Stone Pharmaceutical Group "first-in-class" antibody new drug approved clinically

On December 1st, Stone Pharmaceutical Group announced that its subsidiary's application for a clinical trial of alMB-0166, a new class 1 drug, had been approved by the State Drug Administration of China (NMPA) to conduct clinical studies in acute spinal cord injury.According to stone pharmaceutical group announcement, ALMB-0166 is a targeted half-channel membrane protein Connexin 43 "first-in-class" humanized monoclonal antibody inhibitor, developed by its subsidiary AlaMab Therapeutics (hereinafter referred to as "AlaMab"), to develop the treatment of acute spinal cord injury, stroke, osteoarthritis and other major neurological diseases.Acute spinal cord injury is a sudden wound that can lead to bruising, partial or complete injury to the spinal cord. It is also a common cause of permanent disability or death in children and adults. As an inhibitor of Connexin 43, ALMB-0166 has demonstrated in preclinical studies the effectiveness of preventing the formation of post-injury glial scarring and promoting functional recovery by inhibiting the innovative mechanism of cellular half-channels, according to an earlier press release issued by Stone Pharmaceuticals.In 2018, the FDA has granted ALMB-0166 orphan drug eligibility for the treatment of acute spinal cord injury. In 2019, ALMB-0166 successfully submitted its first human clinical trial application in Australia, based on the results of in vitro pharmacology and pharmacoetics trials in animals, as well as the safety shown in preclinical toxicology studies. Currently, ALMB-0166 has completed phase 1 clinical trials for acute spinal cord injury in Australia and has shown good safety and tolerance.It is worth mentioning that in addition to ALMB-0166, Stone Pharmaceutical Group subsidiary Alamab has developed another target half-channel membrane protein Connexin 43 "first-in-class" research product - ALMB-0168. ALMB-0168 is a humanized monoclonal antibody agonist, Ishido said in an earlier press release.In preclinical studies, ALMB-0168 can effectively treat bone cancer and cancer bone metastasis by activating the Cx43 protein to release anti-cancer substances. In October 2019, ALMB-0168 was awarded by the FDA for the treatment of rare childhood diseases for bone cancer. ALMB-0168 has been approved to conduct clinical studies in osteosarcoma and tumor bone metastasis in China, according to the CDE website. (Pharmaceutical Mission): 1) in the study of the new "ALMB-0166" in Chinabed approval. Retrieved Dec 24 2020, from