Legendary bio-multiple myeloma drug JNJ-68284528 is eligible for EMA priority drug recognition
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, Kingsley Biotech LimitedCompany(http://announced that its subsidiary Legendary Bio and JohnsonPharmaceuticals(http://subsidiary, Janssen Pharmaceuticals, have jointly developed and commercialized thedrug(http://JNJ-68284528 (LCAR-B38M) for the EuropeanMedicines(http://(EMA) (MA)This certified drug is a B-cell mature antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy developed by Legendary Bio, a subsidiary of the Kingsley Group, a subsidiary of the Company of Life Sciences Research and Development Services andProducts(http://The drug was accepted by the State Drug Administration (formerly the State Food and Drug Administration) in 2017 for clinical trial (http:// application (IND), and in 2018 by China CDE and the United States FDA (http:// IND approval, is currently the only BCMA CAR-T in China, the United States, Europe and Europe to conduct simultaneous registration of clinical trials In December 2017, Legendary Bio and Jansen reached a global partnership and licensing agreement to jointly develop and commercialize BCMA CAR-T products Jansen paid Kingsley a $350 million down payment and subsequent milestone payment, setting a record for the maximum amount of granted down payment the Chinese pharmaceutical company's foreign patent (http:// and the best conditions for cooperation Legendary Bio's European headquarters in Dublin was officially launched in March, and is considered by the industry to be another important step in the legendary layout of the global market JNJ-68284528 (LCAR-B38M) is eligible for this priority drug designation and is based on two clinical studies, namely the 1/2-phase LEGEND-2 study of legendary organisms in China to evaluate LCAR-B38M (NC T03090659) and the 1b/2 PHASE ITUDECART-1 study (NCT03548207) of JNJ-68284528, conducted by Jansen Pharmaceuticals in collaboration with Legendary Bio LEGEND-2's findings were published the 2017 American Society of Clinical Oncology (ASCO), the American Society of Haematology (ASH) and the 2018 American Society of Haemat
ology (HTTP://WWW.CHEMDRUG.COM/EXHIBIT/) at international conferences THE RESULTS OF CARTITUDE-1'S FINDINGS WILL ALSO BE PRESENTED AT FUTURE MEETINGS At present, JNJ-68284528 (LCAR-B38M) clinical trials are being carried out rapidly in China and the United States In the United States and the European Union, the CARTITUDE-1 study is evaluating JNJ-68284528 for the treatment of multiple myeloma patients who have received at least three treatment regimens, including protease inhibitors ("PI"), an immunomodulator ("IMiD") and anti-CD38 antibodies, and patients with a record of disease progression within 12 months of starting the most recent treatment, or a drug and protease.com) in China, Phase 2 CARTIFAN-1 corroborative trial (NCT03758417) is actively recruiting subjects to further assess the effectiveness of LCAR-B38M in patients with late recurrence or refractory multiple myeloma
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