;)
China’s biotech boom: From generics to global innovation powerhouse
🚀 China is now the world’s #2 drug developer, with Morgan Stanley projecting 35% of US FDA approvals from Chinese assets by 2040—unlocking $220B in revenue.
📈 NMPA reforms, surging INDs (+32% in 2023, 76% innovative), and trial efficiency (12.7% of global studies) are fuelling this shift.
🌍 Out-licensing hit US$84B upfront in 2025 alone, drawing US/EU partners for oncology ADCs, bispecifics, and rare disease plays.
For Series A biotechs and investors eyeing China assets:
🔍 We’ve diligenced Chinese-origin drugs for licensing success, spotting regulatory paths early.
📋 Navigated NMPA/CROs to fast-track FiH studies and hit value inflection points.
✅ Built CDPs that align TPPs with global standards, boosting investor confidence.
Adnovate Clinical turns China opportunities into executable strategies. 🎯🎯🎯
What’s your biggest challenge diligencing or developing Chinese innovations? Comment below.
China – an emerging epicentre of the global pharmaceutical landscape
China is experiencing a swift transformation from a generics-based pharmaceutical industry to a globally oriented, innovation-driven biotech hub. Morgan Stanley Research projects that by 2040, assets originating in China will account for around 35% of US FDA approvals, generating an estimated US$220 billion.1
China’s biotech expansion
China’s biopharma growth is driven by a rapidly expanding healthcare economy, investment in cost-effective infrastructure and cutting-edge technologies, modernization and effective implementation of regulatory reforms stated by the National Medical Products Administration (NMPA) to align with international standards. These changes run in parallel with improving efficiency in clinical trials, providing increased therapeutic options and enhancing strategic investment in skilled talent. Together these factors are nurturing local innovation, supporting a rapidly growing clinical research ecosystem, and enabling China to compete globally and accelerate access to new treatments.
Broad and evolving therapeutic portfolio
China is building a diversified portfolio across traditional and next‑generation modalities, including biologics, gene therapies and precision medicines, many of which show strong clinical potential and commercial appeal.2 Between 2007 and 2023, 350 Chinese‑origin innovative drugs entered clinical trials in the US; 45% were small molecules and 22% monoclonal antibodies, with bispecific antibodies, antibody–drug conjugates (ADCs), and cell and gene therapies representing 8%, 7% and 5% respectively.3 In 2023, investigational new drug (IND) applications to the NMPA increased by about 32%, and approximately 76% of these related to studies using innovative drugs across multiple therapeutic areas.³ While Chinese‑origin bispecifics and ADCs have gained strong traction in oncology, activity is steadily expanding into rare diseases, autoimmune conditions and metabolic disorders.4
Growing contribution to clinical trials
China’s efforts to streamline clinical trial processes have helped position the country as a key global hub, accounting for 12.7% of global clinical trials in 2023.³ A recent review by Tan et al. summarises this surge in innovation and clinical activity across multiple dimensions of the ecosystem.³ Between 2007 and 2023, 177 Chinese pharmaceutical companies conducted 691 clinical trials in the US, covering 499 indications; 49% of these trials were Phase I, 39% Phase II and 12% Phase III.5 Although China participates in international multicentre studies, further progress is needed to consistently meet expectations for multi‑regional and global pivotal studies. Recent FDA approvals of Chinese‑developed drugs such as Toripalimab (LOQTORZI)6 and Tislelizumab (TEVIMBRA)7 demonstrate meaningful advances towards this goal.
Out‑licensing and cross‑border collaboration
China’s out‑licensing model is accelerating cross‑border deals by offering global partners access to innovation while mitigating early‑stage risks. Responding to patent expirations and pricing pressures, US and EU pharma companies are increasingly turning to Chinese R&D to bolster pipelines and differentiate portfolios. This shift is creating new opportunities for strategic collaborations and global expansion. In 2025, Chinese companies secured US$84.5 million in upfront payments across 83 out-licensed drugs, generating substantial capital for reinvesting in infrastructure and innovation and further boosting China’s role in global drug development (Huatai Securities Research).8
Global regulatory harmonization
To accelerate access to new therapies, the NMPA is aligning more closely with the FDA, showing openness to accepting surrogate endpoints and limited clinical datasets in areas of high unmet need such as, rare diseases and oncology. At the same time, NMPA is placing increased emphasis on evolving patient safety considerations, which are central to EMA decision‑making.³ To facilitate efficient drug approval and world-wide accessibility, an international collaborative model of regulatory reliance is incorporated at the global scale. Despite the complex geopolitical relationship between the US and China, NMPA remains anchored in supporting the international expansion of Chinese biotechs, including a recent reduction in the review timeline for clinical trial applications involving innovative drugs from 60 to 30 days.9
How Adnovate Clinical can help
Adnovate Clinical’s global team supports the development of innovative drugs across multiple therapeutic areas and has experience working with assets originating in China. The team has provided due diligence support to investors and startups to enable successful licensing of China-developed assets and has extensive experience working with Chinese CROs on study start‑up and execution. This includes navigating Chinese regulatory requirements to facilitate rapid approval of early‑phase studies and integrating China‑based development into global plans. Our bespoke style of working is designed to help clients optimise outcomes at each stage of clinical development.
For more information, please get in touch: https://www.adnovateclinical.com/contact-us/
References
- Morgan Stanley Research – Global Insight – China Biotech: Innovation Dawn, Aug 26th, 2025
- Li G, Liu Y, Hu H, Yuan S, Zhou L, Chen X. Evolution of innovative drug R&D in China. Nat Rev Drug Discov. 2022 Aug;21(8):553-554. doi: 10.1038/d41573-022-00058-6. PMID: 35365768.
- Tan, R., Hua, H., Zhou, S. et al. Current landscape of innovative drug development and regulatory support in China. Sig Transduct Target Ther 10, 220 (2025). https://doi.org/10.1038/s41392-025-02267-y
- Yan Y, Guo X, Li Z, Shi W, Long M, Yue X, Kong F, Zhao Z. New Drug Approvals in China: An International Comparative Analysis, 2019-2023. Drug Des Devel Ther. 2025;19:2629-2639
https://doi.org/10.2147/DDDT.S514132
- Ge, Q., Zhang, X., Kaitin, K. I. & Shao, L. Development of Chinese innovative drugs in the USA. Nat. Rev. Drug Discov. 23, 421–423 (2024).
- https://en.tmtpost.com/post/7697329
- Huatai Research – ASC Update: Chinese Innovative Drugs BD gaining traction – 5th Sept 2025
- https://english.nmpa.gov.cn/2025-10/14/c_1132761.htm
