China’s fast, low-cost gene and cell therapy testing boom draws Western interest

China has been rapidly reforming its drug-regulatory system to make it faster and more innovation‑friendly, with a strategic goal of becoming a global pharmaceutical powerhouse by 2027 and achieving comprehensive market access by 2035.1

Pilot programs and draft rules in 2025 cut or propose to cut clinical‑trial review times for many novel medicines from 60 working days to 30, aligning China’s timelines with the U.S. FDA and enabling much quicker starts for early‑stage studies.1 3

These time reductions directly benefit advanced therapies such as rare‑disease drugs, pediatric cancer treatments, and next‑generation gene and cell therapies, which can move into human testing more quickly under China’s updated review pathways.1 3

On June 10, 2025, China’s Center for Drug Evaluation released the country’s first systematic draft regulation on Advanced Therapy Medicinal Products (ATMPs), clarifying definitions and classifications for cell and gene therapies and laying out a dedicated regulatory framework.2

The ATMP draft aims to streamline and shorten approval processes for cell and gene therapies while emphasizing safety, innovation, and closer alignment with international standards, thereby lowering regulatory friction for global drug developers.2

China’s drug regulator reported that 115 clinical trials for cell and gene therapy drugs were registered in 2024, a 42% increase over 2023, indicating a rapidly expanding pipeline of novel genetic medicines being tested in the country.6

Regulatory reforms in 2025 include enhanced data‑protection and data‑exclusivity measures for clinical‑trial data, which make China more attractive as a location for early‑stage research while protecting proprietary information.1 4

Lower operating costs, large patient pools, and faster approvals together make China a comparatively cheap and quick environment for testing cutting‑edge therapies, which is drawing growing interest from Western biotech and pharmaceutical companies seeking to run or expand trials there.1 3 6

China is integrating digital technologies such as AI, real‑world evidence, and brain–computer–interface tools into its regulatory and clinical‑trial ecosystem, further improving efficiency and decision‑making in the evaluation of novel therapies.1 7

At the same time, China is tightening compliance through anti‑corruption and anti‑monopoly guidelines specific to the healthcare and pharmaceutical sectors, meaning Western companies must balance the attraction of faster, cheaper trials with a more demanding regulatory and compliance environment.1 4 8