Changes in Hong Kong stocks | Yingen Biotech (09606) rose more than 3% in early trading, DB-1310 was granted Fast Track status by the US FDA

The Zhitong Finance App learned that Yingen Bio-B (09606) rose more than 3% in early trading. As of press release, it had risen 3.25% to HK$318, with a turnover of HK$23.395,500.

According to news, according to Yingen Biotech's official WeChat account, on December 18, Yingen Biotech announced that the US Food and Drug Administration (FDA) has granted Yingen Biotech a new generation of HER3 antibody-conjugated new drug DB-1310 Fast Track Designation (FTD) for the treatment of adults who have received or have not received chemotherapy during or within 6 months of completion of adjuvant chemotherapy, to treat advanced stages of the disease during or within 6 months of completion of adjuvant chemotherapy /Unresectable or metastatic hormone receptor (HR) -positive, human epidermal growth factor receptor 2 (HER2) negative (immunohistochemical 0, 1+, or 2+/ in situ hybrid negative) breast cancer patients.

According to reports, DB-1310 became the world's first HER3-ADC drug to receive FTD for this indication. DB-1310 has a wide range of FTD indications in HR+/HER2- breast cancer, covering patients “receiving or not receiving chemotherapy at the stage of unresectable or metastatic disease”. FTD identification of this broad range of indications will help drive the key clinical development of DB-1310 in the two main pathways of HR+/HER2-breast cancer without chemotherapy frontline scenarios and chemotherapy-resistant back-line scenarios.