On December 31, the CDE website showed that Rongchang Bio's vidicetuzumab is proposed to be included in the Breakthrough Therapy list for a new indication, in combination with trastuzumab and toripalimab as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma with high HER2 expression .
Vidicetumab has been included in the Breakthrough Therapy designation three times before . If it passes the public announcement this time, it will become the drug's fourth Breakthrough Therapy designation .

Vidicetumab is a HER2-targeted ADC drug developed by Rongchang Biotechnology. Through a "precision burst" mechanism, it can not only kill HER2-highly expressing tumor cells, but also attack neighboring HER2-low-expressing cells through the "bystander effect." Since its initial approval in 2021, this product has been approved for three indications :

HER2-overexpressing locally advanced or metastatic gastric cancer that has received at least two types of systemic chemotherapy ;

Patients with previously received systemic chemotherapy and HER2-overexpressing locally advanced or metastatic urothelial carcinoma ;

HER2-positive advanced breast cancer with liver metastases who have previously received trastuzumab or its biosimilars and taxane therapy .

In addition to the three approved indications mentioned above, vedicetuzumab has two new indications pending for approval: 1) second-line treatment of HER2-low expression breast cancer ; and 2) in combination with toripalimab for the treatment of patients with HER2-expressing ( immunohistochemical results of 1+, 2+ or 3+ ) locally advanced or metastatic urothelial carcinoma .
HER2 is the hottest target in the ADC field. Insight database shows that there are currently 33 HER2 ADC drug pipelines in clinical development globally (only counting those in active stages ) , of which 5 have been approved for marketing. These include Roche's established drug trastuzumab emtansine , Daiichi Sankyo/AstraZeneca 's blockbuster trastuzumab detrastuzumab , Rongchang Bio 's vidicetuzumab, Kelun Biotech 's bordo trastuzumab, and Hengrui 's Ruikang trastuzumab. In addition, 10 more have entered Phase III clinical trials, from companies such as Lepu Biopharma, Baili Tianheng, and Chia Tai Tianqing.

https://mp.weixin.qq.com/s/T08Jc6NCHiZrweCEVzFKig