CSPC PHARMA(01093)

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石药集团(01093):SYS 6036注射液在中国获临床试验批准
智通财经网· 2025-08-22 10:06
Core Viewpoint - The approval of SYS 6036 injection by the National Medical Products Administration of China marks a significant advancement for the company in the field of tumor immunotherapy [1] Company Summary - The product SYS 6036 is a humanized monoclonal antibody drug aimed at tumor immunotherapy, specifically targeting melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma [1] - The development of SYS 6036 follows the guidelines for biosimilar drug research, indicating a structured approach to its clinical development [1] Industry Summary - The approval for clinical trials in China reflects the growing focus on immunotherapy within the oncology sector, highlighting the potential for innovative treatments in addressing various types of cancer [1] - The research results indicate that SYS 6036 shows high similarity in quality, safety, and efficacy compared to the reference drug, supporting the rationale for further clinical studies [1]
石药集团(01093) - 自愿公告 - SYS6036注射液在中国获临床试验批准
2025-08-22 10:00
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 佈,本集團開發的SYS 6036注射液(「該產品」)已獲中華人民共和國國家藥品監督管理局批 准,可在中國開展臨床試驗。 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的內容概不負責,對其準 確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致的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 SYS 6036注射液在中國獲臨床試驗批准 該產品是一款腫瘤免疫治療的人源化單克隆抗體藥物,按照治療用生物製品3.3類申報,預 計將適用於治療黑色素瘤、非小細胞肺癌、食管癌、頭頸部鱗狀細胞癌等多種腫瘤。 該產品的研發遵循生物類似藥相關研究指南。藥學及非臨床研究結果顯示,該產品與原研 參照藥在質量、安全性和有效性方面高度相似,支持開展後續臨床研究。 承董事會命 石藥集團有限公司 ...
新诺威:获得《药物临床试验批准通知书》
Mei Ri Jing Ji Xin Wen· 2025-08-22 08:10
Group 1 - The core point of the article is that Shionogi & Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of SYS6036 injection [2] - The clinical trial is set to commence shortly, indicating progress in the company's drug development pipeline [2]
石药集团午后一度跌超4% 上半年纯利同比减少15.64% 中期息14港仙
Zhi Tong Cai Jing· 2025-08-22 05:52
Core Viewpoint - The company reported a significant decline in revenue and profit for the first half of 2025, primarily due to the inclusion of two products in centralized procurement, impacting overall financial performance [1]. Financial Performance - Total revenue for the period was 13.273 billion RMB, representing a year-on-year decrease of 18.5% [1]. - Profit attributable to shareholders was 2.548 billion RMB, down 15.64% compared to the previous year [1]. - Basic earnings per share were 22.29 cents [1]. Dividend Announcement - The company proposed an interim dividend of 0.14 HKD per share, down from 0.16 HKD in the same period last year [1]. Gross Margin Analysis - The gross margin for the period decreased by 6.0 percentage points to 65.6%, primarily due to a reduced revenue contribution from the prescription drug business [1].
港股异动 | 石药集团(01093)午后一度跌超4% 上半年纯利同比减少15.64% 中期息14港仙
智通财经网· 2025-08-22 05:45
Core Viewpoint - The company reported a significant decline in revenue and profit for the first half of 2025, primarily due to the inclusion of two products in centralized procurement [1] Financial Performance - Total revenue for the period was 13.273 billion RMB, representing a year-on-year decrease of 18.5% [1] - Profit attributable to shareholders was 2.548 billion RMB, down 15.64% year-on-year [1] - Basic earnings per share were 0.2229 RMB [1] - The company proposed an interim dividend of 0.14 HKD per share, compared to 0.16 HKD in the same period last year [1] Margin Analysis - Gross profit margin decreased by 6.0 percentage points to 65.6% compared to the same period last year [1] - The decline in gross margin was mainly attributed to a reduced proportion of revenue from the prescription drug business [1]
石药集团(01093.HK)中期股东应占溢利同比减少15.6%至25.48亿元 中期息14港仙
Jin Rong Jie· 2025-08-22 05:38
Group 1 - The company reported total revenue of approximately 13.273 billion RMB for the six months ending June 30, 2025, representing a year-on-year decrease of 18.5% [1] - The reported profit attributable to shareholders was approximately 2.548 billion RMB, a decrease of 15.6% year-on-year, with basic earnings per share at 0.2229 RMB [1] - The decline in revenue was primarily due to the inclusion of the products Dumex® and Tsinghua® in centralized procurement [1] Group 2 - The gross profit margin decreased by 6.0 percentage points to 65.6%, mainly due to the reduced revenue share from prescription drugs [1] - Research and development expenses increased by 5.5% year-on-year to 2.683 billion RMB, accounting for 26.2% of prescription drug revenue [1] - The company has nearly 90 products in various stages of clinical trials, with 12 submitted for market approval and over 30 key products in the registration clinical stage [1] Group 3 - The company has over 200 innovative drugs and formulations in development, including more than 90 macromolecules, 60 small molecules, and 50 new formulations [1] - There are currently over 160 clinical trials ongoing, with nearly 60 in Phase III [1] - The company expects to submit over 50 new drugs or new indications for approval by the end of 2028 [1] Group 4 - Year-to-date, the company has received approval for 3 innovative products, acceptance for 5 product applications, breakthrough therapy designations for 4 products, and 28 clinical trial approvals [2] - The company also obtained 7 registration approvals for generic drugs and 9 clinical trial approvals for innovative drugs in North America, along with 1 fast track designation [2]
石药集团将于11月18日派发中期股息每股0.14港元
Zhi Tong Cai Jing· 2025-08-22 05:14
Core Viewpoint - The company, 石药集团 (Stone Group), announced a mid-term dividend of HKD 0.14 per share, to be distributed on November 18, 2025 [1] Company Summary - 石药集团 will distribute a mid-term dividend of HKD 0.14 per share [1]
石药集团发布中期业绩 股东应占溢利25.48亿元 同比减少15.64%
Zhi Tong Cai Jing· 2025-08-22 05:13
Core Viewpoint - The company reported a significant decline in revenue and profit for the first half of 2025, primarily due to the inclusion of key products in centralized procurement, but it remains optimistic about future growth through innovation and international collaboration [1][2][3]. Financial Performance - Total revenue for the first half of 2025 was 13.273 billion RMB, a decrease of 18.5% year-on-year - Profit attributable to shareholders was 2.548 billion RMB, down 15.64% year-on-year - Basic earnings per share were 0.2229 RMB, with an interim dividend proposed at 0.14 HKD per share [1]. Research and Development - R&D expenses increased by 5.5% year-on-year to 2.683 billion RMB, accounting for 26.2% of the revenue from the pharmaceutical business - The company has nearly 90 products in various stages of clinical trials, with 12 submitted for market approval and over 30 key products in the registration clinical phase [1][4]. Strategic Initiatives - The company is focusing on a "dual-driven" strategy of "innovation + internationalization," enhancing partnerships with global pharmaceutical firms through diverse models such as licensing and collaborative R&D - In the first half of 2025, licensing revenue reached 1.075 billion RMB, indicating strong recognition of the company's innovative pipeline in the international pharmaceutical industry [2][3]. Global Expansion - The company is advancing its global strategy by establishing a comprehensive pharmaceutical value ecosystem and conducting multiple multi-center clinical trials in Europe and the U.S. - It has completed four licensing projects this year, with a cumulative contract amount of 9.71 billion USD, and has entered a strategic R&D collaboration with AstraZeneca [3][4]. Innovation Pipeline - The company has been recognized as one of the top 25 pharmaceutical companies globally by Citeline for three consecutive years, ranking 19th this year, an improvement of five places from the previous year - It has over 200 innovative drugs and formulations in development, with more than 160 clinical trials ongoing, including nearly 60 in Phase III [4].
石药集团(01093)将于11月18日派发中期股息每股0.14港元
智通财经网· 2025-08-22 05:11
Core Viewpoint - The company, CSPC Pharmaceutical Group (stock code: 01093), announced a mid-term dividend of HKD 0.14 per share, which will be distributed on November 18, 2025 [1] Company Summary - CSPC Pharmaceutical Group will distribute a mid-term dividend of HKD 0.14 per share [1]
石药集团(01093)发布中期业绩 股东应占溢利25.48亿元 同比减少15.64%
智通财经网· 2025-08-22 05:11
Group 1: Financial Performance - The company reported total revenue of 13.273 billion RMB, a year-on-year decrease of 18.5% [1] - Profit attributable to shareholders was 2.548 billion RMB, down 15.64% year-on-year, with basic earnings per share at 22.29 cents [1] - The gross profit margin decreased by 6.0 percentage points to 65.6%, primarily due to a reduction in the revenue share from the prescription drug business [1] Group 2: Research and Development - R&D expenses increased by 5.5% year-on-year to 2.683 billion RMB, accounting for 26.2% of prescription drug revenue [1] - The company has nearly 90 products in various stages of clinical trials, with 12 submitted for market approval and over 30 key products in the registration clinical phase [1] - The company focuses on high-demand treatment areas such as breast cancer and lung cancer, accelerating the commercialization of core products [2] Group 3: Strategic Initiatives - The company is implementing a "dual-driven" strategy of "innovation + internationalization," enhancing cooperation with global innovative pharmaceutical companies [2] - Authorization revenue reached 1.075 billion RMB in the first half of 2025, providing new growth momentum for the prescription drug business [2] - The company has completed four external authorization projects with a cumulative contract amount of 9.71 billion USD [3] Group 4: Global Expansion and Recognition - The company has been recognized as a "national-level innovative enterprise" and has established key national laboratories [4] - It ranks 19th in the global TOP25 pipeline scale pharmaceutical companies, improving its position by 5 places compared to the previous year [4] - The company is expected to submit over 50 new drugs or new indications for approval by the end of 2028 [4]