Foreign cancer patients are drawn to China to use a world-leading China-developed treatment that targets solid tumors. Shanghai-based biopharmaceutical company CARsgen Therapeutics Holdings’ satricabtagene autoleucel (satri-cel) treatment uses chimeric antigen receptor (CAR) T-cell therapy, involving collecting T cells from a patient’s blood and genetically modifying them before re-infusing them into the body so they can better recognize and attack cancer cells.
The new procedure was given the all clear by the National Medical Products Administration (NMPA) in June. It is the world’s first approved CAR T-cell therapy for the treatment of solid tumors. Until satri-cel’s arrival, commercial CAR T-cell products had been restricted to treating blood cancers. Conquering solid tumors, which make up most human cancers, marks a monumental leap for Chinese biotechnology, medical experts said.
The breakthrough is mirrored by rapid commercial expansion of treatments, after the Administration approved nine of the world’s 17 commercial CAR T-cell treatments, seven of which were developed in China. China is neck-and-neck in a race with the United States for industry dominance. Of the top 10 institutions driving the world’s 1,520 CAR T-cell research and development pipelines, half are from the Chinese mainland. Leading the pack is the Shenzhen Geno-Immune Medical Institute in Guangdong province, with 98 R&D pipelines. Fueled by a massive patient pool, rapid iteration as well as improved insurance and payout systems, China’s CAR T-cell market is exploding and is forecast by one industry analysis to grow from USD900 million last year to USD16.18 billion by 2035. However, hurdles must be overcome for global expansion, including challenges such as the different classification of infectious materials in various jurisdictions and the transportation of “living drugs”.
Hematologist Kwong Yok-lam, who heads the hematology, oncology and bone marrow unit at the University of Hong Kong, said he is unsurprised by the satri-cel breakthrough. It mirrors historical drug development, where innovations emerge for treating blood cancers that are later expanded to treat solid tumors, he said. Kwong helped introduce equecabtagene autoleucel (Fucaso), a multiple myeloma CAR T-cell therapy from IASO Biotechnology based in Nanjing, Jiangsu province to Hong Kong. In December 2024, a 73-year-old advanced myeloma patient became the first person in Hong Kong to be treated with Fucaso through the city’s Named Patient Program, a pathway for drugs not yet registered in Hong Kong but having already received approval for use on the mainland. Fucaso became the first mainland-produced CAR T-cell treatment registered in Hong Kong.
IASO Biotechnology has proved that supplying CAR T-cell treatments to other markets is viable, paving the way for Singapore, Saudi Arabia, South Korea and Japan to acquire them. “The process wasn’t easy,” said Zhang Jinhua, Founder of IASO Biotechnology. A patient’s blood samples are classified as “Category A” – infectious substances that require strict customs clearance – and have to reach a laboratory within 48 hours. Hong Kong’s Department of Health inspected IASO’s Nanjing factory for compliance with international Good Manufacturing Practices. “By keeping core production on the Chinese mainland, we can better control costs. Fucaso is priced at about one-third to one-half of comparable U.S. CAR T-cell therapies,” said Zhang. Since the launch of Fucaso in 2023, at least 60 patients from more than 10 countries and regions have traveled to China to receive treatment.
Zhang expects that within three years, overseas revenue will grow from 10% to 50% of total revenue. As the overseas market expands, IASO’s new production capacity will also scale up to 3,000 batches a year. Hong Kong registration has helped Fucaso enter international insurance networks, she added. The city is also IASO’s natural launchpad for global expansion. Singapore gave Fucaso the green light in June, and Zhang expects Saudi Arabia to do the same this year.
At the commercial vanguard of CAR T-cell therapy is Carvykti, a drug produced by Nanjing-based Legend Biotech that targets multiple myeloma. Carvykti is the first Chinese CAR T-cell product approved by the U.S. FDA. The drug is available in 18 markets, and has so far been used to treat more than 10,000 multiple myeloma patients, according to Legend Biotech’s first-quarter financial report. Following strong sales of about USD1.9 billion (up 96% year-on-year) in 2025, Carvykti had USD597 million in sales in the first quarter of this year, up 62% year-on-year and cementing its position as the world’s top-selling CAR T-cell product. IASO Biotechnology’s Zhang is hopeful China’s innovative drugs will win a significant market share within five years, driven by unrivaled research and development efficiency, rapid clinical trials and superior cost control, the China Daily reports.
