CSPC PHARMA(01093)
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石药集团(01093):司库奇尤单抗注射液III期临床试验获得顶线分析数据
智通财经网· 2025-12-18 10:20
Core Viewpoint - The company announced that its subsidiary, Stone Pharma Biotech Co., Ltd., has achieved positive topline analysis data from a Phase III clinical trial for its drug, Secukinumab Injection, aimed at treating moderate to severe plaque psoriasis [1][2] Group 1: Product Development - Secukinumab Injection is a fully human IgG1 monoclonal antibody that specifically binds to IL-17A, a key molecule in the pathogenesis of psoriasis, thereby inhibiting inflammatory signals [1] - The product is a biosimilar to Cosentyx® (Secukinumab), which has been approved in China for multiple indications including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa [1] Group 2: Clinical Trial Details - The clinical trial was a multicenter, randomized, double-blind, parallel, positive-controlled equivalence study designed to verify the consistency of efficacy between Secukinumab Injection and Cosentyx® in treating moderate to severe plaque psoriasis [2] - The study enrolled patients with moderate to severe plaque psoriasis, randomly assigning them in a 1:1 ratio to either the trial group (Secukinumab Injection) or the control group (Cosentyx®) [2] - The primary endpoint was the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI-75) score from baseline at week 12, which the study successfully met [2] Group 3: Safety and Future Plans - The study demonstrated clinical equivalence between the two products, with good safety profiles and no new or unexpected safety signals, indicating potential for long-term safety in patients [2] - Detailed data from the study will be presented at upcoming academic conferences and published in journals [2]
石药集团(01093.HK):司库奇尤单抗注射液III期临床试验获得顶线分析数据
Ge Long Hui· 2025-12-18 10:20
Core Viewpoint - The company announced that its subsidiary, Stone Pharma, has achieved positive topline results in a Phase III clinical trial for its biosimilar drug, Secukinumab injection, aimed at treating moderate to severe plaque psoriasis [1][2] Group 1: Product Development and Clinical Trials - The product, Secukinumab injection, is a fully human IgG1 monoclonal antibody that specifically binds to IL-17A, a key molecule in the pathogenesis of psoriasis [1] - The Phase III clinical trial was a multicenter, randomized, double-blind, parallel, positive-controlled equivalence study designed to verify the consistency of efficacy between the product and Cosentyx in treating moderate to severe plaque psoriasis patients [2] - The primary endpoint of the study was the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI-75) score from baseline at week 12, which the study successfully met [2] Group 2: Market Context and Patient Impact - There are over 7 million psoriasis patients in China, highlighting a significant market opportunity for effective treatments [1] - The safety profile of the product was found to be good, with no new or unexpected safety signals, indicating it may meet the long-term safety needs of patients [2] - The detailed data from the study will be published in upcoming academic conferences and journals, which may further validate the product's efficacy and safety [2]
石药集团(01093) - 自愿公告 - 司库奇尤单抗注射液III期临床试验获得顶线分析数据
2025-12-18 10:15
該產品是本集團開發的全人源Ig G1單克隆抗體藥物,為司庫奇尤單抗注射液( 可善挺® )的 生物類似藥。可善挺®在中國獲批的適應症包括6歲及以上斑塊狀銀屑病、銀屑病關節炎、 強直性脊柱炎及化膿性汗腺炎,其療效與安全性已獲得廣泛認可。 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 司庫奇尤單抗注射液III期臨床試驗獲得頂線分析數據 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 公 司 附 屬 公 司 石 藥 集 團 巨 石 生 物 製 藥 有 限 公 司 開 發 的 司 庫 奇 尤 單 抗 注 射 液(「 該 產 品」)在用於治療中度至重度斑塊狀銀屑病的等效性III期臨床試驗中獲得頂線分析數據。 銀 屑 病 是 一 種 免 疫 相 關 的 慢 性 、 炎 症 性 、 系 統 性 疾 病 。 目 前 , 中 國 約 有 超 700 萬 銀 屑 病 患 者。全人源白介素(IL) -1 ...
港股收盘(12.18) | 恒指收涨0.12% 航空股再度走强 煤炭、石油股活跃
智通财经网· 2025-12-18 08:55
Market Overview - The Hong Kong stock market showed mixed performance, with the Hang Seng Index closing up 0.12% at 25,498.13 points, while the Hang Seng Tech Index fell 0.73% to 5,418.29 points. The total trading volume was HKD 162.38 billion [1] - Huatai Securities noted that the market's downside is manageable, but the upside potential remains limited. Market sentiment indicators are still in a pessimistic range, indicating a bottoming phase [1] Blue-Chip Stocks Performance - Hang Lung Properties (00101) led the blue-chip decline, falling 2.91% to HKD 8.68, contributing to a 0.74-point drop in the Hang Seng Index. The company announced the retirement of CEO Lu Weibao by August 31, 2026 [2] - Other notable blue-chip movements included CSPC Pharmaceutical (01093) rising 6.52% to HKD 8.01, contributing 6.31 points to the index, and Sinopec (00386) increasing 3.37% to HKD 4.6, adding 5.49 points [2] Sector Highlights - The aviation sector saw significant gains, with China Eastern Airlines (00670) up 8.08% to HKD 5.35, driven by improved passenger load factors and ticket prices. The overall industry supply-demand relationship is favorable [3][4] - Coal stocks generally rose, with China Shenhua (01088) increasing 2.29% to HKD 39.34, supported by new government guidelines tightening coal consumption standards [4][5] - Pharmaceutical stocks were active, with CSPC Pharmaceutical (01093) up 6.52% and CanSino Biologics (09966) rising 4.3% after receiving breakthrough therapy designation from the FDA for a new treatment [5][11] Notable Stock Movements - MicroPort Scientific (00853) surged 7.5% to HKD 10.9 following the approval of a strategic merger aimed at enhancing its capabilities in cardiac care [8] - Zhaojin Mining (01818) rose 6.21% to HKD 31.12, benefiting from the discovery of a significant underwater gold mine in Shandong province [9] - CICC (03908) resumed trading with a 2.53% increase to HKD 19.44, following its merger with Dongxing Securities and Xinda Securities, which is expected to significantly boost its asset scale [10]
港股收盘 | 恒指收涨0.12% 航空股再度走强 煤炭、石油股活跃
Zhi Tong Cai Jing· 2025-12-18 08:52
Market Overview - The Hong Kong stock market showed mixed performance, with the Hang Seng Index closing up 0.12% at 25,498.13 points, while the Hang Seng Tech Index fell 0.73% to 5,418.29 points. The total trading volume was HKD 162.38 billion [1] - Huatai Securities noted that the market's downside is manageable, but the upside potential remains limited. Market sentiment indicators are still in a pessimistic range, indicating a bottoming phase similar to November 2024 [1] Blue-Chip Stocks Performance - Hang Lung Properties (00101) led the blue-chip decline, falling 2.91% to HKD 8.68, contributing to a 0.74-point drop in the Hang Seng Index. The company announced the retirement of CEO Richard Lu by August 31, 2026 [2] - Other notable blue-chip movements included CSPC Pharmaceutical (01093) rising 6.52% to HKD 8.01, contributing 6.31 points to the index, and Sinopec (00386) increasing 3.37% to HKD 4.6, adding 5.49 points [2] Sector Highlights - The aviation sector saw significant gains, with China Eastern Airlines (00670) up 8.08% to HKD 5.35, driven by improved passenger load factors and ticket prices. The overall industry supply-demand relationship is favorable [3][4] - Coal stocks generally rose, with China Shenhua (01088) increasing 2.29% to HKD 39.34, supported by new government guidelines tightening coal consumption standards [4][5] - Pharmaceutical stocks were active, with CSPC Pharmaceutical (01093) up 6.52% and CanSino Biologics (09966) rising 4.3% after receiving breakthrough therapy designation from the FDA for a new treatment [5][11] Notable Stock Movements - MicroPort Scientific (00853) surged 7.5% to HKD 10.9 following the approval of a strategic merger with its subsidiary [8] - Zhaojin Mining (01818) rose 6.21% to HKD 31.12, benefiting from the discovery of a significant underwater gold mine in Shandong [9] - CICC (03908) resumed trading with a 2.53% increase to HKD 19.44 after announcing a merger with Dongxing Securities and Xinda Securities, expected to enhance its asset scale significantly [10]
港股止跌,整个早盘都维持在中轴附近窄幅盘整





Ge Long Hui· 2025-12-18 04:56
Group 1 - The Hong Kong stock market has stabilized, maintaining a narrow range around the mid-axis during the morning session, with slight gains in consumer and technology sectors, while the internet and healthcare sectors experienced a downturn [1] - The consumer sector showed signs of recovery, with a slight increase of 0.32% by midday, driven by stocks such as Li Ning up 4.37%, Shenzhou International up 2.26%, and several others like Stone Pharmaceutical, Lao Pu Gold, WuXi Biologics, and Pop Mart all rising over 1% [3] - The technology sector also saw a minor increase of 0.14% by midday, with Meituan up 1.21%, while major players like JD Group, Alibaba, Tencent Holdings, and SMIC posted slight gains; however, BYD and NetEase faced minor declines [3] Group 2 - The healthcare sector had a lackluster performance, with Stone Pharmaceutical up 1.9% and WuXi Biologics up 1.68%, while other stocks like BeiGene, Innovent Biologics, and 3SBio saw slight increases; in contrast, companies like CanSino Biologics, China Biologic Products, JD Health, and Hansoh Pharmaceutical experienced minor declines [3]
石药集团早盘涨近5% 旗下石药创新拟在香港主板上市 融资支持创新药业务发展
Zhi Tong Cai Jing· 2025-12-18 03:16
石药集团(01093)早盘涨近5%,截至发稿,涨4.79%,报7.88港元,成交额3.96亿港元。 消息面上,12月10日,石药创新首次向港交所递交招股书,拟在香港主板上市。公开资料显示,石药创 新由石药集团分拆而来,已于2019年3月在A股上市,A股简称为新诺威(300765)。若此次港股上市成 功,石药创新将成为又一家"A+H"两地上市的医药企业。 公开资料显示,2023年,石药创新完成企业名称变更,由新诺威正式更名为石药创新。次年又掏出 18.71亿元以增资方式完成对其"兄弟公司"巨石生物51%股权的收购,成为该公司的控股股东,正式将业 务链实质性延伸至生物创新药领域。此次石药创新赴港上市旨在通过外部融资减缓资金压力,支撑创新 药业务发展。 ...
港股异动 | 石药集团(01093)早盘涨近5% 旗下石药创新拟在香港主板上市 融资支持创新药业务发展
智通财经网· 2025-12-18 03:13
公开资料显示,2023年,石药创新完成企业名称变更,由新诺威正式更名为石药创新。次年又掏出 18.71亿元以增资方式完成对其"兄弟公司"巨石生物51%股权的收购,成为该公司的控股股东,正式将业 务链实质性延伸至生物创新药领域。此次石药创新赴港上市旨在通过外部融资减缓资金压力,支撑创新 药业务发展。 消息面上,12月10日,石药创新首次向港交所递交招股书,拟在香港主板上市。公开资料显示,石药创 新由石药集团分拆而来,已于2019年3月在A股上市,A股简称为新诺威。若此次港股上市成功,石药创 新将成为又一家"A+H"两地上市的医药企业。 智通财经APP获悉,石药集团(01093)早盘涨近5%,截至发稿,涨4.79%,报7.88港元,成交额3.96亿港 元。 ...
港股异动 石药集团(01093)尾盘涨近3% 贝派度酸片临床申请获受理 入局全新“非他汀类”降脂药
Jin Rong Jie· 2025-12-17 09:15
Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) has seen an increase of nearly 3% towards the end of trading, currently up by 2.04% at HKD 7.51, with a trading volume of HKD 408 million [1] Group 1: Clinical Application Approval - CSPC Pharmaceutical's wholly-owned subsidiary, CSPC Ouyi Pharmaceutical Co., Ltd., has had its clinical application for Beipiduo Acid Tablets accepted by the China National Medical Products Administration (CDE) [1] - Beipiduo Acid is an ATP-citrate lyase inhibitor primarily used to lower low-density lipoprotein cholesterol (LDL-C) in adult patients who cannot tolerate statin therapy, reducing the risk of myocardial infarction and coronary artery revascularization [1] Group 2: Market Potential - Beipiduo Acid was first approved for market in the United States by the FDA in 2020 [1] - Market analysts estimate that Beipiduo Acid Tablets could capture up to 25% of the cholesterol medication market, with peak sales expected to reach between USD 2 billion to USD 3 billion [1] - Currently, no original or generic versions of Beipiduo Acid Tablets have been launched in the domestic market, with four companies, including CSPC Ouyi Pharmaceutical, having their clinical applications accepted, indicating the start of a competition for the first generic [1]
港股异动 | 石药集团(01093)尾盘涨近3% 贝派度酸片临床申请获受理 入局全新“非他汀类”降脂药
智通财经网· 2025-12-17 08:12
Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose nearly 3% towards the end of trading, with a current increase of 2.04%, priced at HKD 7.51, and a trading volume of HKD 408 million [1] Group 1: Clinical Application Approval - CSPC Pharmaceutical's wholly-owned subsidiary, CSPC Ouyi Pharmaceutical Co., Ltd., has had its clinical application for Beipaidu Acid Tablets accepted by the China National Medical Products Administration (NMPA) [1] - Beipaidu Acid is an ATP-citrate lyase inhibitor used to lower low-density lipoprotein cholesterol (LDL-C) in adult patients who cannot tolerate statin therapy, reducing the risk of myocardial infarction and coronary artery revascularization [1] Group 2: Market Potential - Beipaidu Acid was first approved by the FDA in the United States in 2020, and market analysts estimate that it could capture up to 25% of the cholesterol medication market, with peak sales expected to reach between USD 2 billion to USD 3 billion [1] - Currently, no original or generic versions of Beipaidu Acid Tablets have been launched in the domestic market, with four companies, including CSPC Ouyi Pharmaceutical, having their clinical applications accepted, indicating the start of a first-to-market competition [1]