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]

Group 1 - The company is confident in achieving its annual sales target of 1.6 billion to 1.8 billion yuan, aiming for operational profitability by the second half of 2025 [1][2] - The core product, Nefikastat, has shown exceptional performance with sales revenue of 303 million yuan in the first half of the year, representing an 81% year-on-year increase [1] - As of August, the sales team in the nephrology sector has expanded to 190 members, covering 1,000 target hospitals, with approximately 30,000 new patients expected by the first half of 2025 [1] Group 2 - The company reported a revenue of 446 million yuan for the first half of 2025, a 48% year-on-year increase, with a gross margin of 76.4% [4] - The non-IFRS loss has narrowed by 31% year-on-year, indicating a continued approach towards profitability [4] - The cash balance at the end of the first half reached 1.6 billion yuan, supplemented by recent fundraising of 1.553 billion HKD, bringing total cash reserves to over 2.5 billion yuan [4] Group 3 - The company is focusing on its self-developed core pipeline and accelerating the clinical development and internationalization of global rights products [1] - The product pipeline includes personalized tumor therapeutic vaccines, mRNA tumor therapeutic vaccines, and self-generated CAR-T projects [2] - The CEO emphasized the dual-driven strategy to establish a commercial platform for high-potential markets and to advance the self-generated CAR-T and mRNA vaccine platforms [2]

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]

Group 1 - The company completed a placement and subscription agreement on July 30, 2025, successfully placing a total of 22,561,000 shares at a price of HKD 69.70 per share [1] - The company issued the subscribed shares on August 1, 2025, after all conditions of the subscription were met [1] Group 2 - The net proceeds from the subscription amount to approximately HKD 1,553.39 million [2] - The company plans to allocate the net proceeds as follows: 50% (approximately HKD 776.69 million) for global R&D of pipeline products, 40% (approximately HKD 621.36 million) for ongoing commercialization efforts, and 10% (approximately HKD 155.34 million) for working capital and general administrative purposes [2]

Market Overview - On July 24, the Shanghai Composite Index rose by 0.65% to 3605.73 points, with the Shenzhen Component Index increasing by 1.21%, and the ChiNext Index up by 1.5% [1] - The total trading volume in A-shares was 1.87 trillion yuan, slightly down from 1.9 trillion yuan the previous day [1] - The market showed a low open and high close, with sectors like vaccines and medical beauty experiencing significant gains, particularly the vaccine ETF (159643) which surged by 6.33% in a single day [1][3] Vaccine Sector Analysis - As of July 22, five districts in Foshan reported confirmed cases of Chikungunya virus, totaling 3195 cases, prompting a warning from the World Health Organization about the risk of widespread outbreaks [4] - Bavarian Nordic's Chikungunya vaccine (VIMKUNYA) has been approved in Europe and the U.S., showing a neutralizing antibody response rate of 97.8% after a single dose, marking it as the first effective vaccine against this virus [4] - The domestic vaccine sector has been under pressure since the decline in COVID-19 demand, with the National Vaccine and Biotechnology Index down over 60% from its 2022 peak, leading to low institutional holdings [4] Short-term Industry Outlook - The vaccine industry is currently in a bottoming phase, with overall vaccine batch issuance down 14% year-on-year in Q1 2025, reflecting inventory adjustments and weak self-paid demand [5] - Companies are focusing on pipeline adjustments, emphasizing technological innovation and the development of multi-valent vaccines, particularly in the oncology vaccine sector, which is gaining traction [5] - The upcoming mid-year performance disclosures of relevant companies will be critical to monitor for price pressures and operational efficiency improvements [7] Long-term Growth Drivers - The long-term growth drivers for the vaccine industry remain clear, supported by policy changes, technological advancements, and increasing global demand [6] - The mRNA technology platform is advancing rapidly, with potential applications in respiratory viruses and oncology vaccines, while new products like the shingles vaccine and RSV vaccine could enhance market protection [8] - The aging population and heightened health awareness are expected to drive adult vaccine demand, with significant gaps in vaccination rates for diseases like shingles and HPV [9] Investment Opportunities - The vaccine ETF (159643) tracks the vaccine biotechnology index, which includes companies involved in vaccine research, production, and related biotech services, reflecting the overall performance of the vaccine sector [9]

Core Viewpoint - CICC maintains the profit forecast for CloudTop New Horizon (01952) for 2025 and 2026, adjusting the target price by 14.3% to HKD 80.0, indicating a potential upside of 28.6% from the current stock price [1] Company Status - On June 27, CloudTop New Horizon held an mRNA innovation technology platform R&D day, showcasing three core product lines: the universal on-demand therapeutic vaccine EVM14, the personalized therapeutic vaccine EVM16, and the autologous CAR-T project. The company has established extensive contacts with global top 20 pharmaceutical companies, focusing on leveraging international partnerships to promote the global layout of innovative drugs [2] Complete mRNA R&D and Production Platform - The company has successfully built a comprehensive mRNA platform covering antigen design, algorithm optimization, LNP delivery systems, CMC process development, and GMP industrial production. Key patents include: 1) self-developed third-generation AI algorithm optimization, significantly enhancing target protein expression; 2) proprietary LNP delivery platform with over 500 internal lipid types, capable of liver and extrahepatic delivery, supporting both "passive" and "active" targeting strategies; 3) two major bases in Zhangjiang and Jiashan ensuring process development and industrial production [3] Project Progress - EVM16: Utilizes the company's self-developed EVER-NEO-01 "MiaoSuan" AI algorithm system to identify patient-specific tumor cell mutations and design mRNA vaccines encoding dozens of new tumor antigens. Preclinical data indicates good safety and strong immunogenicity, with IIT research completing the first patient dosing in March this year [4] - EVM14: A universal on-demand therapeutic bivalent vaccine targeting five tumor-related antigens, intended for squamous cell carcinoma, including non-small cell lung cancer and head and neck cancer. Preclinical data shows EVM14 can induce a strong immune response and can be combined with IO drugs to enhance anti-tumor activity, with FDA approval for clinical trials obtained in March [4] - Autologous CAR-T: Developed based on the proprietary LNP (tLNP) system, demonstrating efficient T cell transfection, CAR expression, and B cell clearance effects in monkey models [4]