In the first half of 2011, the FDA approved 20 new molecular entity new drugs. Compared with recent years, this figure is quite impressive. Of the 20 new molecular entities, there are 18 new chemotherapeutic agents and 2 diagnostic agents. It indicates that the overall R&D capability of the pharmaceutical industry is gradually picking up, and on the other hand, it has ushered in more questions. With regard to these new drug data approved by the FDA, it is difficult to make a clear conclusion about the current R&D status of the pharmaceutical industry. Through the further exploration of the approved new drug information, there are two points worth noting.

The BD model promoted the approval of products first. Most of the new drugs approved by the FDA were approved for commercial listing (BD). In this new batch of drugs, most drugs have at least one or several commercial R&D transaction records.

1 Of the 18 drugs, only 7 new drugs were originally researched and applied by traditional pharmaceutical giants. Including five progressive innovative products: angiotensin II antagonist (Edarbi), multi-target tyrosine kinase inhibitor (vandetanib, Vandetanib), long-acting beta-agonist (Arcapta) , DPP-IV inhibitor (Tradjenta) and CTLA4-Ig blocker (Nulojix). There are two other innovative drugs: anticoagulants - Xarelto, a direct factor Xa inhibitor, and Victrelis, a hepatitis C virus protease inhibitor.

Twenty-five biotech original research products were ultimately involved in joint development by large pharmaceutical companies because of their good market value. Among them, Abiraterone (Zytiga) was discovered by the cancer research institute of the BTG fund project licensed by Cougar, and Johnson & Johnson purchased the project later. Daliresp was discovered by the German company BykGulden. Later, the company merged with Altana. Finally, Forest became the applicant for the product. Edurant was discovered by Tibotec's virologists and the company was acquired by Johnson & Johnson. Horizant was discovered by Xenoport and GlaxoSmithKline became the applicant for the product.

34 products originally researched by traditional pharmaceutical companies, Natroba, Dificid, Potiga, and Viibryd, are successfully approved by the NRDO (No-Research, Development Only model, which involves no research involved only in the development phase) business strategy driven products. Before the technology companies saw them, some were already registered and some were in abandonment.

4 Among the 18 new molecular entities, 2 (jointly developed by Benlysta and Vertex) from the new drug discovery to the new drug market application were completed by the original research and biotechnology company. Vertex Pharmaceutical Inc. Incivek is a typical example.

Within a decade, it was difficult to judge the second R&D strategy. Among these approved new molecular entities, most were discovered before the original research company was merged and after multiple mergers and acquisitions, and were discovered by traditional drug discovery organizations. For further reasoning, the author will count the number of years for which these new drugs were first publicly reported. In general, pharmaceutical companies do not publish information on drugs before they enter the clinic. By extrapolating the time for the first disclosure of these drugs, the vast majority of them were born in the 1990s, significantly earlier than the R&D revolution that occurred in the pharmaceutical industry 10 years ago. However, there is no clear conclusion as to whether this phenomenon will ultimately affect the number of FDA approvals for new drugs.

Therefore, although the approval of therapeutic new drugs for 18 new molecular entities is worth celebrating, the information gained from the approval information of these new drugs has gained such inspiration: a commercial R&D model is becoming more and more important in the development of new drugs, and its two new drug development cycles are very long. As for the 10 years, it is difficult to judge changes in the R&D model.