Cancer drugs approved in China but not in the US

Some new cancer medicines are approved by China's regulator (NMPA) years before — or instead of — the US FDA. The list below covers drugs where we could confirm the China approval and the current US status. It is not a complete list.

Talk to your own doctor first. CAR-T and the drugs below are for specific cancers at specific stages, have serious possible side effects, and need close follow-up. Whether any of them fits you can only be decided by specialists who see your records. This page lists approvals and prices; it does not say how well any treatment works for you.
DrugTypeStatus in ChinaStatus in the US
Ivonescimab
依沃西单抗
Akeso
PD-1/VEGF bispecific antibodyFirst approved by NMPA in May 2024; three lung cancer (NSCLC) approvals in China, the latest in August 2026[1]Not FDA-approved. FDA decision date: November 14, 2026[2]
Cadonilimab
卡度尼利单抗
Akeso
PD-1/CTLA-4 bispecific antibodyApproved in China in June 2022 for relapsed or metastatic cervical cancer[3]Not FDA-approved; FDA cleared a Phase 3 gastric cancer trial in December 2025[4]
Disitamab vedotin
维迪西妥单抗
RemeGen
HER2 antibody-drug conjugateFirst approved in China in June 2021 for gastric cancer[5]Not FDA-approved; has FDA breakthrough therapy designation for HER2-positive urothelial cancer[5]
Sintilimab
信迪利单抗
Innovent
PD-1 antibodyApproved in China for several solid and blood cancers[6]Not FDA-approved; the FDA issued a Complete Response Letter in March 2022[6]
Camrelizumab
卡瑞利珠单抗
Jiangsu Hengrui
PD-1 antibodyApproved in China for several cancers[7]Not FDA-approved (with rivoceranib for liver cancer: third Complete Response Letter July 2026; new FDA date April 9, 2027)[7]
Satricabtagene autoleucel (CAR-T)
舒瑞基奥仑赛
CARsgen Therapeutics
Claudin18.2 CAR-T cell therapyApproved June 22, 2026 for Claudin18.2-positive, HER2-negative advanced gastric cancer after two or more lines of therapy[8]Not approved in the US; first CAR-T approved anywhere for a solid tumor[8]

US status checked Nov 7, 2026. FDA decisions can change this list at any time — the ivonescimab decision is due November 14, 2026.

China also approved 10 CAR-T therapies

Most of China's 10 approved CAR-T products are not available in the US. See CAR-T therapy in China.

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Sources

Last verified: Nov 7, 2026. We re-check official pages regularly; rules and prices can change without notice. How we update

  1. Ivonescimab approved in China by NMPA for first-line squamous NSCLC (third China approval; not approved by any other regulator) — Summit Therapeutics (press release), published Aug 2026. Checked Nov 7, 2026.
  2. FDA accepts ivonescimab BLA with November 14, 2026 PDUFA date — Yahoo Finance, published Jan 2026. Checked Nov 7, 2026.
  3. Akeso news: cadonilimab (approved in China for cervical cancer, 2022) — Akeso, Inc.. Checked Nov 7, 2026.
  4. FDA OKs Phase 3 cadonilimab/chemo trial in HER2-negative gastric cancer — CancerNetwork. Checked Nov 7, 2026.
  5. Disitamab vedotin granted FDA breakthrough therapy designation in bladder cancer — Urology Times. Checked Nov 7, 2026.
  6. Lilly announces Complete Response Letter for sintilimab (first-line nonsquamous NSCLC) — Eli Lilly and Company, published Mar 24, 2022. Checked Nov 7, 2026.
  7. FDA sets PDUFA date for rivoceranib/camrelizumab resubmission after third CRL in unresectable HCC — CancerNetwork. Checked Nov 7, 2026.
  8. 全球首款实体瘤CAR-T细胞治疗产品在中国获批上市 (World's first solid-tumor CAR-T approved in China) — The Paper, published Jun 22, 2026. Checked Nov 7, 2026.

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