DEEP RESEARCH · CHINESE BIOTECH
Chinese Biotech: Licensing Surge and Global R&D Rewiring
NMPA acceleration, Big Pharma patent cliffs, and the ADC, obesity, and CAR-T pipeline shift.
0. Bottom line first
I no longer see Chinese biotech as merely a generic manufacturing base. The core 2024-2025 shift is that Chinese companies have become innovation suppliers filling Big Pharmas pipeline gaps.
1. Growth backdrop
Official fact: The source says NMPA/CDE proposed and expanded a pilot to shorten innovative-drug clinical trial review from 60 working days to 30 days.
| Item | Old system | New system | Implication |
|---|---|---|---|
| Review method | Approval notice required | Implied approval if no objection | Lower administrative uncertainty |
| Scope | All INDs | Innovative, pediatric, rare-disease, and global co-development drugs | Priority for high-value R&D |
| Timeline | 60 days | 30 days | Faster MRCT participation |
Interpretation: Big Pharma patent cliffs and weaker internal R&D productivity form the demand-side reason for Chinese out-licensing. Faster regulation and external pipeline demand rose together.
2. Key companies and deals
Jiangsu Hengrui
Partnerships with Merck KGaA, MSD, and GSK show the shift into oncology, metabolic, respiratory, and immunology innovation.
Innovent
Mazdutide, a GLP-1/GCG dual agonist, represents Chinese competitiveness in obesity and metabolic disease.
Kelun and Hansoh
Kelun is framed as an MSD ADC partner, while Hansoh is gaining visibility in B7-family ADCs.
BeiGene and Legend
BeiGene shows hematology commercialization, while Legend is presented as a global CAR-T standard candidate.
3. Modality meaning
- ADC: antibody selectivity, linker stability, and payload design are core out-licensing assets.
- GLP-1/obesity: mazdutide and the Eccogene-AstraZeneca collaboration show China can supply metabolic-disease pipelines.
- CAR-T: Legend Biotechs commercialization experience shows a Chinese platform can expand into global approval and manufacturing.
4. Risks and conclusion
- US-China geopolitics, BIOSECURE-style debates, and data-verification concerns remain discount factors.
- Deal values have grown, but clinical failure, returned rights, and commercialization delays remain possible.
- NewCo structures can improve capital efficiency, but rights ownership and shareholder value capture need scrutiny.
The frame has shifted from low-cost production to global R&D supply. I would track Hengrui, Innovent, Kelun/Hansoh, and BeiGene/Legend as modality representatives.
Sources
- Reference 1: https://m.blog.naver.com/PostView.naver?blogId=star_of_self&logNo=224089281870
- Reference 2: https://www.tbsnews.net/world/chinese-pharmas-rapid-rise-why-us-drugmakers-may-become-more-dependent-china-despite-tensions
- Reference 3: https://biopharmaapac.com/report/60/6738/chinas-biopharma-dealmaking-surges-in-h1-2025-driven-by-record-licensing-and-oncology-focus.html
- Reference 4: https://english.nmpa.gov.cn/2025-10/14/c_1132769.htm
- Reference 5: https://www.fiercebiotech.com/biotech/accelerate-drug-development-china-proposes-shorten-clinical-trial-review-time
- Reference 6: https://source.gbihealth.com.cn/news/detail?id=2056547&utm_source=official
- Reference 7: https://www.covingtonblogs.com/2025/07/03/china-proposes-to-expand-30-day-review-pathway-for-innovative-drug-trials/
- Reference 8: https://bsic.it/big-pharmas-impeding-patent-cliffs/
- Reference 9: https://www.biopharmadive.com/spons/is-2025-the-chinese-year-of-biopharma/738274/
- Reference 10: https://www.cooley.com/news/coverage/2025/2025-03-25-jiangsu-hengrui-pharmaceuticals-announces-license-agreement-with-merck
- Reference 11: https://www.merckgroup.com/en/news/hengrui-oncology-collab-30-10-2023.html
- Reference 12: https://www.merck.com/research/business-development-and-licensing/news/
- Reference 13: https://www.merck.com/news/merck-enters-exclusive-license-agreement-for-hrs-5346-an-investigational-oral-lipoproteina-inhibitor-for-cardiovascular-disease-from-jiangsu-hengrui-pharmaceuticals-co-ltd/
- Reference 14: https://www.biopharmadive.com/news/gsk-hengrui-collaboration-copd-immunology-cancer-drugs/754161/
- Reference 15: https://www.biospace.com/press-releases/mazdutide-9mg-supplementary-application-accepted-for-review-by-chinas-nmpa-potentially-offering-a-novel-drug-option-for-moderate-to-severe-obese-population
- Reference 16: https://www.clinicaltrialsarena.com/news/innovent-boasts-another-pivotal-trial-success-for-obesity-drug/
- Reference 17: https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html
- Reference 18: https://www.goodwinlaw.com/en/news-and-events/news/2023/01/01_09-merck-and-kelun-biotech-announce
- Reference 19: https://www.fiercebiotech.com/biotech/merck-writes-eye-popping-93b-blank-check-biobucks-deal-3rd-kelun-biotech-adc-deal
- Reference 20: https://firstwordpharma.com/story/5887364
- Reference 21: https://www.hspharm.com/news/news-detail-513133.htm
- Reference 22: https://www.hspharm.com/news/news-detail-513373.htm
- Reference 23: https://www.hspharm.com/news/news-detail-513391.htm
- Reference 24: https://www.hspharm.com/news/news-detail-513265.htm
- Reference 25: https://www.gsk.com/en-gb/media/press-releases/gsk-enters-exclusive-license-agreement-with-hansoh-for-hs-20093/
- Reference 26: https://firstwordpharma.com/story/5957436
- Reference 27: https://www.tradingview.com/news/tradingview:861505b4ca425:0-beone-medicines-announces-third-quarter-2025-financial-results-and-business-updates/
- Reference 28: https://www.hopewelltwp.org/DocumentCenter/View/11023/Hopewell-Topping-Off-BeiGene-Press-Release-March-23-2023-PDF
- Reference 29: https://www.pharmaceutical-technology.com/projects/beigenes-new-manufacturing-and-clinical-rd-centre-hopewell-usa/
- Reference 30: https://investors.legendbiotech.com/news-releases/news-release-details/legend-biotech-reports-fourth-quarter-and-full-year-2024-results/
- Reference 31: https://investors.legendbiotech.com/news-releases/news-release-details/legend-biotech-reports-third-quarter-2025-results-and-recent/
- Reference 32: https://www.fiercepharma.com/manufacturing/johnson-johnson-legend-expand-manufacturing-deal-novartis-commercial-production
- Reference 33: https://legendbiotech.com/legend-news/legend-biotech-announces-exclusive-global-license-agreement-for-certain-car-t-therapies-targeting-dll3/
- Reference 34: https://legendbiotech.com/legend-news/legend-biotech-announces-closing-of-license-transaction-for-certain-car-t-therapies-targeting-dll3/
- Reference 35: https://www.fiercebiotech.com/biotech/astrazeneca-after-dumping-one-glp-1-drug-pays-185m-upfront-reenter-oral-obesity-gold-rush
- Reference 36: https://www.astrazeneca.com/media-centre/press-releases/2023/agreement-with-eccogene-for-clinical-stage-glp-1ra.html
- Reference 37: https://www.biospace.com/press-releases/eccogene-receives-milestone-payment-of-60-million-from-astrazeneca-following-dosing-of-the-first-patient-in-global-phase-2b-program-of-ecc5004-azd5004-for-the-treatment-of-obesity-and-type-2-diabetes