CSPC PHARMA(01093)
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石药集团(01093) - 致股东的通知信函及变更申请表格
2025-09-18 09:44
CSPC PHARMACEUTICAL GROUP LIMITED 石藥集團有限公司 (Incorporated in Hong Kong under the Companies Ordinance) (根據公司條例在香港註冊成立) (Stock Code: 1093) (股份代號:1093) NOTIFICATION LETTER 通知信函 19 September 2025 Dear Shareholder, CSPC Pharmaceutical Group Limited (the "Company") — Notice of Publication of 2025 Interim Report (the "Current Corporate Communications") The English and Chinese versions of the Current Corporate Communications are available on the Company's website at www.cspc.com.hk and the website of The Stock Excha ...
石药集团(01093) - 2025 - 中期财报
2025-09-18 09:43
目錄 | | | 1 二零二五年中期報告 3 財務摘要 4 管理層討論及分析 28 簡明綜合財務報表審閱報告 29 簡明綜合收益表 30 簡明綜合全面收益表 31 簡明綜合財務狀況表 33 簡明綜合權益變動表 34 簡明綜合現金流量表 36 簡明綜合財務報表附註 59 其他資料 公司資料 董事會 執行董事: 蔡東晨 (主席) 張翠龍 (副主席兼行政總裁) 王振國 潘衛東 王懷玉 李春雷 姚兵 蔡鑫 陳衛平 獨立非執行董事: 王波 CHEN Chuan 王宏廣 歐振國 羅卓堅 李泉 審核委員會 歐振國 (主席) 王波 CHEN Chuan 提名委員會 蔡東晨 (主席) 王波 CHEN Chuan 李泉 薪酬委員會 歐振國 (主席) 王波 CHEN Chuan 公司秘書 羅泰安 註冊辦事處 香港 灣仔 港灣道18號 中環廣場 32樓 3206室 股份過戶登記處 卓佳證券登記有限公司 香港 夏愨道16號 遠東金融中心17樓 核數師 德勤 • 關黃陳方會計師行 註冊公眾利益實體核數師 證券交易所 香港聯合交易所有限公司(「香港聯交所」) 股份代號 香港聯交所:1093 投資者關係聯絡 電郵:ir@cspc.hk 電話 ...
石药集团(01093) - 致新登记股东之函件及回条
2025-09-18 09:43
現特來函以確定 閣下對收取日後所有公司通訊的意向選擇。在行使 閣下選擇權時,請填妥及簽署隨附 的回條(「回條」),並將回條寄回或親身交回本公司股份過戶登記處卓佳證券登記有限公司(「過戶登記處」), 地址為香港夏愨道16號遠東金融中心17樓。倘若 閣下在香港投寄,可使用回條內的郵寄標籤寄回,而毋 須在信封上貼上郵票;否則,請貼上適當的郵票。 我們鼓勵 閣下選擇電子版本。此舉既有助於保護環境並可促進本公司與股東更具效率的溝通。 若本公司於2025年10月18日或之前尚未收到 閣下填妥並簽署的回條,或任何 閣下反對透過以電子方 式閱覽公司通訊的回應, 閣下將被視作選擇電子版本(而非收取印刷本),本公司將以電郵方式(或如未有 提供電郵地址,則郵寄至 閣下於本公司股東名冊上所示的地址)通知 閣下有關公司通訊已登載於本公 司網站及香港聯交所網站。 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) 各位股東: 石藥集團有限公司(「本公司」) 致新登記股東之函件 — 選擇公司通訊之收取方式 根據香港聯合交易所有限公司證券上市規則(「上市 ...
中国创新药企“闯美”,如何预防政策风险?
Hu Xiu· 2025-09-18 06:03
Core Viewpoint - The Trump administration is drafting an executive order that will impose three major restrictions on commercial transactions involving Chinese innovative drug patents or rights, focusing on national security reviews by the Committee on Foreign Investment in the United States (CFIUS) [1][2]. Summary by Sections Executive Order Details - The draft includes three main provisions: 1. Inclusion of Chinese innovative drug BD transactions in the CFIUS mandatory review list, ending the previous "low-risk automatic exemption" practice [2]. 2. FDA will implement "racial sensitivity supplementary reviews" for drugs relying on Chinese clinical data, requiring at least 20% comparative data from non-Asian populations [2]. 3. Establishment of a "key drug domestic production fund" to provide production subsidies for 15 categories of drugs, including antibiotics and acetaminophen, while implementing a "domestic priority" principle in federal procurement [2]. Market Reaction - The market reacted swiftly to the policy risks, with the Hong Kong innovative drug index (HK1105) dropping 3.82% on September 11, 2025, and the A-share innovative drug sector (BK1106) declining 2.17%, with over 80% of stocks in the sector experiencing pullbacks [3]. - The following day, the indices showed signs of recovery, indicating investors' responses to policy uncertainties and rational corrections [3]. Globalization Trends - Despite the geopolitical risks, the trend of Chinese innovative drugs going global remains intact, with total license-out transactions to Europe and the U.S. reaching $9.43 billion as of September 2025 [3]. - Major transactions include a $950 million licensing deal between BeiGene and Royalty Pharma, and a $6 billion global licensing agreement between 3SBio and Pfizer, highlighting a shift towards milestone payments and regional licensing [3]. Industry Challenges - The domestic market faces challenges, with annual growth in medical insurance fund spending (approximately 12%) lagging behind the growth in innovative drug R&D investment (approximately 25%) [4]. - The average reduction in medical negotiations remains high at 54%, and commercial health insurance coverage for innovative drugs is below 15%, creating a supply-demand imbalance that necessitates going global [4]. Risk Resilience Assessment - Goldman Sachs has categorized Chinese innovative drug companies into three risk resilience tiers based on their sensitivity to policy changes and operational capabilities [4][5]. - Companies with mature global layouts exhibit the strongest resilience, while those heavily reliant on domestic markets show the weakest resilience [5][10]. Strategic Defense Framework - A three-dimensional defense system is proposed to address risks associated with the executive order, focusing on transaction review, data compliance, and supply chain security [13]. - Strategies include conducting national security risk pre-assessments for transactions over $50 million and establishing partnerships with U.S. law firms to navigate regulatory challenges [14][15]. Conclusion - The construction of a quantifiable "risk resilience index" is essential for Chinese innovative drugs in the global 2.0 era, emphasizing the need for companies to embed policy hedging clauses in transaction structures and consider racial diversity data in clinical stages [23].
石药集团(01093.HK):ALMB-0166在中国获临床试验批准用于治疗帕金森氏症
Ge Long Hui· 2025-09-15 10:36
Core Viewpoint - The approval of ALMB-0166 for Phase II clinical trials in China represents a significant advancement in the treatment of Parkinson's disease, addressing a critical need for new therapies in this area [1][2]. Group 1: Company Developments - The company has received approval from the National Medical Products Administration of China to conduct Phase II clinical trials for ALMB-0166, a first-in-class humanized monoclonal antibody inhibitor targeting the novel target Connexin43 (Cx43) [1]. - ALMB-0166 is developed by the company's subsidiary, AlaMab Therapeutics Inc., and is intended for treating neurological diseases such as Parkinson's disease, acute ischemic stroke, and acute spinal cord injury [1]. Group 2: Industry Context - Parkinson's disease is the second most common neurodegenerative disease globally, characterized by the progressive degeneration of dopaminergic neurons in the substantia nigra and the formation of Lewy bodies [2]. - Current treatments, primarily based on levodopa, only alleviate symptoms without reversing disease progression or achieving a cure, highlighting the urgent need for new therapeutic options [2]. - ALMB-0166 targets Cx43 hemichannels to inhibit the release and spread of neuroinflammatory factors, thereby maximizing neuroprotection [2]. - Preclinical studies in subacute and chronic Parkinson's disease animal models have shown that ALMB-0166 significantly inhibits the reduction of dopamine levels in the brain and restores behavioral and functional abilities, demonstrating a favorable dose-response relationship [2]. Group 3: Future Plans - The company is committed to advancing the clinical research of ALMB-0166 across various indications, aiming for its expedited market launch [3].
石药集团:ALMB-0166在中国获临床试验批准用于治疗帕金森氏症
Zhi Tong Cai Jing· 2025-09-15 10:36
Core Viewpoint - The company has received approval from the National Medical Products Administration of China to conduct Phase II clinical trials for ALMB-0166, a first-in-class humanized monoclonal antibody inhibitor targeting the novel target Connexin43 (Cx43), aimed at treating Parkinson's disease [1][2]. Group 1: Product Development - ALMB-0166 is developed by the company's subsidiary, AlaMab Therapeutics Inc., and is intended for treating neurological diseases such as Parkinson's disease, acute ischemic stroke, and acute spinal cord injury [1]. - The company is committed to advancing clinical research for ALMB-0166 across various indications, aiming for its swift market launch [3]. Group 2: Parkinson's Disease Context - Parkinson's disease is the second most common neurodegenerative disease globally, characterized by the progressive degeneration of dopamine neurons in the substantia nigra and the formation of Lewy bodies [2]. - Current treatments, primarily centered around levodopa, only alleviate symptoms without reversing disease progression or achieving a cure, highlighting the urgent need for new therapeutic options [2]. - ALMB-0166 targets Cx43 hemichannels to inhibit the release and spread of neuroinflammatory factors, thereby maximizing neuroprotection [2]. - Preclinical studies in subacute and chronic Parkinson's disease animal models have shown that ALMB-0166 significantly inhibits the reduction of dopamine levels in the brain and restores behavioral and functional capabilities, demonstrating a favorable dose/effect relationship [2].
石药集团(01093):ALMB-0166在中国获临床试验批准用于治疗帕金森氏症
智通财经网· 2025-09-15 10:32
Core Viewpoint - The approval of ALMB-0166 for Phase II clinical trials in China represents a significant advancement in the treatment of Parkinson's disease, addressing a critical need for new therapies in this area [1][2]. Group 1: Company Developments - The company, Shiyao Group, has announced that its developed drug ALMB-0166 has received approval from the National Medical Products Administration of China to conduct Phase II clinical trials for evaluating its efficacy in patients with Parkinson's disease [1]. - ALMB-0166 is a first-in-class humanized monoclonal antibody inhibitor targeting the novel target Connexin 43 (Cx43), developed by the company's subsidiary, AlaMab Therapeutics Inc. [1]. - The company is committed to advancing the clinical research of ALMB-0166 across various indications, aiming for its swift market launch [3]. Group 2: Industry Context - Parkinson's disease is the second most common neurodegenerative disease globally, characterized by the progressive degeneration of dopamine neurons in the substantia nigra and the formation of Lewy bodies [2]. - Current treatments, primarily based on levodopa, only alleviate symptoms without reversing disease progression or achieving a cure, highlighting the urgent need for new therapeutic options [2]. - ALMB-0166 targets Cx43 hemichannels to inhibit the release and spread of neuroinflammatory factors, maximizing neuroprotection, and preclinical studies have shown significant efficacy in preserving dopamine levels and restoring behavioral functions in animal models [2].
石药集团(01093) - 自愿公告 - ALMB -0166在中国获临床试验批准用於治疗帕金森氏症
2025-09-15 10:26
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 主席 ALMB -0166為一款同類首創( First-in-class )針對全新靶點半通道膜蛋白Connexin 43 (Cx43)的 人源化單克隆抗體抑制劑,由本公司附屬公司AlaMab Therapeutics Inc.自主研發,用於治療 帕金森氏症、急性缺血性腦卒中、急性脊髓損傷等神經系統疾病。 帕金森氏症是全球第二大神經退行性疾病,以黑質多巴胺神經元進行性退變和路易小體形 成為主要病理特徵。帕金森氏症的病因迄今尚未完全明確,臨床表現以靜止性震顫、肌強 直、動作遲緩、姿勢平衡障礙的運動症狀和睡眠障礙、認知和精神障礙等非運動症狀為顯 著特徵。其運動和非運動症狀會隨疾病進展逐漸加重,嚴重影響患者的生活質量,並給家 庭和社會帶來沉重的經濟與 ...
港股石药集团涨超3%
Mei Ri Jing Ji Xin Wen· 2025-09-15 02:44
每经AI快讯,石药集团(01093.HK)涨超3%,截至发稿,涨2.32%,报10.58港元,成交额5.26亿港元。 (文章来源:每日经济新闻) ...
石药集团涨超3% SYH2066片在中国获临床试验批准
Zhi Tong Cai Jing· 2025-09-15 02:26
石药集团(01093)涨超3%,截至发稿,涨2.32%,报10.58港元,成交额5.26亿港元。 该产品为集团自主研发的化学1类新药,是一款作用于呼吸道合胞病毒(RSV)的新型口服小分子候选药 物。本次获批的适应症为用于治疗由RSV引起的呼吸道感染(该疾病)。临床前研究表明,该产品具备良 好的口服生物利用度等药代动力学性质,并在疾病动物模型中能显著降低RSV病毒滴度,且安全性较 高。 目前,国内外尚无靶向RSV的小分子药物上市。该产品有望成为针对该疾病的有效治疗药物,具有较高 的临床开发价值。 消息面上,9月12日,石药集团发布公告,集团开发的SYH2066片(该产品)已于2025年9月获中华人民共 和国国家药品监督管理局批准,可在中国开展临床试验。 ...