The story
Eighteen years from a spliced gene to a licence
The target was found in Mainz. The therapy was built in Shanghai and proven in Beijing. That sequence is the story of satri-cel, and the credit belongs where the work was done.
In 2014 Zonghai Li (李宗海) left a research post at Shanghai Jiao Tong University School of Medicine to found CARsgen (科济药业) at a moment when the entire CAR-T industry was crowding into blood cancers. His reasoning was demographic before it was scientific: China records more than 350,000 new gastric cancers a year, and most of the world's malignancies are solid tumours. He chose the harder problem because it was the bigger one.21
The first Claudin18.2 CAR-T patients anywhere were dosed in China: a Changhai Hospital study opened in 2017, and CT041's own first-in-human trial began at Peking University Cancer Hospital in 2019 under Lin Shen (沈琳), with Changsong Qi (齐长松) as first author of the papers that followed.152 The interim phase 1 results reached Nature Medicine in 2022 — an overall response rate of 48.6% in 37 heavily pre-treated patients, 57.1% in gastric cancer, with no grade 3 cytokine release syndrome and no neurotoxicity.2 The randomised trial recruited from March 2022 to July 2024, was presented at ASCO and published in The Lancet in June 2025, earned China's breakthrough-therapy designation in March 2025, and moved from application to approval in twelve months — the fastest CAR-T review in the country's history.121
2008
The target is namedŞahin and colleagues identify claudin-18 splice variant 2 as a gastric-lineage marker retained and exposed on malignant transformation — "a novel, highly attractive pan-cancer target".32014
CARsgen is founded in ShanghaiZonghai Li leaves academia to build CAR-T for solid tumours while the field builds it for blood.212017 → 2019
First Claudin18.2 CAR-T patients, in ChinaChanghai Hospital opens the first registry-listed study; CT041's first-in-human trial starts at Peking University Cancer Hospital.1522020 → 2021
Western regulators noticeFDA orphan-drug designation (2020), EMA orphan status (2021), and EMA PRIME in November 2021 — the first solid-tumour CAR-T in the scheme; FDA RMAT followed.21222022
Nature MedicinePhase 1 interim results: ORR 48.6%, gastric ORR 57.1%, six-month overall survival 81.2% in gastric cancer.22025
The Lancet, and a breakthrough designationCT041-ST-01: the first randomised CAR-T trial in a solid tumour; PFS hazard ratio 0.37.122 Jun 2026
NMPA approvalThird-line Claudin18.2-positive, HER2-negative gastric/GEJ adenocarcinoma. Launch price 990,000 yuan.1620
Primary sourceThe German discovery and the Chinese therapy are two halves of one arc. Ganymed, the Mainz company Şahin and Özlem Türeci co-founded, turned the same antigen into the antibody zolbetuximab, approved in the United States in 2024 for first-line use.414 CARsgen took the antigen the other way — into a living drug — and China's regulator licensed it first. Of the 26 Claudin18.2 CAR-T studies on the global registry as of September 2026, 24 are Chinese.15

























