SHANGHAI - Simcere Pharmaceutical, a leading Chinese drug and biotech firm, has signed an agreement with the U.S.-based OSI Pharmaceutical to license OSI's cancer treatment candidate OSI-930 in China.

"Licensing OSI-930 not only adds an excellent innovative oncology compound, which has been clinically tested to be safe and effective so far in the U.S., into our R&D pipeline, but also it complements and strengthens our oncology pipeline," said Wang Peng, Simcere's chief scientific officer.

Nanjing-based Simcere expects to conduct clinical trials on the new compound in China in 18 months, according to Wang.

"Initially we will target lung cancer and ovarian cancer as suggested from OSI's studies," he said. "We will also consider cancers more common in China such as stomach cancer and liver cancer," said Wang, who holds a doctorate in biochemistry from the University of Tokyo.

"Oncology is one of our major therapy areas. Although we already have several oncology compounds in our pipeline, OSI-930 has a unique molecular mechanism in inhibiting two validated molecular targets, making this compound highly promising as a safe and efficacious compound for multiple cancers," he added.

Before joining Simcere as CSO in May, Wang was vice president of discovery biology at WuXi PharmaTech, a leading Chinese contract research organization that is listed in the U.S.

Long Island-based OSI, a NASDAQ-listed pharmaceutical outfit, has completed Phase I clinical trials involving OSI-930 in the U.S.

"We've entered into a license agreement for Chinese rights to OSI-930 with Simcere, a leading Chinese pharmaceutical company with a successful track record of developing and commercializing oncology products in China," OSI's chief executive officer, Colin Goddard, said during a recent earnings call with investors.

"In addition to receiving a modest upfront payment, we will have the right to access and use data generated on OSI-930 via Simcere," Goddard added.

Simcere has marketed several products in oncology, including its leading biopharmaceutical Endu (recombinant human endostatin injection) for non small cell lung cancer.

"In addition, we have Sinofuan (fluorouracil implant), which is an innovative anti-cancer drug [that] is the only approved sustained release anti-cancer drug for implantation launched in China. It is applied directly onto the tissues around a tumor after surgical removal of the tumor," CSO Wang said.

"China needs such innovative new drug candidates more than the West, since innovative new drug discovery capabilities of the Chinese pharmaceutical industry have been relatively lower than the West thus far," Wang noted.

"We will continue to aggressively evaluate opportunities of in-licensing good innovative compounds. In addition, we are aggressively exploring a new model of co-developing innovative compounds with Western pharmaceutical companies," said Wang, who worked on Schering-Plough's discovery and early development team for 18 years.

Simcere in August unveiled a partnership with the Guangzhou-based Sun Yat-Sen University Cancer Center, in southern China, to cooperate on researching and developing innovative anti-cancer drugs, as well as conducting a joint training program for R&D personnel.

Earlier this year, Simcere signed a co-development deal with the San Francisco biotech firm Epitomics on a monoclonal antibody treatment for cancer (Also see "Simcere Enters Co-development Partnership With San Francisco Biotech Outfit On Monoclonal Antibody Treatment, Scans China For Takeover Targets" - Scrip, 13 March, 2009.).

- Dai Jialing (j.dai@elsevier.com)

China's Simcere Signs Novel Licensing Agreement Covering U.S.-based OSI Pharmaceutical's Cancer Drug

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