Qilu Pharmaceutical's Etanercept Biosimilar Injection Approved by China's NMPA

Dec 22, 2023 15:56 CST Updated 15:56

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Source: Medic Observer

On December 21, the official website of China's National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical Co., Ltd. had submitted an application.Etanercept Biosimilar for InjectionThe marketing application has been approved.Etanercept is a tumor necrosis factor-alpha (TNF-α) inhibitor.

Screenshot source: NMPA official website

Etanercept is a TNF-α inhibitor that can specifically bind to human TNF-α and block its biological function. TNF-α is an endogenous cytokine in the human body, participating in normal inflammatory and immune responses, while also being involved inAnkylosing Spondylitis (AS)、Rheumatoid Arthritis (RA), juvenile idiopathic arthritis, psoriasis and other diseases play an important role in the inflammatory process, and its imbalance leads to joint lesions. EtanerceptThe original product was developed by Amgen and Pfizer., which was first approved for marketing in the United States in 1998. In China, etanercept was first approved in 2010. The currently approved indications include RA and AS, etc.

According to the official website of the Chinese Clinical Trial Registry and Information Disclosure Platform, a biosimilar of Etanercept (i.e., Recombinant Human Tumor Necrosis Factor Receptor II-Antibody Fusion Protein for Injection, research and development codeQL0902），Qilu Pharmaceutical has completed two clinical studies, respectively:A Phase 1 Clinical Study,Comparison in Healthy SubjectsPharmacokinetics and Safety of QL0902 Compared with the Original Etanercept: A Multicenter, Randomized, Double-blind Phase 3 Clinical Study in ChinaPatients with active rheumatoid arthritis who have been receiving a stable dose of methotrexateIn China ComparisonQL0902 and Enbrel Original TreatmentEfficacy and safety.

Public information shows,Rheumatoid ArthritisIt is a chronic, inflammatory autoimmune disease that can cause a series of symptoms, including pain and swelling in the joints, especially in the hands, feet, and knees. When patients do not follow up regularly, it can easily lead to treatment interruption, disease recurrence, or worsening, significantly affecting the long-term prognosis of the disease.Ankylosing SpondylitisIt is a chronic inflammatory autoimmune disease that primarily affects the sacroiliac joints and spinal joints, and can also involve peripheral joints, tendon and ligament insertion points, and other tissues. AS hasLong disease course, prone to recurrence, likely to cause disability, and most patients require lifelong treatment.and other characteristics, seriously affecting the physical and mental health and quality of life of patients.

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