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The IND application for XinKanghe IL-17-A/F monoclonal antibody treatment for ankylosing spondylitis has been accepted by the CDE.

Release time:

2020-12-22 15:36

 

2020Year12Month21On the day, XinKangHe Biopharmaceutical's independently developed"Recombinant Anti-HumanIL-17A/FHumanized Monoclonal Antibody Injection" targets ankylosing spondylitis (AS) clinical trial application (INDapplication) has been accepted byCDEfor public announcement.ASIt is a chronic, progressive spinal inflammation, with a higher incidence in men than in women. If not treated promptly or treated improperly, the three-year disability rate for patients is45.5%.The five-year disability rate is as high as70%.Currently, there are about500hundreds of thousands to1000millions of ankylosing spondylitis patients in our country, urgently needing to provide multiple medication options forASclinical treatment.

IL17Family asa new type of pro-inflammatory factor,is associated with the occurrence of various systemic and local autoimmune diseases. InASthe serum, synovial fluid, and joints of patients, the level ofIL-17has been significantly increased, and blocking this signaling pathway has a predictable effect on the inflammation control ofAS.2020Year4Month28On the day, Secukinumab (IL-17Atarget) was approved by the National Medical Products Administration for the treatment of adult patients with ankylosing spondylitis who have poor efficacy with conventional treatments.

This project is a target sequence independently developed by XinKangHe, and is rapidly advancing in conjunction with Lizhu monoclonal antibody for different indications. Currently, there are no antibody drugs on the market that simultaneously act on IL-17A/F globally, and no other companies in the country have applied for clinical trials. In February 2020, the clinical trial application for IL-17A/F psoriasis indication jointly applied by XinKangHe and Lizhu monoclonal antibody was approved. The acceptance of this IND application is another important milestone in the development history of XinKangHe Biopharmaceutical, and we look forward to the excellent performance of IL-17A/F in the treatment of AS, bringing more treatment options to patients as soon as possible.

IL-17-A/F


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