China: the second engine of cancer drug development

Digestive cancers dominate. Stomach, liver and oesophageal cancer sit in the top five by deaths, driven by chronic hepatitis B, Helicobacter pylori, salted and pickled food, hot beverages and alcohol, and concentrated in rural high-incidence belts (Taihang mountains, Huai river basin, Qidong). Most are diagnosed late, where five-year survival is low.

Universal newborn hepatitis B vaccination since 1992 (free since 2005) is already cutting liver cancer: the Qidong cluster-randomised trial showed in Qidong, Jiangsu, 39,292 newborns vaccinated between 1985 and 1990 (34,441 unvaccinated controls) had 84% (95% CI 23 to 97%) protection against HBV-related primary liver cancer before age 30 and 72% lower HBsAg carriage by young adulthood. The National Cancer Center runs endoscopic screening for oesophageal and stomach cancer in high-incidence rural counties and liver ultrasound plus AFP screening in HBV carriers. Chemo-immunotherapy from five Chinese PD-1 trials (JUPITER-06, ESCORT-1st, RATIONALE-306, ORIENT-16, CARES-310) is now first-line standard in oesophageal, gastric and liver cancer, and the first Claudin 18.2 CAR-T (Satricabtagene autoleucel) was approved for gastric cancer in 2025.

Survival lags rich countries. Age-standardised five-year relative survival for all cancers was 30.9% in 2003 to 2005 and remains well below the roughly two-thirds seen in the US, Japan and Western Europe, with wide urban-rural and east-west gaps in stage at diagnosis and access to specialist care.

The Healthy China 2030 outline (2016) set a national target to raise the overall cancer five-year survival rate by 15 percentage points by 2030 and lift life expectancy to 79.0 years; the Healthy China Action (2019) made cancer one of fifteen special actions with screening, early diagnosis and standardised treatment goals. Survival has improved from 30.9% in 2003 to 2005 to 43.7% in 2019 to 2021. National quality-control centres, tumour boards and CSCO and CACA guidelines aim to standardise treatment across provinces.

Paying for innovation. Until 2017 most new targeted drugs and all PD-1 antibodies were self-pay, out of reach for the majority; catastrophic spending on cancer drugs was common, and a listed drug could still be unavailable if hospitals declined to stock it because of budget caps.

The National Healthcare Security Administration (National Healthcare Security Administration) now negotiates the National Reimbursement Drug List every year: the 2017 negotiation listed 15 targeted anticancer medicines and cut the cost per defined daily dose by 48.9% on average; the dedicated 2018 oncology round added 17 innovative anticancer medicines to the list; since 2019 dozens of oncology drugs join each round at discounts usually above half, and for metastatic lung cancer drugs the largest price fall comes at NRDL negotiation (median 54.8% reduction). Renewal rules cap further cuts for drugs already listed (of 104 anticancer drugs negotiated between 2017 and 2023, 68 went through renewal negotiations), a dual-channel policy (2021) lets designated pharmacies dispense listed drugs when hospitals do not, and provincial supplementary insurance (huiminbao) covers some drugs still off the list. The trade-off: prices so low that some Western drugs are not launched in China, and cell therapies (list prices above CN¥ 1 million) remain unlisted.

China-only evidence travels badly. Registration trials run entirely in China with chemotherapy comparators (sintilimab's ORIENT-11) were rejected by the FDA in 2022, and camrelizumab plus rivoceranib has drawn three complete response letters over inspections and trial conduct, so Chinese PD-1s reached Western patients years late or not at all.

The NMPA and CDE reforms since 2015 (backlog cleared, ICH membership 2017, acceptance of overseas data, breakthrough and conditional pathways) made Chinese trials faster; companies now run multiregional confirmatory studies (RATIONALE-302 for tislelizumab, HARMONi-3 for ivonescimab, ASTRIDE for serplulimab, FRESCO-2 for fruquintinib) and license Western rights to partners who run them. Tislelizumab, toripalimab, penpulimab, fruquintinib, zanubrutinib, ensartinib and ciltacabtagene autoleucel now hold FDA approvals.

Quantity over differentiation. More than a dozen PD-1 and PD-L1 antibodies are approved in China, many for the same indications, and the resulting price war has left most of them unprofitable; me-too kinase inhibitors crowd the EGFR, ALK and BTK classes.

The next wave is differentiated: PD-1 x VEGF and PD-1 x CTLA-4 bispecifics (Ivonescimab, Cadonilimab), topoisomerase-payload ADCs (Sacituzumab tirumotecan, Trastuzumab rezetecan, Izalontamab brengitecan), fully human BCMA CAR-Ts and solid-tumour CAR-Ts, and BTK degraders. Western pharma is buying it: the deals below total tens of billions of dollars in headline value, most signed since 2023.

Nasopharyngeal carcinoma is endemic in Guangdong, Guangxi and Hong Kong, tied to Epstein-Barr virus, and until 2018 had no approved immunotherapy anywhere.

Sun Yat-sen University Cancer Center trials under Jun Ma and colleagues set induction chemotherapy and EBV DNA-guided treatment; JUPITER-02 made toripalimab the first PD-1 antibody approved for nasopharyngeal cancer in China (2021) and the US (2023), with penpulimab following in 2025. Plasma EBV DNA screening of 20,174 asymptomatic men in Hong Kong found 34 nasopharyngeal cancers, 71% at stage I or II versus 20% in an unscreened historical cohort, pointing to a screening route for endemic regions.