By Fineline Cube China’s Junshi Biosciences (HKG: 1877, SHA: 688180) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study of its PI3K-α inhibitor RP903 (JS105) in combination with fulvestrant for hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER-2)-negative, PIK3CA-mutated advanced or metastatic breast cancer in women (postmenopausal) and men.
Drug Profile
RP903 (JS105) is an orally administered small molecule PI3K-α inhibitor developed to treat patients with advanced breast cancer that is HR-positive, HER-2-negative, and PIK3CA mutation positive during or after endocrine therapy. Preclinical studies have shown significant efficacy in animal models of breast cancer, as well as promising results in cervical cancer, renal cancer, colorectal cancer, esophageal cancer, and other solid tumors. The drug also demonstrated a favorable safety profile.
Licensing Agreement
Junshi Biosciences entered into a licensing agreement with Risen (Suzhou) Pharmaceuticals Co., Ltd in February 2019, securing 50% of the rights to the drug and another inhibitor globally. The company paid RMB 150 million (USD 22.4 million) for each drug. In April 2021, the two companies established the joint venture Junshi Runjia to develop, clinically apply, manufacture, and commercialize the drug.
Market Context
Currently, only Novartis’s Piqray (alpelisib), also a PI3K-α inhibitor, is commercially available for the treatment of HR-positive, HER-2-negative, PIK3CA-mutated advanced breast cancer globally.-Fineline Info & Tech