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石药集团(01093):达雷妥尤单抗注射液在中国获临床试验批准
智通财经网· 2025-12-23 10:20
Core Viewpoint - The approval of Daratumumab injection by the National Medical Products Administration of China marks a significant advancement for the company in the field of targeted therapies for multiple myeloma [1] Group 1: Product Development - The product is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38) [1] - It is a biosimilar to the original drug, Darzalex, and has been filed under Class 3.3 for therapeutic biological products [1] - The development of the product adheres to the relevant guidelines for biosimilar research, demonstrating high similarity in quality, safety, and efficacy compared to the reference drug [1] Group 2: Clinical Trials - The approval allows the company to initiate clinical trials in China for the treatment of adult patients with multiple myeloma [1] - The results from pharmaceutical and non-clinical studies support the continuation of subsequent clinical research [1]
石药集团(01093.HK):达雷妥尤单抗注射液在中国获临床试验批准
Ge Long Hui· 2025-12-23 10:15
Core Viewpoint - The company, Stone Pharmaceutical Group, has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials for its drug, Daratumumab injection [1] Group 1: Product Development - The product is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38) [1] - It is a biosimilar to the original drug, Darzalex, and is classified under Category 3.3 for therapeutic biological products [1] - The drug is intended for the treatment of adult patients with multiple myeloma [1] Group 2: Research and Compliance - The development of the product adheres to the relevant research guidelines for biosimilars [1] - Pharmaceutical and non-clinical research results indicate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting further clinical research [1]
石药集团(01093) - 自愿公告 - 达雷妥尤单抗注射液在中国获临床试验批准
2025-12-23 10:12
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 自願公告 達雷妥尤單抗注射液 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 布,本集團開發的達雷妥尤單抗注射液(「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。 該 產 品 是 一 種 靶 向 ADP - 核 糖 基 環 化 酶 (CD38) 的 重 組 全 人 源 Ig G1 單 克 隆 抗 體 , 為 原 研 藥 兆 珂®的生物類似藥,按照治療用生物製品3.3類申報,適用於治療多發性骨髓瘤成年患者。 該產品研發遵循生物類似藥相關研究指導原則,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。 ...
從認購證單日漲19%說起:如何利用衍生工具參與石藥短期行情
Ge Long Hui· 2025-12-23 04:53
Core Viewpoint - The article discusses the recent performance and market outlook of CSPC Pharmaceutical Group (01093), highlighting the divergence in institutional views regarding the company's short-term operational challenges and long-term business development (BD) potential [4][5]. Technical Analysis - CSPC's stock price recently recovered above the 10-day moving average (approximately 7.75 HKD) and stabilized above the 30-day moving average (approximately 7.74 HKD), indicating a strengthening short-term momentum [1]. - The Relative Strength Index (RSI) has reached 61, suggesting overbought pressure, which may lead to a technical correction to digest profit-taking and build new momentum [1]. - The stock is facing a key resistance level at 8.49 HKD; a successful breakout could target 9.03 HKD, while support is at 7.79 HKD, with a critical level at 7.47 HKD [1]. Market Perspectives - There is a significant divergence in market opinions regarding CSPC's future, with optimistic views focusing on the company's sustainable growth drivers through BD transactions [4]. - UBS raised its target price to 10 HKD, citing untapped potential in BD transactions and effective sales expense control [4]. - Conversely, Daiwa downgraded CSPC from "Hold" to "Sell," arguing that the stock price reflects optimistic expectations for BD transactions while the core pharmaceutical sales face growth pressures [5]. Derivative Instruments - In light of the stock's critical resistance levels and market divergence, warrants and bull/bear certificates offer investors flexible tools to respond to short-term volatility without large direct stock purchases [6]. - Recent performance of derivative products shows that when CSPC's stock rose by 3.00% over two trading days, linked warrants experienced price increases of 19%, 14%, and 12% respectively, demonstrating the leverage effect of these instruments [6]. Product Selection Guidance - Investors optimistic about breaking the 8.49 HKD resistance may consider higher strike price warrants, such as those from Morgan Stanley and Société Générale, which offer relatively high leverage [9]. - For those anticipating a potential pullback, Société Générale's bear certificate with a redemption price set at 9.5 HKD provides a higher leverage option for bearish strategies [9].
ETF盘中资讯 | 港股通创新药回暖,100%创新药研发标的“520880”摸高1.53%!石药集团领涨,创新药龙头集体跟进
Jin Rong Jie· 2025-12-23 02:50
Core Viewpoint - The Hong Kong Stock Connect innovative drug sector is experiencing a rebound, with significant trading activity and price increases among leading innovative drug companies, indicating a positive shift in market sentiment towards this sector [1][3]. Group 1: Market Performance - The Hong Kong Stock Connect innovative drug ETF (520880) reached a peak increase of 1.53% and traded over 140 million yuan during the session [1]. - Leading companies in the innovative drug sector, such as CSPC Pharmaceutical Group, recorded gains exceeding 5%, while others like 3SBio and Hengrui Medicine saw increases of over 2% [1]. Group 2: Investment Insights - Analysts from Zhongtai Securities noted that the current innovative drug market differs from the 2019-2021 period, as the sector is transitioning from narrative to actual performance, with trading volumes hitting new highs [1]. - Long-term support from domestic policies for innovative drugs is evident, with the introduction of commercial insurance directories enhancing payment capabilities [1][3]. - Changjiang Securities emphasized the emergence of a new policy support cycle for the pharmaceutical industry, particularly for innovative drugs, suggesting a focus on high-quality assets with strong overseas potential [3]. Group 3: ETF Characteristics - The Hong Kong Stock Connect innovative drug ETF (520880) is designed to track the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, which has three key advantages: it exclusively includes innovative drug companies, has a high concentration of leading firms, and employs risk control measures for less liquid stocks [3][4]. - The top ten holdings in the ETF account for over 72% of its weight, showcasing the dominance of leading innovative drug companies [4]. Group 4: Alternative Investment Options - For investors seeking to mitigate volatility while still focusing on innovative drugs, the only ETF in the market (562050) offers a mix of innovative and traditional Chinese medicine stocks, providing a balanced approach [4].
港股通创新药回暖,100%创新药研发标的“520880”摸高1.53%!石药集团领涨,创新药龙头集体跟进
Xin Lang Ji Jin· 2025-12-23 02:50
Core Viewpoint - The Hong Kong Stock Connect innovative drug sector is experiencing a rebound, with significant trading activity and price increases among leading innovative drug companies, indicating a shift in the market dynamics for innovative pharmaceuticals in China [1][3]. Group 1: Market Performance - On December 23, the Hong Kong Stock Connect innovative drug ETF (520880) reached a peak increase of 1.53% and recorded over 1.4 billion yuan in trading volume [1]. - Leading companies in the innovative drug sector, such as CSPC Pharmaceutical Group, saw stock price increases exceeding 5%, while others like 3SBio and Hengrui Medicine rose over 2% [1]. Group 2: Investment Insights - Analysts from Zhongtai Securities noted that the current innovative drug market differs from the 2019-2021 period, as it has transitioned from narrative to actual performance, with trading volumes hitting new highs, reflecting a leap in China's innovative capabilities [1]. - Changjiang Securities emphasized that the innovative drug sector is entering a new cycle of policy support, suggesting a focus on high-quality innovative drug assets with strong overseas potential [3]. Group 3: ETF Characteristics - The Hong Kong Stock Connect innovative drug ETF (520880) tracks the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, which has three unique advantages: it exclusively includes innovative drug companies, has a high concentration of leading firms (over 72% in the top ten), and employs measures to control risks associated with less liquid stocks [3][4]. - The ETF's current market price is close to its initial listing price, presenting a potential value opportunity for investors [3]. Group 4: Composition and Strategy - The top ten holdings of the Hong Kong Stock Connect innovative drug ETF account for 72.57% of the total weight, showcasing significant dominance by leading companies in the sector [4]. - For investors seeking to mitigate volatility while still focusing on innovative drugs, alternative ETFs that include a mix of traditional Chinese medicine and innovative drugs are available, providing a balanced investment approach [4].
石药集团涨5.5% 近4日累涨近20% 昨日获股东增持高达1.1亿港元
Jin Rong Jie· 2025-12-23 02:30
12月23日,石药集团(1093.HK)持续上涨行情,目前涨5.5%报8.7港元,近4日累计升幅近20%,总市值 重回千亿港元大关。 消息上,根据香港联交所最新披露的文件,蔡东晨于12月22日以每股均价8.1957港元增持石药集团345.4 万股普通股股份,价值约1.1亿港元。增持后,蔡东晨最新持股数目为29.1亿股股份,好仓比例由 25.14%升至25.26%。 本文源自:格隆汇 ...
石药集团(01093.HK)涨超4%
Mei Ri Jing Ji Xin Wen· 2025-12-23 02:17
每经AI快讯,石药集团(01093.HK)涨超4%,截至发稿涨4.12%,报8.59港元,成交额4.43亿港元。 ...
港股异动丨石药集团涨5.5% 近4日累涨近20% 昨日获股东增持高达1.1亿港元
Ge Long Hui· 2025-12-23 02:07
石药集团(1093.HK)持续上涨行情,目前涨5.5%报8.7港元,近4日累计升幅近20%,总市值重回千亿港元大关。消息上,根据香港联交所最新披露的文件, 蔡东晨于12月22日以每股均价8.1957港元增持石药集团345.4万股普通股股份,价值约1.1亿港元。增持后,蔡东晨最新持股数目为29.1亿股股份,好仓比例由 25.14%升至25.26%。 ...
石药集团涨超4% 获主席蔡东晨增持 SYH2085片于中国获批临床试验
Zhi Tong Cai Jing· 2025-12-23 02:01
Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) has risen over 4%, currently trading at HKD 8.59 with a transaction volume of HKD 443 million, following significant insider buying and the approval of a new drug for clinical trials [1] Group 1: Stock Performance - CSPC Pharmaceutical Group's stock increased by 4.12% to HKD 8.59 [1] - The trading volume reached HKD 443 million [1] Group 2: Insider Activity - Chairman and Executive Director Cai Dongchen purchased 13.454 million shares at HKD 8.1957 each, totaling approximately HKD 110 million [1] - Post-purchase, the total number of shares held by Cai is about 2.91 billion, representing a 25.26% ownership stake [1] Group 3: Product Development - CSPC has received approval from the National Medical Products Administration of China for its self-developed SYH2085 tablet to conduct clinical trials [1] - SYH2085 is a novel oral small molecule candidate aimed at inhibiting the RNA polymerase acidic protein (PA) endonuclease activity of the influenza virus, targeting treatment for adults and adolescents aged 12 and above with uncomplicated influenza A and B [1] - This product is expected to be an effective treatment for influenza, enhancing the company's product pipeline in the field of anti-infective therapies [1]