According to the Hong Kong Stock Exchange, on February 26, Jiangsu Qyuns Therapeutics-B passed the IPO hearing on the main board of the Hong Kong Stock Exchange and will be listed soon.

It is reported that Qyuns Therapeutics was established in 2015. It is a clinical-stage biotechnology company completely focused on biotherapeutics of autoimmune and allergic diseases, covering four major disease areas: skin, rheumatism, respiratory and digestive tract diseases.

According to its official website, based on its complete independent innovation capabilities, Qyuns Therapeutics has formed two core products, QX002N and QX005N, as well as a product pipeline of seven other drug candidates. One variety has been accepted by BLA, one is in clinical phase 3, and four varieties are in clinical phase 2 and 1 respectively. The indications cover silver eyebrow disease, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, It covers four major disease areas including asthma, inflammatory bowel disease, skin, rheumatism, respiratory, and digestive diseases. It is one of the companies with the most IND approvals in the field of autoimmune and allergic diseases in China.

Specifically, QX001S, an IL-12/IL-23p40 inhibitor for the treatment of psoriasis (Ps), is the first domestic ustekinumab biosimilar to submit a BLA in China and may be the one of the first ustekinumab biosimilars approved in China; QX002N (an IL-17A inhibitor in phase III clinical trials with good efficacy in the treatment of ankylosing spondylitis (AS)); QX005N (A monoclonal antibody (mAb) that blocks IL-4Rα, a well-validated broad target for a wide range of indications). QX005N is one of China's most mature biopharmaceutical candidates for atopic dermatitis (AD) and the first biopharmaceutical candidate developed by a domestic company to undergo clinical trials for prurigo nodularis (PN).

QX002N is one of the core products of Qyuns Therapeutics. It is a high-affinity monoclonal antibody targeting IL-17A. IL-17A plays a key role in the pathogenesis of various autoimmune diseases. IL-17A inhibitors, together with TNF-α inhibitors, are recommended by current clinical guidelines as second-line treatments for AS patients who still have high disease activity after receiving first-line traditional treatments. Among the two classes of biological therapies, IL-17A inhibitors have clear clinical benefits in patients who are intolerant to TNF-α inhibitors or unable to achieve adequate disease control.

Qyuns Therapeutics has obtained IND approval for QX002N for ankylosing spondylitis and lupus nephritis. QX002N has shown good efficacy in phase Ib and phase II clinical trials for AS. In the Phase Ib clinical trial, the ASAS20 and ASAS40 response rates at week 16 for subjects who received QX002N (160 mg) every 2 weeks were 62.5% and 37.5%, respectively. In the Phase II clinical trial, subjects who received QX002N (160mg) every 4 weeks achieved ASAS20 and ASAS40 response rates of 60.0% and 40.0% respectively at week 16.

According to the hearing information, Qyuns Therapeutics conducted a pre-phase consultation on QX002NIII with the NMPA, and the NMPA did not raise any major issues in its official reply issued in July 2023, and confirmed that it had There are no objections to carrying out the relevant trials. Phase III clinical trials of QX002N will be launched in September 2023 and are expected to be completed in the second half of 2025.

QX005N is another core product of QQyuns Therapeutics. QX005N is designed to inhibit IL-4Rα, which is a well-proven broad-spectrum target that can be applied to a wide range of indications. Because IL-4Rα controls IL-4 and IL-13 signaling, which is critical for the occurrence of type 2 inflammation, it has become a key target for the development of new drugs in related indications.

According to Frost & Sullivan, to date, IL-4Rα inhibitors have been approved or are in development for the treatment of 20 indications worldwide. Dupilumab is the first IL-4Rα inhibitor approved by the FDA and is one of the best-selling biological drugs for allergic diseases in the world, with annual sales in 2023 of 10.715 billion euros (approximately US$11.717 billion).

At present, Qyuns Therapeutics has obtained IND approval for seven types of QX005N (i.e. adult AD, adolescent AD, PN, CRSwNP, CSU, asthma and COPD), which is the drug with the most indications among China's IL-4Rα targeted drug candidates.

According to the hearing information of Qyuns Therapeutics, QX005N has shown good safety and efficacy in the treatment of AD in its Phase Ia and Phase Ib clinical trials. In a Phase Ib clinical trial in patients with moderate to severe AD, 75.0% of subjects in the 300 mg and 600 mg groups achieved an Eczema Area and Severity Index-75 (EASI-75) response (defined as a greater EASI score than Improvement from baseline of 75% or more), while 50.0% of subjects achieved an Investigator Global Assessment (IGA) score (0 or 1) without significant increased safety risk.

Qyuns Therapeutics has started a phase II clinical trial for AD and completed patient enrollment in February 2023. In addition, we started a Phase II clinical trial for PN in February 2023. According to Frost & Sullivan, QX005N is the first biologic drug candidate developed by a domestic company in China to begin clinical trials for PN in China. In January 2024, the Center for Drug Evaluation granted QX005N breakthrough therapy designation for the treatment of PN, marking its superior clinical efficacy compared with existing treatment methods. This designation is designed to expedite the development and regulatory review of innovative medicines that show significant potential to address serious diseases. In April 2023, Quanxin Biotech began a phase II clinical trial of QX005N for the treatment of CRSwNP.

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