Qyuns Therapeutics Co., Ltd. has received approval from China’s National Medical Products Administration (NMPA) for its ustekinumab biosimilar, SAILEXIN, indicated for the treatment of moderate-to-severe plaque psoriasis in adults. This marks a significant milestone for the company, representing the first biosimilar approval for Qyuns and a substantial advancement in its research and development pipeline.
The approval enables Qyuns Therapeutics to market SAILEXIN in China, addressing a critical need for cost-effective treatment options for psoriasis patients. Psoriasis, a chronic autoimmune disease, affects millions worldwide, with a significant proportion experiencing moderate-to-severe symptoms that require advanced therapies. Ustekinumab, a human monoclonal antibody, targets the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23), key cytokines involved in the pathogenesis of psoriasis.
SAILEXIN's commercialization will be managed by Zhongmei Huadong, a well-established pharmaceutical company in China, leveraging its extensive distribution network and market expertise. Cellularforce will handle the production of the biosimilar, ensuring a reliable supply chain to meet the anticipated demand. This strategic partnership aims to maximize the impact of SAILEXIN on the Chinese pharmaceutical market and improve access to biologics for psoriasis patients.
The introduction of ustekinumab biosimilars like SAILEXIN is expected to lower treatment costs, making biologic therapies more accessible to a broader patient population. While specific pricing details have not been disclosed, biosimilars typically offer a significant discount compared to their reference products. This cost reduction can alleviate the financial burden on patients and healthcare systems, particularly in a market where access to innovative medicines may be limited by affordability.
The approval of SAILEXIN underscores Qyuns Therapeutics' commitment to developing and commercializing high-quality biosimilars to address unmet medical needs. The company's robust R&D capabilities and strategic partnerships position it for continued growth and success in the rapidly evolving Chinese pharmaceutical market.
