CHINA Trends and Developments Contributed by: Min Zhu, Ya-ling (Michelle) Gon, Yang (Aaron) Gu, Chai Lu, Ying Li and Shiye Yuan, Han Kun Law Offices
2025, more than 60 biotech companies remained in the Hong Kong IPO review pipeline. Venture capital/private equity financing In 2025, approximately 1,200 financing events were disclosed in China’s pharmaceutical industry, rep- resenting a slight year-on-year decrease of 2.9%. However, the aggregate disclosed financing amount exceeded CNY68.239 billion, marking a 56.17% year- on-year increase. This indicates that, while the number of transactions declined marginally, capital became increasingly concentrated on larger and higher-quality projects. Within the innovative drug segment, 319 financing events (excluding post-IPO financing) were recorded, with total financing of approximately USD9.2 bil- lion, representing a 4.5% year-on-year increase and accounting for approximately 15% of global innova- China’s pharmaceutical M&A market remained active in 2025, with 78 mergers, acquisitions and strategic investment transactions recorded during the year, reflecting continued industry consolidation. In the first half of 2025, 49 M&A transactions were completed, broadly in line with the same period in 2024. However, the aggregate transaction value was approximately CNY12.7 billion – significantly lower than the previous year – indicating structural diver- gence between transaction volume and average deal size across different market cycles. tive drug financing (USD61.8 billion). Mergers and acquisitions (M&A) In the A-share market alone, 64 M&A transactions had been disclosed as of early December 2025, involving an aggregate transaction value exceeding CNY100 billion. State-owned enterprises (SOEs) played a leading role in these transactions, pursuing indus- try chain integration through controlling or minority equity investments. At the same time, certain private pharmaceutical companies utilised M&A to strengthen their innovative drug pipelines. Regulatory Trends China is progressing towards a mature regulatory framework that balances innovation with compliance
enforcement, spanning biomedical research, human genetic resources (HGR) management, advertising integrity, and prevention-oriented anti-bribery com- pliance governance. On 10 October 2025, China’s State Council officially released the Regulations on the Administration of Clinical Study and Clinical Translation and Applica- tion of New Biomedical Technologies (the “Regula- tions”), which marks a new phase in the regulatory framework for cutting-edge biomedical fields in China. The Regulations define the scope of new biomedical technologies and establish distinct filing and approval regimes for clinical studies and for clinical translations and applications. The Regulations also stipulate that medical institutions may charge fees for the clinical application of approved new biomedical technolo- gies. The Regulations build upon and expand the suc- cessful pilot achievements implemented in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port, offering a legal basis to support the clinical activities of such new biomedical technologies. Regarding HGR administration, the National Health Commission (NHC) further clarified supervisory requirements through issuance of the Frequently Asked Questions on HGR Administration and the Answers to Questions Concerning the Administration of HGR (Parts I to V) in 2025. These documents pro- vide targeted responses to practical issues, including whether commercialised human cell lines and patient- derived tumour xenograft models are subject to HGR supervision, and outline the specific operational steps for applicable procedures. In July 2025, the State Administration for Market Reg- ulation (SAMR), the NHC and the National Administra- tion of Traditional Chinese Medicine (NATCM) jointly issued the Guidelines for the Identification of Medical Advertisements . The guidelines refine the principles and criteria for identifying medical advertisements by enumerating specific scenarios including those that do not constitute medical advertisements and those that constitute disguised medical advertising. Additionally, the guidelines limit the scope of entities authorised to publish medical advertisements, and
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