Dr Reddy's gets Chinese regulator nod for anti-blood clotting drug

Hyderabad-based Dr Reddy’s Laboratories (DRL), which is betting big on the Chinese drug market, recently got an approval for a $1.6-billion anti-blood clotting drug from the Chinese regulator after an 11-year wait. 

Sources said the company got approval earlier this month for generic Clopidogrel, which is used primarily to prevent blood clotting and acts against cardiovascular problems. The launch of the product is still some time away. This would be DRL’s biggest product in China in terms of market potential. The drug is now undergoing generic equivalent assessment (China requires drugmakers to conduct bioequivalence studies). 

“DRL is the largest international generic pharmaceutical company in China with presence across all provinces. In FY18, DRL clocked around $100 million sales from 8-10 products with sales accounted for in its joint venture (JV), Kunshan Rotam Reddy (DRL owns 51.3 per cent interest),” Edelweiss said. The JV has a sales and marketing team covering 5,000 hospitals spread over China. 

According to Edelweiss analyst, DRL has seven to eight products awaiting approval from the Chinese drug regulator and it expects to increase the number of filings. 

China is the world’s second-largest single country pharma market after the US and according to estimates around 25 per cent of the drugs by value to Chinese hospitals are supplied by companies outside of the country. 

China is undergoing some market-friendly reforms, which will expedite the generic approval timelines. 

Approvals, typically used to take around seven to eight years in China. However, now the government is looking at speeding up the process. Thus, approvals for companies from outside China have increased in the recent months, say analysts. 

DRL had launched generic Clopidogrel in the US market with its partner Mylan in March 2012 after the patent for Sanofi-Aventis’ Plavix expired. Plavix was one of the best selling drugs in the US and during the patent period, the drug roughly had an annual sales of around $6.7 billion.