FWD1802 Received IND Approval for Combination Therapy
On May 16, 2025, FWD1802 has received IND clearance from the China National Medical Products Administration (NMPA) for the combination therapy targeting breast cancer indications. This marks another significant milestone following the approval of FWD1802's monotherapy IND, signifying authoritative recognition of the drug's potential in breast cancer treatment. It also brings new therapeutic hope to millions of breast cancer patients.
Image source: Center for Drug Evaluation, National Medical Products Administration website
The leading principle investigator for this combination study is Professor Zhang Jian, Chief Physician of the Department of Medical Oncology at Fudan University Shanghai Cancer Center, Doctoral Supervisor, and Executive Director of the Phase I Clinical Trial Unit at Fudan University Shanghai Cancer Center.
Breast cancer ranks as the most common cancer among women. According to World Health Organization (WHO) statistics, approximately 420,000 new breast cancer cases were diagnosed in China in 2022, with about two-thirds being estrogen receptor-positive (ER+) subtype. The most pressing challenge for patients with advanced ER+/HER2- breast cancer is emerging resistance to current standard endocrine therapies. FWD1802 is a third-generation orally available, selective estrogen receptor degrader (oral SERD) for breast cancer treatment. FWD1802 acts as a competitive antagonist of the estrogen receptor (ER), inducing conformational changes in the ER protein and promoting its degradation, as well as ER antagonism, thereby as a complete ER antabonist, demonstrating superior in vitro and in vivo efficacy compared to other oral SERDs under development. It remains effective against ESR1 mutations emerging after standard endocrine therapy. This positions FWD1802 not only as a treatment option for ESR1-mutated breast cancer resistant to conventional endocrine therapy but also as a potential replacement for existing endocrine regimens, establishing it as a new standard endocrine treatment. Additionally, FWD1802 demonstrates favorable in vivo bioavailability, enabling convenient oral administration for patients in clinical settings.
FWD1802 has demonstrated favorable safety and antitumor efficacy in monotherapy clinical trial. In this combo study, the combination of FWD1802 together with other drugs featuring distinct mechanisms of action will synergistically activate multiple antitumor pathways, thereby enhancing antitumor efficacy and providing breast cancer patients with an improved treatment option. The approval of this FWD1802 combo trial not only marks another major milestone in Forward Pharma's clinical development but also demonstrates the significant development potential of FWD1802 as a next-generation endocrine therapy backbone drug.
About Forward Pharmaceuticals
Forward Pharmaceuticals is an innovative biopharmaceutical company with independent R&D capabilities spanning the entire drug discovery process - from target validation, drug discovery, early-stage development, translational medical research, and preclinical studies to clinical development and regulatory registration. Headquartered in Nanshan, Shenzhen, the company has established international operations and R&D teams in Shanghai and Wuhan. Forward Pharmaceuticals has built a drug discovery platform with core proprietary intellectual property and a distinctive drug R&D innovation system over its decade-long journey. Leveraging this platform, the company has developed a product pipeline matrix featuring over 10 innovative drugs, with indications spanning multiple solid tumors and autoimmune diseases.
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