3SBio gets China FDA IND nod for PEG-irinotecan candidate

Shenyang-based 3SBio won an investigational new drug nod from China FDA to start trials of in-licensed chemotherapy candidate PEG-irinotecan. The candidate was originally developed by Beijing-based JenKem Technology and China rights came to 3SBio in 2014. The financial terms were not available. Irinotecan is a first generation Topo-I inhibitor and was approved in the U.S. in 1994, though issues with toxicity and a short half-life came to the fore. The PEGylated version however was designed to overcome those issues. "3SBio intends to develop PEG-irinotecan as a National Class I drug for relapsed or refractory cancers, such as colorectal cancer, metastatic breast cancer, and platinum-resistant ovarian cancer," the company said in a release. "In China, the incidence rates for colorectal cancer, breast cancer and ovarian cancer are 33.1 per 100,000, 27.3 per 100,000 and 4.9 per 100,000 annually." 3SBio returned to the public markets in July last year via the Hong Kong Stock Exchange and has expanded its activities in deal making and biotech drug development. Release


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