A Review of the Class 1 Oncology Drugs Approved in China in Recent Years

The oncology drug market size has continued to increase in recent years, and the oncology drugs have been a field that pharmaceutical enterprises are unwilling to let go. However, for China where the modern drug R&D started relatively late, the new drug R&D, especially the development of the Class 1 oncology drugs, was once a vulnerability of the Chinese pharmaceutical enterprises. In the decade from 2000 to 2010 when foreign pharmaceutical enterprises were rapidly developing new oncology drugs, Chinese enterprises failed to successfully develop even a Class 1 oncology drug that was approved for marketing. However, the R&D strength of China has grown in recent years thanks to China’s national strategy and other factors: it has successively approved the marketing of 7 Class 1 oncology drugs since 2011, getting rid of the previous embarrassment of no Class 1 new drug in the oncology field in a decade.

Table I. Class 1 Oncology Drugs Approved in China in Recent Years

The 7 Class 1 oncology drugs approved in China in recent years are as shown in Table I, including 3 chemical drugs and 4 biological drugs. The chemical drug icotinib hydrochloride successfully developed by Zhejiang Betta was once a model of the Class 1 oncology drug R&D in China, which the industry took delight in talking about. Icotinib is also the first small molecule anticancer drug independently developed in China; this drug molecule was said to have a structure extremely similar to the marketed drug erlotinib under Roche, but it is a new drug molecule that has never been synthesized before. Furthermore, the sales of icotinib reached a new high owing to its excellent treatment effect against NSCLC, exceeding RMB 1 billion in 2016.

Besides icotinib, the other two chemical Class 1 oncology drugs were both approved in 2014. Independently developed by Jiangsu Hengrui, the apatinib mesylate approved in October 2014 is the world’s first small molecule anti-angiogenesis targeted drug safe and effective against advanced gastric cancer, and the only oral preparation among the multiple gastric cancer targeting drugs. Proved by clinical research, the drug itself could significantly extend the survival of patients who failed the advanced gastric cancer standardized treatment. While the chemical Class 1 oncology drug chidamide approved in December 2014 is an HDAC inhibitor under Chipscreen and mainly indicated for peripheral T-cell lymphoma.

Bio-medicine has obtained major support and been treated as the strategic direction in the pharmaceutical development in China in recent years, with remarkable results achieved, under which context, the 4 Class 1 oncology biological drugs were developed. The iodine[131i] metuximab (Licartin) approved in May 2011 is the world’s first monoclonal antibody radio-immunity targeted drug for primary liver cancer; it can specifically bind to the HAb18G antigen in cell membrane protein of liver cancer, deliver the loaded radioactive iodine 131I to the tumor site to thus treat the liver cancer. In addition, the nimotuzumab under Biotech Pharma, Recombinant Human Adenovirus Type 5 Injection under Shanghai Sunway Biotech Co., Ltd., and recombinant human endostatin under Yantai Medgenn are all excellent Class 1 oncology biological drug, especially, the recombinant human endostatin is mainly indicated for the NSCLC with a very huge patient base, possessing very broad market prospects.

We can see from the above that there have been only 7 Class 1 oncology drugs approved in China in recent years, where there was the embarrassing situation of no any Class 1 oncology drug in 10 years, however, such situation is being gradually improved owing to China’s national policy support and enhancement of the pharmaceutical innovation capacity, etc. in recent years, especially China has lifted the bio-medicine development to a national strategic level in recent years, and has even surpassed the European and American developed countries in many aspects. We can be certain that there will be constantly more excellent Class 1 oncology drugs emerging in China in the future, to benefit the broad tumor patients.

Register as Visitor to CPhI China 2018!