CSPC PHARMA(01093)
Search documents
石药集团(01093):罗哌卡因长效注射液(SYH9089注射液)在中国获临床试验批准
智通财经网· 2026-02-16 05:39
智通财经APP讯,石药集团(01093)发布公告,集团开发的罗哌卡因长效注射液(SYH9089注射液)(该产 品)已获得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。 该产品可通过抑制神经细胞钠离子通道,阻断钠离子流入神经纤维细胞膜内,从而对沿神经纤维的衝动 传导产生可逆性的阻滞;亦能降低给药频率,满足临床术后的持续镇痛需求,减少患者对阿片类药物的 依赖,避免持续镇痛装置感染或移位风险,从而显著提高治疗依从性及用药安全性。依托集团的长效药 物递送技术平台,该产品可将单次给药镇痛持续时间延长至一周,有望成为中国首款镇痛持续时间达到 一周的超长效镇痛产品。 临床前研究显示,该产品未见全身系统毒性或新增毒性靶器官,与市售罗哌卡因注射液相比展现出显著 的长效镇痛优势,具有良好的安全性和有效性。 本次获批的临床适应症为术后镇痛。该产品临床试验的获批,有望填补超长效术后镇痛领域迫切的临床 需求,是集团在中枢神经领域的重要成果。 ...
石药集团(01093):GLP -1/GIP受体双偏向性激动多肽长效注射液在美国获临床试验批准
智通财经网· 2026-02-16 05:39
SYH2082可选择性激活cAMP通路,降低β-arrestin募集,从而减少受体内吞及脱敏,提升药效并延长作 用持续时间。同时,SYH2082结合长半衰期修饰平台技术和长效制剂平台技术,旨在实现给药间隔内的 持续减重。在临床前研究中,SYH2082在长效减重及维持方面较同类上市产品表现出更优的疗效,且支 持每月一次的用药方案。在毒理学研究中,SYH2082的耐受性良好,未观察到显著不良反应。 本次获批的临床适应症为肥胖或超重合并至少一种体重相关合并症人群的体重管理。此外,SYH2082亦 具备改善成人2型糖尿病(T2DM)患者的血糖控制的潜力,带来额外临床获益。本次临床试验的获批,是 本集团在代谢领域创新长效产品布局的重要成果,为未来更多创新产品的开发奠定坚实基础。 智通财经APP讯,石药集团(01093)发布公告,本集团开发的GLP-1/GIP受体双偏向性激动多肽长效注射 液(SYH2082注射液)已获得美国食品药品监督管理局(FDA)批准,可在美国开展临床试验。 SYH2082有望成为临床开发阶段具领先潜力的长效GLP-1/GIP受体双重偏向性激动剂,每月给药一次。 依托本集团的长效制剂技术平台,SYH ...
石药集团(01093) - 自愿公告 - GLP-1/GIP受体双偏向性激动多肽长效注射液(SYH2...
2026-02-16 05:34
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) 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。 – 1 – 本 次 獲 批 的 臨 床 適 應 症 為 肥 胖 或 超 重 合 併 至 少 一 種 體 重 相 關 合 併 症 人 群 的 體 重 管 理 。 此 外,SYH2082亦具備改善成人2型糖尿病( T2DM )患者的血糖控制的潛力,帶來額外臨床獲 益。本次臨床試驗的獲批,是本集團在代謝領域創新長效產品佈局的重要成果,為未來更 多創新產品的開發奠定堅實基礎。 承董事會命 石藥集團有限公司 主席 蔡東晨 香港,2026年2月16日 自願公告 GLP -1 / GIP受體雙偏向性激動多肽長效注射液(SYH2082注射液) 在美國獲臨床試驗批准 石 藥 集 團 有 限 公 司(「 本 公 司 」, 連 同 其 附 屬 公 司 統 稱「 本 集 團 ...
石药集团(01093) - 自愿公告 - 罗哌卡因长效注射液(SYH9089注射液)在中国获临床试验...
2026-02-16 05:32
CSPC PHARMACEUTICAL GROUP LIMITED 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。 (股份代號:1093) (於香港註冊成立之有限公司) 承董事會命 石藥集團有限公司 自願公告 羅哌卡因長效注射液(SYH 9089注射液) 在中國獲臨床試驗批准 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,本集團開發的羅哌卡因長效注射液( SYH 9089注射液 )(「該產品」)已獲得中華人民共和 國國家藥品監督管理局批准,可在中國開展臨床試驗。 該產品可通過抑制神經細胞鈉離子通道,阻斷鈉離子流入神經纖維細胞膜內,從而對沿神 經 纖 維 的 衝 動 傳 導 產 生 可 逆 性 的 阻 滯 ; 亦 能 降 低 給 藥 頻 率 , 滿 足 臨 床 術 後 的 持 續 鎮 痛 需 求,減少患者對阿片類藥物的依賴,避免持續鎮痛裝置感染 ...
中国创新药对外授权年交易额突破千亿美元,4年增长近10倍
YOUNG财经 漾财经· 2026-02-14 09:10
Core Insights - The annual transaction value of China's innovative drug licensing has surpassed $100 billion, marking a nearly tenfold increase over four years, with a total of $137.7 billion in licensing deals signed in 2025 [2] - Major global pharmaceutical companies, including Novartis, AstraZeneca, and GSK, have signed significant agreements with Chinese firms, indicating a strong interest in China's next-generation innovative drug development pipelines [3] - The average transaction size for licensing deals involving Chinese biopharmaceutical companies has significantly increased this year, with an average deal size of $1.3 billion, a 76% increase from 2025 and six times the average size in 2021 [4] Group 1 - In 2025, there were 186 licensing transactions involving Chinese companies, reflecting a growing trend in the biopharmaceutical sector [2] - The average upfront payment for licensing deals this year is $77.7 million, double that of 2025 and three times the average in 2021 [4] - Notable recent agreements include a strategic partnership between Innovent Biologics and Eli Lilly worth $8.85 billion, and a potential $18.5 billion collaboration between AstraZeneca and CSPC Pharmaceutical Group [4] Group 2 - Macquarie Capital predicts that oncology drugs will continue to attract global pharmaceutical companies, highlighting China's strong capabilities in chemical drug development [5] - Multinational companies are increasingly viewing China as a critical part of their global R&D infrastructure, especially as they face patent cliffs and seek to reduce costs [5] - Vision Lifesciences reports that China leads the world in specific molecular types, with Chinese companies accounting for nearly 90% of global licensing transactions for antibody-drug conjugates (ADCs) [5]
中国创新药对外授权年交易额突破千亿美元,4年增长近10倍
Di Yi Cai Jing· 2026-02-14 06:37
Core Insights - Many multinational companies are increasingly viewing China as a crucial part of their global R&D infrastructure, especially as they face patent cliffs and seek to cut costs [1][4] - The value of licensing agreements for new drugs from Chinese biopharmaceutical companies is expected to reach a historic high of over $100 billion by 2025, with a total of $137.7 billion in licensing deals signed in 2025, nearly a tenfold increase from 2021 [1][4] Group 1 - Global pharmaceutical giants, including Novartis, AstraZeneca, and GSK, signed multiple significant agreements with Chinese companies last year [3] - Tom Barsha, head of Asia-Pacific M&A at Bank of America Securities, predicts that the total value of these licensing deals could double again in the next 18 to 24 months, as global companies focus on finding next-generation innovative drug pipelines in China [3] - There have been nearly 40 licensing transactions involving Chinese biopharmaceutical companies this year, with average deal sizes significantly higher than last year [3] Group 2 - The average deal size for licensing agreements from Chinese pharmaceutical companies this year has reached $1.3 billion, a 76% increase from 2025 levels and approximately six times the average from 2021 [4] - The average upfront payment this year is $77.7 million, doubling from $38.8 million in 2025 and tripling from the average in 2021 [4] - Macquarie Capital's Asia healthcare research department predicts that a class of drugs considered foundational for cancer treatment will continue to attract global pharmaceutical interest [4] Group 3 - Many multinational companies are recognizing China's strength in chemical fields, allowing them to obtain promising molecular licenses at lower costs compared to internal R&D [4] - Vision Lifesciences' report highlights that China is a world leader in specific molecular types, with Chinese companies accounting for nearly 90% of global licensing deals for antibody-drug conjugates (ADCs) [4]
大健康风向标〡跨越千亿美元门槛:中国分子站在全球化起点
Jing Ji Guan Cha Wang· 2026-02-13 07:06
Core Viewpoint - The keyword for the stock market in 2025 is expected to be "innovative drugs," with significant stock price increases driven by the potential of in-development innovative drugs and BD (business development) transactions rather than traditional revenue from already marketed drugs [1] Group 1: BD Transactions - In 2025, China's innovative drug BD transaction total exceeded $100 billion, with notable orders reaching $10 billion, and upfront payments from multinational pharmaceutical companies reaching a new high of $1.25 billion [1] - Landmark transactions include a $13 billion collaboration between Qihuang Dejian and Biohaven/AimedBio in January, marking a milestone for China's ADC technology [2] - In May, 3SBio's deal with Pfizer exceeded $6 billion, setting a record for upfront payments in China at $1.25 billion, highlighting the value of both first-in-class and fast-follow drugs [2] - In July, a $12 billion strategic partnership between Hengrui Medicine and GlaxoSmithKline showcased the depth of early-stage pipelines in leading Chinese pharmaceutical companies [2] - In October, Innovent Biologics and Takeda's collaboration worth $11.4 billion included a cost-sharing model for global R&D, enhancing operational capabilities for future international ventures [2] Group 2: Milestone Payments and Emerging Fields - Several past BD transactions reached milestone payments in 2025, including a $300 million payment to China National Pharmaceutical's subsidiary from Merck and a $250 million payment to Bairui Tianheng from Bristol-Myers Squibb [3] - The focus of BD transactions is shifting from oncology to other therapeutic areas, with autoimmune diseases, metabolism, and central nervous system disorders emerging as new hot fields [3] - Notable deals include the global rights licensing of BTK inhibitor Orelabrutinib for multiple sclerosis by Nocera Biopharma, with a potential total transaction value exceeding $2 billion [3] - The metabolic field is gaining traction, driven by global weight loss trends, with several companies entering into licensing agreements for GLP-1 targeted drugs [3] Group 3: Independent Clinical Trials and Regulatory Approvals - Numerous innovative drug companies in China are advancing their own overseas clinical trials, achieving significant progress [4] - In early 2025, Dize Pharmaceutical's lung cancer targeted drug received priority review from the FDA and was approved in July, becoming the first globally innovative drug independently developed in China to gain approval in the U.S. [4] - Other advancements include breakthrough therapy designations for CS0159 by Kexi Kedi and a Phase III trial approval for a recombinant human albumin injection by Heyuan Biopharma [4] - These developments indicate that the Chinese innovative drug industry is becoming a significant force in global innovation, transitioning from fast-following to original innovation and integrating deeply into the global value chain [4]
港股创新药概念股走低,相关ETF跌超2%
Sou Hu Cai Jing· 2026-02-12 03:16
Group 1 - The Hong Kong innovative drug concept stocks have declined, with companies such as 3SBio, Kelun-Botai Biopharmaceuticals falling over 3%, and CSPC Pharmaceutical Group, China Biologic Products, and Hansoh Pharmaceutical dropping over 2% [1] - The Hong Kong innovative drug-related ETFs have also seen a decline of over 2% [1] Group 2 - Current analysis indicates that the healthcare sector presents multiple investment opportunities, with the CXO industry experiencing sustained improvement due to a recovery in overseas orders and domestic capacity reduction, while still having room for valuation recovery [2] - The medical device sector is benefiting from domestic equipment upgrade policies and overseas market expansion, with continuous catalysts in cutting-edge areas such as brain-computer interfaces and AI imaging [2] - Internet healthcare is seeing improved operational efficiency in the context of deepening medical insurance payment reforms, leading to a clearer profit growth trajectory [2]
港股红利ETF工银(159691)已连续3日遭遇资金净赎回,区间净流出额6916.43万元
Xin Lang Cai Jing· 2026-02-11 03:12
Core Viewpoint - The Hong Kong Dividend ETF (工银, 159691) has experienced significant net redemptions recently, indicating potential investor concerns or shifts in market sentiment [1][2]. Group 1: Fund Performance - As of February 10, the latest scale of the Hong Kong Dividend ETF (工银, 159691) is 8.78 billion yuan, with a net outflow of 27.79 million yuan on that day, representing 0.32% of the previous day's scale [1]. - Over the past five days, the fund has seen net redemptions totaling 70.53 million yuan, ranking 11th out of 215 in cross-border ETF net outflows [1]. - Year-to-date, the fund's shares have decreased by 4.58%, while its scale has increased by 4.09% compared to the end of 2025 [2]. Group 2: Trading Activity - The cumulative trading amount for the Hong Kong Dividend ETF (工银, 159691) over the last 20 trading days is 7.123 billion yuan, with an average daily trading amount of 356 million yuan [2]. - Since the beginning of the year, the fund has recorded a cumulative trading amount of 9.096 billion yuan over 27 trading days, averaging 337 million yuan per day [2]. Group 3: Fund Holdings - The top holdings of the Hong Kong Dividend ETF (工银, 159691) include China National Offshore Oil Corporation (14.55%), China Shenhua Energy Company (9.65%), and China Pacific Insurance (8.90%), among others [3]. - The fund's significant holdings reflect a diversified investment strategy focused on high-dividend stocks within the Hong Kong market [3].
机构观点 | A股缩量盘整 Seedance概念掀涨停潮
Shang Hai Zheng Quan Bao· 2026-02-10 18:12
Group 1 - Seedance2.0 is expected to be a pivotal moment for AI in the film industry, particularly in the production of AI comics and short dramas, leading to significant cost reductions and efficiency improvements in content creation [2] - The release of Seedance2.0 has sparked widespread evaluation and discussion within the industry, showcasing impressive capabilities in multi-modal thinking and video generation from various input types [2] - The film and television sector saw a substantial increase, with the film industry index rising by 13.83%, significantly outperforming other sectors, driven by the excitement around AI applications [2] Group 2 - The innovative pharmaceutical sector is experiencing a resurgence, with notable stock price increases among companies such as Wanbangde and Guangshengtang, indicating renewed investor interest [3] - The National Medical Products Administration announced that by 2025, China's pharmaceutical industry will accelerate its internationalization, with cumulative overseas licensing transactions for innovative drugs expected to exceed $130 billion [3] - A strategic cooperation agreement between Shiyao Group and AstraZeneca could yield up to $18.5 billion, marking a significant milestone in the company's business development transactions [3] Group 3 - Emerging technologies remain a key focus for the market, with a recommendation to concentrate on sectors benefiting from AI applications and international expansion [4] - The recent volatility in the Chinese stock market is attributed to global financial tightening concerns and pre-holiday cautious sentiment, but there is optimism regarding the domestic economic outlook [4] - The semiconductor sales growth is projected to accelerate, with high demand for domestic chips and related industries expected to continue through 2026 [4][5]