Star drug DS-8201 is about to land in China!

A few days ago, the official website of the Center for Drug Evaluation of the State Food and Drug Administration announced that the marketing application of the HER2-targeting antibody-drug conjugate (ADC) DS-8201 jointly developed by Daiichi Sanyo and AstraZeneca was included in the priority review.

Source: CDE official website

Anyone who plays moba games knows that ADC is the C position in the team with the highest output, and ADC drugs can also play a similar role in tumor treatment

Antibody-drug conjugates (ADC) are composed of three parts: monoclonal antibodies targeting specific antigens responsible for specific recognition, small molecule cytotoxic drugs responsible for effective killing, and linkers linking antibodies and cytotoxic drugs

Superstar in ADC - DS-8201

The trade name of DS-8201 is Enhertu.

In addition, DS-8201 is approved for locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma and a breakthrough therapy for patients with HER2-mutant metastatic NSCLC whose disease has progressed during or after platinum-based chemotherapy It is determined that good clinical trial data have also been obtained in the treatment of HER2-positive colorectal cancer, which can be described as an "all-rounder against cancer"

Notably, in a pivotal Phase III clinical trial of DS-8201 in patients with unresectable or metastatic breast cancer with low HER2 expression, DS-8201 significantly prolonged progression-free survival in such patients compared to chemotherapy And overall survival, the trial results are expected to change the treatment landscape of HER2-low breast cancer

The basic information of ADC drugs currently approved by the US FDA and EU EMA for breast cancer treatment is shown in Table 1

Table 1: Basic situation of ADCs in the field of breast cancer treatment that have been marketed abroad

More than ten new ADC drugs are lined up, will the breast cancer treatment landscape change?

In recent years, the competition in the domestic ADC R&D track has become intensified

Table 2 Representative anti-breast cancer ADCs that have been marketed or are under research in China

We can see that currently, for the indication of breast cancer, the targets of ADC under research are HER2 and TROP2.