By Fineline Cube 
Hangzhou Bio-Sincerity Pharma-tech Corp., Ltd (SHE: 301096) has secured clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 oral drug BIOS-0618. The drug is intended for the treatment of excessive daytime sleepiness (EDS) in patients with obstructive sleep apnea syndrome (OSA).
Drug Profile
BIOS-0618 is designed to address symptoms of OSA, including paroxysmal excessive daytime sleepiness, cataplexy, pre-sleep hallucinations, sleep paralysis, and nighttime sleep disturbances. This approval marks a significant milestone in the development of innovative therapies for sleep disorders.
Innovation and Market Potential
BIOS-0618 represents a novel approach to managing OSA-related EDS, with no similar products currently approved globally. Previously approved for neuropathic pain studies in China, this expanded indication underscores the drug’s potential to address a broader spectrum of neurological conditions.-Fineline Info & Tech