Group 1 - The core point of the article is that Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of LXH-1211 tablets [2] Group 2 - The approval signifies a step forward in the development of LXH-1211, which may enhance the company's product pipeline and market position [2] - This development reflects the ongoing regulatory support for pharmaceutical innovations in the industry [2]

证券代码：000756 证券简称：新华制药 公告编号：2025-56 山东新华制药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或 重大遗漏。 近日，山东新华制药股份有限公司（以下简称"新华制药"或"本公司"）收到国家药品监督管 理局核准签发的LXH-1211片（以下简称"本品"）《药物临床试验批准通知书》。现将相关情况公告 如下： 一、基本情况 药品名称：LXH-1211片 剂型：片剂 申请人：山东新华制药股份有限公司 申请事项：药品注册（临床试验） 规格：0.5mg；1mg；2mg；5mg 药品分类：处方药 注册分类：化学药品1类 1 LXH-1211片是针对肺动脉高压的临床表现和疾病病理本质设计的结构全新的化合物。研究显示， LXH-1211具有双重作用机制，既能通过刺激可溶性鸟苷酸环化酶(sGC)产生血管舒张效应，降低肺动脉 高压，也能通过抑制AMP-激活蛋白激酶(AMPK)阻止血管重构和纤维化进程。本品拟定的临床适应症为 治疗肺动脉高压。 三、风险提示 公司将严格按照批件要求开展临床试验，并于临床试验结束后向国家 ...

Core Viewpoint - Xinhua Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of LXH-1211 tablets for the treatment of pulmonary arterial hypertension [1] Company Summary - Xinhua Pharmaceutical (000756.SZ) announced the receipt of the clinical trial approval notice for LXH-1211 tablets [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the clinical trial of LXH-1211 tablets, a novel compound designed for pulmonary arterial hypertension treatment [1] Group 1: Product Development - LXH-1211 is a structurally innovative compound targeting the clinical manifestations and pathological essence of pulmonary arterial hypertension [1] - The research indicates that LXH-1211 has a dual mechanism of action, stimulating soluble guanylate cyclase (sGC) to induce vasodilation and reduce pulmonary arterial hypertension, while also inhibiting AMP-activated protein kinase (AMPK) to prevent vascular remodeling and fibrosis [1] - The proposed clinical indication for LXH-1211 is the treatment of pulmonary arterial hypertension [1]

智通财经APP讯，新华制药(000756.SZ)公告，公司收到国家药品监督管理局核准签发的LXH-1211片 《药物临床试验批准通知书》，LXH-1211片获准开展肺动脉高压的临床试验。 ...

Core Viewpoint - Xinhua Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of LXH-1211, a new compound designed for pulmonary arterial hypertension [1] Company Summary - Xinhua Pharmaceutical (000756.SZ) announced the receipt of the clinical trial approval notice for LXH-1211, which is specifically aimed at treating pulmonary arterial hypertension [1] - The drug features a dual mechanism of action, indicating its innovative approach in addressing the condition [1] - The company will conduct clinical trials in strict accordance with the approval requirements and will submit relevant documents to the National Medical Products Administration for production registration after completion [1] Industry Summary - The approval of LXH-1211 highlights ongoing advancements in the pharmaceutical industry, particularly in the development of treatments for complex conditions like pulmonary arterial hypertension [1] - The lengthy and uncertain nature of drug development cycles is emphasized, indicating potential challenges within the industry [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of LXH-1211 tablets, aimed at treating pulmonary arterial hypertension [1] Company Summary - The clinical trial application for LXH-1211 tablets was accepted on July 10, 2025, and meets the requirements for drug registration [1] - LXH-1211 is a novel compound designed specifically for the clinical manifestations and pathological essence of pulmonary arterial hypertension [1] Mechanism of Action - LXH-1211 exhibits a dual mechanism of action: it stimulates soluble guanylate cyclase (sGC) to induce vasodilation and reduce pulmonary arterial hypertension, while also inhibiting AMP-activated protein kinase (AMPK) to prevent vascular remodeling and fibrosis [1] Clinical Indication - The proposed clinical indication for LXH-1211 is the treatment of pulmonary arterial hypertension [1]

LXH-1211片是针对肺动脉高压的临床表现和疾病病理本质设计的结构全新的化合物。研究显示LXH- 1211具有双重作用机制，既能通过刺激可溶性鸟苷酸环化酶(sGC)产生血管舒张效应，降低肺动脉高 压，也能通过抑制AMP-激活蛋白激酶(AMPK)阻止血管重构和纤维化进程。本品拟定的临床适应症为 治疗肺动脉高压。 智通财经APP讯，山东新华制药股份(00719)发布公告，近日，公司收到国家药品监督管理局核准签发的 LXH-1211片《药物临床试验批准通知书》。 根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年7 月10 日受理的LXH-1211 片临床试 验申请符合药品注册的有关要求，同意本品开展肺动脉高压的临床试验。 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of LXH-1211 tablets, aimed at treating pulmonary arterial hypertension [1] Group 1: Clinical Trial Approval - The clinical trial application for LXH-1211 was accepted on July 10, 2025, and the drug has been approved for clinical trials targeting pulmonary arterial hypertension [1] - The approval process included a communication meeting request submitted in September 2024, with feedback received in December 2024, leading to the final approval in September 2025 [1] Group 2: Drug Mechanism and Design - LXH-1211 is a novel compound specifically designed for the clinical manifestations and pathological essence of pulmonary arterial hypertension [1] - The drug exhibits a dual mechanism of action: it stimulates soluble guanylate cyclase (sGC) to induce vasodilation and lowers pulmonary arterial pressure, while also inhibiting AMP-activated protein kinase (AMPK) to prevent vascular remodeling and fibrosis [1]

新华制药公告，近日，公司收到国家药品监督管理局核准签发的 LXH-1211 片《药物临床试验批准通知 书》。药品名称为 LXH-1211 片，剂型为片剂，规格为 0.5mg；1mg；2mg；5mg，药品分类为处方药， 注册分类为化学药品 1 类。审批结论为根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 7 月 10 日受理的 LXH-1211 片临床试验申请符合药品注册的有关要求，同意本品开展肺动脉高压的 临床试验。 ...