the drug to enter Phase II clinical trials [1]. - The inclusion in the MSCI Global Small Cap Index is anticipated to boost the company's global funding attention and positively impact liquidity [1]. Group 2 - CICC's research report highlights that ABSK043 has the potential to be a globally competitive oral small molecule PD-L1 inhibitor [1]. - The company’s strategy of combining oral therapies is expected to offer better patient compliance and safety profiles compared to the traditional injection plus oral combination [1]. - Future clinical developments of the combination treatment are deemed worthy of attention [1].

Core Viewpoint - The company, He Yu-B (02256), has seen a significant stock price increase following the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, Goreserib, for treating KRAS G12C mutated NSCLC in China, and its inclusion in the MSCI Global Small Cap Index [1] Group 1: Clinical Development - The IND application for the oral PD-L1 inhibitor ABSK043 in combination with Goreserib has been approved in China, allowing it to enter Phase II clinical trials [1] - The combination therapy targets KRAS G12C mutations in non-small cell lung cancer (NSCLC) [1] Group 2: Market Impact - The stock price of He Yu-B rose over 6% in early trading, with a current increase of 4.92%, reaching HKD 17.93, with a trading volume of HKD 39.0714 million [1] - Inclusion in the MSCI Global Small Cap Index is expected to enhance the company's global visibility and potentially improve liquidity [1] Group 3: Analyst Insights - CICC's report highlights ABSK043 as a promising oral small molecule PD-L1 inhibitor with global potential [1] - The oral + oral combination therapy is anticipated to offer better patient compliance and safety profile compared to injection + oral combinations, warranting attention on future clinical developments [1]

Group 1 - The core viewpoint of the article is that HeYu has received IND approval in China for its oral PD-L1 inhibitor ABSK043 and the KRAS G12C inhibitor, which is expected to attract market attention due to its clinical progress [1] - HeYu has been included in the MSCI Global Small Cap Index, which is anticipated to enhance the company's global funding visibility and positively impact its liquidity [1] - The company maintains its profit forecast for the next two years at 48 million and 320 million, respectively, and has raised the target price by 33.3% to HKD 20, while maintaining an "outperforming the industry" rating [1]

Group 1 - The company maintains its net profit forecast for 2025 and 2026 at 48 million and 320 million respectively, while upgrading the target price by 33.3% to 20.0 HKD, indicating an upside potential of 18.3% from the current stock price [1] - The company announced the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor for treating KRAS G12C mutated NSCLC in China, and it has been included in the MSCI global small-cap index [2][4] - ABSK043 is a promising oral small molecule PD-L1 inhibitor with good bioavailability and selectivity, showing good safety and anti-tumor activity in phase I studies, and is currently entering phase II clinical trials in combination with the KRAS G12C inhibitor [3] Group 2 - Being included in the MSCI global small-cap index is expected to enhance the company's visibility and liquidity, positively impacting global fund attention [4]

Group 1 - The core viewpoint of the report maintains the profit forecast for the company at 0.48 billion CNY for 2025 and 3.2 billion CNY for 2026, while raising the target price by 33.3% to 20.0 HKD, indicating an 18.3% upside potential from the current stock price [1] - The company has received IND approval in China for the oral PD-L1 inhibitor ABSK043 and the combination treatment with the KRAS G12C inhibitor for NSCLC [2] - ABSK043 is a promising oral small molecule PD-L1 inhibitor with good bioavailability and selectivity, showing good safety and anti-tumor activity in phase I studies [3] Group 2 - The company is advancing to phase II clinical trials for the combination of ABSK043 and the KRAS G12C inhibitor, which may offer better patient compliance and safety compared to injection plus oral combinations [4] - The company has been included in the MSCI Global Small Cap Index, which is expected to enhance global investor attention and improve liquidity [5]

Core Viewpoint - The adjustment of the national medical insurance and commercial health insurance drug directories is a significant event for the innovative drug investment landscape in the second half of the year, with over 650 drugs entering the basic medical insurance directory and commercial insurance innovative drug directory [1][2]. Group 1: Medical Insurance Directory Adjustments - A total of 534 drug generic names passed the initial review for the basic medical insurance directory, with 310 drugs being added to the directory, a significant increase from 249 in 2024 [2]. - The directory adjustments allow newly approved innovative drugs to have the opportunity to enter the insurance directory, including several notable drugs such as the lung cancer drug Gorailis and the autoimmune drug Fuanqi [2]. Group 2: Commercial Health Insurance Directory - The commercial health insurance innovative drug directory has approved 121 drugs, including five CAR-T therapies and a domestic vaccine, marking a new approach for market access for preventive biological products [3]. - Notable CAR-T therapies that made it into the directory include products from Fosun Kite, Huyuan Bio, and WuXi AppTec, with the latter's product achieving $808 million in revenue in the first half of the year, reflecting a doubling in growth [3]. Group 3: Future Outlook for Innovative Drugs - The upcoming months will see significant overseas pharmaceutical conferences and further developments in the medical insurance directories, providing ample opportunities for speculation and investment in innovative drugs [4]. - The domestic innovative drug sector is expected to benefit from increased clinical data catalysts and a rebound in funding and secondary market activity, enhancing the demand for new drug development [4].