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KN035 is Corning Jerry's independent research and development of recombinant humanized PD-L1 monomediant Fc fusion protein injection, by the idea of Di Pharmaceutical is responsible for its clinical development of tumor adaptation, the first acoustic pharmaceutical industry is responsible for the commercialization of Chinese mainland.
, KN035 is the world's first monolithic antibody for tumor immunotherapy and is expected to be the world's first off-cortective injection of PD-L1 inhibitors, according to a press release.
Compared with the PD-(L)1 antibody, which is currently on the market and under study, it has obvious differentiation advantages: good safety, subdern injection, stable at room temperature, easy to complete the administration process, greatly shorten the time of administration, improve the quality of life of patients, and take a key step towards the goal of long-term management of tumors as chronic diseases.
application is based on KN035 single-drug treatment of MSI-H/dMMR advanced solid tumor phase 2 key clinical trial data.
study, using a one-arm open label design, the main endpoint of the study was the Independent Review Committee (BIRC) evaluation of the confirmed objective mitigation rate (ORR).
msI-H status of colorectal cancer (CRC) and stomach cancer (GC) was confirmed by central pathology, and the dMMR status of other tumors was assessed locally.
results showed that the orR was 42.7% for the general population (n s 103), or 43.1% for patients with CRC (n s 65), 44.4% for GC patients (n s 18), and 40.0% for other solid tumor patients (n s 20).
DOR in the overall population did not reach, with a 12-month DOR rate of 92.2%, a medium progress-free lifetime (PFS) of 11.1 months, and a 12-month OS rate of 74.6%.
KN035: Crystal Structure (Photo Source: Resources) Reference: The world's first subdermal injection of PD-L1 antibody Nvolly monoantigen injection (KN035) submitted to China's new drug market application.Retrieved Nov 16,2020, From Synth Pharmaceuticals Official Micro
