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Hengrui Medicine's 1.1 category new drug pyrrotinib new indication listing application is planned to be included in priority review

 Last Update: 2021-10-23
 Source: Internet
 Author: User

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On September 24, the information on the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China showed that the new indications of the new indication of Hengrui Medicine's 1.

Screenshot source: CDE official website

According to data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world's largest malignant tumor and one of the most common malignant tumors in women

In June 2021, Hengrui Medicine announced that in a phase 3 clinical study called HR-BLTN-III-NeoBC, the main research endpoint of pyrrotinib tablets reached the pre-specified superiority standard of the plan.

Pirrotinib is a small molecule, irreversible, pan-ErbB receptor tyrosine kinase inhibitor.

In August 2018, pyrrotinib received conditional approval to market in China for the targeted therapy of human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer

▲Pirrotinib-related clinical research progress (screenshot source: Hengrui Medicine's official website)

In addition to breast cancer indications, Hengrui Medicine continues to explore the clinical research of pyrrotinib for non-small cell lung cancer, biliary tract cancer and other indications

Reference materials:

[1] Priority review and publicity details.

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