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 (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]

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].

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].

Core Viewpoint - CloudTop New Drug (1952.HK) reported a strong performance in its 2025 interim results, with a revenue increase of 48% year-on-year, driven by its core product, Nefukang, which is expected to achieve significant sales growth in the coming years [1][2][4]. Financial Performance - The company achieved a revenue of 446 million RMB, with a gross margin of 76.4% after excluding non-cash items [1]. - Operating expenses as a percentage of revenue decreased by 40.1 percentage points, and the total loss under non-IFRS standards narrowed by 31% [1]. - Cash reserves stood at 1.6 billion RMB, bolstered by a recent fundraising of approximately 1.553 billion HKD [1]. Product Performance - Nefukang, a treatment for IgA nephropathy, generated sales of 825 million RMB from January to August, with August sales alone reaching 520 million RMB [2][3]. - The company anticipates Nefukang's annual sales to reach between 1.2 billion and 1.4 billion RMB, with projections for 2026 sales between 2.4 billion and 2.6 billion RMB [2][3]. - The product is the only IgA nephropathy drug included in the medical insurance system across 29 provinces, significantly enhancing patient accessibility [3]. Market Potential - The market for IgA nephropathy treatment is substantial, with over 5 million patients in China and 1 million diagnosed cases [3]. - The company has expanded its nephrology sales team to 160 members to meet growing demand and has received approval for production capacity expansion [3]. R&D Progress - The company has made significant advancements in its self-developed pipeline, particularly in mRNA cancer therapeutic vaccines and CAR-T platforms [4]. - The personalized tumor therapeutic vaccine EVM16 has initiated its first human clinical trial in China, with positive preliminary data [4]. - The universal tumor therapeutic vaccine EVM14 has received FDA approval for clinical trials, with patient enrollment expected to begin by September 2025 [4]. Strategic Developments - The company successfully removed the "B" mark from its Hong Kong stock, reflecting market confidence in its R&D pipeline and commercialization capabilities [7]. - A recent fundraising effort raised approximately 1.5725 billion HKD, indicating strong interest from international long-term funds [7]. - The company has increased its stake in I-Mab to 16.1%, becoming its largest shareholder, which complements its mRNA vaccine and CAR-T pipeline [7]. Future Outlook - The company aims to leverage its dual-driven strategy focusing on Nefukang and VisiPing as key products, with projected peak sales exceeding 25 billion RMB [8]. - The integration of AI and mRNA technology platforms is expected to drive early-stage R&D and internationalization efforts [8].

Financial Data and Key Metrics Changes - The company reported revenue of RMB 446 million for 2025, representing a 48% year-over-year growth, although the first half was impacted by supply constraints [14][15] - Revenue from Nephicon alone reached RMB 520 million in August 2025, indicating a strong recovery from earlier supply issues [15] - The full-year revenue guidance for 2025 is set between RMB 1.6 billion to RMB 1.8 billion, with Nephicon expected to contribute RMB 1.2 billion to RMB 1.4 billion [16] - The gross margin on a cash basis was 76.4%, slightly lower than 2024 due to price reductions after NRDL inclusion, but expected to recover above 80% in the long run [17] - The non-IFRS net loss was approximately RMB 147 million, down 31% year-over-year, indicating improved operational efficiency [18] Business Line Data and Key Metrics Changes - Nephicon generated RMB 825 million in revenue from January to August 2025, with NRDL coverage achieved in 29 provinces [6][7] - The autoimmune disease franchise, particularly Velsipiti, is in the final stages of NDA review, with expectations for early 2026 approval [9] - XERAVA in the anti-infective franchise showed steady growth, with revenue growth of 37% year-over-year [26] Market Data and Key Metrics Changes - The company plans to expand Nephicon's market coverage to 1,000 hospitals, targeting 30,000 new IGAM patients [22] - The estimated market for IGAM in China includes about 5 million patients, with 100,000 new confirmed cases each year [23] - The ulcerative colitis market is projected to reach RMB 14 billion, with significant unmet medical needs [29] Company Strategy and Development Direction - The company aims to achieve operational profitability in 2025, with a focus on expanding its commercial platform and advancing its R&D pipeline [19][37] - The strategy includes leveraging a combination of commercial execution and in-house discovery to drive growth [72] - The company is also pursuing strategic investments, such as a USD 30.9 million investment in I Mab, to enhance its oncology platform [70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong market potential for Nephicon and Velsipiti, citing robust clinical data and regulatory approvals [81][82] - The company is optimistic about achieving peak sales of RMB 5 billion for Nephicon, supported by a growing patient base and favorable market conditions [80] - Future growth is expected to be driven by multiple near-term catalysts, including upcoming NDA approvals and market expansions [71][72] Other Important Information - The company has made significant progress in its R&D platform, including advancements in mRNA technology and CAR T therapies [48][49] - The company is preparing for pivotal trials in 2026 for its autoimmune renal disease treatments, indicating a strong pipeline for future growth [45][46] Q&A Session Summary Question: Peak sales for Etrasimod - The company raised peak sales estimates for Etrasimod to RMB 5 billion due to strong clinical data and an underdeveloped market with significant unmet needs [80][81] Question: Clinical development plan for EVER-one - The company is finalizing the design for a Phase II basket trial and plans to initiate pivotal studies in 2026, with ongoing regulatory interactions [88][89]