BRIEF—China drug approvals for Helsinn/Mundipharma and UCB

Swiss pharma firm Helsinn Group and Mundipharma China Pharmaceutical, the market leader of pain management have received approval from the Chinese National Medical Products Administration (NMPA) for their anti-emetic agent Aloxi (palonosetron).

This is the first Helsinn cancer supportive care product to be approved for marketing in China, where Mundipharma China Pharmaceutical has exclusive marketing, promotion and sale rights for Aloxi.

Aloxi IV is our first cancer supportive care product to be approved by the NMPA and we are delighted that it will soon be available to patients also in China. In the countries where Aloxi IV has been launched so far, Aloxi has been central to the prevention of CINV for many years and has helped define the standard of care for this condition. In China, we are collaborating with our longstanding and trusted partner, Mundipharma China Pharmaceutical, and we look forward to working with them to bring this product to the many patients in China that suffer from CINV,” said Riccardo Braglia, Helsinn’s vice chairman and chief executive.

Additionally, Belgium-based global bio-pharmaceutical company UCB today announced it has received an Import Drug License (IDL) from the National Drug Administration of China (CNDA), creating a pathway to make Vimpat (lacosamide) available to treat people living with epilepsy in China.

With this IDL, Vimpat is now indicated in China as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent patients 16 years of age and older with epilepsy.