Gumokimab is the 8th most successful independently developed drug Akeso (6 have already been approved on the market). It is also the third non-ontological innovative drug following Ebronucimab (PCSK9) and Ebdarokimab (IL-12/IL-23) to advance to the commercialization stage.
Gumokimab has been evaluated in four clinical studies involving patients with moderate to severe plaque psoriasis, including one pivotal phase III clinical trial (AK111-301) and three supporting studies.
Efficacy data show that gumokimab acts quickly, Significant treatment improvement was observed after just 2 weeks of treatment.
short-termeficagefiture: At week 12, the response rate for PASI 75 is approaching 96% and the response rate for SPGA 0/1 is approaching 90%. The PASI 90 response rate was close to 80%, the PASI 100 response rate was over 40%, and all efficacy measures were significantly better than the placebo group. More than 80% of patients achieved a PASI 90 response and approximately 50% achieved a PASI 100 response.
Long term effectiveness: Gumokimab monotherapy demonstrated sustained efficacy over 52 weeks, with continued improvement and long-term maintenance. By week 52, the PASI 75 response rate approached 100% with a stable SPGA 0/1 response rate. PASI 90 and PASI 100 response rates improved to nearly 90% and 65%, respectively.
Safety: Adverse event rates were similar between the gmokimab and placebo groups during both the placebo-controlled phase and the overall treatment phase, with the gmokimab group having slightly lower values for all metrics.
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Psoriasis patients urgently need better treatment options, and Akeso This can be addressed with evdalokimab and gumokimab, which target different disease pathways and complement each other in treatment, meeting the needs of a wide range of patients.
Successful launch of products such as ebronucimab (PCSK9), evdalokimab (IL-12/IL-23), gumokimab (IL-17) and efficiency of innovative non-existent drugs targeting multiple indications including manfidokimab Advances in IL-4R (IL-4R), IL-4R/ST2 bispecific antibodies, and treatments for neurodegenerative diseases strengthen the vitality and synergy of our product portfolio. This progress improves significantly Akeso’s Global competitiveness in non-overview business segments. At the same time, with the development and optimization of a more systematic, sophisticated and efficient commercialization team, we have formulated a comprehensive and scientific commercialization strategy for non-learning products. This strategy is designed to accelerate market expansion and positions Non-Existence Business as a strong driver of high-quality growth for the company. ”
About gumokimab
Gumokimab is an innovative, humanized IL-17 (Interleukin-17) monoclonal antibody. Akeso For the treatment of autoimmune diseases such as psoriasis and ankylosing spondylitis. IL-17 is a pro-inflammatory cytokine secreted primarily by activated Th17 cells, which binds to its receptor (IL-17R) on the cell surface and mediates immune-inflammatory responses, leading to psoriasis and arterial It plays an important role in the pathogenesis of aneurysmal myelitis. Gumokimab targets IL-17 and blocks the IL-17/IL-17R signaling pathway, inhibiting the initiation and progression of associated immune-inflammatory responses. Currently, the NDA for gmokimab in moderate to severe plaque psoriasis has been accepted by the NMPA, and a Phase III clinical trial in ankylosing spondylitis is ongoing.
About Akeso
Akeso (HKEX:9926.hk) is a leading biopharmaceutical company committed to researching, developing, manufacturing and commercializing the world’s first or best innovative biomedical products. Founded in 2012, the company has created a unique integrated R&D innovation system with a comprehensive end-to-end drug development platform (ACE platform) and BI-specific antibody drug development technology (Tetrabody) as Core. It is also a commercialized system with advanced operating modes and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. Using a fully integrated multi-functional platform, Akeso We are working internally on a robust pipeline of more than 50 innovative assets in cancer, autoimmune diseases, inflammation, metabolic diseases and other key disease areas. Among them, 22 candidates are participating in clinical trials (including 11 bispecific/polysegregating antibodies and bipolar antibody drug analogues). Additionally, five new drugs are on the market and five new drugs across seven indications are currently undergoing regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso We consistently integrate superior global resources to develop first-in-class and best-in-class new medicines, provide affordable therapeutic antibodies to patients around the world, create more commercial and societal value, and develop global biotechnology. Become a pharmaceutical company.
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