Chipscreen Bioscience is a closely watched phenomenon in China as it passes the two-month mark of selling its breakthrough lymph-node cancer drug on the local market. The China FDA approved the drug Dec. 23.
Not only is its Epidaza (chidamide) for treating peripheral T-cell lymphoma the first of its kind in China, it is only the fourth in the world, and the company's research-and-development costs were only one-tenth of the cost in developed countries. For all that, the company is being watched as a possible bellwether of China's future as a drug innovator and the CFDA's approval performance.
Epidaza is being developed and is in clinical trials in other countries, including Japan where U.S.-based HUYA Bioscience International's chidamide is in early-stage accelerated-development trials.
Aside from Chipscreen's success so far, it is also of interest to the rest of the pharmaceutical world for the manner in which it began its 14-year odyssey from founding to market.
Xian-Ping Lu is a co-founder of the drugmaker and director of research, but he represents what some consider a possible trend of researchers from the undeveloped world leaving their multinational employer to start up their own biotech companies at home. Lu got his start at Galderma R&D in the United States.
China's government encourages such moves as it seeks to make the transition from a maker of generics to one of innovative drugs. It may be counting on its lower research costs, which were $70 million for Lu's Epidaza in this case, but analysts told the Wall Street Journal that China still offers a dichotomy in its treatment of drugmakers.
As it encourages more innovators, China also is encouraging more generic purchases by its citizens and is taking steps to lower its own spending on drugs and other health care, one analyst told the newspaper.
- here's the Wall Street Journal story
- and the Chipscreen release
- plus the HUYA release