One of our Core Products, QX002N, is a high-affinity mAb targeting IL-17A, a key player in the pathological mechanism of various autoimmune diseases. IL-17A inhibitors, together with TNF-α inhibitors, are recommended by prevailing clinical guidelines as second-line treatment for ankylosing spondylitis (AS) patients with high disease activity after receiving first-line traditional treatments. Between the two classes of biologics, IL-17A inhibitors have shown clear clinical benefit in patients who are intolerant to or fail to achieve adequate disease control with TNF- α inhibitors.

We have obtained IND approval for QX002N for AS and LN and plan to prioritize the development of the former indication. QX002N demonstrated promising efficacy in our Phase Ib and Phase II clinical trials for AS. In our phase Ib clinical trial, 62.5% and 37.5% of subjects receiving QX002N (160 mg) once every 2 weeks achieved ASAS20 and ASAS40 responses at week 16, respectively. In March 2023, our Phase II clinical trial reached its primary endpoint as reviewed by the independent data monitoring committee (IDMC), which recommended that we proceed to a Phase III clinical trial. We expect to consult with the NMPA in the second quarter of 2023 for the commencement of such trial.

According to Frost & Sullivan, the prevalence of AS in China was 3.9 million in 2021,and is estimated to reach 4.0 million in 2030. The AS drug market in China was US$1.6 billion in 2021, and is estimated to reach US$6.7 billion in 2030, at a CAGR of 17.1%. Approved biologic drugs and drug candidates in clinical development in China for AS are exclusively TNF inhibitors and IL-17 inhibitors.