2025年5月底以来，港股和A股创新药板块轮番上演"普涨"行情，在本土创新药"出海"收获大单，以及监管利好政 策的接连推动下，二级市场创新药板块行情延续上涨至今。 创新药板块行情来了 5月20日，三生制药宣布与辉瑞的交易，首付款12.5亿美元及潜在总金额超430亿人民币，创国产创新药出海纪 录。此后，本土创新药企业接连发布消息，与跨国药企的达成多个BD(商务拓展，常指药企之间的管线授权)，进 一步引爆市场热情。截至6月25日，今年以来港股创新药指数上涨65.50%，万得创新药指数上涨24.83%。7月1 日，国家医保局联合国家卫健委发布《支持创新药高质量发展的若干措施》，推动A股、港股创新药板概念继续 走强。 值得注意的是，在本轮创新药资本热潮中，目前还有一个相对"低调"的板块，即本土创新疫苗。据Frost&Sullivan 预测，到2030年全球疫苗市场规模将达1310亿美元，而2022年，四家头部跨国药企占据全球疫苗市场产值约75% 的份额，高行业集中度，对于本土创新疫苗企业而言，也意味着"国产替代""后发追赶"的机会。 事实上，近年来已有一些拔尖的本土疫苗企业，从跨国巨头手中拿下一部分市场，也在一些创新 ...

智通财经记者 | 李科文 智通财经编辑 | 谢欣 7月2日，智通财经记者获悉，在最新的世界卫生组织预认证列表中，华兰生物流感疫苗已被剔除。 对此，7月2日，华兰生物向智通财经记者回应称，原有通过世界卫生组织预认证（三价流感疫苗，西林瓶包装）的2#车 间从建设至今已18年，计划不再使用，因此向世界卫生组织正式提交了将流感疫苗撤出世卫组织预认证清单的申请，后 续华兰疫苗计划重新提交新车间预认证PQ申请。撤回预认证PQ申请，对公司海外销售及业绩不会造成影响。 华兰生物表示，华兰疫苗目前正常生产流感病毒裂解疫苗（三价）和四价流感裂解疫苗的车间为2021年后投入使用的 3/4/5/6#新生产车间，其生产规模具备年产流感疫苗1亿人份。 世界卫生组织预认证是2001年启动的联合国行动计划，用于扩大选择的优先药物的获取，目标是确保国际基金（如全球 基金GFTAM、联合国援助国际药品采购机制UNITAID）采购药品的质量、疗效和安全性，服务发展中国家的患者。 疫苗预认证是世界卫生组织预认证中非常重要的组成部分，是世界卫生组织为保证疫苗产品的质量、安全性和有效性达 到国际标准而进行的一项评估认证工作，为联合国采购机构疫苗采购提供 ...

深圳康泰生物制品股份有限公司 相关债券 2025 年跟踪评级报告 中鹏信评【2025】跟踪第【399】号 02 信用评级报告声明 除因本次评级事项本评级机构与评级对象构成委托关系外，本评级机构及评级从业人员与评级对象不存 在任何足以影响评级行为独立、客观、公正的关联关系。 本评级机构与评级从业人员已履行尽职调查义务，有充分理由保证所出具的评级报告遵循了真实、客观、 公正原则，但不对评级对象及其相关方提供或已正式对外公布信息的合法性、真实性、准确性和完整性 作任何保证。 本评级机构依据内部信用评级标准和工作程序对评级结果作出独立判断，不受任何组织或个人的影响。 本评级报告观点仅为本评级机构对评级对象信用状况的个体意见，不作为购买、出售、持有任何证券的 建议。本评级机构不对任何机构或个人因使用本评级报告及评级结果而导致的任何损失负责。 本次评级结果自本评级报告所注明日期起生效，有效期为被评证券的存续期。同时，本评级机构已对受 评对象的跟踪评级事项做出了明确安排，并有权在被评证券存续期间变更信用评级。本评级机构提醒报 告使用者应及时登陆本公司网站关注被评证券信用评级的变化情况。 本评级报告版权归本评级机构所有，未经 ...

Core Viewpoint - CloudTop New Horizon (HK01952) has seen a significant stock price increase of 28.6% over the past seven trading days, driven by the presentation of its mRNA technology platform and three products targeting autoimmune diseases at a recent R&D event [1][2]. Company Developments - The company showcased its mRNA technology platform, including the universal tumor therapeutic vaccine EVM14, personalized tumor therapeutic vaccine EVM16, and autologous CAR-T project [1][3]. - EVM14 is set to begin a global multi-center Phase I clinical trial (EVM14 C101), with the first patient expected to be enrolled by Q3 2025 [1][3]. - EVM16 has shown efficacy in mouse melanoma models and is the company's first personalized mRNA tumor vaccine to enter clinical stages, with initial patient dosing expected to be completed by March 2025 [3][4]. Business Strategy - The CEO emphasized a selective business development strategy, focusing on leveraging international partnerships to enhance the global footprint of innovative drugs [1][4]. - The company aims to utilize its mRNA technology platform for developing both preventive and therapeutic mRNA products, with a focus on therapeutic vaccines [2][4]. Market Position - CloudTop New Horizon's mRNA platform has become a focal point for international pharmaceutical companies, potentially accelerating the commercialization of its products [4][7]. - The company has established a comprehensive industry chain platform that includes antigen design, sequence optimization, delivery systems, and large-scale production capabilities [7][8]. Industry Context - The global mRNA tumor vaccine market is projected to reach $21 billion by 2035, with the domestic market expected to reach 10 billion RMB [7]. - Compared to international leaders like BioNTech and Moderna, which have advanced their mRNA tumor vaccine pipelines to Phase II and III clinical trials, CloudTop New Horizon is still in the early stages of development [5][6]. Technical Challenges - Efficient delivery systems remain a significant bottleneck for mRNA vaccines, with limited suppliers for lipid nanoparticles (LNP) and ongoing patent disputes hindering development [8]. - CloudTop New Horizon has developed its proprietary LNP delivery technology, with a rich internal lipid library exceeding 500 types to meet the needs of various projects [8].

证券研究报告 2025 年 06 月 29 日 湘财证券研究所 行业研究 疫苗行业周报 全国首个疫苗检验中心在建，有望推动创新疫苗加速上市 相关研究： 1. 《三级医院设立公共卫生/预 防保健科，助力医防融合的推进》 20250615 2. 《多项政策推动疫苗创新》 20250622 行业评级：增持（维持） 近十二个月行业表现 -20 -10 0 10 20 30 24/07 24/10 25/01 25/04 沪深300_累计 疫苗_累计 证书编号：S0500517110001 Tel：021-50293534 Email：xw3315@xcsc.com 地址：上海市浦东新区银城路88号 中国人寿金融中心10楼 核心要点 医疗保障法草案首次亮相。《中华人民共和国医疗保障法（草案）》6 月 24 日 提请十四届全国人大常委会第十六次会议首次审议。草案共 7 章 50 条，系统 规定医疗保障体系框架、加强医疗保障基金运行管理、优化医疗保障服务、 强化监督管理。草案中提出，发生重大传染病疫情等紧急情况时，国务院医 疗保障行政部门在听取国务院卫生健康、中医药、疾病预防控制、工业和信 息化等部门意见的基础上，可以会同 ...

Group 1 - The ACIP has overwhelmingly recommended that all flu vaccines should stop using thimerosal as a preservative, with a unanimous vote for specific populations including those under 18, pregnant women, and adults [1] - The committee strongly advocates for the adoption of single-dose vials of thimerosal-free flu vaccines to replace traditional multi-dose packaging [1] - Concerns were raised about the potential supply issues if multi-dose vials are completely abandoned, emphasizing the greater risk posed by the flu virus compared to the potential risks of thimerosal [1] Group 2 - Major pharmaceutical companies including GSK, Sanofi, AstraZeneca, and CSL Seqirus have completed the production of flu vaccines for the 2024-2025 season, which will be available in the U.S. market [2] - The stock prices of these four pharmaceutical giants have seen slight increases amid the ongoing debate over vaccine preservatives [2] - The controversy surrounding vaccine preservatives highlights the scientific debates in public health decisions and the influence of anti-vaccine movements on professional agendas [2]

欧林生物(688319.SH)加快扩产步伐。 6月25日，欧林生物发布以简易程序向特定对象发行人民币普通股(A股)股票的预案(修订稿)，募集资金总额为1.75 亿元，拟投资于疫苗研发生产基地技术改造项目。 公司表示，本次募资旨在通过技术改造提升疫苗研发生产基地的生产效率和产品质量，以满足日益增长的市场需 求。 同时，公司核心产品商业化与创新管线研发取得双重突破。长江商报记者注意到，近些年，欧林生物持续坚持创 新投入，2020年至2024年，其研发费用五年累计达到4.7亿元。 拟募1.75亿实施基地技术改造 近日，欧林生物发布以简易程序向特定对象发行人民币普通股(A股)股票的预案(修订稿)。公司拟募集资金总额 1.75亿元，将投资于疫苗研发生产基地技术改造项目。 根据公告，"疫苗研发生产基地技术改造项目"总投资额为2.9亿元，计划实施周期为4年，系在现有疫苗研发生产 基地对各主要产品的生产车间进行升级改造，包括破伤风车间、多糖车间、冻干车间等，同时公司拟对生产配套 相关的设施设备进行技术改造，并将其用于原有疫苗产品的生产。 据了解，该公司自成立以来，经过十余年发展，现形成约8万平方米GMP基地，包括3条原液生产 ...

智通财经APP获悉，经过全面改革的美国疫苗数据审查小组将于近日就一种含汞化合物以及一种常见的 儿童疫苗进行投票。此前，该小组刚刚宣布将重新审视儿童疫苗接种计划。免疫接种实践咨询委员会 (ACIP)预计将于周四确定秋季疫苗中应包含哪些流感病毒株，并就是否使用硫柳汞(一种含汞的疫苗防 腐剂)进行投票。硫柳汞可防止多剂量瓶中细菌生长，使疫苗注射更加便捷。在将原定于周三的会议决 定推迟之后，该委员会还将对默沙东(MRK.US)的单克隆抗体疗法Enflonsia(一种针对婴儿的单次注射疫 苗，可预防常见的呼吸道病毒RSV)进行投票。 如果这种疫苗不再被推荐使用或被认为不再安全，那对制造商默沙东(MRK.US)来说可能是个打击。这 种名为ProQuad的疫苗是三款预防麻疹、腮腺炎、风疹以及水痘的联合疫苗中的一种，每年为其带来约 25 亿美元的收入，是默沙东公司的第四大收入来源。 美国卫生与公共服务部(HHS)部长的小罗伯特·肯尼迪 (Robert F. Kennedy Jr.)近期解雇了ACIP之前的疫苗 专家，并任命了新的成员，其中许多人持有反对接种疫苗的观点。 据主席Martin Kulldorff称，周三，经过重新 ...

美国食品药品管理局（FDA）要求就新冠疫苗接种出具罕见心脏病风险提示。（美联社） ...

Summary of Alessio Therapeutics Virtual KOL Event Company and Industry - **Company**: Alessio Therapeutics - **Industry**: Cancer Immunotherapy, specifically focusing on pancreatic cancer and KRAS-driven therapies Core Points and Arguments 1. **Introduction of ELI O2 Vaccine**: The event discussed the ELI O2 cancer vaccine aimed at treating mutant KRAS-driven pancreatic cancer, highlighting its innovative approach to cancer vaccination [2][3][32] 2. **Challenges in Cancer Vaccines**: The speakers outlined significant challenges faced by cancer vaccines, including selecting suitable antigens, poor potency in humans, and difficulties in targeting the immune system's command center, the lymph nodes [6][10][12] 3. **Amplify Platform**: The Amplify platform was introduced as a solution to enhance vaccine performance by utilizing lymph node targeting, which is crucial for effective immune response [4][32] 4. **Preclinical Studies**: Preclinical studies demonstrated that the AMP vaccines significantly improved lymph node targeting and T cell activation compared to traditional peptide vaccines, showing a potential increase in immunogenicity [20][30][32] 5. **Clinical Development**: The clinical program for ELI O2 is designed to assess safety, immunogenicity, and clinical outcomes in patients with pancreatic cancer, with a focus on KRAS mutations [55][68] 6. **Neoadjuvant and Adjuvant Therapy**: The discussion included the importance of neoadjuvant therapy in pancreatic cancer, which can shrink tumors and facilitate better surgical outcomes [42][43] 7. **KRAS Targeting**: The significance of KRAS mutations in pancreatic cancer was emphasized, with ongoing research into small molecule inhibitors and immunotherapies targeting these mutations [50][70] Additional Important Content 1. **Immunogenicity and Biomarker Response**: The ELI O2 vaccine showed promising results in inducing T cell responses and reducing circulating tumor DNA (ctDNA) levels in early studies, indicating potential clinical benefits [56][65] 2. **Safety Profile**: The vaccine demonstrated a manageable safety profile with mild side effects, which is crucial for patient acceptance and adherence [68] 3. **Future Directions**: The potential for combining ELI O2 with other therapies, including immune checkpoint inhibitors and chemotherapy, was discussed as a strategy to enhance treatment efficacy [70][71] 4. **Regulatory Considerations**: The design of the phase two and phase three trials was discussed, with a focus on disease-free survival as a primary endpoint, reflecting the regulatory landscape for cancer therapies [72] This summary encapsulates the key discussions and findings presented during the Alessio Therapeutics Virtual KOL Event, focusing on the innovative approaches to cancer vaccination and the specific challenges and opportunities within the pancreatic cancer treatment landscape.