CSPC PHARMA (01093) announced that its self-developed drug ALMB-0166 has received approval from China's National Medical Products Administration (NMPA) to conduct Phase II clinical trials in China to evaluate the efficacy of ALMB-0166 in patients with Parkinson's disease.

ALMB-0166 is a first-in-class humanized monoclonal antibody inhibitor targeting the novel target hemichannel membrane protein Connexin 43 (Cx43). The drug was independently developed by the company's subsidiary AlaMab Therapeutics Inc. for treating neurological diseases including Parkinson's disease, acute ischemic stroke, and acute spinal cord injury.

Parkinson's disease is the world's second-largest neurodegenerative disease, characterized primarily by progressive degeneration of dopaminergic neurons in the substantia nigra and formation of Lewy bodies. The etiology of Parkinson's disease remains unclear, with clinical manifestations notably featuring motor symptoms such as resting tremor, muscle rigidity, bradykinesia, and postural balance disorders, as well as non-motor symptoms including sleep disorders, cognitive and psychiatric disturbances.

Both motor and non-motor symptoms progressively worsen as the disease advances, severely affecting patients' quality of life and imposing heavy economic and care burdens on families and society. Currently, Parkinson's disease treatments, including those centered on levodopa, can only alleviate symptoms and cannot reverse disease progression or achieve cure.

Given the limitations of existing therapeutic approaches, there is an urgent need in the Parkinson's disease field to develop novel therapeutic drugs and therapies to effectively delay disease progression and improve patients' quality of life.

ALMB-0166 works by targeting Cx43 hemichannels, inhibiting the release and spread of neuroinflammatory factors, thereby maximizing neuroprotective effects. Preclinical subacute and chronic Parkinson's disease animal model studies showed that ALMB-0166 can significantly inhibit the reduction of dopamine content in animal brains and significantly restore animals' behavioral abilities and functions, while demonstrating good dose-response relationships.

The group will make every effort to advance clinical research of ALMB-0166 across different indications, striving to bring it to market as soon as possible.