China approves first AI-assisted Class 1 innovative drug Mprosevir

Overview

Updated 5 days ago

Westlake University announced September 2 that China's drug regulator conditionally approved Mprosevir, a COVID-19 treatment. It is the country's first 'Class 1' innovative drug developed with AI assistance—the highest tier of China's drug registration system, for drugs never marketed before.

Mprosevir took 3.5 years from candidate discovery to clinical trial completion, about a third of the traditional decade-long pipeline. Researchers screened 49 billion compounds in a DNA-encoded library (DEL), with AI narrowing more than 100 candidates to nine molecules within days. The approval has put AI drug development stocks in focus at Chinese brokerages.

Why it matters

AI-assisted drug development can compress a decade-long pipeline into years, changing how quickly new medicines reach patients.

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Key Indicators

3.5 years

Development time from discovery to trial completion

Traditional small-molecule drug development takes 10+ years on average.

49 billion

Compounds screened in the DEL library

DNA-encoded library screening combined with AI virtual filtering identified candidates in days.

Lead candidates after AI screening

AI narrowed over 100 initial candidates; 6 of the 9 showed strong activity in testing.

34 years

Time from DEL concept to first approved drug

The DEL technology concept was first proposed in 1992.

Voices

Curated perspectives — historical figures and your fellow readers.

Ever wondered what historical figures would say about today's headlines?

People Involved

Shi Yigong

Founder and president of Westlake University

Active; university president since 2018

Marc Horn

President of Merck China

Active

Wang Tingliang

Assistant to the president of Westlake University

Active

Organizations Involved

National Medical Products Administration (NMPA)

Government regulatory agency

Approving authority for Mprosevir

China's national drug regulator, equivalent to the US Food and Drug Administration.

Westlake University

Private research university

Co-developer of Mprosevir

Private research university in Hangzhou founded by structural biologist Shi Yigong.

Westlake Pharmaceuticals

Pharmaceutical company

Co-developer and commercialization partner

Pharmaceutical company affiliated with the Westlake ecosystem in Hangzhou.

Westlake Laboratory

Research institute

Co-developer of Mprosevir

Research institute in Hangzhou affiliated with Westlake University.

Timeline

January 1992 September 2026

6 events Latest: 5 days ago

Tap a bar to jump to that date

September 2026
Brokerages flag AI drug development as strategic focus
Latest Market Reaction

China Post Securities and Zheshang Securities analysts say AI pharma is becoming a strategic focus for major tech companies, following the Mprosevir approval.
5 days ago
NMPA announces conditional approval of Mprosevir
Regulatory Approval

Westlake University announced September 2 that China's drug regulator conditionally approved the first AI-assisted Class 1 innovative drug for mild-to-moderate COVID-19 in adults.
September 2nd, 2026
June 2025
Two-year AI-guided optimization completed
Development

Team improves potency, pharmacology, and toxicity. Progresses from cell assays through mouse studies toward clinical trials.
June 1st, 2025
June 2023
AI narrows candidates; WLU6937 selected
Discovery

AI filters 100+ candidates to nine in days; six show strong activity. WLU6937 chosen as lead.
June 1st, 2023
January 2023
Westlake team begins DEL screening campaign
Discovery

Researchers screen 49 billion compounds in a DEL library targeting the 3CLpro coronavirus protease.
January 1st, 2023
January 1992
DNA-encoded library concept proposed
Scientific Context

Sydney Brenner and Richard Lerner introduce the DEL concept, enabling compound screening at massive scale.
January 1st, 1992

Scenarios

Fully AI-designed drug approved in China by 2027

Possible Resolves by End of 2027

Discussed by: Marc Horn, Merck China president; SCMP coverage of the Asian Financial Forum

Horn predicted at the January 2026 Asian Financial Forum that China could approve a compound fully designed by AI, with no human-directed discovery, possibly as early as 2026-2027. The Mprosevir approval demonstrates the regulatory pipeline accepts AI-heavy development, and the NMPA's 'AI + Drug Regulation' roadmap published in May 2026 builds the formal framework. The 'AI Plus' national program adds government backing. Approval of such a drug would signal AI has moved from assistive to autonomous drug design.

Wave of AI-assisted Class 1 drugs follows within 18 months

Likely Resolves by Q2 2028

Discussed by: Global Times, industry analysts tracking China's biopharma pipeline

Mprosevir establishes the precedent and the regulatory pathway. Chinese drug makers signed a record $135.7 billion in out-licensing deals in 2025, and around 30% of new drug pipelines now originate in China per Marc Horn. The NMPA's AI regulation framework published in May 2026 provides formal guidance. Multiple AI-assisted candidates already in development could reach approval. The question is how many clear the bar and how fast.

US or EU regulators approve DEL-based or fully AI-designed drug

Possible Resolves by End of 2028

Discussed by: Industry observers watching whether this is China-only or a global shift

Mprosevir is the first DEL-approved drug worldwide and the first AI-assisted Class 1 drug in China. Whether the US Food and Drug Administration or the European Medicines Agency follows determines if these technologies become standard or remain a China-specific phenomenon. Both agencies have published guidance on AI in drug development but have not yet approved drugs explicitly developed through these methods.

AI pharma stocks rally on Mprosevir approval

Possible Resolves by End of 2026

Discussed by: 21财经, China Post Securities, Zheshang Securities

The Mprosevir approval has put AI drug development stocks in focus. 21财经 reports institutions and margin traders are watching specific AI pharma stocks, and China Post Securities sees AI pharma as a strategic focus for major tech companies. A sustained rally would signal the market sees AI drug development as commercially viable.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

January 2020 - December 2021

COVID-19 mRNA vaccines (2020-2021)

Operation Warp Speed and the new mRNA platform compressed vaccine development from the typical 10-15 years to under a year. Pfizer-BioNTech and Moderna moved from sequence to emergency authorization in about 11 months, a process that normally takes a decade.

Then

Billions of doses delivered worldwide within 18 months of the pandemic's start.

Now

Demonstrated that regulatory flexibility plus platform innovation can compress biological product timelines dramatically, reshaping vaccine development norms.

Why this matters now

The same dynamic is at work with Mprosevir: a new discovery platform (DEL plus AI) combined with regulatory adaptation compresses a decade-long process into years.

November 2020 - July 2021

AlphaFold protein structure breakthrough (2020-2021)

DeepMind's AlphaFold solved the 50-year protein folding problem, predicting protein structures with atomic accuracy. In 2021, AlphaFold released structures for nearly all of the 200 million proteins cataloged in science—work that would have taken researchers centuries.

Then

Structural biologists gained instant access to predictions for proteins they had spent years trying to crystallize.

Now

Established that AI can outperform traditional experimental methods in biological discovery, fueling investment in AI-driven drug development.

Why this matters now

Mprosevir builds directly on this precedent: AI applied to biological problems changes what's possible, and what was a research tool in 2021 is now producing approved drugs.

1970s-present

Drug development's 'three tens' rule

The pharmaceutical industry's long-standing benchmark: 10 years of development, $1 billion in investment, and less than 10% probability of success for a new drug. This baseline has held for decades despite advances in chemistry, genomics, and screening technology.

Then

High development costs and failure rates have kept drug prices high and limited innovation to well-capitalized firms.

Now

The rule set expectations for how long patients wait for new treatments and how much risk investors accept.

Why this matters now

Mprosevir challenges the baseline directly—3.5 years versus 10, with AI handling screening and optimization that historically consumed years of medicinal chemistry effort.