ZZPZH(SH:600436) Xin Lang Cai Jing·2026-01-13 18:48Core Viewpoint - The announcement indicates that the company has completed the enrollment of the first subject in the Phase II clinical trial for the drug "Wenpai Dingchuan Granules," which targets chronic obstructive pulmonary disease (COPD) [2][3]. Group 1: Drug Information - Drug Name: Wenpai Dingchuan Granules - Dosage Form: Granule - Registration Category: Traditional Chinese Medicine Class 1.1 - Indication: Stable phase of chronic obstructive pulmonary disease (COPD) with lung and kidney qi deficiency and phlegm-stasis obstructing the lungs [2][3]. - Clinical Acceptance Number: CXZL2400015 - Clinical Approval Number: 2024LP01271 - Clinical Trial Phase: Phase II [2]. Group 2: Clinical Trial Details - The Phase II clinical trial is designed as a multi-center, randomized, double-blind, placebo-controlled, dose-exploration study to preliminarily evaluate the efficacy and safety of Wenpai Dingchuan Granules for treating stable COPD [3]. - The trial protocol has been approved by the ethics committee of the leading unit, Guangdong Provincial Hospital of Traditional Chinese Medicine, and the first subject was enrolled on January 5, 2026 [3]. Group 3: Financial and Market Context - As of the announcement date, the cumulative R&D investment for this project is approximately 19 million yuan (about 2.9 million USD) [4]. - The global prevalence of COPD is approximately 11.7%, with an annual death toll of about 3.5 million, and it is projected that by 2030, over 4.5 million people will die from COPD and related diseases [5]. - The Chinese COPD drug market is expected to reach 59.19 billion yuan (approximately 8.4 billion USD) by 2030 [5]. - No other companies have obtained production approval for this product, and no traditional Chinese medicine targeting stable COPD with the specified indications has been approved for market [5].