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Recent popular reports from Yimaike ★ Invitation to the event2021 Oncolytic Virus Drug Development Forum is about to open in Shanghai ★ How to gain a place in the fierce competition? Focus on the protein expression market and master the biopharmaceutical secrets.
Click on the picture and register now.
May 28, 2021/MedClub News/--Legendary Bio announced that the US FDA has accepted its BCMA CAR-T cell therapy ciltacabtagene autoleucel ( cilta-cel) Priority review of the Biological Agent License Application (BLA), the PDUFA date has been confirmed as November 29, 2021.
Recommended reading: Legendary Bio-BCMA CAR-T’s request for accelerated review of the EU listing application has been approved.
It is expected to be submitted in the first half of the year.
Yimai Meng revealed the last CAR-T listing application form at the end of 2020? Legendary biological BCMA CAR-T completes the fifth milestoneYimai Meng broke the news that cilta-cel (Ciltacabtagene autoleucel; JNJ-68284528; LCAR-B38M) is a CAR-T under development that targets B cell maturation antigen (BCMA) Therapies, which carry two antibody protein domains targeting BCMA, are used to treat relapsed and/or refractory multiple myeloma (R/R MM) in adults.
This CAR-T therapy was jointly developed by Nanjing Legend Biotech and Janssen Company.
It is the first Chinese self-developed cell therapy to receive FDA approval for clinical trials.
▲ Schematic diagram of the structure of cilta-cel (picture source: Legend Biotech's official website) In December 2020, Legend Bio has begun to submit a rolling application for cilta-cel's Biologics License (BLA) to the US FDA for the treatment of multiple myeloma.
In addition, cilta-cel has been awarded the breakthrough therapy and orphan drug designation by the FDA, and the orphan drug and priority drug (PRIME) designation and accelerated review by the European Medicines Agency.
At the same time, this CAR-T therapy is also China's first breakthrough treatment variety.
Recommended reading: Focus on the BCMA target: China ushered in the first "breakthrough therapy", and the United States and Europe have supported its approval for listing.
Huang Ying, CEO and CFO of Yimai New Observation Legend Biotech, said: "According to reports so far As a result of the study, Cilta-cel has shown great promise in the treatment of highly preconditioned multiple myeloma patients.
Today’s priority review and approval of this cell therapy is another important milestone.
We look forward to continued cooperation with Janssen , And cooperation with the FDA to bring this conversion therapy to patients who need new treatment options.
"The regulatory submission of Cilta-cel is based on the results of the pivotal Phase 1b/2 CARTITUDE-1 study.
A total of 97 patients were accepted.
In cilta-cel treatment, CAR-T cells of all patients were successfully prepared.
The results of the study showed a consistently high overall response rate (ORR), with a median follow-up time of 12.
4 months, the ORR was as high as 97%, and with the passage of time, the patient’s remission further deepened, and 67% of the patients reached a strict Complete remission, 26% had very good partial remission (≥VGPR remission rate was 93%) and 4% had partial remission.
Reference materials: 1.
https:// Yimike has always been committed to original news reports such as cutting-edge technologies, industry trends, and industry insights in bio-innovative drugs.
160,000+, of which industrial users account for more than 50%, scientific research and clinical users are about 30%, and investment institutions account for more than 5%.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
Click on the picture and register now.
May 28, 2021/MedClub News/--Legendary Bio announced that the US FDA has accepted its BCMA CAR-T cell therapy ciltacabtagene autoleucel ( cilta-cel) Priority review of the Biological Agent License Application (BLA), the PDUFA date has been confirmed as November 29, 2021.
Recommended reading: Legendary Bio-BCMA CAR-T’s request for accelerated review of the EU listing application has been approved.
It is expected to be submitted in the first half of the year.
Yimai Meng revealed the last CAR-T listing application form at the end of 2020? Legendary biological BCMA CAR-T completes the fifth milestoneYimai Meng broke the news that cilta-cel (Ciltacabtagene autoleucel; JNJ-68284528; LCAR-B38M) is a CAR-T under development that targets B cell maturation antigen (BCMA) Therapies, which carry two antibody protein domains targeting BCMA, are used to treat relapsed and/or refractory multiple myeloma (R/R MM) in adults.
This CAR-T therapy was jointly developed by Nanjing Legend Biotech and Janssen Company.
It is the first Chinese self-developed cell therapy to receive FDA approval for clinical trials.
▲ Schematic diagram of the structure of cilta-cel (picture source: Legend Biotech's official website) In December 2020, Legend Bio has begun to submit a rolling application for cilta-cel's Biologics License (BLA) to the US FDA for the treatment of multiple myeloma.
In addition, cilta-cel has been awarded the breakthrough therapy and orphan drug designation by the FDA, and the orphan drug and priority drug (PRIME) designation and accelerated review by the European Medicines Agency.
At the same time, this CAR-T therapy is also China's first breakthrough treatment variety.
Recommended reading: Focus on the BCMA target: China ushered in the first "breakthrough therapy", and the United States and Europe have supported its approval for listing.
Huang Ying, CEO and CFO of Yimai New Observation Legend Biotech, said: "According to reports so far As a result of the study, Cilta-cel has shown great promise in the treatment of highly preconditioned multiple myeloma patients.
Today’s priority review and approval of this cell therapy is another important milestone.
We look forward to continued cooperation with Janssen , And cooperation with the FDA to bring this conversion therapy to patients who need new treatment options.
"The regulatory submission of Cilta-cel is based on the results of the pivotal Phase 1b/2 CARTITUDE-1 study.
A total of 97 patients were accepted.
In cilta-cel treatment, CAR-T cells of all patients were successfully prepared.
The results of the study showed a consistently high overall response rate (ORR), with a median follow-up time of 12.
4 months, the ORR was as high as 97%, and with the passage of time, the patient’s remission further deepened, and 67% of the patients reached a strict Complete remission, 26% had very good partial remission (≥VGPR remission rate was 93%) and 4% had partial remission.
Reference materials: 1.
https:// Yimike has always been committed to original news reports such as cutting-edge technologies, industry trends, and industry insights in bio-innovative drugs.
160,000+, of which industrial users account for more than 50%, scientific research and clinical users are about 30%, and investment institutions account for more than 5%.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
