Akeso's IL-17A MONOCLONAL ANTIBODY (GUMOKIMAB) COMPLETION OF PATIENT ENROLLMENT IN PHASE II CLINICAL TRIAL FOR THE TREATMENT OF ANKYLOSING SPONDYLITIS

HONG KONG,Dec. 28,2021 -- Today,Akeso,Inc. (09926.HK) announces that Gumokimab (IL-17A monoclonal antibody,AK111),an innovative drug independently developed by the Companyfor the treatment of active ankylosing spondylitis has been completed. Such clinical trialaims to evaluate the efficacy and safety of Gumokimab for the treatment of patients withactive ankylosing spondylitis.

Ankylosing spondylitis is a chronic inflammatory disease that affects the medial joints and can lead to spinal deformity and loss of function to patients.IL-17,a key inflammatory cytokine in thepathogenesis of ankylosing spondylitis,has demonstrated good commercial value with itsunique efficacy and safety advantages,and has become a new therapeutic target.

Secukinumab and Ixekizumab,which have the same drug targets as AK111,have been approved by the Food and Drug Administration of the United States (FDA) for the treatmentof ankylosing spondylitis. The global sales of IL-17A monoclonal antibody drugs amountedto approximately US$5.783 billion in 2020.

At present,there is no independently developed monoclonal antibody drugs against IL-17 approved for marketing in China,resulting in strong clinical demand. Gumokimab,being anindependently developed and innovative drug in China,is expected to bring new hope topatients with ankylosing spondylitis in the future.

INFORMATION ABOUT GUMOKIMAB (IL-17A MONOCLONAL ANTIBODY,AK111)

Gumokimab is a novel drug targeting IL-17A of autoimmune treatment diseasesindependently developed by the Company. Gumokimab is intended to be used for thetreatment of diseases such as psoriasis and ankylosing spondylitis. Through combination ofcompetitive blockers,namely IL-17A and IL-17R,and blocking the biological activities ofIL-17,Gumokimab has reached the efficacy in immune-related diseases in clinical therapies.The clinical trial of Gumokimab,which involves multiple subcutaneous injections ofescalating doses to subjects with moderate-to-severe plaque psoriasis,has completed. Theclinical trial results have shown that Gumokimab can significantly improve the condition ofsubjects with psoriasis,including the proportion of patients with Psoriasis Area and SeverityIndex (PASI) reaching 100,showing Gumokimab is of good safety and tolerability.Currently,the assessment of primary endpoints of Gumokimab for treatment of all subjectswith moderate-to-severe plaque psoriasis has been completed,and it is expected to advanceto phase III clinical trial in early 2022.

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