Current state of anticancer pipeline development and currently focused anticancer agent; Checkpoint inhibitor. Minjun Lee College of Pharmacy, Yonsei University, Incheon, Republic of Korea ABSTRACT Cancer is a disease that body cells begin to divide without stopping and spread into surrounding tissues. This paper will investigate anticancer drug pipelines that are developed by top 50 pharmaceutical companies and top 25 biotech companies. By comparing characteristics of anticancer drug pipelines such as target diseases and mechanism of action, pharmaceutical companies and biotech companies are both developing chemical-drug pipelines and bio-drug pipelines in common. But their details are different. When comparing chemical-drug pipelines of two types of companies, pharmaceutical companies usually developed pipelines that mainly target solid tumors such as nonsmall cell lung cancer ad breast cancer. Moreover biotech companies usually develop pipelines that mainly target hematological malignancies such as non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphoblastic lymphoma. Among these anticancer agent pipelines, immunotherapy agent has been under focus nowadays. Cancer immunotherapy utilizes the host’s immune system to attack the tumor cells. Cancer immunotherapy includes cancer vaccine therapy, cytokine therapy and monoclonal antibody (mab) therapy. But among these, the checkpoint inhibitor has gained a new spotlight in mab therapy. Checkpoint protein on the cell surface blocks T-cell activity by binding their receptor on an immune cell surface. By inhibiting their interaction between checkpoint protein and their receptor may allow the T-cells to attack the tumor. It will open a new horizon to cancer treatment. INTRODUCTION The United States Food and Drug Administration (FDA) approved the first biosimilar Zarxio (filgrastim-sndz) in 2015, a leukocyte growth factor biosimliar to the reference product Neupogen (http://www.fda.gov, 2015.). Meanwhile Remsima, a tumor necrosis factor α (TNF-α) antagonist biosimilar of Celltrion used to treat rheumatoid arthritis has been approved in Russia after Brazil (http://www.prnewswire.com, 2015). Also Hanmi Pharmaceutical Co. signed an 850 billion won (US$728.8 billion) license agreement with the German pharmaceutical giant Boehringer Ingelheim to jointly develop and commercialize a lung cancer drug pipeline. The two companies agreed to jointly develop and sell HM61713, a novel third generation EGFR-targeted therapy for the treatment of lung cancer with the specific gene mutation (“https://www.boehringer-ingelheim.com, 2015). The annual R&D spending in 2013 in the pharmaceutical and biotechnology sector is nearly USD 137billion
Figure 1. R&D investments by sector and spending by drug classes.
1 (A) R&D investments by sector in 2013 (IFPMA, 2014). (B) Anticipation of spending in 2018 by drug classes (Murray Aitken, 2013).