Trastuzumab deruxtecan injection 德曲妥珠单抗注射液

On February 24, 2023, the official website of the China National Medical Products Administration announced that the injection of trastuzumab deruxtecan, jointly developed by AstraZeneca and Daiichi Sankyo, has been officially approved for marketing in China. [3]
The new antibody-drug conjugate deruxtecan can prolong the median progression-free survival of patients with HER2-positive advanced breast cancer to 28.8 months as a second-line treatment, providing clinicians with a new effective treatment option and is expected to become a new standard for second-line treatment of HER2-positive advanced breast cancer. [4]
On February 21, 2023, Enhertu was first approved for marketing in China. Zhou Yebin, a doctoral student in genetics at the University of Alabama at Birmingham, once wrote in an article in The Paper: “Trastuzumab Deruxtecan has increased the number of HER2-targeted drugs available from less than 20% of HER2-positive patients to more than half of breast cancer patients.” [6]
Trastuzumab deruxtecan is a uniquely designed HER2-targeted antibody-drug conjugate (ADC) jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. [7]
On June 10, 2023, the innovative antibody-drug conjugate (ADC) jointly developed and commercialized by Daiichi Sankyo and AstraZeneca, trastuzumab for injection (trade name: Uruheda), held a launch conference in Beijing. [8]
On August 13, 2024, the official website of the National Medical Products Administration showed that the antibody-drug conjugate (ADC) Uruheda (trastuzumab for injection) was conditionally approved for the treatment of locally advanced or metastatic HER2-positive adult gastric or gastroesophageal junction adenocarcinoma patients who have previously received two or more treatment regimens. [9]
In October 2024, the China National Medical Products Administration approved the fourth indication of trastuzumab (trade name: Uruheda) for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations and who have previously received at least one systemic treatment. This also became the first and only anti-HER2 treatment for non-small cell lung cancer in China. [10]