mRNA肿瘤治疗性疫苗被视为肿瘤免疫治疗领域的重大突破和极具潜力的创新疗法，EVM14基于云顶 新耀自主知识产权的mRNA技术平台研发，是一款靶向5个肿瘤相关抗原（TAA）的通用现货型肿瘤治 疗性疫苗，拟用于治疗多种鳞状细胞癌，包括非小细胞肺鳞癌（sq-NSCLC）和头颈部鳞状细胞癌 （HNSCC）。 EVM14的国际开发已进入新阶段，其新药临床试验申请（IND）此前也已获得中国国家药品监督管理局 （NMPA）的批准，成为云顶新耀首个实现中美IND"双获批"的mRNA肿瘤治疗性疫苗。在EVM14 I期 临床试验探索的瘤种中，大多数患者会表达5个TAA之一。其中，约96%的非小细胞肺鳞癌（sq- NSCLC）患者和97%的头颈部鳞状细胞癌（HNSCC）患者检测到至少一个TAA基因的表达。 "当前，全球鳞癌患者群体庞大，现有免疫疗法和靶向疗法难以形成持久的免疫记忆，仍存在巨大的未 满足医疗需求。肿瘤相关抗原疫苗EVM14能够作为现有疗法的有力补充，并可能减少复发，有望帮助 患者实现'长期无癌生存'的获益。"云顶新耀首席执行官罗永庆表示。 从临床设计来看，EVM14的I期临床试验设计包含EVM14单药队列和EVM1 ...

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 Viewpoint - CloudTop New Horizon (1952.HK) has received IND approval for its mRNA tumor therapeutic vaccine EVM14, marking it as the first mRNA tumor vaccine to achieve dual IND approval in both China and the U.S., showcasing the company's enhanced global clinical development capabilities [1][2]. Group 1: Product Development - EVM14 is developed based on the company's proprietary mRNA technology platform and targets five tumor-associated antigens (TAA), intended for the treatment of various squamous cell carcinomas [1]. - Preclinical trials demonstrated that EVM14 induced dose-dependent antigen-specific immune responses in mice and significantly inhibited tumor growth in multiple mouse models, while also showing the ability to induce immune memory and reduce tumor recurrence [1][2]. - EVM14's combination with immune checkpoint inhibitors has been shown to significantly enhance anti-tumor activity, supporting further exploration of combination therapies in clinical settings [1][2]. Group 2: Market Potential - The targeted tumor types for EVM14 represent a significant unmet medical need, with approximately 96% of squamous non-small cell lung cancer (sq-NSCLC) patients and 97% of head and neck squamous cell carcinoma (HNSCC) patients expressing at least one of the five TAA genes [2]. - EVM14 offers advantages over traditional therapies, including no need for HLA screening, 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 unlock hundreds of billions of dollars in potential, with the possibility of serving as a new type of cancer immunotherapy that is both broadly accessible and personalized [2]. Group 3: R&D Infrastructure - The rapid advancement of EVM14's development is supported by CloudTop New Horizon's comprehensive mRNA technology platform, which encompasses antigen design, sequence optimization, delivery system development, and large-scale production [3]. - The company holds all intellectual property rights and global interests related to its mRNA drug pipelines, including EVM14, EVM18 (CAR-T project), EVM16 (personalized tumor vaccine), and EVM15 (immunomodulatory vaccine) [3]. - EVM18 has completed several studies in non-human primates and plans to initiate clinical trials by the end of 2025, while EVM16 has started its first human clinical trial in China [3].

Group 1 - The company reported a revenue of RMB 446 million for H1 2025, representing a 48% year-on-year increase, with a significant reduction in non-IFRS losses by 31% [1] - The gross margin, excluding non-cash items, was 76.4%, and the cash reserves reached RMB 1.6 billion by the end of June 2025 [1] - Sales of the drug NAI Fukan reached RMB 303 million in H1 2025, an 81% increase year-on-year, with expectations for annual sales to reach RMB 1.2-1.4 billion [1] Group 2 - The drug NAI Fukan is the first targeted therapy for IgA nephropathy, successfully commercialized in mainland China in May 2024 and included in the medical insurance directory in November 2024 [1] - The company anticipates that NAI Fukan will be included in the KDIGO 2025 guidelines and the first IgA nephropathy guidelines in China [1] - Sales of the drug Yijia reached RMB 143 million in H1 2025, a 6% increase year-on-year, with a 37% increase in pure sales from core hospitals [1] Group 3 - The drug EVER001 (Hibutinin) is positioned as a potential best-in-class product, with positive results from ongoing clinical trials presented at the ERA 2025 conference [2] - The drug Aiqumide has completed a significant clinical study in Asia for moderate to severe ulcerative colitis and is expected to receive approval in mainland China by H1 2026 [2] - The company is leveraging its proprietary mRNA technology platform to develop globally competitive products, including personalized cancer vaccines [3] Group 4 - The mRNA-based cancer vaccine EVM16 completed its first patient dosing in March 2025, while EVM14 received FDA IND approval, marking a significant milestone for the company [3] - The company expects to complete preclinical milestones for its CAR-T project based on the mRNA technology platform in the second half of 2025 [3] - The revenue forecast for the company has been raised, with projected total revenues of RMB 1.738 billion, RMB 2.869 billion, and RMB 3.351 billion for 2025-2027 [3]

Core Viewpoint - The company reported a significant increase in revenue for the first half of 2025, driven by the inclusion of its product in the national medical insurance directory and deepening market penetration, indicating strong growth potential in the healthcare sector [1][2]. Group 1: Financial Performance - In the first half of 2025, the company achieved revenue of 446 million RMB, representing a year-on-year increase of 48% [1]. - The non-deductible net profit attributable to the parent company was -250 million RMB, showing a year-on-year reduction in losses of 59.44% [1]. Group 2: Kidney Disease Sector - The product "耐赋康" has been included in the national medical insurance directory since 2024, covering 29 provinces, with sales reaching 303 million RMB in the first half of 2025, an increase of 81% year-on-year [1]. - The product's sales in August alone reached 520 million RMB, with an expected annual revenue of 1.2 to 1.4 billion RMB, leading to anticipated operational profitability in the second half of 2025 [1]. - The clinical trial data for EVER001, a treatment for membranous nephropathy, shows significant reductions in anti-PLA2R antibodies and proteinuria, with a clinical remission rate exceeding 90% [1]. Group 3: Infection Sector - The product "依嘉" achieved revenue of 143 million RMB in the first half of 2025, reflecting a year-on-year growth of 37% [2]. - The company plans to initiate local production and expects to start medical insurance negotiations in 2026 [2]. - Combined revenue from "耐赋康" and "依嘉" is projected to be between 1.6 to 1.8 billion RMB in 2025 [2]. Group 4: Autoimmune Sector - "艾曲莫德" is positioned to become a key product for ulcerative colitis, having been included in the 2025 ACG clinical guidelines as a strongly recommended first-line treatment [2]. - The product has received approvals in multiple regions, with expectations for domestic approval in the first half of 2026 [2]. Group 5: Strategic Developments - The company has launched an AI+mRNA platform and achieved its first clinical results, with the personalized tumor vaccine EVM16 completing its first administration [3]. - The self-generating CAR-T project EVM18 is set to begin clinical trials by the end of 2025 after successful preclinical studies [3]. - The company invested 30.9 million USD in I-Mab, becoming its largest shareholder, which is a strategic move in the field of tumor immunotherapy [3]. Group 6: Revenue Forecast - The company forecasts revenues of 1.806 billion RMB, 3.396 billion RMB, and 5.380 billion RMB for 2025, 2026, and 2027, respectively, with growth rates of 155.63%, 87.98%, and 58.43% [3]. - The net profit attributable to the parent company is projected to be -486 million RMB, 146 million RMB, and 744 million RMB for the same years, with growth rates of -1.38%, 0.42%, and 2.12% [3].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 73.6 per share, up from the previous target of HKD 59.15 [7]. Core Insights - The company has significantly raised its guidance for the drug Naisukan, expecting sales to reach RMB 12-14 billion in 2025, with continued high growth projected for 2026 at RMB 24-26 billion [2]. - The company reported a revenue of RMB 4.46 billion for the first half of 2025, marking a 48% year-on-year increase, with a notable reduction in non-IFRS losses by 31% [1]. - The company is focusing on innovative products with differentiated competitive advantages, particularly in the fields of anti-infection and kidney disease treatments [7]. Summary by Sections Naisukan Performance - Naisukan achieved sales revenue of RMB 3.03 billion in H1 2025, representing an 81% year-on-year growth, with August sales reaching RMB 5.20 billion [2]. - The drug was successfully commercialized in mainland China in May 2024 and included in the medical insurance directory in November 2024 [2]. Other Drug Developments - The drug Yijia generated revenue of RMB 1.43 billion in H1 2025, a 6% increase, with a 37% growth in direct sales to hospitals [3]. - EVER001 (Hibutinib) is showing promising clinical trial results, positioning it as a potential best-in-class product for broad-spectrum autoimmune kidney diseases [4]. Clinical Trials and Approvals - The drug Aiqumide has completed a significant clinical study in Asia and is expected to receive approval in mainland China by H1 2026 [5]. - The company is advancing its mRNA technology platform, with the EVM16 personalized cancer vaccine having completed its first patient dosing and EVM14 receiving FDA IND approval [6]. Financial Projections - The company has revised its revenue forecasts for 2025-2027 to RMB 17.38 billion, RMB 28.69 billion, and RMB 33.51 billion respectively, reflecting the strong performance of Naisukan and the anticipated approval of Aiqumide [7].

Group 1 - The core viewpoint of the report is that due to strong demand for Naisukan, the sales forecast for 2025 and 2026 has been raised, with the 2026 profit forecast adjusted from 0.12 million to 1.19 million [1] - The company reported a revenue of 4.46 billion for 1H25, representing a year-on-year growth of 48%, with Naisukan contributing 3.03 billion, a growth of 81% [2] - The company has set a sales target for Naisukan of 12-14 billion for 2025, which is over 200% growth year-on-year, and 24-26 billion for 2026, approximately 100% growth year-on-year [2] Group 2 - The company is focusing on the progress of EVER001 and mRNA platform for overseas development, with EVER001 being a new generation covalent reversible BTK inhibitor showing positive results in clinical trials [3] - The personalized tumor vaccine EVM16 has completed initial research phases with positive preliminary data, while the universal tumor therapeutic vaccine EVM14 received FDA IND approval in March 2025 [3] - The company's In vivo CAR-T platform has completed several studies in non-human primates, with plans to initiate clinical trials by the end of the year [3]

Group 1 - The core viewpoint is that due to strong demand for Nanfukang, the sales forecast for 2025 and 2026 has been raised, with a significant adjustment in the 2026 profit forecast from 0.12 million to 1.19 million [1] - The company reported a revenue of 4.46 billion for 1H25, representing a year-on-year growth of 48%, with Nanfukang contributing 3.03 billion, a growth of 81% [2] - Nanfukang's sales target for 2025 is set at 12-14 billion, indicating a year-on-year growth of over 200%, while the target for 2026 is 24-26 billion, reflecting a growth of approximately 100% [2] Group 2 - The company is focusing on the progress of EVER001 and mRNA platform for overseas expansion, with positive results from ongoing clinical trials for kidney disease treatments [3] - The personalized tumor vaccine EVM16 has completed initial research phases with positive preliminary data, while the universal tumor therapeutic vaccine EVM14 received FDA IND approval in March 2025 [3] - The company plans to initiate clinical trials for its In vivo CAR-T platform by the end of the year after completing several studies on non-human primates [3]