Business
Ainos Announces Successful Manufacturing of VELDONA GMP Clinical Batch by Swiss Pharmaceutical
Subsequent Phase Involves Completion of Chemistry, Manufacturing, and Controls (CMC) InformationAinos Intends to Submit Investigational New Drug Applications
About this update from Ainos, Inc.
[{"type":"text","content":"Subsequent Phase Involves Completion of Chemistry, Manufacturing, and Controls (CMC) InformationAinos Intends to Submit Investigational New Drug Applications to the U.S. FDA for Multiple Candidates During the First Half of 2024Candidates include HIV Oral Warts Orphan Drug, Sjogren's Syndrome, the Common Cold, and COVID-19SAN DIEGO, CA / ACCESSWIRE / November 28, 2023 / Ainos, Inc. (NASDAQ: AIMD, AIMDW) (\"Ainos\", or the \"Company\"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that its contract manufacturer, Swiss Pharmaceutical Co., Ltd. (Taiwan) (\"Swiss Pharma\"), has completed manufacturing of a Good Manufacturing Practice (\"GMP\") Clinical Batch of the Company's VELDONA® investigational new drugs.Mr. Chun-Hsien (Eddy) Tsai, Chairman, President and CEO of Ainos, commented, \"This marks another important milestone for Ainos. We have been collaborating with Swiss Pharma since August 2022 with the ultimate goal of building a high-quality, cost-effective manufacturing solution for VELDONA®. This cooperation enables Ainos to advance our key programs so that we can facilitate delivery of high-quality, safe, and effective therapeutics to individuals seeking relief from immunity issues or viral infections.\"\"Ainos has dedicated nearly four decades to the development of VELDONA®, accumulating a wealth of clinical data from 68 studies across 16 disease indications. Recognizing immunity as the root of many health issues, Ainos has developed VELDONA® to boost the immune response against disease and infection. Our team continues to explore these assets' latent values, including two drugs with U.S. FDA Orphan Drug Designation: oral warts in HIV-seropositive patients and Behçet's disease. We look forward to continuing our collaboration with Swiss Pharma as we advance our portfolio of VELDONA® product candidates.\"Swiss Pharma has conducted testing, manufacturing, and packaging of VELDONA®'s GMP Clinical Batch for Ainos under both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice (\"PIC/S GMP\") and the United States Food and Drug Administration's (the \"U.S. FDA\") Current Good Manufacturing Practice regulations.Following release of the GMP Clinical Batch by Swiss ...