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China NMPA receives the NDA of Envafolimab (KN035) for the treatment of MSI-H/dMMR advanced solid tumors

 Last Update: 2021-01-15
 Source: Internet
 Author: User

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Biopharmaceutical company TRACON announced today that China's State Drug Administration (NMPA) has accepted a new drug application (NDA) from Envafolimab (KN035) for the treatment of MSI-H/dMMR advanced solid tumors.
Charles Theuer, chief executive of TRACON, said: "Envafolimab's NDA has been reviewed by Chinese regulators, highlighting Envafolimab's advanced nature.
In addition to the registered trial of MSI-H/dMMR advanced solid tumors in China, Envafolimab is in the process of two other registration trials, one in China for stage III of bile daema cancer and the other for sarcoma in the United States."
Envafolimab (KN035) is a new monolith antibody for PD-L1.
microsatellite (MS) refers to a series of repeated DNA sequences in the cell genome in the units of a few nucleotides (mostly 1 to 6).
an abnormality in the DNA Misaling Repair (MMR) function, replication errors in microsatellites are not corrected and accumulate, resulting in changes in the length or base composition of microsatellite sequences, known as microsatellite instability (MSI).
clinical treatment needs of patients with microsatellite highly unstable (MSI-H)/mismatch repair defect (dMMR) solid tumors have not been met.
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