In 2014, 31 new clinical class 1 drugs were applied for biological products

In 2014 (as of October), there were 31 class 1 new biological products (calculated according to the acceptance number), including 15 for treatment and 16 for prevention According to the provisions of the measures for the administration of drug registration, "biological products not marketed at home and abroad" belong to class 1 new drugs However, due to the particularity of biological products, as long as the engineering cell line is changed, it can also be regarded as a class 1 new drug So in the list of class 1 new drugs of biological products, familiar drug names are often seen, but they are actually declared according to class 1 new drugs In 2014 (as of October), there were 31 class 1 new biological products (calculated according to the acceptance number), including 15 for treatment and 16 for prevention If the h7n9 vaccine is not included in the application, only one Watson biological enterprise has applied for two new drugs, and other enterprises have only applied for one new drug Class 1 new drugs of biological products applied for treatment are mainly used in such key disease fields as tumor and diabetes The new drugs for prevention are more vaccines used under high exposure conditions, such as Watson biological declaration two varieties In addition, we can also pay attention to the six valent recombinant human papillomavirus vaccine (6,11,16,18,52,58) (Hansen yeast) of Chengdu Institute of biological products On the way of domestic approval of HPV vaccine, GSK and MSD are both working hard Chengdu Institute of biological products directly declared six valent (GSK is the second price, MSD is the fourth price) H7n9 virus has been infected since last year, causing a round of avian influenza At present, although the epidemic has subsided, a batch of h7n9 vaccines and treatment drugs have been declared In terms of vaccines, Shanghai Institute of biological products applied for 2, Kexing biological applied for 4, Tiantan Biological applied for 2, Hualan biological applied for 4; in terms of therapeutic biological products, there was also a monoclonal antibody from Shenzhou cells All the new drugs declared above, except for two vaccines of Tiantan biology, have been approved in six of this year, and all others are in the state of "under review"