Daiichi Sankyo's ADC Drug Trastuzumab Deruxtecan Submits Third Application for Priority Review in China

On June 10, the CDE website showed that the Trastuzumab Deruxtecan for Injection (T-DXd, DS-8201a) submitted by Daiichi Sankyo is proposed to be included in the priority review, with the proposed indication: monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received one prior treatment regimen. This is the third time the drug has applied to enter the priority review channel, with the previous two times being approved for inclusion in November 2023 and February 2024, respectively.

Image Source: CDE Official Website

Trastuzumab deruxtecan is a DXd antibody-drug conjugate (ADC) targeting HER2 jointly developed by Daiichi Sankyo and AstraZeneca. In 2024, its global sales exceeded 25 billion yuan, increasing by 38.41% year-on-year. It has been approved for marketing in the United States, Japan, the European Union, China, and other countries and regions.

Source of the image: Pharma Data Enterprise Edition - Global Best-Selling Drug Sales Data

Trastuzumab deruxtecan has previously been approved in China for four indications, covering HER2-positive/low-expression advanced breast cancer, HER2-activated mutant non-small cell lung cancer, and HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma that has previously received two or more treatment regimens.

Source of the image: Pharma Data Enterprise Edition - Global Drug Analysis System

According to 2020 WHO data, the incidence rate of gastric cancer ranks fifth globally, and its mortality rate ranks third globally. Nearly half of the new cases and deaths worldwide occur in China. According to Frost & Sullivan's forecast, the global market size for gastric cancer drugs will grow from $22.1 billion in 2024 to $36.4 billion in 2030, with a compound annual growth rate (CAGR) of 8.7%. Data from Pharma Intelligence shows that the market size for gastric cancer drugs in all terminal markets in China has been continuously growing in recent years, surpassing 50 billion yuan in 2024.

Source of the image: Pharma Data Enterprise Edition - Full Terminal Analysis System for Pharmaceutical Market

Trastuzumab deruxtecan has been proposed for inclusion in the priority review and approval process this time. If finally approved, it will bring a breakthrough change for Chinese patients with HER2-positive advanced gastric cancer. This "life acceleration" initiated by the priority review will eventually be transformed into tangible survival hope in the hands of patients.

Editor: Muyan

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