NEWS

Global New Drugs and Their Core Patents in the First Half of the Year

Release time:

2017-08-11 13:50

22 new drugs launched globally in the first half of 1.2017

As of June 30, new drugs were approved globally in the first half of 2017 (mainly in Europe, America, Japan and China), of which:

There are 15 NME new molecular entities (hereinafter referred to as chemical drugs). After last year's depression, the approval of NME new drugs in 2017 returned to the average level of previous years.

There are 7 biological drugs, and the number of approved biological drugs has increased significantly since 2014. In the past three years, the average number of approved biological drugs in half a year is 9, and the 2017 is the same as in previous years.

In the first half of 2017, no Class 1 drug (original research) was approved for marketing in China, but more than 20 Class 1.1 new drugs were clinically approved.

2. Among the newly listed chemical drugs, anti-tumor drugs account for 1/3

Anti-tumor drugs are still the focus of research and development. In the first half of 2017, five small molecule targeted anti-tumor drugs were newly approved worldwide, accounting for 1/3 of the newly approved drugs. Among them, China's Zaanding Pharmaceutical has acquired the PARP inhibitor Zejula.®(Niraparib Tosylate Monohydrate) development rights, in March 2017, the China Food and Drug Administration (CFDA) accepted the application for clinical trials of this product submitted by Zaanding Medicine.

　More than 2/3 of new drugs have compound patent protection

In the first half of 2017, 11 drugs were within the patent protection period of the compound. Most of the patent protection periods of these 11 drugs are after 2027, that is to say, in the next ten years, once these drugs are on the market, they will be in a relatively monopoly position in the industry. Among them, 4 drugs have no compound patent protection in China. They are Deflazacort, Midostaurin, Abaloparatide, and Telotristat Etiprate. The indications are for adrenal hypofunction, autoimmune diseases, allergic diseases and blood system diseases, and acute myeloid Leukemia, new osteoporosis drugs, and carcinoid tumor syndrome.

　　

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4. Antibody biological drugs are the mainstream

Of the 7 newly listed biological drugs, 6 are antibody drugs and 1 recombinant biological enzyme. Half of the antibodies are anti-tumor drugs, the first half of 2017 2 PD-L1 with the target antibody drugs listed, respectively, Merck, Pfizer research and development of Bavencio, indications for cell carcinoma and urothelial cancer, new base, MedImmune research and development of Imfinzi, indications for urothelial cancer.

The above is a brief introduction to the global market of new drugs and their core patents in the first half of 2017, which shows that anti-tumor is the main trend of research and development. Pharmaceutical companies want to get long-term development in the industry, patent protection must be the top priority.