报告导读： Moderna 个体化 mRNA 癌症疫苗 V940 在高危黑色素瘤中的 5 年随访结果 支持疫苗机制能提供持久免疫应答，为后续 III 期与注册推进提供了更充分的临床依据。 事件。 2026 年 1 月 21 日， Moderna 与默沙东联合披露个体化 mRNA 癌症疫苗 V940 （ mRNA-4157 ）联合 Keytruda 用于高危黑色素瘤辅助治疗的 IIb 期 5 年随访结果。该联合治疗方案在较长时间内维持了既往观察到的疗效水平，支持其能够诱导并维持相对持久的免疫应答。 核心读出数据支持疫苗机制能提供持久免疫应答。 KEYNOTE-942 研究结果显示 V940 联合 Keytruda 降低 49% 高危黑色素瘤患者复发或死亡风险，疗效 从 2 年随访时的 44% 提升至 3 年的 49% 并在 5 年随访时仍维持在 49% 。同时未发现新的安全性信号。 V940 的整体推进节奏在同类项目中较为靠前。 mRNA-4157 目前已开展 8 项 II/III 期临床研究，适应症覆盖黑色素瘤、非小细胞肺癌、膀胱癌及肾细胞癌 等多种实体瘤。其中黑色素瘤 III 期临床试验已完成入组，预计将于 ...

股票研究 /[Table_Date] 2026.02.01 持续推荐创新药械产业链 [Table_Industry] 医药 ——国泰海通医药 2026 年 2 月月报 | [姓名table_Authors] | 电话 | 邮箱 | 登记编号 | | --- | --- | --- | --- | | 余文心(分析师) | 021-38676666 | yuwenxin@gtht.com | S0880525040111 | | 郑琴(分析师) | 021-23219808 | zhengqin@gtht.com | S0880525040108 | | 谈嘉程(分析师) | 021-38038429 | tanjiacheng@gtht.com | S0880523070004 | 本报告导读： 持续推荐创新药械及产业链。 投资要点： | [Table_Invest] | | | --- | --- | | 评级： | 增持 | [Table_Report] 相关报告 医药《V940 五年随访数据披露，mRNA 肿瘤疫 苗长期价值验证》2026.01.30 医药《支持政策不断，持续推荐创新药械产业 链》202 ...

Investment Rating - The report assigns an "Overweight" rating for the industry, indicating an expected performance that exceeds the Shanghai and Shenzhen 300 Index by more than 15% [4][10]. Core Insights - The report highlights the five-year follow-up results of Moderna's personalized mRNA cancer vaccine V940 in high-risk melanoma, supporting the vaccine's mechanism to provide durable immune responses, which strengthens the clinical basis for subsequent Phase III and registration advancements [2][5]. - The KEYNOTE-942 study results show that the combination of V940 and Keytruda reduces the risk of recurrence or death in high-risk melanoma patients by 49%, with efficacy maintaining from 44% at the two-year follow-up to 49% at the three-year and five-year follow-ups, without new safety signals being reported [5]. - V940 is advancing ahead of similar projects, with eight ongoing Phase II/III clinical studies covering various solid tumors, including melanoma, non-small cell lung cancer, bladder cancer, and renal cell carcinoma. The Phase III trial for melanoma has completed enrollment and is expected to yield critical data in 2026, with the project also receiving FDA breakthrough therapy designation [5]. Summary by Sections - **Investment Highlights**: The report emphasizes the sustained efficacy of V940 in inducing durable immune responses, differentiating it from previous unsuccessful cancer vaccine attempts, and providing long-term clinical data support for mRNA tumor vaccine technology [5]. - **Clinical Data**: The report details that V940 can encode up to 34 new antigens, activating T-cell responses with immune memory characteristics, complementing PD-1 inhibitors [5].

莫德纳(MRNA.US)盘前续涨5.6%，报52.6美元，该股昨日大幅收涨近16%。消息面上，近日，默沙东与 莫德纳联合披露mRNA肿瘤疫苗mRNA-4157联合K药的二期临床五年随访数据，显示联合疗法较 Keytruda单药治疗将高危III/IV期黑色素瘤患者复发或死亡风险显著降低49%，且疗效持久，有力支持了 mRNA肿瘤疫苗诱导持久免疫应答的科学假设。(格隆汇) ...

Core Insights - The collaboration between Merck and Moderna on the mRNA cancer vaccine mRNA-4157 has shown promising results, significantly reducing the risk of recurrence or death by 49% in high-risk melanoma patients when combined with the PD-1 inhibitor Keytruda [1][2] - The mRNA-4157 vaccine utilizes a personalized neoantigen therapy mechanism, which designs synthetic mRNA encoding up to 34 neoantigens based on the unique mutations in a patient's tumor DNA [2] - The market potential for mRNA cancer vaccines is substantial, with projections indicating that they could become a new class of cancer immunotherapy, combining accessibility and personalization [4] Company Developments - Moderna plans to increase investment in the oncology sector, with the Phase III clinical trial for mRNA-4157 fully enrolled and expanding its indications beyond melanoma [2] - EVM16, a personalized cancer vaccine developed by the domestic company, has entered human trials, marking a significant milestone in the application of mRNA technology combined with AI for neoantigen selection [3] - The clinical data from EVM16 is expected to be released in the next 6-12 months, with the company aiming to initiate Phase Ib studies thereafter [3] Industry Trends - The success of mRNA-4157 highlights the unmet needs in cancer treatment, with the industry recognizing the potential of mRNA cancer vaccines to address these gaps [4] - The competitive landscape for personalized cancer vaccines is evolving, with domestic companies like EVM16 accelerating their development efforts in response to the advancements made by global players [4]

Core Viewpoint - Yuyuan Pharmaceutical (688658.SH) announced that its wholly-owned subsidiary, Beijing Yuyuan Ketech Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. have received approval from the National Medical Products Administration for the clinical trial of injectable YKYY031, a universal mRNA tumor vaccine intended for the treatment of advanced solid tumors [2]. Group 1 - Yuyuan Pharmaceutical's subsidiary has obtained a clinical trial approval for YKYY031 [2] - YKYY031 is designed as a universal mRNA vaccine targeting advanced solid tumors [2]

Core Viewpoint - YKYY031, a novel mRNA tumor vaccine developed by the company, has received approval from the National Medical Products Administration (NMPA) for clinical trials targeting advanced solid tumors [2][3] Group 1: Product Development - YKYY031 is designed as a general mRNA tumor vaccine for the treatment of advanced solid tumors, utilizing a proprietary cationic lipid-based lipid nanoparticle (LNP) delivery system that offers high delivery efficiency and good safety [2] - The vaccine contains mRNA sequences encoding multiple tumor-associated antigens (TAA) and tumor-specific antigens (TSA), which can induce specific cytotoxic T cell responses to inhibit tumor cell growth [2] Group 2: Intellectual Property - The core sequence and delivery system of YKYY031 have been granted invention patent authorization by the National Intellectual Property Administration, and international patent applications have been completed, granting the company global exclusive rights [2] Group 3: Preclinical Research - Preclinical studies have demonstrated significant efficacy and good safety for YKYY031, showing the ability to induce strong and lasting tumor antigen-specific T cell immune responses and clear anti-tumor activity under various dosing regimens [3] - The combination of YKYY031 with anti-PD-1 antibodies has been shown to further enhance therapeutic efficacy [3] Group 4: Stability and Logistics - The product employs advanced LNP freeze-drying technology, which eliminates the dependence on ultra-low temperature cold chain logistics, significantly reducing transportation and storage costs while improving accessibility [3]

Core Viewpoint - Yuyuan Pharmaceutical (688658.SH) has received approval from the National Medical Products Administration (NMPA) for its clinical trial of the injectable YKYY031, a generic mRNA tumor vaccine intended for the treatment of advanced solid tumors [1] Group 1 - The clinical trial approval is granted to Yuyuan Pharmaceutical's wholly-owned subsidiary, Beijing Yuyuan Kete Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. [1] - YKYY031 is designed to treat advanced solid tumors and utilizes a novel cationic lipid YK-009-based lipid nanoparticle (LNP) delivery system, which is characterized by high delivery efficiency and good safety [1]

Core Viewpoint - YKYY031, a novel mRNA tumor vaccine developed by the company, has received approval from the National Medical Products Administration (NMPA) for clinical trials targeting advanced solid tumors [1][2] Group 1: Product Development - YKYY031 is designed to treat advanced solid tumors using a lipid nanoparticle (LNP) delivery system based on the company's proprietary cationic lipid YK-009, which offers high delivery efficiency and good safety [1] - The vaccine contains mRNA sequences that encode multiple tumor-associated antigens (TAA) and tumor-specific antigens (TSA), aiming to induce specific cytotoxic T cell responses to inhibit tumor growth [1] Group 2: Clinical Research and Efficacy - Preclinical studies have demonstrated significant efficacy and good safety for YKYY031, showing the ability to induce durable tumor antigen-specific T cell immune responses and clear anti-tumor activity under various dosing regimens [2] - The combination of YKYY031 with anti-PD-1 antibodies has been shown to further enhance therapeutic efficacy [2] Group 3: Safety and Stability - Toxicological studies indicate that YKYY031 has a good safety profile and a broad therapeutic window, providing a solid foundation for clinical application [2] - The advanced LNP lyophilization process used for YKYY031 overcomes the dependency on ultra-low temperature cold chain logistics, significantly reducing transportation and storage costs while improving accessibility [2]

Core Viewpoint - The announcement indicates that Yuyuan Pharmaceutical's wholly-owned subsidiary, Beijing Yuyuan Ketech Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. have received approval from the National Medical Products Administration for the clinical trial of injectable YKYY031, a generic mRNA tumor vaccine intended for the treatment of advanced solid tumors [1] Group 1 - Yuyuan Pharmaceutical's subsidiary has obtained a clinical trial approval notice for YKYY031 [1] - YKYY031 is designed as a generic mRNA tumor vaccine [1] - The vaccine is aimed at treating advanced solid tumors [1]