Mar 30,2016 | WSJ
SHANGHAI—Drugs that failed to make it to the market in the US and elsewhere, such as Bristol-Myers Squibb's fist-line liver cancer candidate brivanib, are finding new life in China, reported The Wall Street Journal.
Bristol-Myers Squibb halted global trials of brivanib in 2013 after it failed to outperform a competing therapy, and instead licensed the drug to Shanghai-based Zai Lab, which sees high potential for brivanib in China because Bayer and Onyx Pharmaceuticals' rival sorafenib costs around $7500 per month and is not covered by national insurance.
Industry observers say pharmaceutical companies have long sold drugs in China that were never tested or marketed in other countries. "Why? The cynical answer is because they can," remarked Bernstein Research analyst Laura Nelson Carney.
The stroke drug cinepazide was withdrawn from Spain, Italy and France in the late 1980s and 1990s, after reports of blood disorders associated with its use. By 2010, it had become China's top-selling drug, according to Credit Suisse. Sihuan Pharmaceutical, which markets the drug, said its generic cinepazide is more purified than the branded version that was sold in Europe, and its safety and efficacy is recognized by Chinese authorities.
IMS Health estimates that only 21 percent of drugs launched globally between 2008 and 2012 were available in China as of 2013, compared with 68 percent in the US. The news source noted that Chinese regulators currently ask for additional testing of drugs approved by the FDA, and that approval to start trials can take more than a year.
Meanwhile, China's drug regulator has promised to speed up approvals of new drugs for AIDS, cancer and infectious diseases, including those from foreign manufacturers.