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HONG KONG, April 18, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that ebdarokimab, an investigational monoclonal antibody developed by the company, has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of moderate-to-severe plaque psoriasis in adult patients. Ebdarokimab is the company's first Class 1 new drug approved for autoimmune diseases and the second non-oncology new drug to receive marketing approval, following ebronucimab (PCSK9). This approval expands Akeso's commercial portfolio outside of oncology. Ebdarokimab was evaluated in five clinical studies involving Chinese patients with moderate-to-severe plaque psoriasis. Two pivotal Phase III studies demonstrated ebdarokimab's efficacy and safety at both 16 weeks and 52 weeks in these patients. Positive Short-Term Efficacy: Patients receiving ebdarokimab injection 135mg with two doses at weeks 0 and 4 showed a significantly positive efficacy, with a PASI 75 response rate of 79.4% at week 16. Sustained Long-Term Efficacy: Patients receiving ebdarokimab injection 135mg every 12 weeks (Q12W) for maintenance therapy achieved long-term durable efficacy, with a PASI 75 response rate of 77.9% at week 52. Significant Improvement in Quality of Life: Long-term maintenance treatment with ebdarokimab significantly improved patients' quality of life, alongside the improvement of skin lesions. After 16 weeks of treatment, the impact of skin disease on patients' quality of life decreased by more than 55%, further decreasing to over 65% by week 52. Good Safety Profile: The incidence of adverse events was low and numerically lower than that of the placebo group. Convenience of Administration: Ebdarokimab, administered as four subcutaneous injections annually, provides treatment convenience and provides long-term, stable improvements in treatment efficacy and patients' quality of life. The clinical data for ebdarokimab was previously reported at the European Academy of Dermatology and Venereology (EADV) congress in 2023 and 2024. Professor Jianzhong Zhang, lead investigator of the pivotal trials and Director of Peking University People's Hospital Dermatology Department, 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, Founder, Chairwoman, President and CEO of Akeso, stated: "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 the late-stage clinical development of competitive pipelines like gumokimab (IL-17 monoclonal antibody) and mandokimab (IL-4R monoclonal antibody), as well as the progress of new mechanism drugs, such as the first IL-4R/ST2 bispecific antibody in autoimmune diseases and therapies for neurodegenerative conditions, Akeso's global portfolio and competitive edge in non-oncology fields are strengthening. We eagerly anticipate the early approval of more of Akeso's independently developed non-oncology drugs, offering improved treatment outcomes for patients worldwide." About Ebdarokimab (IL - 12/IL - 23 Monoclonal Antibody) Ebdarokimab is a novel humanized monoclonal antibody targeting IL-12/IL-23, developed by Akeso. Ebdarokimab is indicated for the treatment of psoriasis, ulcerative colitis, and other autoimmune disorders. By inhibiting the biological activity of cytokines IL-12 and IL-23, it provides therapeutic benefits in autoimmune diseases. Psoriasis pathogenesis is associated with dysregulated immune responses, where IL-12 and IL-23, cytokines sharing a common p40 subunit, play pivotal roles in inflammation and immune modulation. IL-12 induces the activation and proliferation of Th1 cells (T helper cells 1), which secrete interferon-γ and TNF-α (tumor necrosis factor α), while IL-23 is involved in the differentiation of Th17 cells (T helper cells 17), leading to the release of IL-17 (interleukin-17). These cytokines are key mediators in inflammatory processes. Ebdarokimab binds to the p40 subunit of IL-12 and IL-23, preventing their interaction with cell surface receptors, thereby attenuating the release of cytokines such as interferon-γ, TNF-α, and IL-17 from T cells. This inhibition of cytokine-driven immune responses effectively modulates the aberrant immune activity in psoriasis. About Akeso Inc. Akeso,Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of innovative antibody drugs that are affordable to patients worldwide. Since the Company's inception, the Company has established an end-to-end comprehensive drug development platform (ACE Platform), encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology) that can overcome three CMC challenges in the development and manufacturing of bi-specific antibodies: 1.low expression levels, 2. process development hurdles, and 3. antibody stability and druggability. The Company currently has a portfolio of over 50 innovative programs covering the therapeutic areas of oncology, autoimmune and metabolic diseases. Among these programs are 6 approved products independently developed by the Company and 2 products under NDA review by the NMPA. We are conducting Phase III clinical trials of 12 products, and Phase I/II clinical trials of other 12 products. 15 of the products are potential global first-in-class (FIC) or best-in-class (BIC) bi-specific antibodies/polyclonal antibodies/bi-specific ADCs. The Company's vision is to become a leading global biopharmaceutical company through focused innovation in R&D, the establishment of world class manufacturing, and continued expansion commercial network. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HONG KONG, Feb. 13, 2025 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce the acceptance of its Investigational New Drug (IND) application by the China National Medical Products Administration (NMPA) for AK139, a bispecific antibody targeting IL-4Rα and ST2. AK139 is under investigation for a number of indications, including respiratory and skin diseases. AK139 is Akeso's first innovative bispecific antibody outside the field of oncology to enter clinical development. It is also Akeso's seventh bispecific antibody to enter clinical development. As the world's first IL-4Rα/ST2 bispecific antibody to enter the clinic, AK139 simultaneously targets and blocks both the IL-4/IL-13 pathway (by binding to the IL-4Rα subunit shared by both IL-4 and IL-13 receptor complexes) and the IL-33/ST2-mediated inflammation pathway. Preclinical studies have demonstrated robust synergistic therapeutic effects between these targets. In preclinical studies, AK139 shows clinical potential compared to existing monotherapy drugs targeting these pathways. AK139 is expected to advance the treatment of respiratory diseases, dermatological conditions, and other disorders where these inflammatory pathways play a critical role in disease pathogenesis. This first in class therapy is set to introduce a "dual-target era" in the treatment of these conditions, providing enhanced therapeutic options for patients with inadequate responses to current treatments. Innovative Dual-Target Mechanism for Improved Therapeutic Potential The IL-4, IL-13, and IL-33/ST2 pathways play a central role in the inflammatory processes underlying asthma, COPD, and other related conditions. AK139, as the first bispecific antibody targeting both IL-4Rα and ST2, offers a targeted approach to modulate these pathways. By binding to both IL-4Rα and ST2, AK139 blocks the key signals associated with IL-4, IL-13, and IL-33, addressing the complex inflammation signaling pathways in these related diseases. IL-4Rα Pathway: IL-4 and IL-13 are primarily involved in immune responses mediated by T-helper 2 (Th2) cells. The Th2-mediated inflammatory pathways play a critical role in the pathogenesis and progression of respiratory diseases, skin conditions, and other related diseases. Research has shown that IL-4 and IL-13 share a common receptor, IL-4Rα. AK139 is highly specific in binding to IL-4Rα, blocking the interaction between IL-4Rα and IL-4 or IL-13, as well as inhibiting the downstream signaling pathways mediated by these interactions, and thus exerting therapeutic effects on these diseases. IL-33/ST2 Pathway: Interleukin-33 (IL-33), acting as an alarm signal, binds to its specific receptor ST2, activating downstream signaling pathways that lead to inflammation in multiple human biological systems, including the respiratory, cardiovascular, and musculoskeletal systems. IL-33 plays a key role in both type 2 and non-type 2 inflammatory responses. Studies have shown that the expression levels of IL-33 and its receptor ST2 are significantly elevated in inflammatory diseases such as respiratory and skin conditions, where they serve as important mediators of disease response. AK139 specifically binds to ST2, inhibiting the inflammatory response mediated by IL-33. Preclinical studies have demonstrated that AK139 showcases strong dual-specific antigen-binding activity and promising pharmacological effects in both in-vitro and in-vivo. The antibody has shown remarkable synergy between the targets, significantly outperforming single-target antibodies targeting IL-4 or ST2 in key measures. These key measures include the inhibition of inflammatory cytokine release and the reduction of tissue infiltration by inflammatory cells. Additionally, preclinical toxicology studies showed that AK139 presents a favorable safety profile. Based on the pre-clinical data so far, AK139 has the potential to become a breakthrough therapy for respiratory and dermatological diseases. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HONG KONG, Jan. 26, 2025 /PRNewswire/ -- 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. S hort-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." About gumokimab Gumokimab is an innovative, humanized IL-17 (interleukin-17) monoclonal antibody developed by Akeso for the treatment of autoimmune diseases such as psoriasis and ankylosing spondylitis. IL-17 is a pro-inflammatory cytokine primarily secreted by activated Th17 cells, which binds to its receptor (IL-17R) on cell surfaces, mediating immune-inflammatory responses and playing a critical role in the pathogenesis of psoriasis and ankylosing spondylitis. Gumokimab specifically targets IL-17, blocking the IL-17/IL-17R signaling pathway to inhibit the onset and progression of related immune-inflammatory responses. Currently, the NDA for gumokimab in moderate-to-severe plaque psoriasis has been accepted by the NMPA, and a phase III clinical trial for ankylosing spondylitis is ongoing. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin, and X . SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED