InventisBio (688382)2024-09-06 07:34Group 1: Company Overview and Product Pipeline - Yifang Bio is an innovative drug development company with a focus on oncology, currently having one product in commercialization and several in various stages of clinical trials [2][4]. - The company’s product, Beifutini (a third-generation EGFR inhibitor), has been approved for both first-line and second-line treatment indications in 2023, with the second-line indication included in the National Medical Insurance Directory [2][4]. - The annual incidence of new non-small cell lung cancer (NSCLC) patients in China is approximately 800,000, projected to reach 1 million by 2030, with about 40% of these patients having EGFR mutations [2][4]. Group 2: Clinical Trials and Research Progress - D-1553, a KRAS G12C inhibitor, is undergoing clinical trials for various cancers, with a focus on non-small cell lung cancer, colorectal cancer, and pancreatic cancer [2][4]. - The Phase II clinical trial for D-1553 showed an overall response rate (ORR) of 50% and a disease control rate (DCR) of 89%, with a median duration of response (DOR) of 12.8 months and a median progression-free survival (PFS) of 7.6 months [4]. - D-1553 has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for new indications in pancreatic ductal adenocarcinoma and colorectal cancer [4]. Group 3: Future Developments and Collaborations - D-0502, an oral selective estrogen receptor degrader (SERD), is currently in a Phase III clinical trial against Fulvestrant for ER-positive, HER2-negative breast cancer [4][5]. - The company is also conducting a Phase II clinical trial for D-0120, a urate transporter 1 inhibitor, which began patient enrollment in September 2022 [5]. - D-2570, a novel oral selective TYK2 inhibitor, has completed its Phase I clinical trial and is now in a Phase II trial for psoriasis [5].