当中国创新药进入去同质化、拼体系与拼长期能力的新阶段，不同药企正在探索各自的生存与增长答 案。云顶新耀正尝试通过"BD引进+自主创新"并行的战略布局，构建一条面向全球的长期增长曲线。围 绕肾科、自身免疫、急重症、心血管及眼科等核心领域，公司通过"BD合作+自研"双轮驱动并行推进。 在商业化层面，云顶新耀旗舰产品耐赋康®（Nefecon®）作为全球首个且唯一实现对因治疗的IgA肾病 药物，通过靶向回肠黏膜免疫系统，从发病机制上游干预疾病进展，显著延缓肾功能下降。耐赋康®全 球上市获批是基于一项为期2年、随机、双盲、全球多中心Ⅲ期临床研究（364例患者）的完整数据，该 产品已在中国获完全批准并纳入医保，且同时被《2025 KDIGO IgA 肾病和IgA血管炎临床实践管理指 南》及《中国成人IgA肾病及IgA血管炎临床实践指南（2025）》推荐为"首选对因治疗药物"。 另一确定性大单品维适平®（艾曲莫德）作为新一代高选择性S1P受体调节剂，在中重度溃疡性结肠炎 （UC）中展现出深度黏膜愈合与良好安全性，为治疗UC的Best-in-Disease药物，已被纳入2024年美国 胃肠病学协会（AGA）临床实践指南和《2 ...

这一跨越式发展的背后，是过去十年药监改革、创新创业生态培育与资本通道畅通的多重共振，更依托 于中国庞大的人口基数、高效的产业制造能力与突出的成本效益优势。 亮眼成绩之下，行业发展的挑战亦不容忽视。一方面，中国上市的生物科技企业（Biotech）总市值不 足美国同类企业的15%，授权预付款通常比全球同类交易低2/3，交易总金额约为全球平均水平的1/2； 另一方面，部分药企商业化能力薄弱，已成为制约其价值释放的重要因素。 2025年，中国创新药行业的成绩单已跃然纸上：生物医药市场规模居全球第二，在研创新药约占全球比 重达30%；创新资产的全球吸引力持续攀升，截至11月18日，国产创新药对外授权总金额突破千亿美 元，较2024年实现翻倍式增长。 权威期刊《经济学人》直言，中国创新药正处于全球化的临界点，"从中国临床试验到对外授权许可， 中国药企的全球占比都显著上升，过去一年中国生物科技企业的股价涨幅甚至远超美国同类企业，这都 说明过去一个世纪中全球生物医药创新的'西方主导'格局已经生变。" 在此背景下，价值重塑的序曲已然奏响，一批头部创新药企已率先蹚出进阶之路，向着全球价值链顶端 全速迈进。今年上半年迎来商业化进程 ...

21世纪经济报道记者 韩利明 2025年，中国创新药行业的成绩单已跃然纸上：生物医药市场规模居全球第二，在研创新药约占全球比 重达30%；创新资产的全球吸引力持续攀升，截至11月18日，国产创新药对外授权总金额突破千亿美 元，较2024年实现翻倍式增长。 权威期刊《经济学人》直言，中国创新药正处于全球化的临界点，"从中国临床试验到对外授权许可， 中国药企的全球占比都显著上升，过去一年中国生物科技企业的股价涨幅甚至远超美国同类企业，这都 说明过去一个世纪中全球生物医药创新的'西方主导'格局已经生变。" 这一跨越式发展的背后，是过去十年药监改革、创新创业生态培育与资本通道畅通的多重共振，更依托 于中国庞大的人口基数、高效的产业制造能力与突出的成本效益优势。 亮眼成绩之下，行业发展的挑战亦不容忽视。一方面，中国上市的生物科技企业（Biotech）总市值不 足美国同类企业的15%，授权预付款通常比全球同类交易低2/3，交易总金额约为全球平均水平的1/2； 另一方面，部分药企商业化能力薄弱，已成为制约其价值释放的重要因素。 在此背景下，价值重塑的序曲已然奏响，一批头部创新药企已率先蹚出进阶之路，向着全球价值链顶端 全速 ...

Core Viewpoint - Cloud-based innovative pharmaceutical company, CloudTop New Medicine (1952.HK), has initiated the first patient dosing of its universal on-demand tumor therapeutic vaccine EVM14 in a global multi-center Phase I clinical trial, marking a significant milestone in clinical development and showcasing the company's strong capabilities in global clinical development [1][2]. Group 1: EVM14 Development and Clinical Trials - EVM14 is an mRNA-based tumor therapeutic vaccine targeting five tumor-associated antigens (TAA) and is intended for treating various squamous cell carcinomas, including non-small cell lung squamous carcinoma (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC) [2]. - The vaccine has received IND approval from both the U.S. FDA and China's NMPA, making it the first mRNA tumor therapeutic vaccine from CloudTop to achieve dual approval [2]. - The Phase I clinical trial design includes both EVM14 monotherapy and EVM14 in combination with PD-1 monoclonal antibodies, focusing on safety, tolerability, and efficacy [3]. Group 2: Clinical Research and Efficacy - Preclinical studies have shown that EVM14 induces dose-dependent antigen-specific immune responses and significantly inhibits tumor growth in various mouse models, demonstrating its potential to reduce tumor recurrence [3]. - The preclinical research also indicates that EVM14 can enhance anti-tumor activity when used in combination with immune checkpoint inhibitors (ICI), supporting further exploration of combination therapies in clinical settings [3]. Group 3: Market Potential and Competitive Advantage - EVM14 offers advantages such as no need for HLA screening, on-demand supply, lower production costs, and applicability to multiple tumor types, indicating a broad market potential [4]. - The global mRNA therapy market is projected to grow from $12.31 billion in 2025 to approximately $45.04 billion by 2034, with a compound annual growth rate (CAGR) of 15.5% from 2025 to 2034 [4]. - CloudTop has established a comprehensive mRNA technology platform, covering antigen design, sequence optimization, delivery systems, and large-scale production, positioning itself as a core competitor in the mRNA field [5].

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].