吴以芳又有了新职。 现年56岁的吴以芳在制药行业拥有逾三十年的丰富专业经验。在加入云顶新耀之前，他曾任复星国际执 行总裁，并在复星医药担任董事长兼首席执行官近十年，期间，作为管理团队的核心成员，主导复星医 药转型为全球领先的生物制药企业，并成功为大中华区引入BioNTech的mRNA技术。此外，吴以芳还联 合创立万邦生化医药，并担任董事长兼首席执行官，为该企业在生物医药创新领域奠定了坚实基础。 吴以芳熟悉的方向之一，与云顶新耀的业务存在重合。 当前，云顶新耀正在大力发展mRNA业务，公司已构建国际领先的、完全整合且本地化的AI+mRNA平 台，重点推进肿瘤和自身免疫疾病领域的产品管线开发，包括通用型现货肿瘤治疗性疫苗EVM14、个 体化肿瘤治疗性疫苗EVM16，以及自体生成CAR-T项目。其中，云顶新耀自主研发的首款个性化 mRNA治疗性肿瘤疫苗EVM16的IIT研究已在今年3月于北京大学肿瘤医院顺利完成首例患者给药。 云顶新耀也在持续深化"授权引进+自主研发"这样的"双轮驱动"战略布局。凭借稳健的资金储备和不断 增强的研发及商业化能力，公司力争在2025年下半年实现经营性盈利。 在10月9日成为康桥资本Ex ...

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].

Financial Performance & Outlook - The company reported revenue of RMB 446 million, a 48% year-over-year increase, primarily driven by NEFECON® and XERAVA®[10, 12] - Gross margin was 76.4%, excluding amortization of intangible assets, reflecting NRDL price reduction of NEFECON® in mainland China and product cost optimization[10, 13] - Non-IFRS net loss decreased by 31% year-over-year to RMB 147 million[10] - The company expects full-year revenue to be between RMB 1.6 billion and RMB 1.8 billion, with NEFECON® revenue projected at RMB 1.2 billion to RMB 1.4 billion[10] - The company anticipates achieving operational profitability in the second half of 2025[9, 11] Key Products & Commercialization - NEFECON® revenue reached RMB 825 million from January to August 2025, with full NRDL coverage achieved in target provinces[8, 20] - NEFECON® is projected to generate RMB 1.2 billion to RMB 1.4 billion in revenue for the full year 2025 and RMB 2.4 billion to RMB 2.6 billion in 2026[10, 25] - XERAVA® generated RMB 143 million in revenue in the first half of 2025, a 6% year-over-year increase, with in-market sales up by 37%[32] - VELSIPITY® demonstrated a 51.9% mucosal healing rate with one year of treatment and is estimated to reach peak sales exceeding RMB 5 billion[49, 52] R&D Pipeline & Investments - EVER001 (Civorebrutinib) showed rapid and deep reductions in both Anti-PLA2R and 24h Proteinuria with an excellent safety profile[67] - The company completed a share placement on August 1, 2025, with net proceeds of HKD 1.6 billion[8, 10] - The company increased its strategic investment in I-MAB, becoming its single largest shareholder with 16.1% ownership[8, 116]

Core Viewpoint - Genting Yongyao is making a strategic investment of $30.9 million in I-Mab, acquiring approximately 16.1% of the company's shares, thus becoming its largest shareholder. This investment aims to enhance the development of next-generation tumor immunotherapy pipelines globally [1][2][3]. Group 1: Investment Details - Genting Yongyao will invest $30.9 million (approximately HKD 242.6 million) in I-Mab, which will result in a total ownership of about 16.1% of I-Mab's shares [1][2]. - The investment will be made through the purchase of 15,846,154 American Depositary Shares (ADSs) at a price of $1.95 per share, contributing to a total fundraising of approximately $65 million by I-Mab [4][5]. - The investment will be classified as a non-current asset under the "Investments" section on Genting Yongyao's balance sheet, with subsequent fair value changes reflected in other comprehensive income [4]. Group 2: Clinical Development and Product Pipeline - I-Mab has recently presented promising results for Givastomig (Claudin 18.2 x 4-1BB bispecific antibody) at the 2025 ESMO GI conference, showing an objective response rate (ORR) of 83% in a phase 1b dose-escalation study for first-line gastric cancer treatment [1][5]. - I-Mab's differentiated 4-1BB receptor-targeting platform and bispecific antibody pipeline complement Genting Yongyao's AI+mRNA platform and autologous CAR-T platform, creating a new generation of tumor immunotherapy product matrix [1][3]. - The collaboration is expected to leverage both companies' strengths in clinical development and business expansion, particularly I-Mab's capabilities in the U.S. and Genting Yongyao's advantages in Asia [4].

Core Insights - The core viewpoint of the articles is that CloudTop New Horizon (1952.HK) has made significant progress with its universal tumor therapeutic vaccine EVM14, which has received formal acceptance for clinical trial application (IND) from the National Medical Products Administration (NMPA) in China, marking a key step in its global regulatory pathway [1][2][3] Group 1: Product Development - EVM14 is based on CloudTop's proprietary mRNA technology platform and targets five tumor-associated antigens, intended for the treatment of squamous non-small cell lung cancer and head and neck squamous cell carcinoma [2] - EVM14 has shown significant therapeutic potential in preclinical studies, inducing dose-dependent antigen-specific immune responses and significantly inhibiting tumor growth in various mouse models [2] - The preclinical data also indicates that EVM14 can enhance anti-tumor activity when used in combination with immune checkpoint inhibitors (ICIs), supporting further exploration of combination therapies in clinical settings [2] Group 2: Market Potential and Strategic Positioning - The global mRNA therapeutic market is projected to exceed $19.68 billion in 2024 and reach $42.64 billion by 2034, indicating a substantial market opportunity for mRNA-based therapies [5] - CloudTop has established a fully integrated AI+mRNA platform that encompasses the entire value chain from antigen design to large-scale production, enhancing efficiency in drug development [5][6] - The company has engaged in extensive outreach with top global pharmaceutical companies, indicating strong interest in collaboration and positioning itself as a core competitor in the mRNA field [7] Group 3: Clinical Trial Readiness - CloudTop has prepared thoroughly for the clinical trials of EVM14, with the first batch of GMP clinical trial samples released from its JiaShan facility, supporting trials in both the U.S. and China [4] - The clinical trial centers include prestigious institutions such as the MD Anderson Cancer Center in the U.S. and Shanghai Chest Hospital in China, enhancing the credibility and reach of the clinical studies [4]

Group 1 - BioNTech's research on mRNA neoantigen vaccines shows potential in treating pancreatic cancer by inducing long-lived CD8+ T cell responses, offering new hope for cancer immunotherapy [1] - The challenge of tumor recurrence and metastasis remains significant in clinical treatment, highlighting the importance of mRNA technology in immune response [1] - Cloud Health's CEO discusses how mRNA technology stimulates T and B cells to create specific immune responses against tumor cells, forming immune memory to reduce recurrence risk [1] Group 2 - mRNA technology shifts drug development from "molecular screening" to "information design," transforming the human body into a smart factory for protein drug production [2] - Despite its advantages, the delivery system poses a major barrier for mRNA technology, as synthesized mRNA is prone to degradation when entering the human body [2] - Cloud Health has made breakthroughs in delivery technology, establishing a proprietary LNP (lipid nanoparticle) delivery platform with patents in ionizable and stealth lipids [2] Group 3 - The third-generation AI algorithm significantly enhances target protein expression levels, enabling Cloud Health to advance mRNA tumor drug development [3] - EVM16 is Cloud Health's first personalized mRNA tumor vaccine entering clinical stages, with the first patient dosing completed in March 2025 [3] - EVM14 is a universal therapeutic vaccine targeting five tumor-related antigens, intended for the treatment of squamous cell carcinoma [3]