Sirtex Medical and its shareholders, China Grand Pharmaceutical and Healthcare Holdings Limited (CGP) have been issued a “Notice of Drug Clinical Trial Approval” by the National Medical Products Administration (NMPA) of the People’s Republic of China.
The notice confirms that SIR-Spheres Y-90 resin microspheres meet the relevant requirements for drug registration in China. With this confirmation, Sirtex is approved to file a New Drug Application (NDA) in the country.
“We are grateful to the members of CGP, Sirtex China, and our Global Regulatory, Quality Assurance, Operations, and Medical teams for their dedicated work in achieving this approval from the NMPA and navigating the complex regulatory process,” comments Kevin R Smith, chief executive officer of Sirtex. “This is a critical milestone toward allowing us to provide a valuable treatment option to people with liver cancer in China.”
The announcement marks a step in Sirtex’s journey to gain market entry into China, thanks to the company’s collaboration with its shareholder, CGP.
“We are proud of our team’s accomplishment and work to achieve this goal,” says Weikun Tang, general manager of Sirtex China. “We are excited for the opportunity to work together with CGP to bring SIR-Spheres Y-90 resin microspheres to our country’s patients.”