SIM0686 / Simcere - LARVOL DELTA

Novel FGFR2b-targeting ADC is approved by the U.S. FDA to enter clinical trials (Simcere Press Release) - "On July 21, 2025, Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that the U.S. Food and Drug Administration (FDA) has recently cleared the company's Investigational New Drug (IND) application for its independently developed antibody-drug conjugate (ADC), SIM0686, which targets FGFR2b (Fibroblast Growth Factor Receptor 2b)....The approval of the IND allows the study to be conducted in the US for patients with FGFR2b-positive, locally advanced, or metastatic solid tumors."

IND • Solid Tumor

A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor

SCR-A002, a novel FGFR2b-targeting ADC for solid tumors (AACR 2025) - "SCR-A002 showed remarkable anti-tumor efficacy in preclinical data, suggesting that SCR-A002 is expected to provide a new treatment option as single agent or combo with SoC for patients with FGFR2b-overexpressing solid tumor."

Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • FGFR2

THE CLINICAL TRIAL APPROVAL FOR SIM0686 (FGFR2b ANTIBODY-DRUG CONJUGATE) ISSUED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (HKEXnews) - "The board (the 'Board') of directors (the 'Directors') of the Company is pleased to announce that, on April 9, 2025, SIM0686, an FGFR2b Antibody-Drug Conjugate ('ADC') which is an anti-tumor drug candidate independently developed by the Group, has obtained the Clinical Trial Approval issued by the National Medical Products Administration...of China, which is intended for commencing the clinical trial for advanced solid tumors."

New trial • Solid Tumor