China-September 15，2023，Shenzhen FORWARD PHARMA announced that it has successfully completed the administration of the first subject in a Phase 1 clinical study of its proprietary third-generation oral selective estrogen receptor degrader (SERD), FWD1802, in patients with ER+/HER2-unresectable locally advanced or metastatic breast cancer. FWD1802 has been approved for clinical trials in the U.S. and China.

SERD is a competitive antagonist of ER that causes conformational changes and degradation of ER proteins. As a small molecule, SERD can reduce the stability of estrogen receptors by binding to ER on the surface of cancer cells and induce their degradation by normal cellular protein degradation mechanisms, thus reducing estrogen receptor levels and inhibiting cancer cell growth.

FWD1802 is precisely the third-generation oral SERD developed by FORWARD PHARMA, which is intended for the treatment of ER+/HER2- breast cancer. The drug candidate combines both ER degradation and antagonism, has stronger in vivo and in vitro efficacy than its counterparts, and is equally effective against ER mutations that have arisen after the previous generation of the drug.

In March 2023, the U.S. FDA approved the clinical trial filing (IND) of FWD1802. In July of the same year, China's NMPA also approved the drug's clinical trial application and agreed to conduct a clinical trial of FWD1802 as a single agent in subjects with ER+/HER2- unresectable locally advanced or metastatic breast cancer.

The study is a clinical trial of monotherapy and combination therapy with perphentermine, consisting of an open dose-escalation and a dose-expansion arm, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of FWD1802 when administered orally in subjects with ER+/HER2-unresectable locally advanced or metastatic breast cancer. The national lead investigator (Leading PI) of the study is Associate Professor Jianfu Zhang Physician of the Department of Medical Oncology, Affiliated Cancer Hospital of Fudan University, and Administrative Director of the Phase I Clinical Research Ward, Affiliated Cancer Hospital of Fudan University.

FORWARD PHARMA is a clinical-stage innovative drug company that adheres to independent research and development. The company's team covers the entire R&D process of target validation, drug discovery, early stage research and development, translational medicine research, preclinical research, as well as clinical development and registration. Since its establishment more than seven years ago, relying on its independently constructed chemical small molecule and monoclonal antibody drug discovery platform, Fuwu Pharmaceuticals has established a product matrix including several Class 1 innovative drugs, with indications covering multiple solid tumors and autoimmune diseases.