Akeso’s antibody treatments show positive results in phase 3 trials

HONG KONG - Akeso Inc. (HKEX:9926), a biotechnology company whose stock has surged 285% over the past year and currently trades near its 52-week high, announced Monday that two of its antibody treatments have achieved positive results in separate Phase 3 clinical trials. According to InvestingPro analysis, the company appears overvalued at current levels despite its strong market performance.

The company’s anti-IL-17A monoclonal antibody, gumokimab (AK111), met all primary efficacy endpoints in a Phase 3 trial for active ankylosing spondylitis. The treatment demonstrated significant improvements in ASAS20 and ASAS40 measurements, indicating effectiveness in alleviating symptoms and improving physical function. With an impressive gross profit margin of 86% and analysts forecasting sales growth this year, Akeso maintains strong operational efficiency in its drug development programs.

Akeso also reported that its anti-IL-4Rα monoclonal antibody, manfidokimab (AK120), met all primary and key secondary endpoints in a Phase 3 trial for moderate-to-severe atopic dermatitis. The treatment showed improvements in skin lesions and provided early relief of pruritus.

The company plans to file a New Drug Application (NDA) for manfidokimab, which would become Akeso’s fourth non-oncology drug to enter the NDA phase. The NDA for gumokimab for the treatment of moderate-to-severe psoriasis was accepted by China’s National Medical Products Administration Center for Drug Evaluation in January 2025.

According to the company, approximately 4 million patients in China suffer from ankylosing spondylitis, a form of arthritis that primarily affects the spine.

These developments follow Akeso’s previous market launches of ebronucimab and ebdarokimab, expanding the company’s presence in the non-oncology therapeutic area.

The information is based on a press release statement from Akeso Inc.

In other recent news, JPMorgan analysts have adjusted their outlook on Akeso Inc, lowering the stock’s price target from HK$110.00 to HK$99.00 while maintaining an Overweight rating. This change is primarily due to regulatory uncertainties in the United States. The concerns stem from Summit’s challenges in filing a biologics license application for ivonescimab, despite positive data from the HARMONi study. The analysts pointed out that the maturity of overall survival data in non-Asian patients remains low, impacting the potential success of ivonescimab in the US market. These developments are significant for investors as they consider the future prospects of Akeso Inc.

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