China has approved a radically new — but potentially transformative — therapy to use as the last line of defense for a type of aggressive blood cancer, the country’s drug regulator announced Wednesday.

China’s National Medical Products Administration approved the first ever CAR T-cell therapy product in the country, used to treat large B-cell lymphoma in patients where other treatments fail or the cancer relapses. The Yescarta drug uses re-engineered immune cells to kill cancer cells in the body and is usually administered as a single-dose injection.

“This is an absolutely major step in China’s cancer field,” Wang Haopeng, a CAR T expert and professor at the ShanghaiTech University, told Sixth Tone. “Its approval will pave the way for future CAR T-cell therapies.”

Yescarta will be manufactured by the Fosun Kite Biotechnology Co., Ltd., a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and U.S. Kite Pharma, Inc. Fosun Kite has obtained the rights to sell it in the Chinese mainland — as well as in Hong Kong and Macao. Currently, the drug is only approved for adults.

Under CAR T-cell therapy treatment, doctors would extract the immune cells from the cancer patient and send them to a lab, where the cells are modified, according to the American Cancer Society. The patient would then receive a transfusion of the altered cells that have the ability to attack cancer cells in the body.

Unlike traditional cancer therapy such as chemotherapy and radiation, the CAR T-cell therapy is tailored to individual patients. The modified cells could exist in the body over years and continue to suppress the cancer, according to Wang.

According to Kite, the treatment has shown a 72% response rate and a 51% complete remission rate in clinical trials. The U.S. approved the Yescarta treatment in 2017, followed by marketing authorization by the European Union regulator the year after.

The Yescarta drugs are, however, costly. While it remains unclear how much Yescarta would cost in China, the single-dose injection treatment costs $373,000 in the U.S.

“I suspect they will set a lower price in China because the market will become much more competitive once more domestic companies produce their own CAR T-cell products,” Wang said, adding that some imported drugs in China have lost their market shares because of their high price tags.

Given the market potential, more Chinese companies are attempting to develop their own CAR T-cell therapies. According to data published in medical journal The Lancet in April, China has registered over 300 CAR T-cell clinical trials — the highest in the world.

While CAR T-cell therapies are seen as a cutting-edge cancer treatment, ensuring the durability of the drugs — how long the cancer-suppressing effects last — remains a significant challenge, according to Wang.

“Yescarta doesn't have the best record in terms of how long it can last in the body compared with some other products available elsewhere,” he said. “So I am waiting to see the long-term disease control rate among recipients over the next few years.” 

The International Agency for Research on Cancer, which is part of the World Health Organization, estimates that there were approximately 727,000 new cases of lymphoma in China in 2020. However, no exact numbers exist for patients eligible for the CAR T-cell therapy.

Editor: Bibek Bhandari.

(Header image: View Stock/People Visual)