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China's biotechnology sector has moved in a decade from copying foreign drugs to inventing its own. In 2024 the National Medical Products Administration (NMPA) approved 48 first-in-class innovative drugs — the most in five years, up from 40 in 2023 and 21 in 2022 — alongside 55 rare-disease medicines and 106 pediatric medicines. Oncology dominates, cell therapies are scaling, and artificial intelligence now runs through drug discovery. This guide explains how the system works, where the innovation is concentrated, and what to watch next.
This article is general information about an industry and its regulation. It is not medical advice and not investment advice. Drug approvals and company status change; check the NMPA's current listings before acting on anything here.
From Follower to Inventor
For most of the 2000s, China's drug industry was built on generics and "me-too" copies of drugs invented elsewhere. The turn came with a series of reforms starting in 2015: review timelines were shortened, clinical-trial applications moved toward a 60-day no-objection window, and in 2017 China joined the International Council for Harmonisation (ICH), aligning its trial standards with the United States, Europe, and Japan.
The effect is visible in the approval numbers. A review of NMPA approvals in 2024 counted 46 Class 1 or 1.1 innovative drugs — 39 domestically developed and 7 imported — a record for the country. The NMPA's own drug-evaluation-center report put the first-in-class count at 48. The two counts differ because they use slightly different definitions; either way, the direction is the same, and oncology was about half of the total.
What changed was not one reform but a system: faster review, clearer rules, and capital that followed. The question for the next five years is whether that system can produce drugs that sell globally, not just drugs that are first in China — and whether the world will buy them.
The Approval Machine: Four Fast Lanes
The NMPA's Center for Drug Evaluation (CDE) runs four expedited pathways, and most innovative drugs use at least one of them:
- Breakthrough therapy designation — for drugs that show a clear advantage over existing treatments in early trials. It brings closer contact with reviewers while trials are still running.
- Conditional approval — market access on the basis of early efficacy data, with confirmatory trials still to come. In 2024, 11 of the 48 first-in-class drugs used this route.
- Priority review — a shorter review clock for drugs that address unmet need. Seventeen of the 48 used it in 2024, and the CDE completed 110 priority-review applications that year, up 29 percent from 2023.
- Special review and approval — reserved for public-health emergencies.
A 30-working-day review pathway for eligible Class 1 innovative drugs, piloted in 2024, was extended nationwide in 2025. The practical result is that a promising Chinese drug can now reach patients in roughly the same time frame as in the United States or Europe — something that was not true ten years ago.
Where the Innovation Concentrates
Oncology first. About half of the innovative drugs approved in 2024 were cancer drugs — 23 of 46 in one count. That concentration reflects both the size of the market and the science: targeted therapies and immunotherapies are where Chinese companies have built the deepest expertise. BeiGene's PD-1 inhibitor tislelizumab, for example, is now approved in the United States, Europe, and China.
Cell and gene therapy. China approved its first CAR-T cell therapy in June 2021 — axicabtagene ciloleucel, made by Fosun Kite for relapsed or refractory large B-cell lymphoma — followed three months later by a domestically developed product, relmacabtagene autoleucel from JW Therapeutics. China now runs more CAR-T clinical trials than any other country, and the approved list has grown to cover CD19, BCMA, and newer targets. The open question is solid tumors, where CAR-T has yet to prove itself anywhere.
Rare diseases and children. Rare-disease approvals rose from 3 in 2022 to 45 in 2023 and 55 in 2024; pediatric approvals reached 106 products in 2024, with 35 more label expansions. These are small markets commercially, but they are where the regulator has been most visibly willing to move fast.
AI in Drug Discovery
The most consequential shift may be computational. Artificial intelligence now helps screen molecules, predict protein structures, and design trials, and Chinese companies were early adopters — partly because the same AI talent pool serves the country's much larger tech sector. Our earlier guide to the new frontier in biotechnology described how AI had already become a driver of drug discovery and personalized medicine; since then, the tools have moved from experiment to routine. Quantum computing is the next layer down the road: still largely research-stage for drug design, but attracting sustained investment because molecular simulation is one of the few problems where quantum hardware has a credible near-term use case.
That AI strength cuts both ways. The same models that design drugs can also be used to generate the data regulators rely on, which is why the NMPA and other regulators are writing rules for AI-generated evidence. Watch for those rules — they will decide how fast AI-designed drugs actually reach patients.
The Wider Technology Base
Biotech does not advance alone. China's broader technology rise — 5G networks, AI, and quantum computing together — supplies the infrastructure: connected hospitals, remote diagnostics, and the data pipelines that make large clinical trials cheaper to run. Robotics is entering the same picture, from surgical assistants to laboratory automation, and the domestic chip industry determines whether the computing behind all of this can be built at home. A biotech sector is only as strong as the technology base underneath it, and that base is now an explicit policy priority.
What to Watch — and What Could Go Wrong
- Global sales, not just approvals. Most Chinese innovative drugs still earn most of their revenue at home. The test is whether drugs invented in China can win reimbursement in the United States and Europe.
- Price negotiation. Inclusion in China's national reimbursement drug list means volume, but at prices the government negotiates down sharply. Companies must balance domestic volume against the margins needed to fund research.
- Data quality and trust. Regulators outside China still scrutinize Chinese trial data more closely than domestic data. More multi-regional trials — run to the same protocol in several countries — would close that gap.
- Geopolitics. U.S.–China tension has already touched biotech supply chains and cross-border investment. A sector that depends on global collaboration is exposed when that collaboration frays.
- Talent — and where it goes. Much of the sector's rise was built by scientists trained abroad who returned to China, and by a generation trained at home in programs that did not exist twenty years ago. That pipeline is now two-way: as opportunities grow elsewhere and immigration rules tighten, retention has become a strategic question, not just a human-resources one. Watch where the senior scientists go — it tells you where the next breakthroughs will come from.
- The solid-tumor wall. Oncology's next leap — making cell therapy and immunotherapy work against solid tumors — is unsolved everywhere. Whoever solves it first will define the next decade.
Three Companies That Show the Shift
Numbers describe a system; companies show how it works in practice. Three names illustrate the three paths Chinese biotech has taken:
- BeiGene took the global path. Its PD-1 inhibitor tislelizumab was developed in China and is now approved in the United States, Europe, and China — the first Chinese biotech to have drugs approved in all three markets at once. It is the model other companies now chase: invent at home, prove globally.
- JW Therapeutics took the domestic-innovation path. Its relmacabtagene autoleucel was the first CAR-T product approved in China as a Category 1 biological product — a domestically developed therapy built on a licensed platform, approved in September 2021.
- Fosun Kite took the partnership path. Its axicabtagene ciloleucel was developed under license from Kite, a Gilead company, and became China's first approved CAR-T therapy in June 2021. The partnership brought a proven product to Chinese patients years before a purely domestic effort could have.
None of these paths is "the" model. The point is that all three now exist side by side, and the companies that succeed in the next decade will likely mix them: domestic discovery, licensed technology, and global trials.
How to Follow the Sector
Start with the primary sources: the NMPA's English site publishes approval announcements and annual reports; the CDE publishes clinical-trial progress reports; Nature Reviews Drug Discovery runs a yearly tally of NMPA approvals. Company press releases are useful for individual drugs but say nothing about whether a drug actually works — for that, read the trial publications, not the announcement. And when a number looks too good — a cure rate, a market size, a timeline — ask whose number it is. In this sector, the source of a figure is usually more informative than the figure itself.
FAQ
Is China's NMPA the equivalent of the U.S. FDA? Yes, in role: it is the national regulator that approves drugs and medical products. Its standards have converged with international norms since China joined ICH in 2017, but its processes, timelines, and data requirements still differ in detail.
What is a "first-in-class" drug? A drug with a new mechanism of action — the first of its kind — as opposed to a "me-too" drug that copies an existing mechanism. China approved 48 of them in 2024.
Why is oncology so dominant in Chinese biotech? Cancer is the largest drug market in China, the science is well understood, and targeted and immune therapies play to Chinese companies' strengths in biologics manufacturing and fast clinical development.
Are Chinese biotech drugs available outside China? Some are. A small number of Chinese-developed drugs have won FDA and EMA approval, and more are in global trials. Most innovative Chinese drugs are still sold mainly in China.
What is the NMPA's Center for Drug Evaluation (CDE)? The technical review arm of the NMPA. It reviews trial applications and marketing applications, publishes guidance, and produces the annual reports that the approval numbers in this guide come from. When a drug is "approved in China," the CDE did the reviewing and the NMPA issued the approval. Its annual drug review report is the single best source for tracking the sector year by year.
How long does NMPA approval take? It varies by pathway. Standard review historically took well over a year; priority review shortens the clock substantially, and the 30-working-day pathway for eligible innovative drugs is the fastest route. The exact timeline depends on the drug, the data, and whether the CDE asks for more information — which it often does.
Where does AI fit in? Across the pipeline: screening candidate molecules, predicting how they bind to targets, selecting trial patients, and monitoring safety. It speeds up discovery; it does not replace clinical trials.
Sources
- National Medical Products Administration / Center for Drug Evaluation annual report, via China Daily: "China approves 48 innovative drugs in 2024" (2025-03-19) and "Measures facilitate approval of 48 first-in-class innovative drugs" (2025-03-21), english.nmpa.gov.cn.
- "New drugs approved by the NMPA in 2024: Synthesis and clinical applications," European Journal of Medicinal Chemistry (2025), PMID 40262297 — 46 Class 1/1.1 innovative drugs, 39 domestic, 7 imported; oncology 50%.
- "Approvals by the China NMPA in 2024," Nature Reviews Drug Discovery 24, 160–161 (2025) — 228 new drug applications total.
- "China enters CAR-T cell therapy era: The Innovation," The Innovation (2021) — first two CAR-T approvals, June and September 2021.
- Fosun Pharma announcement (2021-06-24) — axicabtagene ciloleucel, China's first approved CAR-T therapy.
- "Chimeric antigen receptor-T-cell therapy: China leading the way," Blood Science (2022) — CAR-T trial volume and the two 2021 approvals.
- All sources checked 2026-11-13. Approval counts and policy details change; verify against the NMPA's current pages.
