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On April 12, C4X Discovery Holdings plc announced that it has signed a global exclusive license agreement with Sanofi for its preclinical oral IL-17A inhibitor
.
According to the agreement, C4XD will receive an advance payment of 7 million euros and a potential development, regulatory and commercialization milestone payment of up to 407 million euros
.
IL-17A belongs to the interleukin-17 (IL-17) family and plays an important role in promoting the inflammatory state in the autoimmune response of diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis (AS)
.
IL-17 was first discovered by researchers in 1993, and subsequent studies found that it plays an important role in host defense, autoimmune disease pathogenesis, and tumors, and has gradually become a research hotspot in medicine and immunology
.
There are six subtypes of IL-17 family ligands: IL-17A, IL-17B, IL-17C, IL-17 D, IL-17E (also called IL-25) and IL-17F
.
Among them, IL-17A and IL-17F have high homology (55%) and are often co-expressed
.
At present, 4 macromolecular biopharmaceuticals targeting IL-17/IL-17R have been approved globally, namely Novartis’ Cosentyx (Secukinumab), Eli Lilly’s Taltz (Ixekizumab), Siliq/Lumicef (Brodalumab, Broliumab) of Kylin and Efleira (Netakimab) of Biocad
.
In addition, UCB has also submitted a biological product license application for the target IL-17A/IL-17F monoclonal antibody bimekizumab
.
Cosentyx is the first IL-17A monoclonal antibody approved globally.
It was first approved in Japan in December 2014, and was subsequently approved in Europe and the United States in January 2015.
It has been approved for the treatment of adults and 6 to 18 years old.
Moderate to severe plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and radiology-negative axial spondyloarthritis (nr-axSpA)
.
Taltz is the second IL-17A monoclonal antibody approved by the FDA after Cosentyx.
It was first approved in the United States in March 2016.
It is currently approved for the treatment of adults and 6 to 18 years of age with moderate to severe PsO, PsA, AS and nr-axSpA
.
Siliq (brolizumab, also called bedaluzumab) is the third FDA-approved monoclonal antibody against the IL-17 pathway.
Its target is IL-17RA.
It was approved in Japan in July 2016.
, The trade name is Lumicef, which was approved in the United States in February 2017, the trade name is Siliq, and it was approved in Europe in July 2017, the trade name is Kyntheum, and the indication is PsO
.
The drug was first developed by Amgen, and then AstraZeneca and Kyowa Fermentation Kirin Co.
, Ltd.
Netakimab (BCD-085) was approved in Russia in May 2019 for the treatment of moderate to severe plaque psoriasis under the trade name Efleira
.
In September 2019, SPH PROJECT BIOCAD Limited (hereinafter referred to as SPH PB), a wholly-owned subsidiary of Shanghai Pharmaceuticals, signed an agreement with Biocad to establish a joint venture company to introduce 6 products including the drug into the country
.
These four drugs are all administered by subcutaneous injection.
Cosentyx and Taltz were launched earlier, with the most approved indications, and the market performance is relatively bright.
Sales have increased year by year since they were launched.
Cosentyx has been on the market for two consecutive years since 2019.
Become Novartis' highest-selling drug
.
In view of the market potential of IL-17 pathway-targeted drugs, many domestic companies have begun to deploy.
Among them, Hengrui Pharmaceutical's Vunakizumab and Zhixiang (Shanghai) Pharmaceutical have made rapid progress and are in phase III clinical trials
.
In addition, on May 15, 2020, Chuangsheng Biotechnology introduced the IL-17-like antibody ABY-035 from Affibody at a price of US$225 million in May last year
.
However, it is worth mentioning that the drugs that have been on the market and under development that target the IL-17 pathway are mainly monospecific antibodies, which are mainly administered by subcutaneous injection
.