Life Sciences 2025

CHINA Trends and Developments Contributed by: Min Zhu, Ya-ling Gon, Yang Gu, Chai Lu, Ying Li and Shiye Yuan, Han Kun Law Offices

industry, involving a total transaction amount of RMB112.58 billion. M&A activity in 2024 was predominantly characterised by reorganisations within industry chains, with a notable trend being the acquisition of innovative drug assets by major pharmaceutical companies. Out of the 35 M&A events in 2024, ten involved the acquisi- tion of innovative biotechnology start-ups, and the transaction amounts of these ten events accounted for 61.1% of the total disclosed M&A transactions. Regulatory Trends In 2024, the Chinese regulatory authorities intro- duced a series of pivotal updates to laws and reg- ulations in the life sciences sector. Key changes included easing some of the key restrictions on foreign investment, the nationwide implementa- tion of regulations on investigator-initiated trials (IIT), updated human genetic resource (HGR) regulations, and enhanced oversight of drugs and medical devices. China initiated pilot programmes to gradually ease foreign investment restrictions in the life sciences sector in 2024. On 8 September 2024, three governmental bodies in China jointly issued the Notice on Carrying Out Pilot Programmes to Expand Opening-Up in the Healthcare Sector. The Notice permits foreign-invested enterprises to participate in the development and applica- tion of stem cell, gene diagnosis and therapeu- tic technologies in four free trade zones (FTZs) or ports in Beijing, Shanghai, Guangdong and Hainan. This initiative is expected to stimulate growth and international collaboration in numer- ous industries including IPSCs, CAR-T, TCR-T, CAR-NK, TILs, mRNA, gene sequencing and IVD/LDT. More detailed measures in the FTZs are expected to be introduced soon.

Regarding IITs, the release of the Measures for the Administration of IITs (the “IIT Measures” ) in 2024 marked a new phase in China’s IIT reg- ulations. Under the IIT Measures, all IITs are required to only use marketed drugs approved by the National Medical Products Administration (the “NMPA” ), except for IITs of stem cells and somatic cells. The IIT Measures apply nation- ally, in contrast to pilot regulations implemented in 2021 in selected regions (the “Pilot Regula- tions” ). The IIT Measures further simplify the process for initiating observational studies and strengthen the role of clinical research man- agement committees while retaining many key provisions from the Pilot Regulations, including IIT protocol signing requirements and research filing. In terms of the updates to the HGR Regula- tions in 2024, the State Council issued an order to amend the Administrative Regulations of HGRs to designate the National Health Com- mission (the “NHC” ) as the regulatory authority for HGR, replacing the Ministry of Science and Technology. These amendments highlight that HGR remains China’s key regulatory focus. In January 2025, the administrative guidelines for HGR approval and filing requirements were fur- ther amended, reflecting ongoing refinements in regulatory implementation. In 2024, the State Council issued its Opinion on Deepening Drug and Medical Device Regula- tion Reform to Promote High-Quality Develop- ment of the Pharmaceutical Industry, focusing on improving regulatory efficiency, supporting innovation and strengthening compliance. It also advocates for extending the data protection period, enhancing the market exclusivity system, shortening clinical trial approval timelines and optimising the import approval process for drugs and medical devices.

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