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Established in 2015, the company is a clinical-stage biotechnology company focused entirely on biotherapies for autoimmune and allergic diseases. The company has two core products, QX002N and QX005N, which are developed in-house. QX002N is an IL-17A inhibitor, and the company has conducted phase III clinical trials for the treatment of ankylosing spondylitis (AS) in China. In the phase II clinical trial, participants receiving QX002N (160 mg) every 4 weeks had 60.0% and ASAS40 response rates of 60.0% and 40.0% at week 16, respectively. ASAS20 and ASAS40 indicated that the ASAS score (a widely used measure of symptom improvement in AS patients) improved by 20% and 40% compared to the baseline, respectively.
The phase III clinical trial commenced in September 2023 and is expected to be completed in the second half of 2025. Qx005n is a monoclonal antibody (mAb) that blocks IL-4Rα. The company has initiated phase II clinical trials for atopic dermatitis (AD), prurigo nodosum (PN), and chronic sinusitis with nasal polyps (CRSWnP) in China. The company also has seven other pipeline drug candidates, four of which are in the clinical phase. The company's product line covers the four main areas of autoimmune and allergic diseases, namely skin, rheumatism, respiratory and digestive diseases. QX001S is the first commercial drug expected by the company. It is also the first domestically produced usinumab biosimilar to be submitted to BLA in China, and is probably one of the first usinumab biosimilar drugs approved in China. It targets IL-12/IL-23p40 and is widely regarded worldwide as one of the main treatments for Ps. QX001S has shown clinical efficacy, safety, immunogenicity, and PK properties comparable to usinumab. China and America Huadong (a subsidiary of Huadong Pharmaceutical and the company's QX001S commercialization partner) submitted a BLA in China in July 2023, and the BLA was accepted by the State Drug Administration in August 2023.
After listing, the company's stock market value is expected to be HK$4397-4.486 billion. The company's monoclonal antibody drugs in the field of self-immunity are highly innovative and have a strong competitive advantage, so it is recommended to purchase carefully.