Samsung Bioepis said that China’s National Medical Products Administration has approved its investigational new drug (IND) application for starting phase 3 clinical trial of Ontruzant, a trastuzumab biosimilar (Original: Herceptin).
|Samsung Bioepis’ trastuzumab biosimilar Ontruzant|
Ontruzant is used to treat patients with early breast cancer, metastatic breast cancer, and metastatic gastric cancer, and was the first trastuzumab biosimilar to receive regulatory approval in Europe. Its original, Herceptin, is one of the world’s most purchased medicines with an annual sale of $6.9 billion in 2015.
The trial, which will start in the first quarter of next year, is the first clinical trial that the company will conduct in China. The study will include 208 Chinese breast cancer patients, and the company plans to prove that the safety and efficacy between SB3 and Herceptin do not differ clinically.
The company will conduct the trial with AffaMed Therapeutics, a new biopharmaceutical company established by C-Bridge Capital, a Chinese venture fund company.
Samsung Bioepis signed a licensing agreement with C-Bridge Capital in February. At the time, C-Bridge established AffaMed Therapeutics to collaborate in many areas, including clinical development, regulatory registration, and commercialization on Samsung Bioepis’ four biosimilars -- SB3 (original: Herceptin), SB11 (original: Lucentis), SB12 (original: Soliris), and SB15 (Original: Eylea) -- in China.
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