SINO BIOPHARM (01177) announced that its self-developed "Rotigotine Patch" (brand name: Luofiding®) has received marketing approval from China's National Medical Products Administration. The patch is indicated for monotherapy in early-stage idiopathic Parkinson's disease or as an adjunct to levodopa at all stages of the disease.
Parkinson's disease is a common neurodegenerative disorder among middle-aged and elderly populations. According to the China Parkinson's Disease Report 2025, there are currently over 5 million Parkinson's patients in China. Beyond motor symptoms such as bradykinesia, muscle rigidity, resting tremor, and postural instability, the disease often presents non-motor symptoms including olfactory dysfunction, sleep disorders, depression, anxiety, and constipation.
The root cause of Parkinson's lies in the progressive degeneration of dopamine-producing neurons in the substantia nigra region of the brain, with no cure currently available. As the disease progresses, patients become entirely dependent on medication to supplement dopamine. Fluctuations in drug concentration can lead to "on-off phenomena": during "on" periods when medication is effective, patients experience improved motor function, while "off" periods—marked by waning drug efficacy—result in sudden rigidity and mobility impairment.
The Rotigotine Patch is a non-ergot dopamine receptor agonist delivered via transdermal administration. This method bypasses first-pass liver metabolism and provides sustained release, maintaining stable blood concentration for 24 hours. For patients experiencing "on-off" fluctuations, the patch significantly reduces "off" episodes, prolongs "on" time, and lowers the risk of dyskinesia caused by pulsatile dopamine receptor stimulation, enabling smoother symptom control.
Additionally, the once-daily patch offers convenience, potentially improving medication adherence—particularly beneficial for patients with swallowing difficulties, those awaiting surgery, or elderly individuals with frailty. The Rotigotine Patch has been included in multiple guidelines, including China's Parkinson's Disease Treatment Guidelines, as a recommended initial therapy for early-onset Parkinson's.
Luofiding®, developed using the group's proprietary solvent adhesive technology platform, marks another milestone in SINO BIOPHARM's neurological transdermal therapeutics following its Alzheimer's treatment rivastigmine patch (Suleda®). In recent years, the group has advanced its transdermal patch technology, expanding applications from NSAIDs and local anesthetics to central nervous system disorders like Alzheimer's and Parkinson's.
With over a dozen patch products in its pipeline expected to gain approval by 2030, SINO BIOPHARM aims to further solidify its leadership in the transdermal patch sector.
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