Akeso Announced NDA Acceptance of IL-12/lL-23 Monoclonal Antibody Ebdarokimab for Moderate-to-severe Plaque Psoriasis by China NMPA

HONG KONG, Aug. 24, 2023 /PRNewswire/ -- Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, announced today that the New Drug Application (NDA) for its fully human IgG1 monoclonal antibody, ebdarokimab (IL-12/lL-23, AK101) has been accepted by the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) for the treatment of adult patients with moderate-to-severe plaque-type psoriasis.

Ebdarokimab is Akeso's 6th self-developed innovative drug that has been successfully approved for marketing/NDA submitted, the first patented domestic innovative drug targeting IL-12/IL-23. Ebdarokimab is also the company's 2nd innovative drug in non-oncology segment that has been filed for marketing. The NDA's acceptance of ebdarokimab reflects the strength of the company's R&D in the development of new non-oncology drugs in addition to oncology.

A total of 5 clinical trials were conducted with ebdarokimab in patients with moderate-to-severe plaque psoriasis. Two pivotal Phase III clinical trials provided essential efficacy data for ebdarokimab in patients with moderate-to-severe plaque psoriasis at weeks 16 and 52, respectively. The results showed that ebdarokimab had significant efficacy in the treatment of moderate-to-severe plaque psoriasis at both 16 and 52 weeks with a favorable safety profile. Ebdarokimab was effective in improving patients' quality of life while improving skin lesions.

As a number of competitive products from Akeso such as ebronucimab (PCSK9), ebdarokimab(IL-12/lL-23), gumokimab (IL-17), manfidokimab (IL-4R) and others are approved for the market consecutively, the Company's activity outside of the field of oncology will pave the way for commercialization. Akeso continues to integrate its beneficial resources to build its marketing capacity in non-oncology products with creativity and a strong market development capability, formulate targeted marketing strategies, in order for the non-oncology segment to become a powerful driver for the Company's overall successful growth.

About Ebdarokimab (IL-12/lL-23 Monoclonal Antibody, AK101)

Ebdarokimab is a novel fully human Interleukin-12/Interleukin-23 monoclonal antibody independently developed by Akeso.

The pathogenesis of psoriasis is associated with an aberrant immune response. IL-12 and IL-23 are cytokines that are naturally produced during inflammation and immune reactions, sharing the common p40 subunit, where IL-12 induces Th1 cells (helper T cells 1) to proliferate and release interferon and TNF-α (tumor necrosis factor-α), and IL-23 induces Th17 cells (helper T cells 17) to proliferate and release IL-17 (interleukin-17), etc. These cytokines are crucial for inflammatory and immune responses. By targeting and binding to the p40 subunit of IL-12 and IL-23, and hampering the interaction of IL-12 and IL-23 with cell surface receptors, ebdarokimab reduces the release of cytokines such as interferon, TNF-alpha, IL-17 and other related cytokines from T-cells, and blocks their respective mediated cellular immune responses, thus achieving the objective of treating psoriasis by inhibiting the aberrant psoriasis immune response.

About Akeso Inc.

Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception, we have established a distinctive and 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 fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode.

Akeso is internally working on a robust pipeline of over 30 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease, and other major therapeutic areas. 19 assets have entered the clinical stage and 3 innovative drugs have been approved. Leveraging in-house developed bispecific platform technology ("Tetrabody technology"), the company has advanced four potential first-in-class bispecific antibody drugs into market or clinical development, including cadonilimab (PD-1/CTLA-4), ivonescimab (PD-1/VEGF), PD-1/LAG-3, and TIGIT/TGF-Beta bispecific antibodies. In June 2022, cadonilimab was approved by the NMPA and became the first commercialized PD-1 based bispecific drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab. In August, the NDA submission of ivonescimab was accepted by China's NMPA. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited.

SOURCE Akeso, Inc.