中国生物医药在供应链、审批速度与成本结构上的加速使其在 2018–2025 年间从全球创新边缘跃升为核心力量:全球临床阶段创新药物中,中国的占比由 8% 提升到 30%,美国则由 47% 降至 36%。麦肯锡测算,中国药企从靶点到候选分子及早期临床推进速度为全球平均的 2–3 倍;临床入组速度为 2–5 倍,且患者成本比欧美低 约 50%。这得益于庞大本地人才与工程体系、集中式医院网络与强政策扶持。以 BiBo 工厂为例,从立项到审批仅需 9 天(欧洲最长可达 6 个月),单罐生物产能可达 50,000 L。外企合作亦密集:阿斯利康在 2025 年 6 月与 CSPC 签署 52 亿美元协议;中国对欧美的出海授权占比从 2% 上升至 20%。
快速迭代尤在抗体偶联药物(ADC)与多特异性抗体等“工程型药物”领域体现:中国公司占全球 1/2 左右的早期管线(ADC:54%;多特异性抗体:48%)。四川汇宇等企业单一公司管线可达 17 项;RNAi 初创 Rona 成立 4 年已拥有 15 个候选药物,其中 3 项进入临床。香港 2018 年放宽上市后,本土生物科技普遍以“10 项以上管线”进入资本市场,反映研发成本低带来的多项目试错能力。中国药审简化、资本流入与 CRO/CMO(如药明系)产业链提升,加速了本土知识沉淀。
但国际化仍是瓶颈:中国 FDA(NDA)中的新分子占比虽从 1% 升至 6%,但中国药企仍缺乏全球销售体系、跨国法规经验与海外生产布局。地缘政治亦构成风险:美国正推动供应链回流、限制 CRO/CMO 依赖,并质疑跨国药企扩大在华业务。行业普遍预计,中国公司在全球化能力成熟前仍需依赖跨国药企合资、共同开发与商业化伙伴模式。即便如此,中国作为“高工程密度”的药物创新中心的地位已确立,并正逼近能诞生全球重磅药物的门槛。
China’s biopharma sector has accelerated on the back of supply-chain depth, regulatory speed, and cost advantages, lifting its share of global innovative clinical drug candidates from 8% in 2018 to 30% in 2025, while the US share fell from 47% to 36%. McKinsey estimates Chinese drugmakers advance molecules into candidates and early trials 2–3× faster than global averages, recruit patients 2–5× faster, and conduct trials at ~50% lower per-patient cost. This is driven by a large engineering-heavy workforce, concentrated hospital networks, and policy support. BiBo Pharma’s plant received approval in 9 days (vs. up to six months in Europe) and operates 50,000-litre bioreactor tanks. Foreign dealmaking has surged: AstraZeneca signed a $5.2bn agreement with CSPC in June 2025, and China’s share of licensing deals to the US/EU jumped from 2% to 20%.
China’s speed advantage is clearest in engineering-intensive modalities such as ADCs and multispecific antibodies, where it holds 54% and 48% of phase 1–2 assets, respectively. Firms like Sichuan Biokin have 17 ADC programmes; RNAi start-up Rona (founded 2021) already has 15 candidates, three in clinical trials. Low development costs enable Chinese biotechs to maintain broad pipelines, often exceeding “10 assets” at Hong Kong IPO. Regulatory easing and the rise of domestic CRO/CMO champions (e.g., WuXi AppTec) have further compressed R&D cycles.
Yet globalisation remains incomplete. China-origin drugs represent 6% of recent FDA novel approvals, up from 1% in 2018, but Chinese firms lack global commercial networks, regulatory expertise, and overseas manufacturing, while geopolitical pressure—US efforts to reshore pharma supply chains and limit reliance on Chinese CRO/CMOs—heightens risk. Analysts expect Chinese innovators to rely on multinationals for late-stage development and commercialisation before building independent global footprints. Even so, China’s emergence as a high-velocity innovation hub places it close to producing the next global blockbuster drug.