2021-09-16
First patient dosed in Korea in a global Phase I study for SHR-A1811, a HER2 antibody-drug conjugate with optimized molecular design and good safety profile
September 16, 2021 (Shanghai, China) – Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the first patient in Korea had been dosed in an ongoing multi-country Phase I study for SHR-A1811 for the treatment of HER2-expressing or HER2-mutated advanced malignant solid tumors. Patient enrollment is also ongoing in the US, Australia, and China.
About the Study
SHR-A1811-I-101 (NCT04446260) is a Phase I, multi-country, multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 in patients with HER2-expressing or HER2-mutated advanced malignant solid tumors such as breast cancer, gastric cancer, and non-small cell lung cancer (NSCLC). The study consists of two parts: the dose escalation part and the indication expansion part.
About SHR-A1811
SHR-A1811, a potential best-in-class HER2-targeted antibody-drug conjugate (ADC), is being developed by Hengrui with an optimized molecular design to enhance plasma stability and bystander effect. The preclinical data demonstrated a good therapeutic index of SHR-A1811.
In addition to the SHR-A1811-I-101 study, SHR-A1811 is also being studied in
1. A Phase I study SHR-A1811-I-102 (NCT04513223) for the treatment of HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer;
2. A Phase I/II study SHR-A1811-I-103 (NCT04818333) for the treatment of advanced NSCLC with HER2 expression, amplification, or mutation.
About Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Hengrui is a leading global pharmaceutical company based in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.
BD Contact
Email: bd@hengrui.com
Phone: +86-21-61053532