The new biological antitumor drug of Haiwang, tegio, is about to obtain the production approval

The new anti-tumor drug of Haiwang biological heavyweight, tegio, will be approved for production soon, and it is expected to be listed in 2014 to improve the company's anti-tumor production line According to the website of the State Food and drug administration, the state of class 3.2 anti-tumor drug tegio tablet applied for production by Haiwang Fuyao, a subsidiary of Haiwang biological holding company, has become "under approval" According to the new drug approval process, Haiwang biological is expected to obtain the product production approval document in about one month Apart from the original research pharmaceutical enterprises, at present, only three pharmaceutical enterprises in China have the approval documents for this product, namely Qilu pharmaceutical, Hengrui Pharmaceutical (600276 SH) and Shandong new era pharmaceutical, but all of them are capsule dosage forms As early as 1999, tegio capsule was developed and produced by Dapeng Pharmaceutical Co., Ltd of Japan Its trade name is "ESWAN" It is a fluorouracil derivative oral anticancer agent At present, Aswan has been approved by Japan for the treatment of advanced gastric cancer, head and neck cancer, rectal cancer, non-small cell lung cancer, metastatic breast cancer, pancreatic cancer and cholangiocarcinoma and other seven tumor diseases, with high single drug efficiency In 2009, ESWAN was officially listed in China as an indication of advanced gastric cancer According to the public data, more than 80% of patients in advanced gastric cancer in Japan use tegio, and the treatment efficiency (Cr + PR) can reach more than 44.6%, which has become the first-line drug in the treatment of advanced gastric cancer in Japan According to the latest research report of UBS Securities in January 2014, domestic tegio capsule has been widely used since it was listed in China in 2009 PDB data shows that its compound growth rate from 2010 to 2012 is as high as 124% In 2012, the domestic sales volume is about 446 million yuan, and the terminal scale is expected to be close to 1.4 billion yuan, ranking among the top ten domestic anti-tumor drugs According to the public data, more than 80% of the patients in advanced gastric cancer in Japan use tegio, and the effective rate (Cr + PR) can reach 44.6% At present, tegio's domestic market sales are more than 1.7 billion, and the growth rate is very fast Haiwang biology is mainly engaged in two major sectors: pharmaceutical business and pharmaceutical industry Its products span many fields such as anti-tumor, cardiovascular, marine medicine, respiratory system and anti infection According to CFDA information, in addition to Haiwang biology, there are currently five enterprises applying for tegio tablets Qilu pharmaceutical, as the only one of the five enterprises applying for production approval, its tegio tablets declared in July 2011 are currently under review