Recently, Akeso Biopharma (9926.HK) announced that its novel humanized anti-IL-17A monoclonal antibody, gumozilla (AK111), for the treatment of active ankylosing spondylitis (AS) , has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This signifies that the drug is expected to provide a new treatment option for nearly 4 million AS patients in China .
Active ankylosing spondylitis (AS) is the second indication for which gumozimab has received NDA acceptance, and its application for the treatment of moderate to severe psoriasis was accepted by the CDEin January 2025 .
Gumochimab is Akeso Biopharma 's third blockbuster non-oncology product to enter the market , following inunusicumab (PCSK9) and erogenumab (IL-12/IL-23) . With the successive launches of inunusicumab and erogenumab and their inclusion in the National Reimbursement Drug List , and with products such as Gumochimab and Mandozizumab gradually entering the commercialization stage , along with the efficient progress in the in-depth development of non-oncology innovative target drugs for multiple indications, such as IL-4R/ST2 bispecific antibodies and neurodegenerative diseases, the company's product portfolio is becoming increasingly robust, and the competitiveness of its non-oncology segment continues to strengthen .

This NDA application for gumozilla is based on the excellent results of its pivotal Phase III registrational clinical trial AK111-303. The results showed that gumozilla effectively and rapidly relieved AS symptoms in patients, while significantly improving disease activity, physical function, and quality of life . In this study, gumozilla treatment of patients with active ankylosing spondylitis met all pre-specified efficacy endpoints: the primary endpoint ASAS20 response rate and all subgroup analyses, the key secondary endpoint ASAS40 response rate, and several other pre-specified secondary endpoints , all showing statistically significant and clinically meaningful improvements .
Ankylosing spondylitis (AS) is a chronic inflammatory disease that primarily affects the sacroiliac joints, spine, and peripheral joints, potentially leading to spinal deformities and functional loss, severely impacting patients' lives. Currently, there are approximately 4 million AS patients in China . Despite the availability of various treatment options, significant unmet needs remain regarding the adequacy, long-term maintenance, and accessibility of medications. This is particularly true for patients who do not respond well to traditional treatments, who urgently require more innovative, effective, and safe treatment options. Gumozimab holds promise as a new and highly effective domestically produced treatment option for a wide range of patients, helping them achieve long-term, stable disease control, delaying structural damage, and returning to a high quality of life.

https://bydrug.pharmcube.com/news/detail/5780da08568bdcab4465fb7239560109