Core Viewpoint - The approval of the inhalation powder formulation of Nintedanib by the National Medical Products Administration of China marks a significant advancement for the company in the treatment of idiopathic pulmonary fibrosis (IPF) [1] Company Summary - The stock price of the company, CSPC Pharmaceutical Group (01093), increased by over 4% in the morning session, currently trading at HKD 8.81 with a transaction volume of HKD 595 million [1] - The inhalation formulation of Nintedanib is the first inhaled drug approved in China for clinical trials aimed at treating pulmonary fibrosis [1] Product Summary - Nintedanib is a multi-tyrosine kinase inhibitor that can slow the progression of IPF, with the oral formulation currently available as soft capsules [1] - The inhalation formulation offers significant advantages over the oral version, including improved lung exposure, better lung function, reduced systemic exposure, and significantly lower gastrointestinal side effects [1] - Preclinical studies indicate that the inhalation product can achieve equivalent efficacy at 1/200 of the oral dosage, demonstrating good safety and effectiveness [1]

Group 1 - Baidu Group-SW (09888) proposes to spin off Kunlun Chip for independent listing on the Hong Kong Stock Exchange main board [1] - Dali Group Holdings (01921) subsidiary Dali International Industrial Company has obtained a temporary industrial license issued by MIMR [1] - Guofu Hydrogen Energy (02582) has completed the delivery of a total of 424 sets of vehicle-mounted high-pressure hydrogen supply systems to its customers [1] Group 2 - CSPC Pharmaceutical Group (01093) has received clinical trial approval in China for its inhalation powder of Nintedanib [1] - Fantasia Holdings (01777) has entered into a restructuring agreement with Splendid Fortune to sell 409 million shares of Color Life for USD 4.5284 million [1] - China Hongqiao (01378) has made Hongtuo Industrial a wholly-owned subsidiary of Hongchuang Holdings [1] Group 3 - Brainstorm Cell Therapeutics-B (06681) subsidiary has officially signed a cooperation agreement with Beijing Jianguo Medical for a cognitive digital therapy project [1] - Longpan Technology (02465) plans to invest in a lithium iron phosphate production base with an annual capacity of 240,000 tons, with a total investment not exceeding 2 billion yuan [1] - Zhongzheng International (00943) intends to acquire a digital solution company in the beauty industry for HKD 62.5 million, with resumption of trading on January 5 [1] - Kelun-Biotech (06990) has received approval from the National Medical Products Administration for the clinical trial application of its ITGB6 ADC SKB105 new drug [1]

Core Viewpoint - The approval of the inhaled powder formulation of Nintedanib by the National Medical Products Administration of China marks a significant milestone for the company, as it is the first inhalation formulation approved for clinical trials in China for the treatment of pulmonary fibrosis [1][1]. Group 1 - The inhaled formulation of Nintedanib has received approval for clinical trials in China [1]. - This product is the first of its kind in China specifically aimed at treating pulmonary fibrosis [1][1].

Core Viewpoint - The approval of the inhalation powder formulation of Nintedanib by the National Medical Products Administration of China marks a significant advancement for the treatment of idiopathic pulmonary fibrosis (IPF) in the country, being the first inhalation formulation approved for clinical trials in China [1] Group 1 - The inhalation powder formulation of Nintedanib has received approval for clinical trials in China [1] - Nintedanib is a multi-tyrosine kinase inhibitor that can slow the progression of idiopathic pulmonary fibrosis (IPF) [1] - The currently available formulation of Nintedanib is an oral soft capsule [1]

Core Viewpoint - The approval of the inhaled powder formulation of Nintedanib by the National Medical Products Administration of China marks a significant advancement in the treatment of pulmonary fibrosis, being the first inhaled formulation approved for clinical trials in China [1] Group 1: Product Development - The inhaled formulation of Nintedanib is a multi-tyrosine kinase inhibitor that can slow the progression of idiopathic pulmonary fibrosis (IPF) [1] - The product offers significant advantages over oral formulations, including improved lung exposure, better lung function, reduced systemic exposure, and significantly lower gastrointestinal side effects [1] - Preclinical studies indicate that the product can achieve equivalent efficacy at a dosage of 1/200 of the oral dose, demonstrating good safety and effectiveness [1] Group 2: Clinical Applications - The approved clinical indication for the product is idiopathic pulmonary fibrosis, with potential applications for treating systemic sclerosis-related interstitial lung disease (SSc-ILD) and progressive pulmonary fibrosis (PPF) [1] - This approval is a key achievement for the company's inhalation technology platform, laying a solid foundation for the development of subsequent inhaled formulations in the pipeline [1]

Core Viewpoint - The approval of the inhalation powder formulation of Nintedanib by the National Medical Products Administration of China marks a significant advancement for the company in the treatment of idiopathic pulmonary fibrosis (IPF) [1] Group 1: Product Development - The inhalation powder formulation of Nintedanib is the first inhalation preparation approved for clinical use in China for the treatment of pulmonary fibrosis [1] - Nintedanib is a multi-tyrosine kinase inhibitor that can slow the progression of IPF, with the current available formulation being an oral soft capsule [1] - Compared to the oral formulation, the inhalation product offers significant advantages, including improved lung exposure, better lung function, reduced systemic exposure, and significantly lower gastrointestinal side effects [1] Group 2: Clinical Research and Potential - Preclinical studies indicate that the inhalation formulation can achieve equivalent efficacy at a dosage of 1/200 of the oral dose, demonstrating good safety and effectiveness [1] - The approved clinical indication is for idiopathic pulmonary fibrosis, with potential applications for systemic sclerosis-related interstitial lung disease (SSc-ILD) and progressive pulmonary fibrosis (PPF) [1] - This approval is a key achievement of the company's inhalation technology platform and lays a solid foundation for the development of subsequent inhalation formulations in the pipeline [1]

Core Viewpoint - The approval of the inhalation powder formulation of Nintedanib by the National Medical Products Administration of China marks a significant advancement for the company in the treatment of idiopathic pulmonary fibrosis (IPF) [1] Group 1: Product Development - The inhalation powder formulation of Nintedanib is the first inhalation preparation approved for clinical use in China for the treatment of pulmonary fibrosis [1] - Nintedanib is a multi-tyrosine kinase inhibitor that can slow the progression of IPF, with the current available formulation being an oral soft capsule [1] - The inhalation product offers significant advantages over oral formulations, including improved lung exposure, better lung function, reduced systemic exposure, and significantly lower gastrointestinal side effects [1] Group 2: Clinical Research and Efficacy - Preclinical studies indicate that the inhalation formulation can achieve equivalent efficacy at a dosage of 1/200 of the oral dose, demonstrating good safety and effectiveness [1] - The approved clinical indication is for idiopathic pulmonary fibrosis, with potential applications for systemic sclerosis-related interstitial lung disease (SSc-ILD) and progressive pulmonary fibrosis (PPF) [1] Group 3: Strategic Importance - This approval is a key achievement for the company's inhalation technology platform and lays a solid foundation for the development of subsequent inhalation formulations in the pipeline [1]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年12月31日 | 狀態: | 新提交 | | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | 公司名稱: | 石藥集團有限公司 | | | | 呈交日期: | 2026年1月2日 | | | | I. 法定/註冊股本變動 | 不適用 | | | FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 III.已發行股份及/或庫存股份變動詳情 (A). 股份期權（根據發行人的股份期權計劃） | 1. 股份分類 | | 普通股 | | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號(如上市) | | 01093 | | 說明 | | | | | | | | | 股份期權計劃詳情 | | 上月底結存的股份期權數 | | 本月內變動 | | 本月底結存的 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 自願公告 乙磺酸尼達尼布吸入粉霧劑 在中國獲臨床試驗批准 石藥集團有限公司 主席 蔡東晨 香港，2026年1月2日 – 1 – 於本公告日期，董事會包括執行董事蔡東晨先生、蔡磊博士、魏青杰先生、張翠龍先生、 王 振 國 先 生 、 王 懷 玉 先 生 、 李 春 雷 博 士 、 姚 兵 博 士 、 蔡 鑫 先 生 、 陳 衛 平 先 生 及 屈 志 勇 先 生；及獨立非執行董事王波先生、CHEN Chuan先生、王宏廣教授、歐振國先生、羅卓堅先 生及李泉女士。 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 布，本集團開發的乙磺酸尼達尼布吸入粉霧劑（ ...

Group 1 - The top three companies with the highest short positions are Vanke Enterprises (02202), Dongfang Electric (01072), and COSCO Shipping Holdings (01919), with short ratios of 18.64%, 17.51%, and 16.68% respectively [1][2] - The company with the largest increase in short positions is Dongfang Electric (01072), which saw an increase of 2.20% from the previous short ratio [1][2] - The companies with the largest decrease in short positions include Sanhua Intelligent Control (02050), Tianqi Lithium (09696), and Yuejiang (02432), with decreases of -1.42%, -0.82%, and -0.71% respectively [1][3] Group 2 - The latest short position data shows that Vanke Enterprises has 411 million shares shorted, while Dongfang Electric has 71.45 million shares, and COSCO Shipping Holdings has 480 million shares shorted [2] - The companies with the largest increases in short positions also include JAKS Resources B (01167) and CSPC Pharmaceutical Group (01093), with increases of 0.77% and 0.56% respectively [2] - The companies with the largest decreases in short positions also include Ganfeng Lithium (01772) and Sunac China (01918), with decreases of -0.68% and -0.55% respectively [3][4]