On April 9, the CDE website showed that Yingen Biotech's first ADC drug, trastuzumab perconcave (DB-1303/BNT323), submitted a marketing application. This is Yingen Biotech's first innovative drug to apply for market approval.
In September 2025, the Phase III clinical trial (DYNASTY Breast02) of trastuzumab versus T-DM1 for the treatment of patients with HER2-positive unresectable or metastatic breast cancer who had previously received trastuzumab and taxane therapy met its primary endpoint, namely a significant prolongation of progression-free survival (PFS).
Trastuzumab pac-ascorbic acid (TAA) is a clinical-stage HER2 ADC candidate that employs a stable, cleavable linker and a proprietary topoisomerase inhibitor-based payload design to reduce off-target toxicity and enhance antitumor activity, including bystander-killing effects. These characteristics may make PAC a potential new treatment option for patients with advanced HER2-expressing solid tumors, including those with both high and low HER2 expression.
Trastuzumab perconcanava has received Fast Track and Breakthrough Therapy designations from the FDA and Breakthrough Therapy designations from the National Medical Products Administration (NMPA) for the treatment of patients with HER2-expressing advanced endometrial cancer whose disease has progressed during or after treatment with immune checkpoint inhibitors. Furthermore, treatment responses to perconcanava have been observed in a range of cancers, including breast cancer, endometrial cancer, ovarian cancer, colorectal cancer, and esophageal cancer, supported by global clinical data from patients in the United States, China, Australia, and other countries.
BioNTech, a partner of Yingen Biotech, also plans to submit a marketing authorization application for trastuzumab perconazole for second-line or subsequent treatment of HER2-expressing advanced endometrial cancer.

https://news.futunn.com/post/71283531?level=1&data_ticket=1775782943443856