生物医药出海
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赛分科技扬州二期项目开工 新增年产能20万升
Zheng Quan Shi Bao Wang· 2025-12-08 09:41
近期,中国生物医药行业发展迅速,夏尔巴生物成功完成全国首批2万升规模抗体生产,信达生物达成 重磅BD交易,加速迈向全球市场,甘李药业签署巴西国家级《技术转移与供应协议》,百奥泰 Usymro®获欧盟委员会上市批准,安睿特重组人白蛋白注射液Ⅲ期临床试验完成揭盲,这些赛分科技合 作伙伴的商业化能力不断加强,意味着对高性能表现、大规模供应、高质量水平的国产色谱填料的需求 也将迅速和持续增加。赛分科技扬州二期工程将更好地服务合作伙伴,提升规模化交付能力,持续提供 稳定可靠的产品和配套服务,为合作伙伴各项目的稳定生产和产能增长保驾护航。同时,伴随着中国生 物制药的出海大潮,扬州二期工程也将支持公司扩展海外市场的发展战略,扩大赛分科技在全球色谱层 析市场的影响力。(齐和宁) 赛分科技于今年一月登陆科创板,上市以来,整体业务发展态势强劲,2025年前三季度实现营业收入 3.02亿元,同比增长38.39%,归属于上市公司股东的净利润9321.18万元,同比增长71.07%,其中,工 业纯化板块增长尤为显著,2025年前三季度收入同比增长68.08%。在产能布局方面,作为上市募投项 目的扬州二期工程已全面启动建设,这一举措不仅 ...
生物医药“出海”路在何方?补短板、铸长板,走多元化之路
Di Yi Cai Jing· 2025-10-30 13:28
Core Insights - The article emphasizes the importance of international expansion for Chinese biopharmaceutical companies, particularly through licensing agreements and strategic partnerships, as they seek to enhance their global competitiveness [1][3][4]. Group 1: Market Trends and Opportunities - Chinese biopharmaceutical companies are increasingly focusing on international markets, with a projected licensing-out transaction value of nearly $66 billion in the first half of 2025, surpassing the $51.9 billion total for 2024 [1]. - The U.S. market offers the highest returns, but recent regulatory changes by the FDA have raised challenges for Chinese companies, necessitating a proactive approach to adapt to evolving policies [5]. - There is a growing interest in exploring "small loop" markets such as Hong Kong and Southeast Asia, which could serve as gateways for Chinese products due to similar clinical needs and expedited approval processes [5]. Group 2: Strategic Approaches - Companies are advised to collaborate with larger pharmaceutical firms to leverage their international experience and resources, rather than attempting to enter foreign markets independently [6]. - Establishing a dual strategy that combines "big loop" (focusing on major markets like the U.S. and Europe) with "small loop" (targeting emerging markets) is recommended to enhance market reach [5]. - The importance of building trust and understanding local market regulations is highlighted, suggesting that companies engage with platforms like DIA for better insights into international markets [5]. Group 3: Policy and Regulatory Environment - The article notes that policy and institutional reforms in China, particularly since 2015, have significantly improved the clinical trial environment, aligning it with international standards and attracting foreign investment [3]. - Shanghai has introduced various policies to support the biopharmaceutical industry, aiming to create a comprehensive innovation support system [6].