CSPC Pharmaceutical Group's first-in-class drug was approved for clinical trial for another indication

On December 29, 2022, CSPC Pharmaceutical Group's WeChat public account announced that the Group's ALMB-0166 for the treatment of osteoarthritis has been approved by the National Medical Products Administration of the People's Republic of China and can be used to carry out clinical trials in China.

ALMB-0166 is a first-in-class humanized monoclonal antibody inhibitor against a novel target semichannel membrane protein Connexin 43 , independently developed by AlaMab Therapeutics Inc., a subsidiary of the company, for the treatment of major neurological and bone-related diseases such as osteoarthritis, acute spinal cord injury and stroke. Osteoarthritis is a chronic disease dominated by joint cartilage damage, with more than 300 million patients worldwide, and nearly 100 million patients in China. The treatment methods for osteoarthritis are limited, and the current main treatment is symptomatic treatment such as analgesic drugs, and the treatment method that can fundamentally inhibit cartilage tissue damage from the mechanism is extremely lacking. ALMB-0166 protects cartilage tissue and relieves osteoarthritis-related inflammation and pain by preventing the opening of the Cx43 hemichannel associated with osteoarthritis and inhibiting the release of pro-inflammatory and pro-injury factors from bone cells. Preclinical studies have shown that ALMB-0166 can significantly reduce osteoarticular pain in animals and improve the pathological condition of cartilage tissue in animals, providing a new potential therapy for the fundamental treatment of osteoarthritis.

ALMB-0166 was also certified as an orphan drug by the U.S. Food and Drug Administration (FDA) in 2018 for the treatment of acute spinal cord injury, and has completed Phase I clinical trials in healthy subjects in Australia and is currently conducting Phase I/II clinical trials in China.

CSPC will go all out to promote the clinical research of ALMB-0166 in different indications and strive to launch the product as soon as possible.