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Article source: Medical Rubik's Cube Info
Author: Sunshine
On November 1, Connoa announced that CM338 has obtained CDE clinical trial approval for the treatment of IgA nephropathy
.
CM338 is the first domestic innovative monoclonal antibody drug targeting MASP-2 and the second clinically approved MASP-2 inhibitor in the world
IgA nephropathy (IgAN) is the most common type of primary glomerulonephritis.
The main feature is the deposition of IgA in the kidney.
The pathogenesis is related to the uncontrolled activation of the lectin pathway
.
Studies have shown that 90% of patients with IgA nephropathy have C3 and IgA co-localization, and C3 and C4 are often detected as complement deposits, which are closely related to renal tissue pathological damage and local inflammation
As of 2020, there are about 150 million patients with chronic kidney disease in China, and the number of patients with IgA nephropathy is as high as 8.
23 million
.
At present, the treatment of IgA nephropathy is relatively simple.
The main mechanism for the activation of the lectin pathway is to recognize multiple pathogen-related target molecules through mannose-binding lectin, and then bind to MASP-2 to activate the complement cascade
.
Among them, MASP-2 is the key rate-limiting enzyme
Source: Connoa Prospectus
Pre-clinical studies have shown that CM338 has significant efficacy.
Compared with foreign drugs with the same target, CM338 has higher affinity and in vitro inhibitory activity, up to 30 times
.
In addition, the pharmacokinetic characteristics of CM338 are in line with the performance of antibody drugs, and the results of toxicology studies have shown good safety, which supports the development of the treatment of diseases related to the activation of the complement lectin pathway
Source: Connoa Prospectus
At present, there are 4 drugs with the same target in the world, 2 of which have entered the clinical stage, namely narsoplimab from Omeros and CM338 from Connoa
.
Narsoplimab has submitted a BLA application to the FDA for the treatment of thrombotic microangiopathies related to hematopoietic stem cell transplantation
Note: The original text has been deleted
