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Sinovac Biotech: Clinical trial application for innovative drug GB19 injection approved by the FDA
Sinovac Biotech announcement. Its wholly owned subsidiary, Shenzhen Sinovac Pharmaceutical Co., Ltd., received a notice from the U.S. Food and Drug Administration. The FDA has approved the clinical trial application for GB19 injection, an innovative drug independently developed by Shenzhen Sinovac, allowing clinical trials to be conducted in the United States. The indication is for the treatment of cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE).