The world's first off-skin injection of PD-L1 antibodies! Corning Jerry KN035 (Nwolly single anti-injection) was included in the priority review by the National Drug Administration!

January 19, 2021 // -- Corning Jerry Biopharmaceuticals ("Corning Jerry") recently announced that its recombinant humanized PD-L1 mono-domain antibody Nvolly monoantigen injection (research and development code: KN035) has been listed as a national drug The Drug Review Centre (CDE) of the Supervisory Authority (NMPA) was included in the priority review, and the first application was for an adaptation to other advanced solid tumors of advanced colorectal cancer, stomach cancer/mismatch repair functional impairment (dMMR) that had failed in the past for standard treatment.
review is a procedure established to encourage the research and creation of new drugs, to expedite the review and approval of new drugs with clear clinical value and clinically urgent need.
In accordance with the Measures for the Administration of Drug Registration implemented by the State Drug Administration on July 1, 2020 (Decree No. 27 of the State Administration of Market Supervision and Administration) and the Procedure for priority review and approval of drug listing permits (Trial) on July 7, 2020, drugs included in the priority review will be optimized by the Drug Administration and the review resources, shortening the time limit for review.
Nvolly single anti-injection (developed code: KN035) belongs to anti-PD-(L)1 tumor immunotherapy, which is designed to help detect and fight tumor cells by improving the body's immune system.
worldwide, more than 10 anti-PD-(L)1 therapies have been approved for the market, including Mercado Keytruda (Korida, Pablo Pearl Single Resistance), Baxter Miesquibo Opdivo (Odivo, Navuliyu Mono-Resistance), Roche Tecentriq (Tesanchi, Atili-Zhu Mono-Resistance), AstraZeneca Imfinzi (Infinfan, Dovali single-resistance).
, Mercadon Keytruda is the leader, with global sales of $11.1 billion in 2019 and expected to top $25 billion in 2026, making it the world's best-selling drug.
with the development of immunotherapy and combined therapy, many cancers are expected to become "chronic diseases" in the future, controllable and even curable.
need for home or community medication for cancer patients will be increasing.
Nvolly monoantigenic injection (research and development code: KN035) is Corning Jerry's self-developed PD-L1 monodimenic antibody Fc fusion protein, the world's first monodimensic antibody for tumor immunotherapy, and the world's first subsuterial injection of PD-(L)1 inhibitors, which have demonstrated good safety and effectiveness in clinical trials of multiple tumor indications conducted worldwide.
In addition, Nvolly monoanti-injections, compared with the PD-(L)1 antibodies currently on the market and under study, also have the advantages of stability at room temperature, small single injection, fast dosing process, low injection site restrictions, etc., which can provide innovative treatment options and improve the quality of life of patients under the trend of slow tumor disease.
currently, Nvolly monoantigenic injections (KN035) have been conducted simultaneous clinical trials in China, the United States and Japan for multiple tumor adaptations, which have entered the registered/phase III.
Nvolly single anti-injection (KN035) has been approved by the FDA as an orphan drug for advanced bile disease.
March 30, 2020, Corning Jerry, Thought Di Pharmaceuticals, Synth Pharmaceuticals reached a strategic cooperation, Corning Jerry as the original research party responsible for production and quality, Thought Dee Pharmaceuticals is responsible for clinical development in the field of oncology, Synth Pharmaceuticals is responsible for the exclusive commercial promotion of products in Chinese mainland.
KN035's declaration is based on phase II critical clinical trial data (NCT03667170) for single-drug treatment of microsatellite instability (MSI-H)/mismatch repair functional defects (dMMR) advanced solid tumors.
the study used 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).
the 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.
of 103 patients in the study group, the confirmed objective remission rate (ORR) of the overall population (n-103) was 42.7%, the ORR of CRC (n-65) patients was 43.1%, the ORR of GC patients (n-18) was 44.4%, and the ORR of other solid tumor patients (n-20) was 40.0%.
DOR was not achieved in the BIRC assessment of the overall population, with a 12-month DOR rate of 92.2%, a medium disease-free progression period (PFS) of 11.1 months, and a 12-month OS rate of 74.6%.
16% of the adverse events associated with 3/4 treatment, and deaths were caused by untreated adverse events.
3/4 levels of immune-related adverse events were 8%, and no immune-related pneumonia, colitis, nephritis and neurotoxicity occurred.
9% of patients had an injection site reaction, all at level 1/2.
() Origin: Corning Jerry Biopharmaceuticals