China Medical System Holdings announced that the National Medical Products Administration of China has approved the company’s NDA for diazepam nasal spray for the treatment of seizure clusters in epilepsy patients age 6 and older when the seizures are different for the patient’s usual pattern of seizures. In the US, the diazepam nasal spray, which is marketed as Valtoco, was approved by the FDA in January 2020 and was launched by Neurelis in March 2020.
According to the China Medical System business update announcement, the company acquired the rights to the nasal spray in mainland China, Hong Kong, Macao, and Taiwan from A&B (HK) Company Limited in 2018. The business update notes that the company later acquired the Singaporean rights in 2022. In January 2022, Neurelis announced that Aculys Pharma had acquired the rights to Valtoco in a number of other Asian countries, including Japan, Australia, New Zealand, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, South Korea, Thailand and Vietnam.
Read the China Medical System press release.
