HONG KONG, April 18, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK), a leading biopharmaceutical company, proudly announces that its investigational monoclonal antibody, ebdarokimab, has received marketing approval from the National Medical Products Administration (NMPA) in China. This approval marks a significant milestone for the company as ebdarokimab is specifically indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients.

Notably, ebdarokimab is Akeso's first Class 1 new drug approved for autoimmune diseases and represents a pivotal addition to its expanding commercial portfolio, which has predominantly focused on oncology until now. Following the successful approval of ebronucimab, a non-oncology drug targeting the PCSK9 pathway, this new approval highlights Akeso's commitment to diversifying its drug offerings.

The clinical evaluation of ebdarokimab involved five comprehensive studies with Chinese patients suffering from moderate-to-severe plaque psoriasis. Among these, two pivotal Phase III studies showcased ebdarokimab's efficacy and safety over both 16-week and 52-week treatment periods.

Short-Term Efficacy: In the trials, patients administered ebdarokimab at a dosage of 135mg, with two doses given at weeks 0 and 4, exhibited an impressive efficacy rate. Specifically, a PASI 75 response ratea measure of improvement in psoriasis severitywas recorded at 79.4% after just 16 weeks of treatment.

Sustained Long-Term Efficacy: Furthermore, patients who continued with ebdarokimab injections of 135mg every 12 weeks (Q12W) for maintenance therapy showed enduring results. By week 52, the PASI 75 response rate remained remarkably high at 77.9%, indicating that the treatment provided lasting control over the disease.

Improvement in Quality of Life: The long-term maintenance treatment with ebdarokimab not only enhanced skin conditions but also significantly improved patients' overall quality of life. After 16 weeks, the detrimental impact of psoriasis on patients' lives decreased by more than 55%, further improving to over 65% by week 52.

Safety Profile: Importantly, the treatment exhibited a favorable safety profile, with adverse events occurring at a low incidence rate, which was numerically less than that observed in the placebo group. This suggests that ebdarokimab is not only effective but also safe for long-term use.

Convenience of Administration: Ebdarokimab is administered as four subcutaneous injections over the course of a year, which enhances patient convenience. This dosage regimen ensures that patients can experience stable and long-term improvements in both treatment efficacy and quality of life.

The clinical data supporting ebdarokimab was previously presented at the prestigious European Academy of Dermatology and Venereology (EADV) congress in both 2023 and 2024, underscoring the international recognition of its potential.

Professor Jianzhong Zhang, who served as the lead investigator for the pivotal trials and is the Director of the Dermatology Department at Peking University People's Hospital, commented, "Clinical data consistently demonstrate ebdarokimab's rapid onset, durable efficacy, and excellent safety profile. With only four doses per year, it offers enhanced treatment adherence, enabling long-term disease control and improved quality of life. As clinicians, we believe ebdarokimab will provide a more accessible, effective, and convenient therapeutic option for patients."

Dr. Yu Xia, the Founder, Chairwoman, President, and CEO of Akeso, added, "In addition to our oncology focus, Akeso has built a forward-looking, innovative pipeline targeting high-prevalence, high-potential disease areas, including metabolic, autoimmune, inflammatory, and neurodegenerative diseases. Our products are steadily entering the commercialization phase. With the successful launches of ebronucimab and ebdarokimab, along with late-stage clinical development of competitive pipelines like gumokimab (an IL-17 monoclonal antibody) and mandokimab (an IL-4R monoclonal antibody), we are strengthening Akeso's global portfolio and competitive edge in non-oncology fields. We eagerly anticipate the early approval of more of our independently developed non-oncology drugs, which will significantly improve treatment outcomes for patients worldwide."

About Ebdarokimab (IL - 12/IL - 23 Monoclonal Antibody): Ebdarokimab is a groundbreaking humanized monoclonal antibody that specifically targets IL-12 and IL-23, crucial cytokines involved in the inflammatory processes associated with autoimmune disorders. By inhibiting their biological activity, ebdarokimab provides therapeutic benefits for diseases such as psoriasis and ulcerative colitis. The pathogenesis of psoriasis is linked to dysregulated immune responses, wherein IL-12 and IL-23 play integral roles in inflammation and immune modulation. Ebdarokimab works by binding to the p40 subunit of these cytokines, preventing their interaction with cell surface receptors and thus modulating the immune response effectively.

About Akeso Inc: Akeso, Inc. is a biopharmaceutical company committed to the research, development, manufacturing, and commercialization of innovative antibody drugs aimed at being affordable for patients globally. Since its founding, the company has established a comprehensive drug development platform known as the ACE Platform, which encompasses various functions including target validation, drug discovery, and complying with GMP production standards. Akeso has successfully developed a bi-specific antibody drug development technology known as Tetrabody technology, which addresses significant challenges in the development and manufacturing of bi-specific antibodies.

Currently, Akeso boasts a portfolio of over 50 innovative programs spanning therapeutic areas such as oncology, autoimmune, and metabolic diseases. Among these programs are six approved products developed independently by the company, as well as two products under NDA review by the NMPA. The company is conducting Phase III clinical trials for 12 products, with an additional 12 in Phase I/II trials. Notably, 15 of these products have the potential to become global first-in-class or best-in-class bi-specific antibodies. Akeso aims to ascend as a leading global biopharmaceutical company through focused innovation in R&D, establishing world-class manufacturing capabilities, and expanding its commercial network.

SOURCE: Akeso, Inc.