On March 1, legendary biology, a US listed company, announced that its product cilta cel (R & D Code: lcar-b38m) was approved by FDA for the treatment of adult recurrent / refractory multiple myeloma (mm). Sidakiolenza has become the first cell therapy product approved by FDA in China and the second car-t cell immunotherapy approved to target BCMA in the world.
Car-t therapy is now known as “sky high price medicine”. At present, there are two approved car-t products in China, both selling for more than one million yuan a shot. In 2017, when the first car-t drug of Novartis, a multinational pharmaceutical company, was approved, the price reached US $475000.
It is reported in the industry that the price of the legendary creature sidakiolensy is more than 460000 US dollars. However, people from legendary biology company told our reporter that the company has not announced the pricing yet.
domestic car-t goes to sea
Following PD-1 immunotherapy, cell therapy represented by car-t therapy has gradually become another emerging therapy in the field of tumor therapy in recent years.
According to the introduction of vivid biology, the approval of sidakiolensea is mainly based on the results of key clinical phase 1B / 2 cartitude-1 research. The latest data show that cilta cel has shown an overall remission rate of up to 98% in patients with recurrent or refractory multiple myeloma who have previously received four or more treatments, including proteasome inhibitors, immunomodulators and anti-CD38 monoclonal antibodies.
On February 10 this year, Cinda bio PD-1 broke through the barrier, and the FDA of the United States was blocked, which hit the sea of innovative drugs, while the car-t product of legendary bio sidakiolensy was approved to be listed in the United States, which rekindled the hope of the innovative drug track, which is now at a freezing point.
In this regard, Li Yifeng, chief researcher of Guangzhou pebble investment pharmaceutical industry, told the Securities Daily that the approval of this drug is also a new milestone and breakthrough in the internationalization of China’s innovative drugs after Baiji Shenzhou zebutinib. This approval further shows that clinical value is one of the core standards of FDA approval. Drugs that can solve the actual clinical needs can still successfully go to sea, which further defines the approval requirements of FDA.
In addition, Bao Gang, a researcher of Rongzhi investment under private placement paipaipai.com, believes that the approval of this drug will not only reshape the logic of the market for innovative drugs to go to sea, but also alleviate concerns about CXO track.
The biggest challenge facing innovative drugs after they are approved for marketing will be handed over to the commercialization team. Baojin steel told reporters that the current challenges of car-t track commercialization include high prices, reducing the accessible population, expanding the indications from hematoma to solid tumor, and optimizing the safety and effectiveness.
It is understood that before the products were approved for listing, legendary biology and Janssen signed a global exclusive license and cooperation agreement in December 2017 to develop and commercialize xidakiolensy.
Legendary biology said that the company and Janssen will start the network of certified treatment centers in phases from 2022, expand production capacity and increase the accessibility of sidakiolensea in the United States, so as to ensure that sidakiolensea is provided to oncologists and their patients in a reliable and timely manner.
domestic car-t accelerated listing
In China, car-t therapy is also the focus of R & D layout, in which the targets are mainly focused on cd-19 and BCMA, involving a small number of other emerging targets. “The competition is quite fierce.” An industry person who declined to be named told reporters.
according to the research report released by Southwest Securities Co.Ltd(600369) Southwest Securities Co.Ltd(600369) , BCMA targets are mainly targeted at multiple myeloma. A total of 114 projects are under research around the world, including 75 bcma-cart projects. Chinese enterprises are the most active in this field, accounting for 48 projects.
Bcma-cart layout of Chinese listed companies includes Cinda biology, Keji pharmaceutical, Xiansheng pharmaceutical, Yaoming junuo, etc. Among them, it is reported that car-t product ct053 of Keji pharmaceutical will apply for NDA in the first half of 2022, which is expected to become the first bcmacar-t in China.
Bao Gang, an intelligent investment researcher under private placement paipai.com, believes that with the rise of car-t popularity, more and more enterprises enter the track. However, CDE (drug examination center of the State Food and Drug Administration) shows that although many clinical trials are ongoing, due to the shortage of clinical resources and large investment in R & D / clinical trials, the progress is slow, and the R & D of car-t products still has a long way to go.
According to media reports, as the first car-t cell therapy approved by FDA, the annual sales of car-t product kymriah2021 of multinational pharmaceutical company Novartis reached 587 million US dollars, a year-on-year increase of 24%. In the future, whether legendary creatures can create commercial “Legends” has attracted much attention.
