SYH2095 / Hangzhou Innogate Pharma, CSPC Pharma - LARVOL DELTA

SYH2095-001: SYH2095 for Advanced Malignant Tumors: Phase I Study (clinicaltrials.gov) - P=N/A | N=140 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

First-in-human • New trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

CSPC Pharmaceutical Group Limited…is pleased to announce that SYH2095 tablets…have obtained approval from the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China (HKEXnews) - "Previously, the Product also obtained approval from the U.S. Food and Drug Administration (FDA) in April 2026 to conduct clinical trials in the U.S....It is intended for the treatment of advanced malignant tumour."

IND • New trial • Solid Tumor

Discovery of a highly potent KAT6 Inhibitor for potential treatment of advanced, metastatic and refractory ER+Her2- breast cancers (AACR 2025) - "Frequent genomic alteration of KAT6A and KAT6B have been found in a variety of cancer types. The molecule also exhibited good in vitro safety profile in hERG and well tolerated in rodent study. Collectively, these results provide preclinical evidence that our PCC molecule could be a superior KAT6A/6B inhibitor to treat patients with advanced, metastatic, refractory, fulvestrant-sensitive or-resistant, ER+Her2- breast cancers."

Metastases • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CCND1 • ER • HER-2 • KAT6A • KAT6B • KAT8