Since the global explosion of the Highly Pathogenic Avian Influenza in 2005, the highest priority has been given to the development of anti-bird-flu drugs in order to prevent and cure substantial epidemic diseases and to protect the national economic security and social stability in China. The year of 2009 witnessed the attack by H1N1 Flu, for which there is a high possibility of virus variation. Therefore the R&D as well as the reserves of effective anti-flu drugs becomes extremely crucial.

In order to meet this exigent demand of the country, SIMM (Shanghai Institute of Materia Medica) has been working closely with Nanjing Simcere Dongyuan Pharmaceutical Ltd. and Nanjing Yifang Pharmaceutical R&D Center Ltd. since 2005 and effectively developed the Zanamivir API under strong supports of MOST and CAS grants. The API got also the authorization from GSK; a new type of formulation “Inhalant Zanamivir Capsule” was further developed. With the clinical trial approval from the State Food and Drug Administration (SFDA) in October 2008, the new drug certificate and production certificate were finally granted for Zanamivir API on February 10th, 2010.

Zanamivir, approved by U.S. FDA and the EMEA in 1999, has been applied for the prevention and treatment on Flu infections. This drug was widely used and took very good effect on the flu explosion in Europe at the end of 1999. SIMM has successfully accomplished the Oseltamivir and Zanamivir production and formulation, respectively, which has enriched and enhanced the strategic reserves of anti-flu medicine in China.