On August 28th, according to Cai Lian News, Legend Biotech's CAR-T therapy, Xydacilon Saline Injection (brand name: Kawei), which has a global sales of over $0.3 billion in H1 this year, was approved for marketing in China on the 27th. In order to increase commercial value, domestic CAR-T companies, in addition to exploring more indications, will continue to participate in national negotiations this year, hoping to be included in medical insurance.

Industry experts analyze that CAR-T therapy has broad application prospects. In this year's medical insurance negotiations, the national negotiation team and pharmaceutical companies will become more rational in assessing the value of CAR-T therapy.

The third domestically launched targeted BCMA CAR-T therapy.

On August 27th, Legend Biotech announced that its CAR-T therapy, Kawei, has been approved by the National Medical Products Administration (NMPA) for marketing. It is used to treat relapsed or refractory multiple myeloma (R/R MM) in adult patients who have received at least three lines of treatment (including the use of a proteasome inhibitor and an immunomodulator).

It is worth noting that Xydacilon Saline Injection targets BCMA, and its target and indications are the same as those of the already marketed Eliotheon Saline Injection and Zevoki Saline Injection.

Before the launch of Xydacilon Saline Injection, there were already 5 CAR-T therapies approved for marketing in China, with prices ranging around millions of RMB per vial. They are Akilon Saline Injection from Fosun Kite, Ruthilon Saline Injection from Ascletis-B (02126.HK), Eliotheon Saline Injection from Reindeer Biotechnology, Nakilon Saline Injection from Heyuan Biotechnology, and Zevoki Saline Injection from Koji Pharmaceutical-B (02171.HK).

The issue of the high price of CAR-T therapy has always attracted market attention, but Legend Biotech has not responded to questions about product pricing or other related issues.

In December 2017, Legend Biotech signed a global exclusive license and collaboration agreement with Johnson & Johnson's subsidiary Janssen, to develop and commercialize Sadaclorin. Legend Biotech is responsible for market development and commercialization in the Greater China region, while Johnson & Johnson will lead in other regions worldwide. Prior to this, the drug has already been approved for the same indication in the United States, European Union, and Japan.

Sadaclorin injection has brought considerable returns to Legend Biotech overseas. According to Johnson & Johnson's second quarter financial report released in July, the global sales of the drug in the first half of this year reached 0.343 billion US dollars, a year-on-year increase of 81.5%. In Q2, the sales reached 0.186 billion US dollars, a year-on-year increase of 59.8%.

"Four battles" in CAR-T therapy's path to commercialization

In addition to the original indications, CAR-T therapy is continuously expanding its treatment areas to gain a larger market.

On the 27th, WuXi AppTec announced that its drug Ritclorin injection (trade name: Benoda) has obtained marketing approval for a new indication, which is the treatment of adult relapsed or refractory mantle cell lymphoma (r/r MCL) patients who have undergone second-line or higher systemic therapy, including Bruton's tyrosine kinase inhibitors (BTKi).

This is the third marketing approval application submitted by WuXi AppTec for Benoda. In addition, in April, Kite's CAR-T therapy obtained FDA approval for second-line treatment of multiple myeloma (MM), making it the first and only CAR-T therapy for second-line treatment globally. As early as June 2023, Akey's injection (trade name: Yikaide) obtained official approval from the National Medical Products Administration for the second indication, which is adult diffuse large B-cell lymphoma that is refractory to first-line immunotherapy or relapsed within 12 months after first-line immunotherapy.

When contacted by reporters from CaiLian Press regarding the market prospects after the approval of the new indication for Benoda, and the competition landscape of CAR-T therapy, WuXi AppTec has not yet responded as of the time of publication.

Wang Heng, General Manager of Beijing BestPower Marketing and Planning Co., Ltd., said in an interview with CaiLian Press that CAR-T therapy has broad application prospects. In theory, after gaining clinical experience, CAR-T therapy will gradually expand to common cancers. Currently, CAR-T therapy is in an imperfectly competitive market. In the future, on the one hand, as the application volume increases, costs will be reduced through cost-sharing. On the other hand, due to the continuous entry of new products, competition will inevitably lead to price reductions. The key to promoting CAR-T therapy now lies in price.

Due to the highly personalized nature of CAR-T therapy, its price is very expensive, and the price of hundreds of thousands of yuan per dose in the Chinese market often makes people hesitate.

In January this year, Fosun Kite launched China's first lymphoma value-based payment plan: eligible patients using Yescarta for treatment, if they fail to achieve complete remission (CR), will receive a refund of up to 0.6 million RMB.

In addition to introducing innovative payment methods, CAR-T therapy is also hoping to enter the national medical insurance. Akynzeo injection, Rykuzeo injection, Nakynzeo injection, and Ikyzeo injection all appeared in this year's initial national medical insurance negotiation list. Earlier, Akynzeo injection and Rykuzeo injection caused a stir by appearing in the initial national medical insurance negotiation list in 2023, but ultimately both CAR-T therapies failed in the medical insurance negotiation. This year is already the fourth time CAR-T therapy has "fought" in the national negotiation.

Wang Heng's analysis believes that the key to whether negotiations can be successful lies in the price. Through the negotiations of previous years, both the national negotiation team and pharmaceutical companies have become more rational about the value of CAR-T therapy. This year, perhaps both sides can bite the bullet and accept a price that is more acceptable, allowing more patients to benefit.