Recently, the orphan drug KBMAB-16 (intravenous injection of tumor necrosis factor-α inhibitor), a major project of a well-known Chinese pharmaceutical company located in Chengdu, was successfully approved for clinical trial application (IND) by the US Food and Drug Administration (US FDA).
Shanghai Medicilon would like to express its sincere congratulations. Relying on compliant and efficient R&D technology, Medicilon provided the project with long-term toxicity test services that meet the requirements of China and the United States.
Sarcoidosis is a chronic multisystem inflammatory disease of unknown etiology characterized by noncaseating epithelioid granulomas with mononuclear cell infiltration and microarchitectural disruption. The disease can affect the skin, eyes, heart, and central nervous system, and the lungs in more than 90% of cases. The disease is one of significant, unmet medical needs.
As a new drug approved by the FDA Orphan Drug Qualification, KBMAB-16 is a human-mouse chimeric anti-tumor necrosis factor monoclonal antibody with a molecular weight of about 149 kilodaltons, which is used for the treatment of sarcoidosis with or without extrapulmonary involvement. Novel biological products. At present, no tumor necrosis factor-α inhibitor has been approved for the treatment of sarcoidosis, but the physicochemical properties and pharmacological effects of KBMAB-16 as a tumor necrosis factor-α inhibitor have been extensively studied.
Medicilon is honored to undertake the long-term toxicity test of KBMAB-16. In response to the difficulty of designing the trial cycle, the Medicilon Toxicology R&D team designed the trial plan reasonably and carefully in accordance with international standards, advanced the project in a rigorous and orderly manner, and completed the trial with high quality and efficiency, which helped the drug successfully obtain FDA approval for clinical trials trials provide strong support.
Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.
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