Biopharmaceutical company Everest Medicines has received approval from China’s National Medical Products Administration (NMPA) for its new drug application (NDA) related to Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI) in adults.
With this approval, the firm intends to introduce Xerava in the Chinese market in the third quarter of this year.
Xerava is a new fully synthetic, broad-spectrum, fluorocycline and parenteral antibiotic of the tetracycline class, which has demonstrated a wider in vitro activity against gram-negative and gram-positive pathogens.
These pathogens have acquired multidrug resistance (MDR) and are widely spread in China.
Everest Medicines CEO Rogers Yongqing Luo said: “We are very excited to receive NMPA approval for Xerava and launch the product as the first product Everest will commercialise in China.
“This will lead Everest’s transformation from a biotech to a fully-integrated biopharmaceutical company.
“We expect to have three or more product approvals in 2023-2024, including Nefecon to be approved and commercialized later this year. Together with Xerava, these products will help Everest develop into a full commercial-stage company.”
Currently, Xerava is approved to treat cIAI in the US, EU, UK, Singapore and Hong Kong.
This medicine is also under assessment for cIAI in the Taiwan region.
Everest secured the license for Xerava from Innoviva’s wholly-owned subsidiary Tetraphase Pharmaceuticals.
Under the licence, the company has exclusive rights to develop and commercialise Xerava in Greater China, South Korea, and certain Southeast Asian markets.