Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive unresectable or metastatic biliary tract cancer (BTC) in patients who have previously received one or more lines of therapy. SHR-A1811 has already achieved BTDs for five indications in China.
The ADC market in China has seen approvals from global pharmaceutical companies such as Roche’s Kadcyla and AstraZeneca/Daiichi Sankyo’s Enhertu, which were approved for import into China in 2019 and 2023, respectively. Additionally, RemeGen’s disitamab vedotin received conditional approval in China in June 2021.- Flcube.com
