Founded in 2015, we are a clinical-stage biotech company exclusively focused on biologic therapies for autoimmune and allergic diseases. We have two Core Products, QX002N and QX005N, both of which are self-developed. QX002N is an IL-17A inhibitor and we have initiated a Phase III clinical trial for ankylosing spondylitis (AS) in China. QX005N is a monoclonal antibody (mAb) blocking IL-4R and we have initiated Phase II clinical trials for atopic dermatitis (AD), prurigo nodularis (PN) and chronic rhinosinusitis with nasal polyps (CRSwNP) in China. As of the Latest Practicable Date, we had seven other pipeline drug candidates in addition to our Core Products, four of which were in the clinical stage. Our pipeline covers four major areas in the autoimmune and allergic disease field, namely, skin, rheumatic, respiratory and digestive diseases.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET OUR CORE PRODUCTS AND OTHER PIPELINE PRODUCTS SUCCESSFULLY.
Our Core Products
QX002N
One of our Core Products, QX002N, is a high-affinity monoclonal antibody (mAb) targeting IL-17A, a key player in the pathological mechanism of various autoimmune diseases. IL-17A inhibitors are recommended by prevailing clinical guidelines as second-line standalone treatment (the same designation as TNF inhibitors) for AS patients with high disease activity after receiving first-line traditional treatments. Between the two classes of biologics (i.e., TNF inhibitors and IL-17A inhibitors), IL-17A inhibitors have shown clear clinical benefit in patients who are intolerant to or fail to achieve adequate disease control with TNF- 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 Assessment of Spondyloarthritis International Society 20 (ASAS20, defined as 20% improvement from baseline in the ASAS score) and ASAS40 (defined as 40% improvement from baseline in the ASAS score) responses at week 16, respectively. In our Phase II clinical trial, the ASAS20 and ASAS40 response rates of subjects receiving QX002N (160 mg) once every 4 weeks reached 60.0% and 40.0% at week 16, respectively. ASAS20 and ASAS40 indicate 20% and 40% improvement, respectively, from baseline in the ASAS score, a widely used measurement of symptom improvement for AS patients. We conducted a pre-Phase III consultation with the NMPA, which raised no material questions and confirmed that it had no objections to the commencement of such trial in its official response in July 2023. We commenced the Phase III clinical trial in September 2023 and expect to complete it in the second half of 2025.
Addressable Market and Competitive Landscape
According to Frost & Sullivan, the prevalence of AS in China was 3.9 million in 2022, and is estimated to reach 4.0 million in 2030. The AS drug market in China was US$1.8 billion in 2022, and is estimated to reach US$6.5 billion in 2030, at a CAGR of 17.4%. Upon its approval and commercialization, we expect QX002N to face intense competition from approved biologic drugs from multinational pharmaceutical companies as well as potential competition from drug candidates in clinical development in China for AS. As of the Latest Practicable Date, such drugs and drug candidates were exclusively TNF inhibitors and IL-17 inhibitors. The TNF inhibitors include adalimumab and numerous adalimumab biosimilars and proposed biosimilars. As of the Latest Practicable Date, there were two IL-17A antibody drugs approved for AS treatment in China, namely, secukinumab and ixekizumab, both of which had also been approved by the FDA. As of the same date, in addition to our QX002N, there were ten IL-17-targeting biologic drug candidates indicated for AS in the clinical stage in China. The following table sets forth details of QX002N and IL-17 antibody drugs or drug candidates for AS in the clinical stage in China as of the Latest Practicable Date.
QX005N
Our other Core Product, QX005N, is designed to inhibit IL-4R, a validated target investigated for a wide range of indications. Because IL-4R controls the signaling of both IL-4 and IL-13, which is critical in the initiation of type 2 inflammation (an overactive immune response driven by certain type 2 immune cells), it has emerged as a key target for new drug development in related indications. According to Frost & Sullivan, IL-4R inhibitors had been approved or were under development for 20 indications globally as of the Latest Practicable Date. Dupilumab, the first FDA-approved IL-4R inhibitor, is one of the best-selling biologic drugs globally for allergic diseases, with annual sales of US$8.7 billion in 2022.
As of the Latest Practicable Date, we had obtained seven IND approvals for QX005N (namely, AD in adults, AD in adolescents, PN, CRSwNP, CSU, asthma and COPD). QX005N demonstrated favorable safety and efficacy results in our Phase Ia and Phase Ib clinical trials for AD. In the Phase Ib clinical trial in patients with moderate-to-severe AD, in each of the 300 mg and 600 mg groups, 75.0% of subjects achieved Eczema Area and Severity Index-75 (EASI-75) responses (defined as 75% improvement from baseline in the EASI score) and 50.0% of subjects reached Investigator’s Global Assessment (IGA) scores (0 or 1) at week 12 without significantly increased safety risks. We have started a Phase II clinical trial for AD and completed patient enrollment in February 2023. In September 2023, we conducted a formal consultation with the CDE of the NMPA inquiring whether the NMPA had any objections to or additional requirements on our conduct of the Phase Ib/Phase II clinical trial, and the NMPA did not raise any objections or additional requirements. In addition, we commenced a Phase II clinical trial for PN in February 2023. According to Frost & Sullivan, QX005N was the first biologic drug candidate developed by a Chinese domestic company to start a clinical trial for PN in China. In January 2024, the CDE granted QX005N the breakthrough therapy designation for the treatment of PN, signifying its superior clinical benefits compared to current treatment methods. The designation is designed to expedite the development and regulatory review of innovative drugs demonstrating substantial potential in addressing serious conditions. We also commenced a Phase II clinical trial of QX005N for CRSwNP in April 2023.
Addressable Market and Competitive Landscape
Upon approval and commercialization of QX005N, we expect it to face intense competition from approved biologic drug as well as potential competition from drug candidates in clinical development in China for the same indication. The industry landscapes of the major indications in China are as follows:
‧ AD. According to Frost & Sullivan, the prevalence of AD in China was 70.3 million in 2022, and is expected to reach 78.5 million in 2030. The AD drug market in China was US$1.0 billion in 2022, and is estimated to grow rapidly to reach US$7.1 billion in 2030, at a CAGR of 23.3%. As of the Latest Practicable Date, dupilumab was the only biologic drug approved in China for AD, which had also been admitted to the NRDL. As of the same date, there were 21 biologic drug candidates for AD in the clinical stage in China, among which 10 were IL-4R inhibitors. Biologics targeting IL-13, TSLP, IL-33, ST2, CD200R, OX40, IL-2R and IL-17RB are also being developed for AD. The following table sets forth details of QX005N as well as approved biologic drugs and drug candidates for AD in the clinical stage in China that target IL-4R as of the Latest Practicable Date.
‧ PN. According to Frost & Sullivan, the prevalence of PN in China was 2.0 million in 2022, and is estimated to reach 2.1 million in 2030. Development of the PN drug market in China is still at an early stage with dupilumab being the only biologic drug approved in China as of the Latest Practicable Date. As of the same date, there were only two biologic drug candidates for PN in the clinical stage in China, both of which were IL-4R inhibitors, as set out below.
‧ CRSwNP. According to Frost & Sullivan, the prevalence of CRSwNP in China was 20.4 million in 2022, and is estimated to reach 22.3 million in 2030. The CRSwNP drug market in China was US$141.7 million in 2022, and is expected to reach US$633.4 million in 2030, at a CAGR of 20.6%. As of the Latest Practicable Date, no biologic drug had been approved for the treatment of CRSwNP in China. As of the same date, there were 13 biologic drug candidates for CRSwNP in the clinical stage in China, including six IL-4R inhibitors. Biologics targeting IL-5 and TSLP are also being developed for CRSwNP. The following table sets forth details of QX005N as well as the biologic drug candidates for CRSwNP in the clinical stage in China as of the Latest Practicable Date.
Our Other Key Drug Candidates
‧ QX001S: QX001S is our first expected commercial drug, the first domestically developed ustekinumab biosimilar with BLA submitted in China and potentially one of the first ustekinumab biosimilars to be approved in China, which targets IL-12/IL-23p40 and has been widely regarded as one of the major treatments for Ps worldwide. In our Phase I clinical trial for Ps, QX001S demonstrated a safety and PK profile comparable to that of ustekinumab. In our Phase III clinical trial for Ps, QX001S demonstrated clinical equivalence to ustekinumab in terms of efficacy, safety, immunogenicity and PK profile. Zhongmei Huadong, a subsidiary of Huadong Medicine and our commercialization partner for QX001S, submitted a BLA in China in July 2023, which was accepted by the NMPA in August 2023 and under review as of the Latest Practicable Date. We expect QX001S to face fierce competition upon its commercialization, especially considering that the other two ustekinumab biosimilar candidates in China commenced their Phase III clinical trials at a similar time as our Phase III trial. See “Risk Factors—Our drug candidates will be subject to intense competition with biologics drugs and other drugs for autoimmune and allergic diseases after commercialization and may fail to compete effectively against competitors” for details.
‧ QX004N: We are developing QX004N, an IL-23p19 inhibitor, for Ps and CD. We completed a Phase Ia clinical trial of QX004N in healthy subjects for the Ps indication in China in September 2023 and QX004N showed a good safety profile. As of September 30, 2023, we had also commenced a Phase Ib clinical trial and a Phase II clinical trial in China to evaluate QX004N for this indication and expect to complete them in the second quarter of 2024 and the first half of 2025, respectively. We also commenced a Phase Ia clinical trial for CD in China in February 2023.
‧ QX006N: We are developing QX006N, an IFNAR1-targeting mAb, for the treatment of SLE, a difficult indication for new drug development. The first-in-class IFNAR1 inhibitor, SAPHNELO (anifrolumab), was approved by the FDA in 2021, making it the only new SLE treatment in more than 10 years. As of the Latest Practicable Date, our QX006N was one of the only two IFNAR1 inhibitors developed by Chinese domestic companies that had entered the clinical stage for SLE in China. QX006N showed a good safety profile in our Phase Ia clinical trial, and promising potency and affinity comparable to those of an internally prepared anifrolumab analog in our preclinical studies. We initiated a Phase Ib clinical trial in SLE patients in March 2023 and expect to complete such trial in the fourth quarter of 2024.
‧ QX008N: QX008N is a humanized IgG1 mAb targeting TSLP, designed for the treatment of moderate-to-severe asthma and moderate-to-severe COPD. TSLP-targeting therapy is the only class of biologic drugs globally approved for asthma that can slow disease progression for asthma patients with low-level or no expression of type 2 biomarkers. QX008N demonstrated a potency superior to an internally prepared tezepelumab analog and exhibited a good safety profile in our Phase Ia clinical trial. We commenced a Phase Ib clinical trial in adult patients with moderate-to-severe asthma in August 2023, the remainder of which will be completed by Joincare, our licensing partner.
Source: Qyuns Therapeutics-B (02509) Prospectus (IPO Date : 2024/03/12) |