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]

Core Insights - The BD (Business Development) sector in China's biotech industry has experienced unprecedented growth, with the total amount of domestic innovative drug licensing exceeding $100 billion by November 18, 2025, doubling compared to 2024 [1][5] - The strong performance of BD transactions reflects the increasing competitiveness and value of Chinese pharmaceutical assets globally, marking a critical period for the industry [1][2] - The focus is shifting from the quantity and value of signed agreements to the realization of product value post-agreement, influenced by factors such as global clinical progress and competitive landscape changes [1][2] Industry Trends - The compound annual growth rate (CAGR) for external BD by Chinese innovative drug companies is expected to decline over the next five years but will still maintain double-digit growth [2] - Future BD transactions will show two main characteristics: an increase in late-stage pipeline proportions and a shift from pure technology transfer to "licensing + joint development + commercialization participation" [2][9] Major Transactions - Significant BD deals in 2025 include: - A $5 billion upfront payment from GSK to Hengrui Medicine for the global exclusive rights to a PDE3/4 inhibitor project, with a potential total value of $12 billion [3] - A $12.5 billion upfront payment from Pfizer to 3SBio for a PD-1/VEGF bispecific antibody, with milestone payments potentially reaching $48 billion [3][5] - A $12 million upfront payment from Takeda to Innovent Biologics for a global strategic partnership, with a total potential value of $114 billion [3][10] Market Dynamics - The BD market is characterized by a growing interest from multinational corporations in early-stage innovative pipelines from China, driven by cost-effectiveness and potential efficacy [7] - The License-out model remains the dominant transaction mode, accounting for 91% of upfront payments and 99% of total amounts in related transactions in the first half of the year [9][10] Future Outlook - The next wave of BD opportunities is expected to arise from advancements in second-generation technologies, such as ADCs and CAR-T therapies, which are anticipated to meet unmet clinical needs [14][15] - The overall BD market is projected to continue its momentum into 2026, with a focus on high-quality pipelines and the potential for significant transactions [16][17]

Core Viewpoint - The article highlights the unprecedented surge in business development (BD) activities in China's biotech sector, with the total amount of domestic innovative drug licensing exceeding $100 billion by November 18, 2025, marking a doubling compared to 2024. This trend reflects the increasing global competitiveness and value of Chinese pharmaceutical assets, while also prompting a deeper examination of transaction quality and product value realization post-agreement [1][2]. Summary by Sections BD Market Dynamics - The BD market in China is experiencing a significant boom, with a projected compound annual growth rate (CAGR) for external BD activities expected to remain in double digits over the next five years, despite a forecasted decline in growth rate [2]. - Key characteristics of future transactions include an increase in late-stage pipeline contributions and a shift from pure technology transfer to models involving "licensing + co-development + commercialization" [2]. Major Transactions - Notable transactions in 2025 include: - Hengrui Medicine's collaboration with GSK, involving a total potential amount of approximately $120 billion, with an upfront payment of $500 million [3]. - Innovent Biologics' agreement with Takeda, with a potential total of $114 billion and an upfront payment of $1.2 billion [3]. - A record-setting deal between 3SBio and Pfizer, with an upfront payment of $12.5 billion and potential milestone payments reaching $48 billion [5][6]. Global Interest in Chinese Biotech - Chinese innovative drugs are gaining significant traction in global markets, with multinational corporations increasingly sourcing early-stage innovation pipelines from China due to cost-effectiveness and potential efficacy [7][8]. - The trend indicates a shift where Chinese biotech firms are evolving from technology providers to value co-creators in the global pharmaceutical landscape [7]. Transaction Models - The dominant transaction model remains "License-out," which accounted for 91% of upfront payments and 99% of total amounts in related transactions in the first half of the year [10]. - NewCo models are gaining popularity, allowing companies to inject parts of their product pipelines into newly formed entities with foreign capital, reflecting a flexible asset operation strategy [10][11]. Future Outlook - The BD market is expected to continue thriving, driven by the need for multinational companies to replenish their pipelines as many blockbuster drugs face patent expirations, creating a significant market opportunity [15]. - Emerging technologies, particularly in ADCs and bispecific antibodies, are anticipated to dominate future BD transactions, with a notable interest in metabolic and autoimmune products [16][17]. Challenges and Considerations - Despite the growth, challenges remain in ensuring compliance with international standards and protecting intellectual property during global collaborations [13]. - The market is expected to stabilize, with a rational return to expectations regarding BD transactions, as the industry matures and the focus shifts from explosive growth to sustainable value creation [17].

声明：市场有风险，投资需谨慎。本文为AI基于第三方数据生成，仅供参考，不构成个人投资建议。 本文源自：市场资讯 国家知识产权局信息显示，石药集团中奇制药技术（石家庄）有限公司取得一项名为"一种阿瑞匹坦注 射液的体外释放方法"的专利，授权公告号CN117250269B，申请日期为2023年8月。 天眼查资料显示，石药集团中奇制药技术（石家庄）有限公司，成立于2003年，位于石家庄市，是一家 以从事研究和试验发展为主的企业。企业注册资本3975.47万人民币。通过天眼查大数据分析，石药集 团中奇制药技术（石家庄）有限公司共对外投资了6家企业，参与招投标项目13次，专利信息446条，此 外企业还拥有行政许可34个。 作者：情报员 ...

Core Viewpoint - The A-share pharmaceutical sector in 2025 exhibits structural differentiation, with innovative drugs and CXO sectors thriving due to overseas demand and business development, while traditional Chinese medicine, medical devices, and pharmaceutical commerce face performance pressures [3][20]. Summary by Category Overall Market Performance - The A-share pharmaceutical and biotechnology sector saw an overall increase of 25.64% from January 1 to December 30, 2025, despite a slight decline in revenue and a stabilization in profits, with total revenue of 18,544.52 billion yuan, down 1.42% year-on-year, and net profit of 1,407.32 billion yuan, down 1.65% year-on-year [4][21]. Innovative Drug Sector - The innovative drug sector was a standout performer in 2025, with the chemical pharmaceutical segment rising by 32.58% and the medical services segment by 32.91% [4][21]. - Companies like BeiGene (百济神州) reported significant growth, achieving revenue of 27.595 billion yuan, a 44.2% increase year-on-year, surpassing the total revenue of 27.21 billion yuan for 2024 [4][22]. Business Development (BD) Trends - The business development landscape for innovative drug companies is evolving, with significant partnerships such as the 11.4 billion USD deal between Innovent Biologics and Takeda, and a 12.5 billion USD collaboration between Hengrui Medicine and GlaxoSmithKline [5][22][24]. - The total value of business development transactions reached approximately 94.158 billion USD in the first three quarters of 2025, significantly exceeding the total for 2024 [25]. CXO Sector Performance - The CXO sector, driven by the demand for innovative drug research, achieved a 32.91% increase in 2025, with total revenue of 1,365.72 billion yuan, up 3.63% year-on-year, and net profit of 209.12 billion yuan, up 36.47% year-on-year [10][27]. - Leading companies like WuXi AppTec (药明康德) and Kanglong Chemical (康龙化成) returned to growth, with WuXi AppTec reporting a revenue increase of 18.61% and net profit growth of 84.84% [28][31]. Traditional Chinese Medicine and Medical Devices - The traditional Chinese medicine sector experienced a modest increase of 6.75% in 2025, with total revenue of 2,590.69 billion yuan, down 4.33% year-on-year, and net profit of 294.99 billion yuan, down 1.53% year-on-year [36]. - The medical device sector reported a revenue of 1,792.10 billion yuan, down 2.24% year-on-year, with notable performance differences among sub-sectors, where companies like Mindray Medical (迈瑞医疗) showed strong overseas revenue growth [33][34].

Group 1 - The Hong Kong innovation drug sector continues to experience a downturn, with leading companies like BeiGene and China Biologic falling over 1%, and Innovent Biologics and 3SBio dropping more than 3% [1][7] - The Hong Kong Innovation Drug ETF (520880) has seen a decline for four consecutive days, reaching a new low since July 10, with a premium rising inversely, indicating strong buying interest [8][1] - Recent analysis from Zhongyou Securities indicates that the innovation drug sector is in a continuous correction phase, primarily driven by a retreat from previously optimistic business development (BD) expectations [3][10] Group 2 - Looking ahead to 2026, the maturity of clinical data is expected to be a key factor driving the innovation drug market, with BD being a necessary outcome of enhanced competitiveness of domestic new drugs [3][10] - Dongwu Securities suggests that the current period may represent a favorable configuration window for the Hong Kong innovation drug sector, which has been in adjustment since September, lasting over three months [10] - The Hong Kong Innovation Drug ETF (520880) and its associated funds track the Hang Seng Hong Kong Innovation Drug Select Index, which has three unique advantages: it is purely focused on innovation drugs, has a high concentration of leading companies, and offers better risk control [10][11] Group 3 - The top ten holdings in the Hong Kong Innovation Drug ETF account for over 72% of the index, highlighting the dominance of leading companies in the sector [4][10] - The total market capitalization of the top ten companies in the ETF is approximately HKD 12.87 billion, with BeiGene having a weight of 11.51% and a market cap of HKD 3.07 billion [4][10] - For investors looking to reduce volatility while still focusing on innovation drugs, the only drug ETF in the market (562050) is recommended, which emphasizes both innovation drugs and traditional Chinese medicine [12][13]