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HONG KONG, Feb. 10, 2022 /PRNewswire/ — Akeso, Inc. (9926.HK) announced that the clinical trial application of the innovative nerve growth factor (NGF) monoclonal antibody (research and development code: AK115) injection developed in-house by the Company, has obtained approval from the Centre for Drug Evaluation of China’s National Medical Products Administration to begin clinical trial for the treatment of pain (including cancer pain).

The most commonly used clinical analgesics include nonsteroidal anti-inflammatory drugs(NSAIDs) and opioid central analgesics, however these two types of drugs cannot fully meet the clinical needs of pain treatment due to side effects, such as, in the cancer pain field, where approximately 25% of patients with painful bone metastases still suffer from uncontrollable pain.

Since genetic mutations in nerve growth factor (NGF) or its receptor TrkA cause congenital hypoalgesia with anhidrosis, the role of NGF in pain perception and transmission has attracted extensive attention. NGF monoclonal antibody is considered to be the most promising next-generation analgesic drug in the field of pain, with the advantages of long-term safety, non-addictive and non-resistance.

AK115 (NGF monoclonal antibody) is a humanized IgG1 subtype monoclonal antibody targeting NGF independently developed by the Company. It has good structural stability and can bind to the NGF in human body with high affinity, blocking its interaction with receptors, thereby blocking the signals sent by the nociceptors responsible for the perception of pain, to achieve the purpose of pain relief. At the same time, AK115 introduces amino acid point mutations in the Fc region that eliminate the binding of Fc receptors and complement C1q, which will help AK115 (NGF monoclonal antibody) achieve a better safety profile compared with other subtypes with the same targets under research such as IgG4. AK115 (NGF monoclonal antibody), with the characteristics of long-term safety and non-addictive, will give priority to the evaluation of safety and efficacy in advanced cancer patients, which is expected to bring hope to opioid-resistant advanced cancer patients and improve their quality of life.