Chinese biotechs are now outpacing multinationals at getting drugs into pivotal trials — but MNCs still win the race to final approval. In this piece from the September 2026 edition of DIA Global Forum, Li Wang of Lilly’s China Drug Development & Medical Affairs Center digs into fresh 2023–2025 timeline data to show where each side’s edge actually comes from: local companies’ lean, in-house-driven early development versus MNCs’ strength in navigating complex multi-regional trials through to NDA approval.
Over the past decade, China’s pharmaceutical research and development (R&D) has been significantly transformed. Systemic regulatory reforms launched in 2015—including clinical trial licensing, rolling submissions, and expedited approval pathways—sharply accelerated development timelines and released a wave of domestic innovation.* China has emerged as a major source of global pharmaceutical innovation, accounting for nearly half of new drug molecules entering human trials in the first half of 2025. At the same time, domestic developers have achieved several world-first approvals in novel therapeutic modalities, reflecting China’s transition from a fast follower to an increasingly important innovation contributor.
Overall Comparison: Local Companies vs. MNCs
Total clinical development cycles for Chinese local companies and MNCs are now comparable, and both shortened in 2023–2025 (Figure 1 and Figure 2). Median time from Investigational New Drug (IND) application to New Drug Application (NDA) approval fell to 73.8 months for local companies and 83.8 months for MNCs, down from 80.3 and 89.6 months in 2020–2022, reflecting reductions of approximately 8% and 6% respectively.
Local companies hold a clear early-stage lead: Their median 37.8 months from IND to the start of pivotal trials compares to 56.5 months for MNCs from 2023-2025; this gap has widened to 18.7 months from 9.3 months in 2020-2022. In phase 3, the two are essentially level at about 34 months each.
