Legend Bio's cilta-cel has been approved by the FDA for the launch of domestic CAR-T target competition

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On February 28th, Eastern Time, the US FDA officially approved Legend Bio’s BCMA-targeting chimeric antigen receptor T cell (CAR-T) product, Ciltacabtagene autoleucel (cilta-cel, Cidaki Orenza, trade name Carvykti) )

cilta-cel is a BCMA-targeted CAR-T therapy independently developed by Legend Bio for the treatment of adult relapsed and/or refractory multiple myeloma (R/RMM), containing a 4-1BB co-stimulatory structure domain and two BCMA-targeting single-domain antibodies

This time, Legend Bio cilta-cel was officially approved for listing in the United States, becoming the first successful example of China's first self-developed CAR-T product to go overseas

cilta-cel: Legend Bio's CAR-T therapy "leader"

cilta-cel is Legend Bio’s product that became famous in one fell swoop, and there was no lack of “charm” in terms of regulatory dynamics before:

In 2018, the therapy obtained the first CAR-T clinical trial application (IND) approval from the China National Medical Products Administration and IND approval from the US FDA; Breakthrough Therapy Designation granted by the U.

It is reported that the submission of cilta-cel's marketing application (BLA) is mainly based on the results of the pivotal Phase Ib/II CARTITUDE-1 study, which evaluated the efficacy of ciltacel in patients with relapsed and/or refractory multiple myeloma and security

At a median follow-up of 12.

In addition to the previously outstanding clinical data, at the 40th JPMorgan Chase Healthcare Annual Conference not long ago, Dr.

In addition to this cilta-cel, which is running at the end of regulatory victory, in the field of hematology, Legend Bio has developed single-target/dual-target/triple-target CAR-T products targeting multiple potential targets, including BCMA, CD4, CD20, CD33/CLL-1, CD19/CD20/CD22,

It is worth noting that earlier this month, Legend Bio received an email from the FDA stating that the Phase I clinical trial of its LB1901 was suspended

In the field of solid tumors, Legend Bio has developed a number of products to deal with gastric cancer, liver cancer, small cell lung cancer, non-small cell lung cancer and ovarian cancer.

In addition, Legend Bio also owns a Chimeric Antigen Receptor Natural Killer Cell (CAR-NK) platform

The CAR-T market has broad prospects, and the first targeted BCMA product is facing its rivals

CAR-T (Chimeric Antigen Receptor T-Cell Immunotherapy) cell therapy has been proven to be a powerful weapon against blood cancers

Up to now, the US FDA has approved 6 CAR-T cell therapies, of which four target CD19 and two target BCMA

On the market side, according to Frost & Sullivan, the global CAR-T cell therapy market has grown from US$100 million in 2017 to US$700 million in 2019 and US$1.

According to the 2021 results announcements recently released by major pharmaceutical companies:

Novartis' Kymriah, the first to go public, has sales of $587 million in 2021, up 24% year over year

And cilta-cel, as the world's second approved BCMA-targeting CAR-T therapy, is the most direct competitor after it - Abecma from Bristol-Myers Squibb from the same track.

However, based on previous clinical data, Abecma-treated patients with prior Category 3 therapy had a median OS of 24.
8 months, ORR was 73%, and 33% of patients achieved CR
.
As mentioned above, the clinical data of Legend Bio cilta-cel showed that its ORR reached 98%, 80% of patients achieved sCR, and the safety also had certain differentiated advantages
.

It can be seen that the sales of cilta-cel in the future may be slightly better
.

It is understood that the legendary creature has been favored by the giant MNC long before cilta-cel took shape
.
In December 2017, Legend Bio reached a global cooperation and licensing agreement with Janssen, a subsidiary of Johnson & Johnson
.
According to the cooperation agreement, in the Greater China region, Legend Bio and Janssen jointly bear the costs and share the benefits in a ratio of 7:3; in other regions of the world, the two companies will share 50-50
.

At present, Legendary Bio has received an upfront payment of $350 million and a milestone payment of $250 million
.

Domestic companies are unwilling to lag behind, and CAR-T target competition is poised to take off

Domestically, the State Food and Drug Administration has approved the listing of two CAR-T products, both targeting CD19
.
These two products are Fosun Kite's akirenxe injection and WuXi Junuo's Ruijiorenxe injection.
It is reported that both products are co-introduced products.
Kate was introduced to Kite Company, and Ruiki Orenza Injection was introduced to Juno Company by WuXi Ju Nuo
.

It is worth mentioning that on February 27, WuXi Junuo announced that the second indication of its CAR-T product, Ruiki Aurenzai Injection, has been accepted by the State Food and Drug Administration for the treatment of recurrence.
or refractory (r/r) follicular lymphoma (FL)
.

In addition, domestic companies such as Heyuan Bio, Keji Pharmaceutical, and Yimiao Shenzhou have actively joined in, and all of their products have entered the clinical stage
.
Its research and development targets mainly focus on CD19, followed by BCMA, and there are also dual-target products
.

Reference source: Yaodu "Global CAR-T Therapy R&D Guide"