“Biological products not sold in Chinese and foreign markets” belong to category 1 new drug, as stipulated by Provisions for Drug Registration, however, due to the particularities of biological products, the biological products changed engineering cell lines can also be classified as category 1 new drug in actual operation. Therefore, some familiar pharmaceutical product names are frequently seen in the list of category 1 new drug of biological product, but they are indeed applied as category 1 new drugs.
There have been 31 category 1 new drugs of biological products applying for clinic (calculated according to acceptance number) in 2014 (by October), therein: 15 for treatment, and 16 for prevention.
In the enterprises applying for category 1 new drug of biological products, if H7N9 vaccine that has been applied by many enterprises is not counted, only Walvax Biotechnology applied for 2 new drugs, other enterprises all applied for only one new drug respectively.
The category 1 new drugs of biological products applied for treatment were mainly for treating tumor and diabetes and other key disease fields. And the new drugs for prevention were mostly some vaccines that can be used under high exposure, such as the two varieties applied by Walvax Biotechnology.
Furthermore, the hexavalent recombinant human papillomavirus (HPV) vaccine (6,11,16,18,52,58 type) (hansenula polymorpha) of Chengdu Institute of Biological Products can also be noted--on the approval road of HPV vaccine in China, GSK and Merck are making great efforts, and Chengdu Institute of Biological Products directly applied for one hexavalent HPV (GSK’s of bivalent, and Merck’s of quadrivalent).
