2月8日，信达生物与礼来达成合作，共同推进肿瘤及免疫领域创新药全球研发，信达生物将获3.5亿美 元首付款及最高约85亿美元里程碑付款及销售分成。 无独有偶，2月5日，复宏汉霖与日本卫材签订协议，授予其在日本区域内斯鲁利单抗注射液用于肿瘤适 应症治疗的开发、生产及商业化权利，交易总金额近4亿美元。 回顾2025年，中国创新药对外授权（License-out）交易总金额突破1300亿美元，中国医药企业的国际化 进程已逐步成为行业当前发展的主旋律。然而，在推动企业"走出去"的实践中，呈现出显著的分层特征 与结构性不均衡。一方面，以华润医药、百济神州、复星医药等为代表的龙头企业已具备较为扎实的国 际化基础；另一方面，大量中小企业则因国内市场竞争高度内卷及集采带来的经营压力，将海外市场视 为新的生存机会与发展路径。 突破核心瓶颈 合规能力是国际化的核心前提。对于原料药、中间体企业而言，过去凭借成本与产能优势尚可维持出 口，但若要进入生物医药、高端医疗器械乃至医保报销体系，则必须满足ICH、PIC/S、FDA、EMA等 国际通行的法规与质量标准。值得肯定的是，中国已正式加入ICH，并正在积极申请加入PIC/S。后者 一旦 ...

Core Viewpoint - The company is advancing its internationalization strategy by signing an exclusive supply agreement with GOODFELLOW in the Philippines for the product Efparepoetin alfa, aimed at enhancing economic benefits and brand influence [1][2] Group 1: Strategic Initiatives - The agreement allows the subsidiary Luzhou Bichang Biopharmaceutical Co., Ltd. to appoint GOODFELLOW as the exclusive agent for the registration, clinical trials, promotion, distribution, and sales of Efparepoetin alfa in the target region [1] - This transaction marks a significant breakthrough in the company's internationalization process within its biopharmaceutical strategy, contributing to both economic gains and brand value enhancement [2] Group 2: Market Expansion - The signing of the agreement aims to quickly convert the company's research and development achievements into commercial benefits through collaboration and licensing, thereby broadening the overseas market for Efparepoetin alfa [2] - The company emphasizes a dual approach of independent research and open collaboration, strengthening international partnerships to maximize product value and enhance core competitiveness [2]