On January 2, GenScript Biotechnology recently announced that the marketing application for new drugs submitted by subsidiary Legend Biologics has been accepted
by the State Food and Drug Administration.
If approved, this will become the third CAR-T drug
approved for marketing in China.
It is reported that before this, Fosun Pharma's subsidiary Fosun Kite's Aquilencel injection was approved for marketing in June 2021; WuXi JW Therapeutics' CAR-T cell immunotherapy product for the treatment of relapsed or refractory large B-cell lymphoma in adult patients after two or more lines of systemic therapy was also approved for marketing
in September 2021.
According to the data, Cedarchicel proposed by Legendary Bio is a chimeric antigen receptor T cell (CAR-T) therapy
with two single-domain antibodies targeting B-cell mature antigen (BCMA).
CAR-T is a new type of precision targeted therapy for the treatment of tumors, and in recent years, both overseas and domestic research and development has been very hot
.
In China, incomplete statistics show that the number of CAR-T clinical trials currently carried out has exceeded 500.
Cedakicel received the first clinical trial application (IND) approval for CAR-T cell products from the National Medical Products Administration in March 2018, and became the first product
under development recommended for breakthrough therapy designation in China in August 2020.
As of June 30, 2022, the quarter generated net trade sales of approximately $24 million, or approximately $162 million
.
Legend's marketing application is based on data from a confirmatory clinical study CARTIFAN-1 (NCT03758417/CTR20181007) conducted in China that evaluated the efficacy and safety
of cedarchicel in patients with relapsed or refractory multiple myeloma (RRMM).
As a one-time infusion-administered therapy, this study was used to evaluate cedarchi-cel for the treatment
of adult patients with RRMM who had previously received at least 3 lines of therapy, including a proteasome inhibitor and an immunomodulator and anti-CD38 antibody.
It is worth mentioning that previously, the legendary creature Cedarkioren has been approved
in the United States and the European Union.
In February 2022, cedarcel was approved by the US Food and Drug Administration (FDA), becoming the first cell therapy drug
approved by the FDA in China.
Three months later, the European Commission (EC) granted cedarcel conditional marketing authorization for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who had previously received at least three prior treatments, including immunomodulatory drugs, proteasome inhibitors, and anti-CD38 antibodies
, and had last treated disease progression.
Subsequently, on September 27, Legend Bio announced that the Japanese Ministry of Health, Labor and Welfare had approved cedarchicel for the treatment of adult patients
with relapsed or refractory multiple myeloma (R/R MM).
At present, the industry is very optimistic about the prospect of the launch of cedarchicel new drugs
.
It is reported that as soon as the news of its listing application was accepted, GenScript's stock price rose
accordingly.
On January 4, GenScript's share price climbed as high as HK$27.
45 per share, a new high
in more than four months.
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