Anke Biomab New Drug Obtained Clinical Approval

It was learned from the State Administration of Drug Administration that a new biological product declared by Anke Biology had obtained clinical approval on the 13th. The processing status showed that the certification was completed and the approval has been issued to Anhui Province. It is reported that the approved variety is a new "humanized tumor monoclonal antibody" drug developed by the company and Shanghai Kangdai Biomedical Technology Co., Ltd. Anke Bio said that once the recombinant human HER2 monoclonal antibody for injection is mass-produced, the annual output can reach about 40,000. Refer to the current market price of HER2 humanized antibodies of similar products on the market (at 15,000 yuan / support). Annual output value Up to 600 million yuan.

Anke Biotech signed a "Technology Development Contract" with Shanghai Kangdai Biomedical Technology Co., Ltd. in 2009 to develop recombinant human HER2 monoclonal antibody for injection. Analysts expect that the new drug will be officially entered into clinical trials before the end of the year. If the clinical trials are successful, the new drug can be formally applied for registration in about three years.

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