Which will be the Final Winner on the Market: Original Drugs or Generic Drugs?

Xinwei VS Gleevec

The imatinib mesylate is originally developed by Novartis, and indicated for chronic myelogenous leukemia and malignant gastrointestinal stromal tumors. Novartis’ Gleevec entered the Chinese market in 2002, and became off-patent in China in April 2013. Thereafter, the generic drugs of Chinese pharmaceutical enterprises have been successively marketed: Jiangsu Hansoh first marketed Xinwei in 2013, followed by Chia Tai Tianqing’s Genike, and CSPC’s Nuolining, breaking the situation of only Gleevec on the Chinese imatinib market.

However, Gleevec still dominates the imatinib market in China, as seen from the public medical institution terminal. According to the HDM system data, the imatinib market reached RMB 427 million on the public hospital market of key cities in China in 2016, wherein, Gleevec accounted for 83.87%; Xinwei had the highest proportion among the relevant generic drugs, accounting for 12.31% hospital market, Genike and Nuolining separately accounted for 3.63% and 0.19%. The drug use of imatinib is expected to exceed RMB 2 billion market size in China in 2017.

One of the most-watched events of the Chinese imatinib market in 2017 was the competition for entering China’s national medical insurance drug catalog: both Xinwei, currently with the highest sales among relevant generic drugs, and the original drug Gleevec successfully entered the new-edition national medical insurance drug catalog of China, and the reimbursement proportion of Gleevec can reach about 80% after being included in the category B list.

Besides China’s national medical insurance drug catalog, both Gleevec and Xinwei have entered the provincial medical insurance drug catalogs of Hebei, Zhejiang, Guangdong, Yunnan, and Xinjiang, etc., which will continue to drive the growth. From previous data, Gleevec still strongly dominated the markets of big drug consuming provinces such as Guangdong and Zhejiang, however, Xinwei had violent growth momentum, and still had big room for future growth.

Medical Insurance Coverage Situation in Major Provinces

Note: The data were by 2016 Q1. The current situations change slightly.

According to the 2016 financial report of Novartis, Gleevec’s sales started to decline sharply as impacted by the marketing of generic drugs on the U.S. market, with the sales revenue of USD 3.323 billion, down by nearly 30% year on year. Novartis’ latest Q3 financial report did not disclose the sales of specific varieties, but its sales on the Chinese market grew by 11% year on year. According to incomplete statistics, there are more than 50 Chinese enterprises applying for imatinib mesylate. Predictably, there will be a large number of competitors entering the Chinese market in the future, and the dominance of Gleevec on the Chinese market will be tested.

Aiheng VS Eloxatin

Developed by Swiss Debiopharm Company and sold and promoted by Sanofi with the trade name of "Eloxatin", oxaliplatin, the main chemotherapy drug for colorectal cancer, was marketed in France in 1996, entered the Chinese market in 1999, and is currently category-B medicine in China’s national medical insurance drug catalog.

In 2000 with Hengrui taking the lead in developing API and lyophilized powder of oxaliplatin in China, the Chinese-produced oxaliplatin "Aiheng" was born and marketed. Aiheng also separately passed the marketing approval of the EU and FDA in 2012, and 2014, to develop both the Chinese and overseas markets at the same time.

Eloxatin became one of the 5 best-selling anticancer drugs on the U.S. market in 2011, and became off-patent in 2013. The global sales of the product reached USD 1.1 billion in 2012, and reduced to USD 6 million in 2014 as impacted by generic drugs, according to IMS data, while Hengrui’s Aiheng achieved USD 20 million sales in less than two months after being marketed in the U.S., with rapid growth.

Hengrui’s Aiheng possesses strong single-variety competitiveness as seen from the drug use quantity in Chinese hospitals, while Eloxatin is almost neck and neck with Aiheng as seen from the amount, unlike its gradual decline on the U.S. market.

Drug Use Quantity of Manufacturers’ Oxaliplatin in Hospitals of China in 2012-2014 (10,000 Tablets)

Drug Use Amount of Manufacturers’ Oxaliplatin in Hospitals of China in 2012-2015 Q3 (RMB 10,000)

Source: Sinohealth CMH

Hengrui is currently the bellwether among the Chinese-produced oxaliplatin, followed by Qilu Pharmaceutical, Nanjing Pharmaceutical, and Yangzhou Aosaikang, etc. Hengrui’s Aiheng currently accounts for half of the sales volume of Chinese-produced oxaliplatin. However, the growth of oxaliplatin has slowed down in recent years due to reasons such as price reduction.

Keep reading: Which will be the Final Winner on the Market: Original Drugs or Generic Drugs? (2)