经济观察网康希诺生物近期在研发与财务方面取得重要进展。PCV24疫苗获批临床试验，2025年业绩预 计扭亏为盈，多项产品商业化持续推进。 公司项目推进 2026年1月6日，康希诺生物宣布其自主研发的24价肺炎球菌多糖结合疫苗(PCV24)获得国家药品监督管 理局批准开展临床试验。该产品是全球首个进入临床阶段的24价肺炎结合疫苗，采用双载体技术，覆盖 24种血清型，有望填补市场空白。临床试验的启动是公司技术平台升级的关键里程碑。 最近业绩情况 2026年1月27日，公司发布业绩预告，预计2025年年度实现营业收入10.40亿至10.80亿元，同比增长 22.88%至27.61%；归属于母公司所有者的净利润为2450万至2900万元，同比扭亏为盈。扭亏主要得益 于四价流脑结合疫苗曼海欣的持续放量、成本管控优化及非经常性收益。 业务与技术发展 百白破组分疫苗已完成三期临床，预计2026年上半年获批。曼海欣在印度尼西亚获得清真认证并实现出 口，公司正深化海外临床合作，聚焦东南亚、中东等新兴市场。13价肺炎结合疫苗优佩欣于2025年9月 上市，正加速市场准入；多项在研疫苗处于临床阶段。 以上内容基于公开资料整理，不构成 ...

Core Viewpoint - The company, CanSino Biologics, is expected to turn a profit in 2025, with significant advancements in vaccine development and ongoing expansion into international markets [1][2]. Financial Performance - The company forecasts revenue between 1.04 billion to 1.08 billion yuan for 2025, representing a year-on-year growth of 22.88% to 27.61%. Net profit attributable to shareholders is projected to be between 24.5 million to 29 million yuan, indicating a turnaround from previous losses. The audited annual report is scheduled for release in 2026 [2]. Product Development Progress - The self-developed DTPa vaccine has completed Phase III clinical trials and is expected to receive market approval in the first half of 2026, potentially replacing imported products and expanding into the high-end vaccine market. The 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24) has been approved for clinical trials by the National Medical Products Administration of China, marking it as the first 24-valent pneumonia vaccine to enter clinical trials globally [3]. Business Expansion - The company is actively expanding into overseas markets in Southeast Asia, the Middle East, North Africa, and South America. For instance, the Manhaixin vaccine has received halal certification in Indonesia and has begun exports, with potential for deeper local partnerships and technology transfers [4]. Future Development - Other research pipeline updates include the prioritization of the DTPa vaccine for infants, acceptance of the application for the Tetanus vaccine, and international support for the recombinant poliovirus vaccine (VLP-Polio). The clinical and approval progress of these products may significantly impact the company's long-term development [5].

深耕肺炎疫苗领域多年，康希诺已积累扎实的技术积淀。2025年9月，公司自主研发的13价肺炎球菌多 糖结合疫苗优佩欣®（PCV13i）正式上市供应，该产品是我国首款采用CRM197与破伤风类毒素（TT） 双载体技术的肺炎球菌结合疫苗。通过创新双载体设计，优佩欣®有效规避了单一载体过量引发的不良 反应风险，减少与其他疫苗共注射时的免疫干扰，显著提升免疫原性，尤其对我国儿童疾病负担最重的 19F、19A、7F、3型等血清型实现精准防护。 在优佩欣®成功上市的基础上，康希诺加速推进高价次疫苗研发进程。此次获批的PCV24疫苗实现关键 技术突破，不仅覆盖当前肺炎球菌主要流行血清型，更延续了双载体技术优势，采用多糖抗原与蛋白载 体共价结合工艺，完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺及成品处方的开发与确 认。该疫苗拟适用于2月龄（最小6周）及以上全人群接种，可有效预防24种肺炎球菌血清型引发的感染 性疾病，有望进一步填补高价次肺炎疫苗的市场空白。 2026年新年伊始，康希诺生物(688185)传来研发进展：公司自主研发的24价肺炎球菌多糖结合疫苗 （CRM197/破伤风类毒素，简称"PCV24"）正式获得国 ...