Manufacturer of Pertuzumab

The original product, Pertuzumab produced by Roche, was approved by the U.S. Food and Drug Administration (FDA) in June 2012 and by the European Medicines Agency (EMA) in March 2013. Pertuzumab is a monoclonal antibody that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, thereby preventing them from signaling in a manner that promotes cell growth and proliferation.

Randomized, double-blind, placebo-controlled, multinational,The phase III CLEOPATRA trial demonstrated the efficacy of intravenous pertuzumab (840 mg loading dose, then 420 mg every 3 weeks) combined with trastuzumab plus docetaxel in the first-line treatment of HER2-positive metastatic breast cancer. Pertuzumab plus trastuzumab and docetaxel significantly increased independently assessed median progression-free survival (primary endpoint), objective response rate, and overall survival compared with placebo plus trastuzumab and docetaxel.

Pertuzumab is a strictly controlled drug. The original drug has been marketed in China and has entered the ranks of medical insurance, but it is only reimbursed for patients who meet the indications. The price of each box may be more than more than 5,000 yuan, and the price of the Hong Kong version may be more than 20,000 yuan (the price may fluctuate due to exchange rates). The price of each box of the European version of Pertuzumab's original drug marketed overseas may be more than 10,000 yuan, and the price of each box of the Turkish version may be more than 6,000 yuan (the price may fluctuate due to exchange rates). The ingredients of the domestic and foreign original drugs are basically the same, and there are currently no generic versions of Pertuzumab on the market.