Huiyu Pharmaceutical(SH:688553) Zheng Quan Zhi Xing·2025-07-30 16:13Core Viewpoint - Sichuan Huiyu Pharmaceutical Co., Ltd. has successfully completed the first administration of its innovative drug injection HY0001a in a Phase I clinical trial for treating advanced solid tumors [1][2]. Group 1: Drug Overview - Injection HY0001a is a first-class innovative biological product developed by the company's wholly-owned subsidiary, Huiyu Haiyue Pharmaceutical Technology Co., Ltd., aimed at treating advanced solid tumors [1][2]. - The clinical trial application for HY0001a was accepted by the National Medical Products Administration (NMPA) in April 2025, and the clinical trial approval notice was received in June 2025 [1]. Group 2: Research and Development Progress - Following the approval from NMPA, a multi-center, open-label Phase I/II clinical study has been initiated to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of HY0001a in patients with advanced malignant solid tumors [2]. - The main objectives of the study include assessing the safety and tolerability of HY0001a as a monotherapy, exploring the maximum tolerated dose (MTD), and providing recommended dosing for subsequent clinical studies [2]. - As of June 30, 2025, the cumulative R&D investment in this project is approximately RMB 60.10 million (unaudited) [2]. Group 3: Market Potential - Research indicates that CDCP1 is highly expressed in various cancers such as gastric, breast, lung, colorectal, and pancreatic cancers, making it an important target for ADC drug development [3]. - Preclinical studies have shown that HY0001a exhibits excellent anti-tumor effects and good safety profiles across multiple solid tumor models, indicating significant clinical development value [3].