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浙江医药股份有限公司 关于XC2309注射液获得药物临床试验批准通知书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-22 19:35
一、药品基本情况 药物名称:XC2309注射液 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性承担个别及连带责任。 近日,浙江医药股份有限公司(以下简称"公司")收到国家药品监督管理局核准签发关于XC2309注射 液的《药物临床试验批准通知书》,经审查,XC2309注射液临床试验申请符合药品注册的有关要求, 同意本品开展临床试验。现将相关情况公告如下: 剂型:注射剂 规格:5ml:10mg(按C21H22FN3O3S计) 注册分类:化学药品1类 通知书编号:2025LP02083 申请人:浙江医药股份有限公司新昌制药厂 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,2025年6月4日受理的XC2309注 射液临床试验申请符合药品注册的有关要求,同意本品开展临床试验。申请的适应症:本品临床拟用于 各种情况引起的消化道溃疡出血。提交的临床试验方案:评价XC2309注射液在健康成年受试者中单次/ 多次给药后的安全性、耐受性、药代动力学和药效学特征及生物利用度的I期临床研究。 二、药品研究及相关情况 根据Pharmarket数据库, ...
梓橦宫:“创新发展”打开成长新空间
Quan Jing Wang· 2025-05-17 00:06
Core Insights - The company conducted a video live-streaming event to interact with investors, presenting a comprehensive overview of its business performance and strategic planning, enhancing investors' understanding of the annual report's key content [2] Financial Performance - In 2024, the company achieved an operating income of 415.67 million yuan and a net profit of 85.64 million yuan, with a basic earnings per share of 0.59 yuan [4] Product Development - The company currently has an influenza treatment drug, Oseltamivir Phosphate Capsules, and cold medications including Amantadine Hydrochloride Capsules and Paracetamol Tablets [4] - The company is advancing its research pipeline with a new drug, Maja Zhi Capsules, targeting gastrointestinal tumors, which has entered Phase Ia clinical trials [4] - A generic drug, Fumarate Vornorate Tablets, has been submitted for drug registration approval [4] - New projects initiated in 2024 include Tartrate Sinibiri Tablets, Ibuprofen Sustained-Release Capsules, Dydrogesterone Tablets, and Lidocaine Hydrochloride Sterile Gel [4] Strategic Focus - The company emphasizes "innovation-driven" development, aiming to accelerate research and development, marketing, and management innovations to lay a solid foundation for the successful launch of its 14th Five-Year Plan [4]