康希诺 20250821 摘要 康希诺上半年净亏损大幅收窄 94%，主要得益于有效的成本控制和费用 管控措施，包括疫苗销售费用率、管理费用率和研发费用率的同比下降， 以及核心产品曼海欣的良好销售增长。 核心产品曼海欣延续良好销售增长，并在印尼获得注册证书，预计下半 年开始贡献海外收入。优沛欣已获批上市，批签发及准入工作按计划推 进，有望成为新的增长点。 PCV13（优沛欣）已完成三个省份的准入和挂网，目标是年内完成中国 半数以上主要省份的准入，为 2026 年实现几十万剂的销量目标奠定基 础。 婴幼儿用组份百白破疫苗已纳入优先审评，预计 2025 年底获批，2026 年初上市。成人和青少年用组份百白破产品预计 2026 年底进行 NDA 申 请，破伤风单苗预计明年上半年获批。 康希诺国际化战略稳步推进，已获得印尼曼海欣注册，并积极布局东南 亚、中东及北非、拉丁美洲市场，通过快速注册、临床研究和技术转移 深耕当地市场。 Q&A 公司 2025 年上半年业绩表现如何？有哪些业务进展？ 2025 年上半年，公司营业收入超过 3.82 亿元，同比增长 26%。其中流脑产 品实现销售收入约 3.64 亿元，较去年同期增 ...

Core Insights - Business Development (BD) transactions are becoming a crucial pathway for Chinese innovative pharmaceutical companies to advance globalization, with over 40% of significant upfront payments from multinational corporations (MNCs) originating from China in the first half of 2025 [1] - Maiwei Biotech has made substantial progress in BD transactions, reflecting its transition from "generic innovation" to "global innovation" [1][4] Group 1: BD Transactions - Maiwei Biotech recently entered into a collaboration with Calico Life Sciences, receiving a non-refundable upfront payment of $25 million for global rights to develop, produce, and commercialize the IL-11 monoclonal antibody 9MW3811 outside Greater China [2] - The agreement with Calico includes potential milestone payments of up to $571 million and tiered royalties based on global sales, indicating significant long-term revenue potential [2] - Additionally, Maiwei Biotech signed an agreement with Qilu Pharmaceutical for exclusive rights to develop, produce, and commercialize injectable Agonist α in Greater China, with a maximum upfront payment of 500 million RMB and sales milestone payments [3] Group 2: Revenue and Financial Impact - The two BD transactions are expected to generate at least 650 million RMB in short-term revenue, alleviating financial pressure and supporting the development of innovative drug pipelines [3] - The collaborations enhance the company's revenue sources and provide a solid foundation for its domestic market strategy [3] Group 3: R&D and Pipeline Development - Maiwei Biotech has established a comprehensive R&D system that supports its BD activities, with a pipeline consisting of 16 products, including 12 innovative drugs and 4 biosimilars [4] - The company focuses on oncology and age-related diseases, with several ADC pipelines and a strong presence in various therapeutic areas [4][6] - The innovative drug-centric pipeline structure allows for immediate commercialization cash flow while reserving long-term growth potential through innovative drug development [4] Group 4: Technological Platforms - The company has developed four major technological platforms, including specialized platforms for ADCs and bispecific antibodies, which enhance its R&D capabilities [5][6] - The integration of these platforms fosters sustainable innovation and positions the company as an attractive partner for collaborations [6] Group 5: Future Prospects - Maiwei Biotech aims to achieve significant breakthroughs in its BD business by 2025, with ongoing collaborations on key pipelines such as Nectin-4ADC and B7-H3ADC [6] - The company is recognized for its early investments in ADCs, with promising clinical developments for its products, including 9MW2821, which is leading in clinical trials for cervical cancer [6][7]