(Yicai) Dec. 1 -- Chinese pharmaceutical companies have replied to the US Food and Drug Administration's warnings claiming that chimeric antigen receptor T-cell therapies can cause secondary cancers, saying that the therapies' benefits outweigh the risks.

The risks that the US FDA listed need further observation, an insider from a Chinese biopharmaceutical company said, adding that the benefits brought by CAR T-cell therapies to patients are greater than their risks.

The US FDA said on Nov. 28 that it launched an investigation into CAR-T therapies to find out whether they may be associated with the risk of developing secondary cancers, after receiving reports for 19 cases of T-cell malignancy.

Legend Biotech, the first Chinese biotechnology firm to have its CAR T-cell therapy approved overseas, told Yicai that multiple myeloma patients can develop T-cell malignancies even without receiving CAR T-cell therapies. Other therapies to treat myeloma, such as immunomodulatory drugs and autologous stem cell transplantation, can all hike risks of secondary cancers, the firm added.

JW Therapeutics told Yicai that Relmacabtagene Autoleucel injection, its CAR T-cell therapy, has already cured hundreds of patients, and no risks similar to those noted by the US FDA have been detected so far. The Chinese innovative biotechnology firm believes that the FDA's investigation will not impact the research, development, and commercialization of its products.

CAR-T therapies harness a patient's T-cells, alter them in a lab so that they will attack cancer cells, and then give the modified T-cells back to the patient through injections. Most CAR T-cell therapies approved worldwide are applied to patients with hematologic tumors.

The US FDA has approved six CAR T-cell therapies for marketing, including Yescarta and Tecartus, developed by Kite Pharma, a unit of California-based biopharmaceutical giant Gilead Sciences, Kymriah, developed by Swiss pharmaceutical firm Novartis, and Carvykti, co-developed by Legend Biotech and US multinational Johnson & Johnson.

Meanwhile, four CAR T-cell therapies have been approved for marketing in China. They include Axicabtagene Ciloleucel, developed by Fosunkite, a joint venture between Chinese drugmaker Shanghai Fosun Pharmaceutical and Kite Pharma, and JW Therapeutics' Relmacabtagene Autoleucel.

Prices of CAR T-cell therapies are quite high. In China, they exceed CNY1 million (USD140,634), while overseas, they are about USD450,000.

Editor: Futura Costaglione