New Drug Application for Axio’s Gumokimab Monoclonal Antibody (IL-17) for the Treatment of Moderate-to-Severe Psoriasis by NMPA Investing.com

hong kong, January 26, 2025 /PRNewswire/ — Aceso, Inc. (9926.HK) (“It’s coming.“or “the Company”) developed its IL-17-targeted monoclonal antibody gumokimab (AK111) in a New Drug Application (NDA) by Drug Evaluation Center (CDE) of National Treatment (TASE:) products management (NMPA) for the treatment of moderate to severe plaque psoriasis. The strategic combination of drugs such as gumokimab and ebronucimab (PCSK9) to address diverse psoriasis treatment needs has further enhanced the company’s overall product mix in the autoimmune disease field.

Gumokimab is the eighth drug to be successfully approved independently. It’s coming. (with six already approved), and is also the third non-oncology breakthrough drug, following ibronucimab (PCSK9) and ibdarokimab (IL-12/IL-23).

Gumokimab was evaluated in four clinical studies involving patients with moderate to severe plaque psoriasis, including one pivotal phase III clinical trial (AK111-301) and three supportive studies.

Efficacy data show that gumokimab works quickly; Significant clinical improvement was observed after 2 weeks of treatment.

SHort-time effectiveness; At week 12, the PASI 75 response rate approached 96%, while the sPGA 0/1 response rate approached 90%. The PASI 90 response rate approached 80%, and the PASI 100 response rate exceeded 40%, all efficacy measures significantly greater 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 improvement and long-lasting maintenance over 52 weeks. At week 52, the PASI 75 response rate approached 100%, with stable sPGA 0/1 response rates. PASI 90 and PASI 100 response rates improved to 90% and 65%, respectively.

Security: In both the placebo-controlled phase and overall treatment phase, the incidence of side effects was comparable between the gumokimab and placebo groups, with the gumokimab group showing slightly lower values ​​in all parameters.

Prof Xu JinhuaPrincipal investigator of the critical registration study of gumokimab, Professor B Huashan Hospital, Fudan UniversityHe said: “There is an increasing demand for drugs that provide rapid onset, short-term efficacy, long-term stability and good tolerance. Gumokimab, an IL-17A IgG1 monoclonal antibody, directly targets the IL-17RA pathway. It is a driver of psoriasis, providing faster and more effective results. It shows the potential to better meet patient needs, especially in wound healing. It shows safety and tolerance. China.”

Dr. Yu XiaFounder, Chairman and CEO It’s coming.He said: “We are very excited about the impressive results of gumokimab in clinical trials and the successful commercialization of the new drug application. I would like to express my sincere thanks to all the participants in the project and to all the patients who participated in this clinical trial for their hard work and confidence.”

Psoriasis patients urgently need better treatment options, and It’s coming. He is talking to ibdarokimab and gumokimab, which target different disease pathways and are therapeutically complementary, allowing us to meet different patient needs.

The successful launch of new non-oncology drugs targeting multiple indications, including ibronucimab (PCSK9), ibdarokimab (IL-12/IL-23) and gumokimab (IL-17), as well as manfidokimab (IL-4R), IL-4R/ST2 bispecific antibody, and therapies for neurodegenerative diseases, Vitality and the combination of our product portfolio It gets stronger. This growth will increase significantly Accused Global competitiveness in the non-oncology business segment. Likewise, we have designed a comprehensive and scientific marketing strategy for our non-oncology products, developing and improving a more strategic, refined and efficient marketing development team. This strategy is designed to accelerate market expansion, positioning our non-oncology business as a powerful driver for the company’s high-quality growth.

About Gumokimab

Gumokimab is an innovative, humanized IL-17 (interleukin-17) monoclonal antibody. It’s coming. To treat autoimmune diseases such as psoriasis and ankylosing spondylitis. IL-17 is a pro-inflammatory cytokine produced primarily by activated Th17 cells, which binds to its receptor (IL-17R) on the cell surface, mediates immune responses, and plays an important role in the pathogenesis of psoriasis and ankylosing spondylitis. Gumokimab specifically targets IL-17 by blocking the IL-17/IL-17R signaling pathway to inhibit the initiation and progression of relevant immune-inflammatory responses. Currently, an NDA in moderate to severe plaque psoriasis has been approved by the NMPA, and a phase III clinical trial for ankylosing spondylitis is underway.

In Care Of It’s coming.

It’s coming. (HKEX: 9926.HK) is a leading biopharmaceutical company committed to research, development, manufacturing and marketing. In the year Founded in 2012, the company has developed a unique integrated R&D innovation system with an end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as a core, GMP-compliant manufacturing system. and a marketing system with advanced operational status and gradually transformed into a globally competitive biopharmaceutical company focused on innovative solutions. With a fully integrated multi-functional platform, It’s coming. It is working on a strong pipeline of more than 50 new properties in cancer, immunology, inflammation, metabolic disease and other major disease areas. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). In addition, 5 new drugs are on the market, and 5 new drugs in 7 indications are currently under regulatory review for approval. Through efficiency and R&D innovation, It’s coming. It will always integrate superior global resources, develop new drugs at first-in-class and first-class levels, provide affordable therapeutic antibodies to patients worldwide, and become a global leading biopharmaceutical enterprise by continuously creating more commercial and social values.

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