Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the New Drug Application (NDA) of its internally-developed IL-17-targeting monoclonal antibody gumokimab (AK111) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. The strategic combination of drugs such as gumokimab and ebronucimab (PCSK9) to address the differentiated treatment needs of psoriasis has further enhanced the company's overall product synergy in the autoimmune disease field.

Gumokimab is the eighth successfully approved drug developed independently by Akeso (with six already approved for market), and it is also the third non-oncology innovative drug, following ebronucimab (PCSK9) and ebdarokimab (IL-12/IL-23), to progress 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 supportive studies.

Efficacy data show that gumokimab acts quickly, with significant therapeutic improvement observed after just 2 weeks of treatment.

Short-term Efficacy: At week 12, the PASI 75 response rate approached 96%, with an sPGA 0/1 response rate nearing 90%. The PASI 90 response rate was close to 80%, and the PASI 100 response rate exceeded 40%, all efficacy measures significantly superior to the placebo group. Over 80% of patients achieved a PASI 90 response, and approximately 50% achieved a PASI 100 response.

Long-term Efficacy: Gumokimab monotherapy demonstrated sustained efficacy over 52 weeks, with continuous improvement and long-lasting maintenance. By week 52, the PASI 75 response rate approached 100%, with stable sPGA 0/1 response rates. The PASI 90 and PASI 100 response rates further improved to nearly 90% and 65%, respectively.

Safety: During both the placebo-controlled phase and the overall treatment phase, the incidence of adverse events was comparable between the gumokimab and placebo groups, with the gumokimab group showing slightly lower values across all metrics.

Professor Xu Jinhua, the principal investigator of the pivotal registration study of gumokimab, professor at Huashan Hospital, Fudan University, stated: "There is an increasing demand for medications that offer rapid onset, short-term efficacy, long-term stability, and good tolerability. Gumokimab, an IL-17A IgG1 monoclonal antibody, directly targets the IL-17RA pathway, a key driver of psoriasis, providing faster and more effective results. Data from four studies demonstrate its potential to better meet patient needs, particularly in achieving near-clearance of lesions and maintaining disease stability. Moreover, the incidence of adverse events with gumokimab is comparable to that of the placebo, indicating good safety and tolerability. We eagerly anticipate the early availability of Gumokimab as a more efficient treatment option for psoriasis patients in China."

Dr. Yu Xia, Founder, Chairwoman, and CEO of Akeso, stated: "We are excited about the outstanding results of gumokimab in clinical trials and the successful submission of its new drug application for market approval. I would like to express my sincere gratitude to all the participants in the project and to all the patients who took part in the clinical trials for their hard work and trust.

Psoriasis patients are in urgent need of better treatment options, and Akeso is addressing this with ebdarokimab and gumokimab, which target different disease pathways and complement each other in treatment, allowing us to meet a wide range of patient needs.

With the successful launch of products such as ebronucimab (PCSK9), ebdarokimab (IL-12/IL-23) and gumokimab (IL-17), as well as the efficient advancement of innovative non-oncology drugs targeting multiple indications, including manfidokimab (IL-4R), IL-4R/ST2 bispecific antibody, and therapies for neurodegenerative diseases, the vitality and synergy of our product portfolio are growing stronger. This progress significantly enhances Akeso's global competitiveness in the non-oncology business segment. At the same time, with the development and optimization of a more systematic, refined, and efficient commercialization team, we have formulated a comprehensive and scientific commercialization strategy for our non-oncology products. This strategy is designed to accelerate market expansion, positioning our non-oncology business as a powerful driver of the company's high-quality growth."