在全球生物医药产业格局深刻重塑的当下，中国创新药企的集体"出海"，已成为一股不可忽视的浪潮。 在这股浪潮背后，提供临床试验支持与服务（CRO）的国际巨头，正从曾经的"幕后支持者"转变为关键 的"全球化推手"。 "我们一方面帮助亚太的药企'走出去'，开展国际水准的中国和全球多中心临床试验；另一方面也协助 全球的药企'走进来'，在亚太地区落地全球性或本地临床项目。"精鼎医药高级副总裁、亚太区企业战 略负责人兼大中华区负责人郑唯玲（Vera）表示。 依托全球网络，经验与前沿科学和洞察，精鼎医药正试图在中国医药创新从"跟跑"到"并跑"乃至部 分"领跑"的进程中，捕捉新的增长极。 赋能"出海"必修课：全球化视野与本土化洞察 精鼎医药的全球版图中，亚太地区正扮演着日益核心的角色。"我们全球现有24000位专家员工，其中亚 太地区就有近9000位。"郑唯玲介绍称，这意味着，公司超过三分之一的全球人力资本部署于此，其战 略权重不言而喻。 在郑唯玲看来，亚太区的定位是双重的：一方面，它是服务本土蓬勃发展的生物科技（Biotech）公 司、助其走向全球的端口；另一方面，它也是承接跨国药企在亚太进行全球多中心临床试验的枢纽。 此外 ...

Group 1 - The forum "Emerging Market Development Forum for China's Pharmaceutical Industry" was successfully held during the 2025 CPHI & PMEC Pharmaceutical Industry Exhibition in Shenzhen, focusing on opportunities and challenges in emerging markets [1] - The Shenzhen Pharmaceutical and Medical Device Industry Outbound Union aims to create a collaborative ecosystem for companies to expand internationally, involving major enterprises and professional service institutions [1] - The forum featured industry leaders discussing the evolution of the global pharmaceutical landscape and innovative practices for internationalization, highlighting the growing interest in emerging markets [1] Group 2 - IQVIA's analysis indicates that the global biopharmaceutical market is undergoing significant restructuring, with China accounting for one-third of global innovation in drug development [2] - The report emphasizes that Chinese pharmaceutical companies are entering a new era of internationalization, with opportunities arising from technological advancements and innovative business models [2] - The "API+ANDA," "NewCo," and "JV" outbound models were discussed, outlining their characteristics and advantages [2] Group 3 - The MENA and South Asia regions are identified as key markets, with a pharmaceutical market size of approximately $35 billion and an annual growth rate of 6.3%, projected to increase by 35% to 55% over the next five years [3] - Kexing Pharmaceutical's localized marketing strategies in Algeria, Egypt, and Saudi Arabia demonstrate the potential for Chinese pharmaceutical companies in the MENA region [3] - In South America, regulatory compliance and local partnerships are crucial for market entry, with Brazil being the largest contributor to growth in the region [3] Group 4 - The roundtable discussion highlighted the role of new productive forces in the pharmaceutical sector, focusing on biotechnological innovation, digital R&D, and intelligent management [4] - Chinese pharmaceutical companies are encouraged to collaborate with trustworthy partners to enhance their international competitiveness through innovation and ecological synergy [4] - The successful forum aims to provide strategic guidance for Chinese pharmaceutical companies looking to enter emerging markets, with Kexing Pharmaceutical committed to building high-level international exchange platforms [4]

Core Insights - The FDA has publicly released 202 drug approval rejection letters (CRLs), exposing the failure records of global pharmaceutical companies, including four Chinese firms [1][2] - The transparency brought by the CRL publication is expected to reshape industry standards and compel companies to improve compliance and clinical design [4] Group 1: Chinese Pharmaceutical Companies' Rejections - Zhejiang Innovation Biotech faced three rejections for its Vancomycin injection due to non-compliance in production facilities and significant safety report omissions [3] - Luye Pharma's Risperidone injection was rejected twice due to severe safety concerns, including unexplained spikes in blood drug concentration during key clinical trials [3] - Baiji Shenzhou's Bevacizumab biosimilar failed due to flaws in analytical methods, leading to the dismissal of key efficacy data and multiple quality control issues [3] - Kangfang Biotech's Pembrolizumab was blocked due to insufficient clinical data and unstable production cell lines, although it later received approval for two indications after addressing the FDA's concerns [3] Group 2: Industry Implications - The cases highlight common weaknesses among Chinese pharmaceutical companies, such as clinical design flaws, quality control lapses, and insufficient bioequivalence evidence [4] - The experience of Kangfang Biotech demonstrates that CRLs are not the end; companies can successfully reverse decisions by providing additional data [4] - The shift from a "black box" to a "glass house" in the approval process necessitates that Chinese firms integrate compliance awareness throughout the entire R&D chain to gain lasting trust in global markets [4]