China surpasses US in cancer drug approvals 2020-2025 | 94 vs 87, US still leads on first-in-class
TL;DR
A Health Affairs study shows China approved 94 novel oncology drugs from 2020-2025, surpassing the FDA's 87. China took the lead in 2023 and held it through 2025 — in 2025 alone, China's approvals were nearly 3× the US total. The US still leads on first-in-class drugs: 30 of 36 first-in-class oncology approvals hit the US first, with FDA median review 117 days faster.
A study published in Health Affairs shows: from 2020 to 2025, China approved 94 novel oncology drugs, surpassing the FDA's 87 over the same window. Guancha followed with the Chinese-language report on July 21. It's a historic marker — the first full six-year window in which Chinese oncology approvals passed the US.
The catch-up came fast. China took the lead in 2023 and held it through 2025; in 2025 alone, China approved nearly 3× as many novel oncology drugs as the US. That's ~5 years ahead of expectations set when China launched its 2015 drug regulatory reform ("No. 44 order," priority review pathway, accelerated approvals). Original industry estimates put the crossover at 2028-2030.
The contrast line is first-in-class drugs. Of the 36 first-in-class oncology approvals in the study, 30 hit the US first. FDA's median review is 117 days faster than China's — the US still owns the "global first-launch market" line comfortably.
The takeaway is a clean split: China surpasses on volume and follow-speed; the US still leads on first-in-class concept and fastest review. Researchers note that China has moved over 15 years from a generic-drug-dominated industry to a new stage with innovation R&D and commercialization capacity — the ultimate validation of the 2015 regulatory reform.
Beyond the AI narrative — Chinese innovation drugs overtaking the US is 2026's second US-China tech-parity line; the first was NEV sales. Semiconductors, frontier AI models, biotech innovation — Chinese catch-up curves in all three now sit at the "quantitative overtake" stage.
via Guancha
The catch-up came fast. China took the lead in 2023 and held it through 2025; in 2025 alone, China approved nearly 3× as many novel oncology drugs as the US. That's ~5 years ahead of expectations set when China launched its 2015 drug regulatory reform ("No. 44 order," priority review pathway, accelerated approvals). Original industry estimates put the crossover at 2028-2030.
The contrast line is first-in-class drugs. Of the 36 first-in-class oncology approvals in the study, 30 hit the US first. FDA's median review is 117 days faster than China's — the US still owns the "global first-launch market" line comfortably.
The takeaway is a clean split: China surpasses on volume and follow-speed; the US still leads on first-in-class concept and fastest review. Researchers note that China has moved over 15 years from a generic-drug-dominated industry to a new stage with innovation R&D and commercialization capacity — the ultimate validation of the 2015 regulatory reform.
Beyond the AI narrative — Chinese innovation drugs overtaking the US is 2026's second US-China tech-parity line; the first was NEV sales. Semiconductors, frontier AI models, biotech innovation — Chinese catch-up curves in all three now sit at the "quantitative overtake" stage.
via Guancha