China Medical System Holdings Limited announced that on 7 June 2023, the New Drug Application (NDA) of Diazepam Nasal Spray received approval from the National Medical Products Administration of China (NMPA). The Product is the first nasal spray formulation of diazepam in China, and it is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e. seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. The Company has obtained the drug registration certificate on 12 June 2023.

The Product is one of the Group's important and innovative products. To benefit epilepsy patients in China as soon as possible, the Group will swiftly complete the asset transfer transaction and prepare for commercialization in an orderly way. Diazepam Nasal Spray: The Product is a proprietary formulation of diazepam administered through the nasal mucosa, via a unique combination of Vitamin E-based solvents and Intravail® absorption enhancer.

Intravail® transmucosal absorption enhancement technology enables the non-invasive delivery of a broad range of proteins, peptides and small-molecule drugs. The Product is the first drug approved in China for the treatment of seizure clusters. It can be administered intranasally at the appropriate time by patients or their caregivers under prescription from a doctor and guidance from medical staff.

This can meet current clinical needs of domestic epilepsy patients with cluster seizures who lack accessible and convenient treatment options which can be administered anytime and anywhere, and can provide better treatment options for patients with recurrent epilepsy. The active pharmaceutical ingredient of the Product is Diazepam, belonging to the class of benzodiazepines, which are the first-choice drugs for the treatment of seizure clusters. The Product has high bioavailability, outstanding absorbability, tolerance and reliability, and has the differentiated advantage of seizure rescue, with the characteristic of convenience and optimization through intranasal administration.

There is a pending patent claiming composition and use in China. The results of the Product's US related clinical trial showed that 87% of seizure cluster episodes used a single dose of the Product over a 24-hour period. A post hoc analysis of these data showed the Product had a rapid onset of action with the median time from administration of the Product to seizure cessation of 4 minutes.

Further analyses showed that using the Product as intermittent rescue therapy significantly improves the quality of life of epileptic patients and may reflect a beneficial effect in increasing time between seizure clusters. The Product has also been approved for marketing in the United States of America.