DS-8201 was approved in China to update the domestic progress of targeting HER-2 ADC

On February 24, 2023, DS-8201/T-Dxd (Enhertu) was approved in China, which is a single drug applicable to unresectable or metastatic HER-2 positive adult breast cancer patients who have received one or more anti-HER-2 drugs in the past, officially opening a new era of ADC for breast cancer in China.

Enhertu is a new generation ADC drug developed by Daiichi SanRepublic Astrazeneca to target HER-2 in the treatment of solid tumors expressing HER-2. 2019.12.20 was approved in FDA for the first time for the backward treatment of advanced breast cancer with positive HER-2, and then successively approved for gastric cancer, lung cancer and other indications. Among them, the indications for breast cancer moved from the back line to the front line, from the traditional definition of positive HER-2 to low expression of HER-2. With the increase of indications, the target audience kept expanding.

From 2019 to 2022, Enhertu's global sales volume was 322, 490 and 1.238 billion dollars respectively, successfully entering the 1 billion dollar club. Analysts predict that the sales volume will exceed 1.4 billion dollars in 2023. By 2027, annual sales will exceed $3 billion.

Datamonitor Healthcare analysts give Enhertu a clinical value score of 73.5 and a commercial value score of 83, which is almost higher than a number of competing HER-2 positive breast cancer products (top right of Figure 2). 

Interestingly, the dimension of "Satisfaction of unmet needs" has been added to the clinical value scoring standard of products at present. The appeal for unmet clinical needs is top-down and bottom-up, from regulations to guidelines to research and development. Here, its weight is second only to the dimension of efficacy, which is consistent with tolerance.

Informa analysts gave a full score of 10 for Enhertu in the dimension of efficacy and frequency of administration, and a score of 9 for the dimension of unmet demand. Relative low scores were safety (4 points), tolerance (5 points) and route of administration (3 points). It is suggested that for the subsequent competitors, the efficacy is difficult to surpass, and there is still a lot of room for improvement in safety and other aspects. Differentiation should be made to provide the most suitable drugs for the most suitable patients.

The score of business value is above 8 points in all dimensions except the limited target audience dimension, which is low (6 points), including commercial resources (8 points), counterfeit competition risk (10 points), access (9 points), novelty (10 points), commercial success potential (8 points), pricing (8 points) and market entry speed (10 points).

Anti-her-2 ADC in clinical stage in China

As of 2023.02.25, a total of 14 anti-HER-2 ADCs in China are in the clinical stage.