On Jan. 22ed (BJT), Roche's HER2-ADC drug Entrastuzumabimtansine (Trastuzumabemtansine, trade name: Kadcyla, TDM1 for short) has been approved for marketing in China, and it is expected to be approved in the near future. Marketed for HER2-positive breast cancer. As there is no ADC drug officially launched in China, Kadcyla will become the first ADC drug listed in China, and it will also be the first blockbuster imported drug in China in 2020.
The marketing application (acceptance No.: JXSS1900013) of Roche’s HER2-ADC: Trastuzumab Emtansine for Injection (trade name: Kadcyla, T-DM1 for short) in China has recently been changed to "Under approval", which is expected to be approved for marketing soon, with the indication of HER2-positive breast cancer. Trastuzumab emtansine, if marketed successfully in China, will become the first ADC marketed in China and the first imported blockbuster drug marketed in China in 2020, offering a good start this year.
Pharmaceutical Product Registration Progress Query Results | |
Acceptance No. | JXSS1900013G |
Enterprise name | Roche (China) Investment Co., Ltd. |
Handling status | Under approval |
Status start time | Jan. 16, 2020, 17:18:58 |
Notification time | Nil |
Date of receiving receipt of reference standard | Not required |
Charge | Paid |
Charge collection date | Mar. 25, 2019 |
Date of receiving the inspection report | Not submitted |
Pharmaceutical product approval No. |
|
Content of notice | Nil |
(Source: NPMA)
The first ADC approved to treat solid tumors
Trastuzumab emtansine is an ADC formed by the HER2-targeting trastuzumab and microtubule inhibitor DM1 (a maytansinoid) conjugated via MCClinker. Wherein, trastuzumab is expressed via CHO cells, MCC and DM1 are produced through chemical synthesis, with every antibody connected with 3.5 pieces of DM1 averagely. The drug has been approved by the FDA for marketing in 2013 to be indicated as a single agent for the treatment of patients with HER2-positive, metastatic breast cancer who previously received Herceptin and a taxane-based chemotherapy, separately or in combination. It was originally developed by Genentech under Roche.
The marketing application for trastuzumab emtansine was filed to the NMPA in Mar. 2019, and the clinical study thereof in China for HER2-positive gastric cancer is in phase II/III. As the world’s first ADC approved to treat solid tumors, trastuzumab emtansine achieved global sales of CHF979 million in the world in 2018, growing by 8% year on year.
Three generations of ADCs
ADCs mean antibody-drug conjugates. ADCs consist of monoclonal antibodies, linkers, and cytotoxic small molecule drugs; small molecule drugs are conjugated with monoclonal antibodies through linkers. ADCs reach tumor cells relying on the specificity and targeting of monoclonal antibodies against the related antigens of tumor cells and enter the cells through endocytosis, where linkers break under the action of the low pH or lysosome protein in the cells and release cytotoxic drugs. ADCs have filled in gaps in antibody drugs and traditional chemotherapy drugs and improved drug specificity and therapeutic window. ADCs have so far experienced three generations.
Representative ADCs of Each...
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