InventisBio (688382)2024-11-08 09:44Company Overview - Yifang Bio is an innovative drug development company with a product pipeline that includes one product in the NDA stage, one in registration clinical trials, two in Phase II clinical trials, and multiple preclinical projects [1]. Product Pipeline 1. Beifu's Nib (Third-generation EGFR Inhibitor) - Beifu's Nib has been approved for both second-line and first-line treatment indications in 2023 and is included in the National Medical Insurance Directory [1]. - Approximately 800,000 new cases of non-small cell lung cancer (NSCLC) are reported annually in China, with projections of 1,000,000 cases by 2030, of which about 40% are EGFR mutations [1]. 2. Garsorasib (D-1553, KRAS G12C Inhibitor) - D-1553 is designed for treating KRAS G12C mutation-positive NSCLC and colorectal cancer, with KRAS G12C mutations occurring in about 14% of NSCLC cases and 4% of colorectal cancer cases [1]. - In the Chinese population, KRAS mutations are found in approximately 4.3% of lung cancer, 2.5% of colorectal cancer, and 2.3% of cholangiocarcinoma patients [1]. - D-1553's new drug application was accepted by CDE in December 2023 and is undergoing priority review [1]. Clinical Trial Progress D-1553 - A Phase III clinical trial comparing D-1553 to docetaxel for KRAS G12C mutation-positive NSCLC has commenced [4]. - Recent results from a Phase II study showed an objective response rate (ORR) of 52%, disease control rate (DCR) of 88.6%, median duration of response (DOR) of 12.5 months, median progression-free survival (PFS) of 9.1 months, and median overall survival (OS) of 14.1 months [4]. D-0502 (Selective Estrogen Receptor Degrader) - D-0502 is currently in a Phase III trial against fulvestrant for ER-positive, HER2-negative breast cancer, with a clinical benefit rate (CBR) of 47.1% and an ORR of 15.7% reported [4]. Other Products - D-0120, a URAT1 inhibitor, is in a Phase IIb trial in China, while D-2570, a TYK2 inhibitor, has completed Phase I and is in a Phase II trial for psoriasis [4].