Is Ado-trastuzumab emtansine on the market?

In February 2013, Ado-trastuzumab emtansine was approved by the U.S. Food and Drug Administration (FDA) for marketing in China.The generic name is“Ado-trastuzumab emtansine," is approved for the treatment of adults with HER2-positive metastatic breast cancer who have previously received trastuzumab and a taxane, separately or in combination, and was designated T-DM1 during clinical studies. Then in November of the same month, it was approved in the UK and EU and sold under the trade name Kadcyla.

Among patients treated with trastuzumab, there was a significant improvement in survival compared with standard care. Regarding the safety of trastuzumab, the overall side effects are considered manageable and the overall safety profile is considered better than other currently available drugs. In 2019, the FDA approved trastuzumab for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based therapy. EnmetratrastuzThe monoclonal antigenic drug was approved by the State Food and Drug Administration in 2020 and was launched in China under the trade name Hercelet.

Trastuzumab, which is marketed in China, has entered the scope of medical insurance and can only be reimbursed for eligible patients. The price of 100 mg per box may be around RMB 20,000. This drug is a strictly controlled drug. Listed overseas Enmei Trastuzumab The single-unit generic drug has Turkish and European versions, with specifications The price of each box of 100 mg may be around 3,000-8,000 yuan (the price may fluctuate due to the exchange rate). The ingredients of the originator drugs sold domestically and abroad are basically the same, and there are currently no generic versions of Enmei Trastuzumab produced and launched.