Choose from drugs: chemicals, biological products, therapeutic biological products, preventive biological products, traditional Chinese medicine, raw materials, pharmaceutical machinery combinations, pharmaceutical excipients, packaging materials, in vitro diagnostic reagents, others, etc. Understand the declaration and listing of various new drugs.
According to the database, there are 82 new drugs listed in China this year, and 93 companies have applied for listing, and the acceptance number is 142. Recently, the following are more interesting:
1.？ The first subcutaneous injection of PD-L 1 will be approved soon.
2.？ Osekan's first new drug is listed.
3.？ Columbotai PD-L 1 antibody announced its listing.
According to the database, the application for envolizumab injection has entered "approval", which will become the first PD-L 1 inhibitor in China and the first subcutaneous injection of PD-L 1 inhibitor in the world. It is reported that envolizumab has been awarded orphan drugs for cholangiocarcinoma by FDA before. If it is officially approved, there will be 65,438 drugs in China.
Latest list of new drugs
Osekan's first 1 new drug was declared for listing.
According to the database, ASK 120067 tablets of Jiangsu Ao Si Kang Pharmaceutical Co., Ltd. submitted an application for listing today, which was accepted by CDE. ASK 120067 tablets, the third generation EGFR-TKI new drug of Si Kang Pharmaceutical Co., Ltd., and ASK 120067 tablets known in the drug review database are special review drugs that entered the clinical review in 20 17 years. Mainly used in the field of tumor treatment; The treatment of EGFR mutation non-small cell lung cancer is a third-generation oral EGFR-TKI new drug with independent intellectual property rights, brand-new molecular entity and remarkable activity, which is jointly developed by Shanghai Institute of Pharmacology of China Academy of Sciences, Guangzhou Institute of Biomedicine and Health of China Academy of Sciences and Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Market situation of new drugs
Columbotai PD-L 1 new antibody drug application for listing.
According to the data, tetley monoclonal antibody of PD-L 1, the first Columbine new antibody drug, has been declared and accepted by CDE, and its indication is Hodgkin's lymphoma.
Declaration and listing of new drugs
The above is the recent declaration and listing of new drugs. To know about the declaration and listing of other new drugs, you can query in the drug evaluation database in the database, including not only the declaration and listing, but also the clinical application, production application, conformity evaluation, import, registration, supplementary application, re-registration, application for registration or supplement, evaluation and so on. , can be found in China drug evaluation database.