To understand the situation of new drug declaration and listing, it is recommended to use the database query, in the "China Drug Evaluation Database" under the drug research and development, to understand the situation of new drug declaration and listing, you can select "new drug" in the type of application in the conditional screening, and select "application for listing" in the type of application for the acceptance number. You can select "new drug" for the application type in the condition filter, and select "application for listing" for the application type of acceptance number. Click on the search to search for new drugs declared on the market, but also in

Types of drugs can be selected: chemical drugs, biological products, therapeutic biological products, biological products for prevention, Chinese medicine, APIs, pharmaceutical combinations, pharmaceutical excipients, pharmaceutical packaged goods, in vitro diagnostic reagents, other and so on, to understand a variety of varieties of new drugs declared on the market.

In the database kind of understanding, at present the domestic new drug this year declared for listing varieties *** 82 kinds, a *** 93 enterprises declared for listing, acceptance number *** have 142, the recent more attention:

1.? The first subcutaneous injection of PD-L1 will be approved soon

2.? Oxycontin's first new drug filed for marketing

3.? Kerenbutai PD-L1 antibody declared on the market

According to the database, Envolizumab injection, the current listing application has entered the "in the approval" after approval, will become the first domestic PD-L1 inhibitor, but also the world's first subcutaneous PD-L1 inhibitor, it is reported that Envolizumab is the first PD-L1 inhibitor, and the first PD-L1 inhibitor, which is the first PD-L1 inhibitor that can be injected under the skin.

Latest new drugs on the market

Osaikang's first Class 1 new drug declared on the market

According to the database, Jiangsu Osaikang Pharmaceuticals, which is the first PD-L1 inhibitor in China, will be the first PD-L1 inhibitor in the world to be injected subcutaneously, and the world's first subcutaneous PD-L1 inhibitor in the world, after approval of its marketing application, which is now in "in-approval". Understand today's ASK120067 tablets of Jiangsu Ausaikang Pharmaceuticals submitted a listing application and received CDE acceptance, Ausaikang Pharmaceuticals third-generation EGFR-TKI new drug ASK120067 tablets, in the drug review database can be understood ASK120067 tablets is a special review of the drug in 2017 into the clinical review; is mainly used for the treatment of oncology field; treatment EGFR Mutant non-small cell lung cancer, is the Shanghai Institute of Pharmaceutical Sciences of the Chinese Academy of Sciences and the Guangzhou Institute of Biomedicine and Health of the Chinese Academy of Sciences, as well as Jiangsu Ausaikang Pharmaceuticals Co. Ltd. jointly developed with independent intellectual property rights, a new molecular entity, the activity of the significant oral third-generation EGFR-TKI new drugs.

New drug listing situation

ColombTech's new PD-L1 antibody drug filed for listing

Data shows that ColombTech's first new antibody drug, PD-L1 antibody tetralizumab, has been filed for listing and accepted by the CDE, with an indication of Hodgkin's lymphoma.

New drug listing situation

The above is the recent new drug listing situation, to understand the other new drug listing situation can be queried in the database of the drug review database, not only can query the declaration of the listing, but also query the application for clinical, application for production, consistency evaluation application, import, import in the registration, supplemental application, reregistration, application for registration or supplementation, review, etc., both new drugs and imported. The situation, whether it is a new drug or imported, generic drugs, imported re-registration, etc. can be queried in the China Drug Evaluation Database to understand.