每经AI快讯，12月12日，悦康药业(688658.SH)公告，全资子公司北京悦康科创医药科技股份有限公 司、杭州天龙药业有限公司于近日获得国家药品监督管理局核准签发的关于同意注射用YKYY031用于 开展晚期实体瘤的《药物临床试验批准通知书》。注射用YKYY031是一种通用型mRNA肿瘤疫苗，拟 用于晚期实体瘤的治疗。 （文章来源：每日经济新闻） ...

注射用YKYY031临床前研究充分证实其具备显著的有效性与良好的安全性，优势突出。有效性方面， 注射用YKYY031可诱导显著且持久的肿瘤抗原特异性T细胞免疫反应，并在多种给药方案下表现出明确 的抗肿瘤活性，且与抗PD-1抗体联合使用可进一步增强疗效。安全性方面，毒理学研究显示安全性良 好，存在宽泛治疗窗口，为临床应用奠定坚实基础。稳定性方面，本品采用先进的LNP冻干工艺，能够 彻底突破mRNA产品对超低温冷链的依赖，大幅降低运输和储存成本，提高本品可及性。 智通财经APP讯，悦康药业(688658.SH)发布公告，公司全资子公司北京悦康科创医药科技股份有限公 司、杭州天龙药业有限公司于近日获得国家药品监督管理局(以下简称"NMPA")核准签发的关于同意注 射用YKYY031用于开展晚期实体瘤的《药物临床试验批准通知书》。 注射用YKYY031是一种通用型mRNA肿瘤疫苗，拟用于晚期实体瘤的治疗。项目采用基于公司自主知 识产权的新型阳离子脂质YK-009组成的脂质纳米颗粒(LNP)递送系统，该系统具备递送效率高、安全性 良好的特点。注射用YKYY031所含的mRNA序列编码由多个在实体瘤组织中高表达的肿瘤相关 ...

注射用YKYY031是一种通用型mRNA肿瘤疫苗，拟用于晚期实体瘤的治疗。本项目采用基于公司自主 知识产权的新型阳离子脂质YK-009组成的脂质纳米颗粒（LNP）递送系统，该系统具备递送效率高、 安全性良好的特点。 格隆汇12月12日丨悦康药业(688658.SH)公布，公司全资子公司北京悦康科创医药科技股份有限公司、 杭州天龙药业有限公司于近日获得国家药品监督管理局（以下简称"NMPA"）核准签发的关于同意注射 用YKYY031用于开展晚期实体瘤的《药物临床试验批准通知书》。 ...

注射用YKYY031临床前研究充分证实其具备显著的有效性与良好的安全性，优势突出。有效性方面， 注射用YKYY031可诱导显著且持久的肿瘤抗原特异性T细胞免疫反应，并在多种给药方案下表现出明确 的抗肿瘤活性，且与抗PD-1抗体联合使用可进一步增强疗效。安全性方面，毒理学研究显示安全性良 好，存在宽泛治疗窗口，为临床应用奠定坚实基础。稳定性方面，本品采用先进的LNP冻干工艺，能够 彻底突破mRNA产品对超低温冷链的依赖，大幅降低运输和储存成本，提高本品可及性。 智通财经APP讯，悦康药业(688658.SH)发布公告，公司全资子公司北京悦康科创医药科技股份有限公 司、杭州天龙药业有限公司于近日获得国家药品监督管理局(以下简称"NMPA")核准签发的关于同意注 射用YKYY031用于开展晚期实体瘤的《药物临床试验批准通知书》。 注射用YKYY031是一种通用型mRNA肿瘤疫苗，拟用于晚期实体瘤的治疗。项目采用基于公司自主知 识产权的新型阳离子脂质YK-009组成的脂质纳米颗粒(LNP)递送系统，该系统具备递送效率高、安全性 良好的特点。注射用YKYY031所含的mRNA序列编码由多个在实体瘤组织中高表达的肿瘤相关 ...

悦康药业公告，全资子公司北京悦康科创医药科技股份有限公司、杭州天龙药业有限公司于近日获得国 家药品监督管理局核准签发的关于同意注射用YKYY031用于开展晚期实体瘤的《药物临床试验批准通 知书》。注射用YKYY031是一种通用型mRNA肿瘤疫苗，拟用于晚期实体瘤的治疗。 ...

Group 1 - Company shares of CloudTop New Medicine (01952) rose over 6%, reaching a price of 54.45 HKD with a trading volume of 142 million HKD [1] - The company announced the successful enrollment of the first patient in a global multi-center Phase I clinical trial for its universal on-demand tumor therapeutic vaccine EVM14 at NEXT Oncology Virginia [1] - This clinical trial progress follows the approval of the Investigational New Drug (IND) application for EVM14 by both the FDA and NMPA [1] Group 2 - The development of EVM14 addresses significant clinical pain points in the treatment of squamous cell carcinoma, a condition with a large patient population and unmet medical needs [2] - EVM14 offers advantages such as no HLA screening requirement, on-demand supply, lower production costs, and applicability to multiple tumor types, indicating a broad application potential in cancer treatment [2] - The mRNA tumor vaccine market is projected to reach 40.651 billion USD under neutral scenarios, with universal vaccines expected to have a higher penetration rate than personalized products due to cost advantages [2] - EVM14 is positioned to lead in clinical development amidst intense industry competition due to its differentiated advantages [2]

Group 1 - Company Genscript Biotech (01952) saw a significant stock increase of over 6%, reaching HKD 54.45 with a trading volume of HKD 142 million [1] - The company announced the successful enrollment of the first patient in its global multicenter Phase I clinical trial for the universal on-demand cancer therapeutic vaccine EVM14 at NEXT Oncology Virginia in the United States on October 14 [1] - This clinical trial progress follows the approval of the Investigational New Drug (IND) application for EVM14 by both the U.S. FDA and China's NMPA, marking a significant milestone for the company [1] Group 2 - The development of EVM14 addresses critical clinical pain points in the treatment of squamous cell carcinoma, a condition with a large patient population and significant unmet medical needs due to unsatisfactory results from existing standard treatments [2] - EVM14, as a universal on-demand vaccine, offers advantages such as no HLA screening requirement, on-demand supply, lower production costs, and applicability to multiple tumor types, indicating a broad application potential in cancer treatment [2] - The mRNA cancer vaccine market is projected to reach USD 40.651 billion under neutral scenarios, with universal vaccines expected to have a penetration rate significantly exceeding that of personalized products due to cost advantages [2] - EVM14 is positioned to lead in clinical development amidst intense industry competition due to its differentiated advantages [2]

Core Insights - Cloud-based innovative pharmaceutical company, CloudTop New Horizon, has successfully enrolled its first patient in a global multi-center Phase I clinical trial for its universal on-demand tumor therapeutic vaccine EVM14 in the United States, following the approval of its Investigational New Drug (IND) application by the National Medical Products Administration of China [1][2] Group 1: Vaccine Development - EVM14 targets five tumor-associated antigens (TAA) and is intended for the treatment of various squamous cell carcinomas, including non-small cell lung squamous carcinoma and head and neck squamous cell carcinoma [2] - The vaccine is based on CloudTop's self-developed mRNA technology platform, addressing unmet medical needs in current squamous carcinoma treatments [2] Group 2: Clinical and Market Potential - EVM14 has shown the ability to induce immune memory in preclinical studies, potentially reducing tumor recurrence and offering patients the possibility of "long-term cancer-free survival" [2] - As a universal on-demand vaccine, EVM14 has advantages such as no need for HLA screening, on-demand supply, lower production costs, and applicability to multiple tumor types, indicating a broad application prospect in tumor treatment [2] Group 3: Future Developments - Besides EVM14, CloudTop has several other promising products, including the autologous CAR-T project EVM18, which is expected to initiate clinical trials by the end of the year, and the personalized tumor therapeutic vaccine EVM16, which has already started its first human clinical trial in China [2]

Core Insights - CloudTop New Horizon's EVM14 injection, a universal therapeutic vaccine for cancer, has successfully enrolled its first patient in a global multi-center Phase I clinical trial in the U.S. [1] - The vaccine received approval for its Investigational New Drug (IND) application from China's National Medical Products Administration, marking a significant milestone in synchronized clinical development between China and the U.S. [1] - EVM14 targets five tumor-associated antigens (TAA) and aims to treat various squamous cell carcinomas, addressing unmet medical needs in the current treatment landscape [1][2] Company Developments - EVM14 is based on CloudTop's self-developed mRNA technology platform and is designed to be a readily available treatment option without HLA screening, with lower production costs and applicability across multiple tumor types [1] - The vaccine has shown promising preclinical results, inducing dose-dependent antigen-specific immune responses and significantly inhibiting tumor growth in mouse models [2] - EVM14's ability to induce immune memory and reduce tumor recurrence positions it as a potential long-term solution for cancer patients [2] Industry Context - The mRNA sector is experiencing rapid growth, with significant investments and acquisitions by major pharmaceutical companies, indicating a competitive landscape [3] - The global mRNA tumor vaccine market is projected to reach $40.651 billion, with universal vaccines expected to have a higher penetration rate due to cost advantages [3] - CloudTop's EVM14 is leading in clinical development amidst fierce competition, with participation from top institutions in both China and the U.S. for the ongoing Phase I trial [3] Technological Advancements - CloudTop has established an integrated AI+mRNA platform that enhances mRNA expression levels and supports the entire vaccine development process from antigen design to large-scale production [4] - EVM14 is one of several promising projects in CloudTop's pipeline, which includes EVM18, a CAR-T project expected to start clinical trials by the end of the year, and EVM16, a personalized cancer vaccine that has already begun human trials in China [4]

Core Insights - CloudTop New Horizon (01952) announced the successful enrollment of the first patient in the global multi-center Phase I clinical trial of its universal on-demand tumor therapeutic vaccine EVM14 at NEXT Oncology Virginia in the U.S. This milestone follows the approval of the Investigational New Drug (IND) application by the National Medical Products Administration (NMPA) in China, marking a significant step in synchronized clinical development in both countries [1][2] Company Summary - EVM14 is based on CloudTop's self-developed mRNA technology platform and targets five tumor-associated antigens (TAA), intended for treating various squamous cell carcinomas, including non-small cell lung squamous carcinoma and head and neck squamous cell carcinoma [1] - The vaccine addresses significant unmet medical needs in the treatment of squamous cell carcinoma, which has a large patient population but currently lacks satisfactory treatment options [1] - EVM14 offers advantages such as no HLA screening requirement, on-demand supply, lower production costs, and applicability to multiple tumor types, showcasing broad application prospects in cancer treatment [1] Clinical and Preclinical Insights - Preclinical results demonstrated EVM14's potential by inducing dose-dependent antigen-specific immune responses and significantly inhibiting tumor growth in multiple mouse models. It also showed the ability to induce immune memory, effectively reducing tumor recurrence [2] - The combination of EVM14 with immune checkpoint inhibitors has been shown to significantly enhance anti-tumor activity, supporting further exploration of combination therapies in clinical settings [2] - The lead researcher, Professor Lu Shun, emphasized the importance of tumor-associated antigen vaccines as a powerful complement to existing therapies, potentially reducing recurrence and aligning with global trends in cancer drug development [2] Industry Context - The mRNA field is experiencing a surge, with frequent strategic moves by global pharmaceutical companies. For instance, recent acquisitions include Bristol-Myers Squibb's $15 billion purchase of Orbital for its CAR-T therapy and RNA technology platform, and BioNTech's $1.25 billion acquisition of CureVac to integrate mRNA technology advantages [3] - The mRNA tumor vaccine market is projected to reach $40.651 billion under neutral scenarios, with universal vaccines expected to have a higher penetration rate than personalized products due to cost advantages [3] - EVM14 is positioned to lead in clinical development amidst intense industry competition, with a multi-center Phase I trial involving top institutions in both the U.S. and China focusing on the vaccine's safety and efficacy [3] Pipeline Highlights - EVM14 is just one highlight in CloudTop's mRNA pipeline, which also includes the autologous CAR-T project EVM18 expected to start clinical trials by the end of the year, the personalized tumor therapeutic vaccine EVM16 that has initiated its first human clinical trial in China, and the on-demand immune modulation vaccine EVM15 that has completed preclinical concept validation [4]