The first off-skin injection PD-L1! Corning Jerry/ Idea Dean Worley single anti-trump priority...

On January 8th, according to the CDE Priority Review section, Sichuan Thought Dikangrui Pharmaceuticals' "Nwolli Single Anti-Injection" listing application was to be included in the priority review approval with "qualified approved drugs", and the formulation of the adaptation was microsatellite highly unstable (MSI-H) advanced colorectal cancer and MSI-H advanced gastric cancer and its DNA mismatch repair function defect (dMMR) advanced solid tumor.
Nvolly monoantigen injection (developed under the code name KN035, generic name: Envafolimab) is Corning Jerry's self-developed PD-L1 monolithic antibody Fc Fusion Protein, developed in 2016 in cooperation with Chinese mainland Widi Pharmaceuticals;
KN035 can be injected under the skin, stable at room temperature, in terms of safety, convenience and compliance advantages, can be used for patients suitable for intravenous fluids, while having low medical costs.
KN035 has conducted clinical trials in China, the United States and Japan for multiple tumor adaptations, some of which have entered phase III clinical trials.
Enwoli monoantigen project Details Source: Insight Database () Currently, PD-(L)1 treatment on the market requires frequent intravenous injections, which will not meet the patient's need for ease of use of the drug, but will also affect the patient's compliance with the drug.
KN035 is expected to become the world's first subdern injection of PD-L1 inhibitors, patients do not need intravenous injection to easily complete the dosing process, greatly reducing the time (in seconds), and has the potential to home-based self-administering, thereby improving the quality of life of patients.
the results of two studies on KN035 at the 2020 ASCO Conference.
open label Phase II study evaluated the safety and anti-tumor activity of KN035 in patients with advanced MSI-H/dMMR cancer.
data released by the Chinese Government as of December 17, 2019, 103 patients with advanced MSI-H/dMMR cancer were recruited at 25 centers in China.
results showed a confirmed objective mitigation rate of 30% in the major efficacy groups (PEPi) and 80% of the relief continued at the end of the data cutoff.
54.2% of CRC patients who had previously been treated with fluorouracil and oxaliplatin or olithycom.
confirmed objective mitigation rate of 34.0% for the overall population and 85.7% for the population as of the data cut-off date.
6.6 months for both PEPi and the population as a whole.
phase 2 clinical study data from another KN035 combination chemotherapy treatment for advanced gastric or gastroesoesus consortation (G/GEJ) tumors showed that the efficacy of 15 patients in the study was assessable, with a confirmed ORR of 60%, a medium remission time (DOR) not achieved, and a medium PFS of 6.8 months.
January 18, 2020, KN035 was approved by the U.S. FDA as an orphan drug for advanced bile tube cancer.