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Not long ago, the refusal of Innovent PD-1 to go overseas caused a heated discussion in the industry, and it also made everyone more worried about the difficulty of domestic new drugs going overseas
.
However, there is good news recently that the domestic cell therapy product Sidaji Orenza has been approved by the FDA, which is also a new achievement for domestic new drugs to go overseas
.
It is reported that the U.
S.
marketing application (BLA) of Legend Bio's cilta-ce has been approved by the U.
S.
FDA for the treatment of adult relapsed/refractory multiple myeloma (MM).
Experience an FDA-approved cell therapy product, which is the second BCMA-targeting CAR-T cell immunotherapy approved in the world after Abecma
.
It is understood that cilta-ce is a chimeric antigen receptor T cell (CAR-T) therapy independently developed by Legend Bio.
The product contains two single-domain antibodies targeting B cell maturation antigen (BCMA), which can treat patients In vivo T cells are genetically transduced to express a chimeric antigen receptor (CAR) that recognizes and kills BCMA-expressing cells
.
BCMA is mainly expressed on the surface of malignant multiple myeloma B-lineage cells, advanced B cells and plasma cells
.
In December 2017, Legend Bio granted Janssen the rights to co-develop and promote cilta-cel globally
.
The product received the first CAR-T clinical trial application (IND) approval from the State Food and Drug Administration in 2018, and was approved by the U.
S.
FDA for IND in the same year, and subsequently obtained FDA breakthrough therapy and orphan drug designation, and obtained the European Medicines Agency.
Priority Medicine Designation (PRIME) qualification and breakthrough therapy designation granted by the US FDA, in August 2020, cilta-ce was included in the list of the first breakthrough therapy drug varieties in China
.
In December 2020, Legend Bio submitted a rolling Biologics License Application (BLA) for cilta-cel to the FDA
.
Results from the CARTITUDE-1 Phase 1b/2 study showed an overall objective response rate (ORR) at a median follow-up of 18 months of 98%, of which 80% achieved a strict complete response (sCR), an increase of 13 percentage points from the data published in ASH 2020
.
The 18-month progression-free survival (PFS) rate was 66%, and the overall survival (OS) rate was 81%
.
Patients had received a median of 6 lines of prior therapy (range, 3–18); 88% were triple-resistant and 42% were quintuple-resistant
.
Various data show the advantages of this product, so the progress of its FDA approval has also attracted much attention and expectations in the industry
.
In May 2021, the U.
S.
FDA accepted the BLA application for Sidaki Aurexa and granted priority review status.
However, at the beginning of November, the FDA delayed the review time from November 29 to February 28, 2022.
Reasons Yes, it will take time to review "new information related to updated analytical methods submitted in accordance with FDA information requirements
.
" Now, this domestic cell therapy product has finally been successfully approved, which means that Legend Bio will officially start the commercialization process
.
According to Legend Bio's 2021 annual report released on February 18, the company's sales and marketing expenses in 2021 will be approximately $95.
3 million to $106.
2 million
.
In this regard, the company stated that this was mainly due to the increase in costs associated with the commercial preparation activities of Cidaki Orenza
.
It can be seen that the company has made sufficient preparations for the commercial preparation of the Western Orenza
.
In addition, on June 22, 2021, Legend Bio also announced the establishment of a high-level manufacturing facility in Belgium as part of a joint investment with Janssen to expand global manufacturing capabilities for innovative cell therapies to develop and commercialize cilta cel
.
The manufacturing site will provide strong support for the production and delivery of cilta cel to patients worldwide
.
Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to anyone
.
.
However, there is good news recently that the domestic cell therapy product Sidaji Orenza has been approved by the FDA, which is also a new achievement for domestic new drugs to go overseas
.
It is reported that the U.
S.
marketing application (BLA) of Legend Bio's cilta-ce has been approved by the U.
S.
FDA for the treatment of adult relapsed/refractory multiple myeloma (MM).
Experience an FDA-approved cell therapy product, which is the second BCMA-targeting CAR-T cell immunotherapy approved in the world after Abecma
.
It is understood that cilta-ce is a chimeric antigen receptor T cell (CAR-T) therapy independently developed by Legend Bio.
The product contains two single-domain antibodies targeting B cell maturation antigen (BCMA), which can treat patients In vivo T cells are genetically transduced to express a chimeric antigen receptor (CAR) that recognizes and kills BCMA-expressing cells
.
BCMA is mainly expressed on the surface of malignant multiple myeloma B-lineage cells, advanced B cells and plasma cells
.
In December 2017, Legend Bio granted Janssen the rights to co-develop and promote cilta-cel globally
.
The product received the first CAR-T clinical trial application (IND) approval from the State Food and Drug Administration in 2018, and was approved by the U.
S.
FDA for IND in the same year, and subsequently obtained FDA breakthrough therapy and orphan drug designation, and obtained the European Medicines Agency.
Priority Medicine Designation (PRIME) qualification and breakthrough therapy designation granted by the US FDA, in August 2020, cilta-ce was included in the list of the first breakthrough therapy drug varieties in China
.
In December 2020, Legend Bio submitted a rolling Biologics License Application (BLA) for cilta-cel to the FDA
.
Results from the CARTITUDE-1 Phase 1b/2 study showed an overall objective response rate (ORR) at a median follow-up of 18 months of 98%, of which 80% achieved a strict complete response (sCR), an increase of 13 percentage points from the data published in ASH 2020
.
The 18-month progression-free survival (PFS) rate was 66%, and the overall survival (OS) rate was 81%
.
Patients had received a median of 6 lines of prior therapy (range, 3–18); 88% were triple-resistant and 42% were quintuple-resistant
.
Various data show the advantages of this product, so the progress of its FDA approval has also attracted much attention and expectations in the industry
.
In May 2021, the U.
S.
FDA accepted the BLA application for Sidaki Aurexa and granted priority review status.
However, at the beginning of November, the FDA delayed the review time from November 29 to February 28, 2022.
Reasons Yes, it will take time to review "new information related to updated analytical methods submitted in accordance with FDA information requirements
.
" Now, this domestic cell therapy product has finally been successfully approved, which means that Legend Bio will officially start the commercialization process
.
According to Legend Bio's 2021 annual report released on February 18, the company's sales and marketing expenses in 2021 will be approximately $95.
3 million to $106.
2 million
.
In this regard, the company stated that this was mainly due to the increase in costs associated with the commercial preparation activities of Cidaki Orenza
.
It can be seen that the company has made sufficient preparations for the commercial preparation of the Western Orenza
.
In addition, on June 22, 2021, Legend Bio also announced the establishment of a high-level manufacturing facility in Belgium as part of a joint investment with Janssen to expand global manufacturing capabilities for innovative cell therapies to develop and commercialize cilta cel
.
The manufacturing site will provide strong support for the production and delivery of cilta cel to patients worldwide
.
Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to anyone
.
