CAR-T cell therapy has flourished since its first use in 2010, leading to eight approved medicines for various blood cancers. But adapting the powerful technique, which involves engineering a patient’s own T cells to fight cancer, to solid tumors has proven a vexing challenge.
Last week, a biotech finally broke through, securing approval to market a CAR-T therapy designed to attack gastric tumors. But the breakthrough didn’t come from a U.S. industry hub like Boston or San Francisco, nor did the science underlying it originate at leading American research institutions like the University of Pennsylvania or the National Cancer Institute, where scientists pioneered CAR-T decades ago.
Instead, it was Shanghai-based CARsgen Therapeutics that was the first to successfully develop a solid tumor CAR-T. On June 22, China’s National Medical Products Administration granted CARsgen the right to sell satricabtagene autoleucel (satri-cel) to treat advanced gastric or gastroesophageal junction adenocarcinomas that are HER2-negative and Claudin18.2-positive.
“This is great news,” Carl June, M.D., who led the development of the first CAR-T therapy at Penn, said of the approval. “It is the first large market approval for any CAR-T. This will help maintain momentum for the field, which has so much progress with in vivo therapy and autoimmune diseases.”
The man behind satri-cel, Zonghai Li, M.D., Ph.D., was “homegrown in China,” he told Fierce Biotech in an interview, completing all of his education and training in the country. While screening potential CAR-T targets as a professor at Shanghai Cancer Institute, Li noticed that a transporter protein called Claudin18.2 was overly abundant on stomach cancer cells.
“It's not expressed in normal stomach stem cells,” Li explained. He had started working on CAR-T cells in 2010, but founded CARsgen Therapeutics after recognizing he didn’t have the funds to support trials for his numerous prospects.
CARsgen debuted in 2014 with a series A led by Chinese private equity firm BVCF and soon after launched studies for different CAR-T candidates in liver cancer and glioblastoma. A phase 1 trial for what would become satri-cel was not far behind, kicking off at Shanghai’s Changhai Hospital in 2017.
With satri-cel now approved in heavily pretreated patients, Li is determined to move the breakthrough therapy into earlier lines of treatment and even into the adjuvant setting for various solid tumors.
At the annual meeting of the European Society for Medical Oncology in 2025, the biotech presented data showing that five of six patients who received satri-cel following surgical removal of pancreatic tumors remained free of recurrence six months later.
“For patients at high risk of recurrence after surgical resection of pancreatic cancer, there are currently very few effective treatment options,” Li said in CARSgen’s release at the time, calling pancreatic cancer adjuvant therapy a “highly challenging setting.”
Speaking with Fierce, Li said he’s excited to see how satri-cel could perform in pancreatic cancer when paired with RAS inhibitors, which have recently been made extremely popular by Revolution Medicine’s superstar candidate, daraxonrasib.
But while satri-cel may soon broaden its reach to more and more Chinese cancer patients, the game-changing cell therapy is unlikely to hit the U.S. market anytime soon. A phase 1/2 trial of the CAR-T in the U.S. and Canada was hit with a clinical hold in December 2023 after an FDA inspection flagged CARsgen’s North Carolina facility for manufacturing issues.
“We built up the facility in 2022, during COVID-19,” Li recalled. Working remotely, “it was really hard to build up a strong leadership team there.”
When he finally was able to visit the site in person himself, the CEO was unsatisfied, he told Fierce.
Though the hold was lifted about a year later, Li said it will take time for the biotech to re-establish its efforts with the FDA. The focus for CARsgen right now will be to bring satri-cel to earlier lines and advance the rest of its pipeline in China.
That said, interest in satri-cel is strong among U.S. physicians, Li said, with many sending emails asking for chances to collaborate. The ultimate goal is to bring each of the company’s therapies global, he added.
“We are developing the global plan on each product,” Li said. “We need to take time to do that.”
Beaten to the punch
While celebrating CARsgen’s monumental China approval, leading CAR-T researcher June has in the past expressed dismay over regulatory hurdles standing in the way of similar cell therapy progress in the U.S.
Speaking to Fierce in April at the American Association for Cancer Research annual meeting, June highlighted as an example one of his lab’s “armored” CAR-T cells. These cells are engineered to target CD19, a common CAR-T target, while also secreting interleukin-18 in order to boost the cells’ potency.
Though June had the results in 2016 and published the paper outlining the technique in 2017, it wasn’t until 2025 that he was able to run an investigator-initiated trial at Penn with 21 patients.
“We had an 80% response rate in that trial and there was no difference in the toxicity,” June said. “But the sad thing is, I had that back in 2016 in my lab.”
“In China it would be done a year later,” June continued. He said the FDA used to be more lenient with academic trials, but “bureaucratic mission creep” has gummed up the works.
The biggest hang-ups for early CAR-T trials come back to manufacturing requirements and the need for investigational new drug (IND) approval from the FDA and ethical approval from institutional review boards (IRBs). The agency has made some noise about reforms to these early-stage trial processes throughout the second Trump administration, but has only just recently formally announced plans to act.
“It makes sense to streamline unnecessary steps that may be impeding phase 1 research,” Holly Fernandez Lynch, a medical ethicist at the University of Pennsylvania School of Medicine, told Fierce after the FDA’s June 22 announcement. “But I’m concerned that there is so little discussion of ethical oversight.”
“These are the riskiest studies and they are often done in healthy subjects,” Lynch went on. “I’d like more than hand-waving about how they are going to be held to the highest ethical standards.”
Whether June gets his wish for a smoother regulatory process or not, it’s likely a matter of when, and not if, the U.S. gets its first solid tumor CAR-T therapy. Companies ranging from pharma giants like AstraZeneca and Johnson & Johnson to nimble biotechs like Allogene Therapeutics are angling to be the first across the FDA finish line.