Akeso's Ebdarokimab NDA Accepted by China NMPA for Psoriasis

25 August 2023 | Friday | News

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 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
Image Source : Public Domain

Image Source : Public Domain

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.

Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox


Forgot your password?



Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in