Tonghua Dongbao Alert:NDA approved for a class 1drug
Received NDA approval for peg-interferon alfa-2b.
Tonghua Dongbao (THDB) announced today that its subsidiary, XiamenAmoytop Biotech, had obtained marketing approval for peg-interferon alfa-2binjection. The R&D cost for this drug was RMB126m. Peg-interferon alfa-2b isa class 1 biological drug, indicated for the first line therapy of chronic hepatitisB and C, in combination with ribavirin. Amoytop gained approval for hepatitisC this time. In addition, Amoytop is also in the first place for the application ofanother similar drug, peg-interferon alfa-2a, which has a larger marketopportunity. We remind investors that THDB owns 34.4% equity share inAmoytop.
Background of peg-interferon alfa-2a & 2b.
Peg-interferon alfa-2a was developed by Schering-Plough (acquired by Merck)under the brand name of PegIntron. The drug was approved for hepatitis C bythe US FDA in 2001, and was approved for hepatitis B and C by CFDA in 2004and 2007 respectively. In addition, peg-interferon alfa-2a is a similar drug thatwas developed and marketed by Roche under the brand name of Pegasys. Itwas approved for hepatitis B and C by the US FDA in 2002 and 2005respectively, and approved in China in 2003 and 2005 for the two indicationsrespectively.
Competitive landscape of peg-interferon in China.
We highlight Roche and Merck have achieved marketing approvals in China forpeg-interferon alfa-2a and 2b respectively. In 2015, Merck delivered globalsales of RMB1.2bn and China sales of RMB130m for peg-interferon alfa-2b,while Roche delivered sales of RMB3.7bn and RMB360m for peg-interferonalfa-2b in global and China markets respectively. We highlight XiamenAmoytop is the only domestic player applying for peg-interferon alfa-2b. Forpeg-interferon alfa-2a, there are four domestic players applying now, includingAmoytop, Hengrui, SBP and CSPC, while Amoytop is in the first place by thefiling date.