#Hong Kong #Akeso #Gumokimab #Manfidokimab

Akeso’s Groundbreaking Phase 3 Trial Results

In a significant breakthrough for biopharmaceuticals, Akeso Inc. (9926.HK) recently shared positive outcomes from its Phase 3 clinical trials involving two promising drug candidates: gumokimab (AK111) and manfidokimab (AK120). These trials mark pivotal moments for both drugs, potentially addressing unmet medical needs in the treatment of ankylosing spondylitis (AS) and atopic dermatitis (AD).

Gumokimab: A New Hope for Ankylosing Spondylitis

Gumokimab, a fully humanized monoclonal antibody targeting IL-17A, has proved effective in treating active ankylosing spondylitis, impacting about four million patients in China. The Phase 3 trials convincingly met all primary efficacy endpoints, notably ASAS20 and ASAS40, as well as several key secondary endpoints, establishing gumokimab as a serious contender in this therapeutic area. Patients in the trial reported rapid alleviation of symptoms, improved disease activity, and enhanced quality of life.

This treatment offers to reshape the treatment landscape for AS, signaling potential approval and market entry that can provide hope to thousands suffering from this chronic condition. Gumokimab also boasts previous positive results from trials focused on moderate-to-severe psoriasis, where an NDA was already submitted to the NMPA CDE as of January 2025, marking another milestone in its journey.

Manfidokimab: Transforming Atopic Dermatitis Treatment

In parallel, manfidokimab, which targets IL-4Rα, also showed significant promise during its Phase 3 clinical trial aimed at moderate-to-severe atopic dermatitis. The drug achieved all primary and key secondary endpoints, showcasing remarkable efficacy in managing skin lesions and providing swift relief from pruritus—itchiness—a hallmark of atopic dermatitis. Given the chronic nature of AD and its profound impact on patients' quality of life, manfidokimab’s development is incredibly timely.

Akeso plans to submit an NDA for manfidokimab, expanding its therapeutic offerings for AD, which could lead to better treatment options within China without relying on imported therapies. This achievement marks manfidokimab as Akeso’s fourth non-oncology drug progressing to the NDA phase, a testament to the company's robust pipeline in autoimmune therapies.

Pipeline and Future Prospects

Akeso has solidified its position as a leader in autoimmune drug development, now boasting a variety of promising therapies. The successful launch of other drugs, such as ebronucimab (PCSK9) and ebdarokimab (IL-12/IL-23), along with the encouraging results from gumokimab and manfidokimab trials, indicates positive commercial growth potential for the company's non-oncology franchise.

With over 50 assets in development, Akeso maintains a focus on creating innovative biological medicines across various therapeutic areas, not limited to autoimmune diseases. The combination of successful trials, market readiness, and an emphasis on innovation strengthens Akeso’s competitive edge on a global scale.

Furthermore, Akeso’s integrated R&D model and extensive pipeline underscore its commitment to advancing healthcare solutions that meet pressing patient needs domestically and internationally.

Conclusion

The promising results from Akeso’s Phase 3 trials not only represent major scientific advancements but also hope for patients battling ankylosing spondylitis and atopic dermatitis. With continued focus on drug development and regulatory submissions, Akeso is poised to impact the biopharmaceutical landscape significantly and address critical health challenges faced by millions.

For more information about Akeso and its innovative therapies, please visit Akeso's Official site.