Qyuns Therapeutics: New Drug Application for Crusekitug Accepted by NMPA

Key Points from the Announcement

• Qyuns Therapeutics Co., Ltd. announced that the National Medical Products Administration (NMPA) has officially accepted the New Drug Application (NDA) for its novel biologic drug, Crusekitug (QX002N).
• Crusekitug is an anti-IL-17A monoclonal antibody injection, developed independently by Qyuns Therapeutics, targeting the treatment of active ankylosing spondylitis (AS) in adults.
• This is the first innovative drug from Qyuns to reach NDA acceptance and the second biologic product to reach this stage, following SAILEXIN, marking a critical milestone for the company’s R&D pipeline.
• The NDA is supported by a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study (CTR20232574), with results presented at the American College of Rheumatology (ACR) annual meeting in October 2025.

Clinical Trial and Efficacy Highlights

• The Phase III study demonstrated that Crusekitug provides significant and sustained improvements in disease activity, clinical signs, and symptoms in AS patients, especially in those with inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).
• The drug showed a favorable safety and tolerability profile over 52 weeks of treatment and follow-up.
• Notably, efficacy was also significant among patients previously treated with tumor necrosis factor (TNF) inhibitors, a population with limited treatment options.
• Crusekitug demonstrated clear benefits in reducing edema and inflammation in the spine and sacroiliac joints, with supportive objective imaging evidence of its disease-suppressing effects.

About Crusekitug

• Crusekitug is a high-affinity monoclonal antibody specifically targeting the IL-17A cytokine, which plays a central role in the pathogenesis of various autoimmune diseases, including ankylosing spondylitis.
• IL-17A is implicated in chronic inflammation and bone remodeling, acting synergistically with other pro-inflammatory cytokines such as IL-6 and chemokine CXCL1, and is a key factor in AS pathology.
• Crusekitug is designed to block IL-17A (including IL-17AA and IL-17AF) from binding to its receptor complex (IL-17RA and IL-17RC), thereby preventing the activation of inflammatory signaling pathways and disease progression.

Strategic and Price-Sensitive Considerations for Shareholders

• The NDA acceptance of Crusekitug marks a significant milestone for Qyuns Therapeutics, reflecting the company’s advancing R&D capabilities and signaling the transition of its pipeline into a potential revenue-generating phase.
• Crusekitug is the first innovative drug internally developed by Qyuns to reach this regulatory stage, enhancing the company’s reputation as a player in the biologics and autoimmune disease treatment space.
• Successful commercialization of Crusekitug, if approved, could represent a major new growth driver for the company, addressing a substantial market with a notable unmet medical need.
• However, the company cautions investors that there is no assurance of ultimate successful development, marketing, or commercialization of Crusekitug at this stage.
• This announcement is likely to be of material interest to investors and could impact share price given the significance of the regulatory milestone and the potential market opportunity.

Corporate Governance Update

• The announcement was approved by the Board, chaired by Mr. Qiu Jiwan, with a detailed list of executive, non-executive, and independent non-executive directors provided, reflecting robust corporate governance oversight.

Conclusion

The acceptance of the NDA for Crusekitug by the NMPA marks a pivotal development for Qyuns Therapeutics, potentially opening up new revenue streams and elevating the company’s profile in the biopharmaceutical sector. Investors should monitor the progression of Crusekitug through the regulatory process, as well as any further clinical or commercial updates, given their potential impact on the company’s valuation and future prospects.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Past performance is not indicative of future results. All forward-looking statements are subject to risks and uncertainties. Investors should conduct their own research or consult a professional advisor before making any investment decisions.

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