Group 1 - The core point of the news is that Yunding Xinyao's EVM14 injection, a universal therapeutic vaccine for tumors, has received formal acceptance for clinical trial application from the National Medical Products Administration (NMPA) in China, marking a significant step in the company's global innovation strategy [1] - EVM14 is based on Yunding Xinyao's proprietary mRNA technology platform and targets five tumor-related antigens, intended for the treatment of squamous non-small cell lung cancer and head and neck squamous cell carcinoma [1] - The company has prepared thoroughly for the clinical trials of EVM14, with the first batch of GMP clinical trial samples released from its Jiaxing factory on June 9, 2025, to support trials in both the US and China [1] Group 2 - In the mRNA treatment field, the company has proactively developed multiple mRNA therapeutic drugs, aiming to create a fully integrated and clinically validated AI+mRNA platform [2] - The company has established a comprehensive end-to-end industrial chain platform that enhances efficiency from antigen design, mRNA sequence optimization, LNP delivery technology to large-scale production [2] - During the "mRNA Innovation Technology Platform R&D Day" held at the end of June, the company revealed that it has engaged with multiple top 20 global pharmaceutical companies, attracting interest for collaboration from several multinational pharmaceutical firms [2]

麦高证券在最新研报中指出，mRNA肿瘤疫苗有潜力成为泛癌种、高可及性、现货化与个性化兼具的新 型肿瘤免疫疗法。其可凭借广泛的联用，以辅助疗法切入临床，逐步释放数百亿美元市场潜力。泛癌种 是肿瘤免疫疗法的特质，mRNA肿瘤疫苗可从联用免疫检查点抑制剂开始，进入目前肿瘤免疫疗法覆盖 的适应症并拓宽应用边界，成为下一个爆款频出的技术领域。 7月15日，港股创新药企云顶新耀（1952.HK）宣布，其通用型的现货肿瘤治疗性疫苗EVM14注射液的 新药临床试验申请（IND）获国家药品监督管理局药品审评中心（CDE）的正式受理。这是该产品继 2025年3月获美国食品药品监督管理局（FDA）批准开展临床后，在全球监管路径上的又一关键进展， 该产品由此成为云顶新耀mRNA平台首个实现"中美双报"的产品，标志着公司在全球创新布局上又迈出 了关键一步。 在业内看来，EVM14成功实现"中美双报"，有力印证了云顶新耀自研mRNA平台已构建起覆盖抗原设 计、LNP递送系统、CMC工艺开发直至产业化生产的端到端全产业链能力。这不仅为后续管线临床推 进与商业化奠定了坚实基础，也将加速其mRNA平台潜力的释放及海外授权合作潜力，推动创新价值 ...