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又一款减重药要来了,石药GLP-1减重新药申报上市,全球多靶点竞速赛道拥挤
3 6 Ke· 2025-10-14 10:53
Core Viewpoint - Domestic pharmaceutical companies are intensifying competition in the GLP-1 market, particularly focusing on weight loss drugs, with Shijiazhuang Pharmaceutical Group making significant advancements in this area [1][2]. Group 1: Product Development and Clinical Trials - Shijiazhuang Pharmaceutical Group's subsidiary, Shijiazhuang Pharmaceutical Baike, has received regulatory acceptance for the new drug application of its innovative GLP-1 drug, Idaglutide α injection, aimed at long-term weight management in overweight or obese adults [1][2]. - The drug is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity, showing significant reductions in weight, waist circumference, blood sugar, blood pressure, and blood lipids compared to placebo [2][4]. - Idaglutide α injection is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein administered weekly, combining weight loss and blood sugar-lowering effects [1][2]. Group 2: Competitive Landscape - Idaglutide α injection is an innovative drug developed by Shijiazhuang Pharmaceutical Group, contrasting with the recently submitted application for the generic drug Semaglutide, highlighting the company's focus on original research [3][4]. - The competitive landscape includes multinational companies like Eli Lilly and Novo Nordisk, which are advancing next-generation weight loss therapies, shifting from single-target to multi-target approaches to enhance drug efficacy and safety [4][7]. - The global market for GLP-1 receptor agonists (GLP-1RA) is projected to reach $51.8 billion in 2024, with a 40% year-on-year growth, driven by significant demand in the weight loss segment [7]. Group 3: Future Prospects and Strategic Positioning - Shijiazhuang Pharmaceutical Group is also developing a long-acting GLP-1 drug, Semaglutide long-acting injection (SYH9017), which is expected to receive clinical approval for weight loss indications in December 2024 [5]. - The domestic weight loss drug market is becoming increasingly crowded, with multiple companies, including Shijiazhuang Pharmaceutical Group, submitting applications for Semaglutide, as the core patent for Novo Nordisk's Semaglutide is set to expire in 2026 [8].
小核酸药物:从罕见病到常见病,治疗范式革命前夜
Investment Rating - The report suggests a positive outlook for the oligonucleotide drug industry, indicating that it is on the verge of a therapeutic paradigm revolution, particularly in the treatment of common diseases [3]. Core Insights - The oligonucleotide drug market is approaching a critical point of explosion, with significant advancements in delivery technologies and therapeutic targets [3]. - The report highlights the potential for multiple innovative treatment paradigms for common liver diseases over the next five years, focusing on lipid-lowering, blood pressure reduction, and hepatitis B [3]. - The report emphasizes the importance of differentiated delivery technologies and the potential for business development (BD) opportunities in the industry [3]. Summary by Sections Industry Overview - The report revisits the previous assessment from January 2021, which predicted that oligonucleotide drugs would become the third major class of therapeutics after small molecules and monoclonal antibodies [3]. - It notes that the market has seen a significant increase in the number of approved siRNA/ASO drugs since 2022, addressing unmet medical needs [4]. Market Dynamics - The report identifies key players in the industry, including Alnylam, Arrowhead, and Ionis, and discusses their market capitalization changes from 2021 to 2025, highlighting Alnylam's significant growth due to successful drug launches [7]. - It mentions that the market for oligonucleotide drugs is expanding into common diseases, with Alnylam's drugs like Amvuttra and Inclisiran showing strong sales potential [20]. Technological Advancements - The report discusses advancements in delivery technologies, particularly the GalNAc conjugation platform, which has significantly improved the efficacy and safety of oligonucleotide drugs [41][42]. - It highlights the ongoing research into dual-target oligonucleotide drugs, which may become a new trend in the industry [36]. Competitive Landscape - The report outlines the competitive landscape, noting that multinational corporations (MNCs) are actively acquiring clinical-stage FIC drugs and exploring collaborations with biotech firms [3]. - It emphasizes the need for targeted delivery systems for different organs, indicating that the advancement and differentiation of delivery platforms will be crucial for the future success of oligonucleotide drug companies [26][27].
裕元集团年内综合营收超60亿美元 新城发展前三季销售额同比下滑逾5成
Xin Lang Cai Jing· 2025-10-13 13:24
Company News - Yuanshan Group (00551.HK) reported a cumulative operating income of approximately $6.017 billion for the first nine months, a decrease of 1% year-on-year [2] - Baoshan International (03813.HK) recorded a cumulative operating income of 12.903 billion yuan for the first nine months, down 7.7% year-on-year [2] - Longyuan Power (00916.HK) achieved a cumulative power generation of 56,546,706 MWh in the first nine months, a decline of 0.53% year-on-year; excluding the impact of thermal power, there was a year-on-year increase of 13.81%, with wind power up 5.30% and solar power up 77.98% [2] Financial Performance - Qinhuangdao Port Co., Ltd. (03369.HK) reported a total throughput of 317 million tons for the first nine months, an increase of 5.56% year-on-year [3] - New China Life Insurance (01336.HK) expects net profit attributable to shareholders for the first three quarters to be between 29.986 billion yuan and 34.122 billion yuan, representing a year-on-year growth of 45% to 65% [3] - Jiangshan Holdings (00295.HK) reported a total power generation of approximately 238,787 MWh for the first nine months, a decrease of 4.83% year-on-year [3] - Morning News Technology (02000.HK) reported an unaudited revenue of 270 million HKD for the first nine months, down 7.6% year-on-year [3] - Dekang Agriculture and Animal Husbandry (02419.HK) sold approximately 7.5509 million pigs in the first nine months, with sales revenue of approximately 14.277 billion yuan [3] Drug Approvals and Developments - Hengrui Medicine (01276.HK) received a clinical trial approval notice for SHR-A2102, a targeted Nectin-4 antibody-drug conjugate (ADC) developed in-house; global sales for similar products are expected to reach approximately $1.949 billion in 2024 according to EvaluatePharma [3] - Hutchison China MediTech (00013.HK) plans to announce FRUSICA-2 registration study data at the 2025 European Society for Medical Oncology annual meeting [3] - CSPC Pharmaceutical Group (01093.HK) had its new drug application for Idaglutide α injection accepted by the National Medical Products Administration [3] Corporate Actions - Huazhen Medical (01931.HK) announced the acquisition of U.S. properties and the establishment of a U.S. subsidiary, ETHK BANK, to promote stablecoins and intellectual property securitization in the U.S. [3] - Lihigh Holdings (08472.HK) plans to invest 24 million HKD in cryptocurrency and commodities [3] - Hisense Home Appliances (00921.HK) and its subsidiaries subscribed to a financial product from Jingu Trust worth 1.739 billion HKD [3] Real Estate Performance - New Town Development (01030.HK) reported cumulative contract sales of 15.050 billion yuan for the first nine months, a decrease of 52.72% year-on-year [3] - Longfor Group (00960.HK) achieved total contract sales of 50.75 billion yuan in the first nine months [3] - CIFI Holdings Group (00884.HK) reported cumulative contract sales of approximately 13.06 billion yuan for the first nine months [3] - Ronshine China Holdings (03301.HK) reported contract sales of 3 billion yuan for the first nine months, down 45.3% year-on-year [3] - Yuzhou Group (01628.HK) reported cumulative sales of 4.913 billion yuan for the first nine months [3] - Yida China (03639.HK) reported contract sales of approximately 572 million yuan for the first nine months, down 24.74% year-on-year [3] Financing and Buyback Activities - Geely Automobile (00175.HK) was approved to issue debt financing instruments totaling no more than 10 billion yuan [3] - HSBC Holdings (00005.HK) repurchased 1.58 million HKD worth of shares at prices ranging from 102.2 to 103.77 HKD [3] - Xiaomi Group-W (01810.HK) repurchased 400 million HKD worth of shares at prices ranging from 47.82 to 50.55 HKD [3] - Shoucheng Holdings (00697.HK) repurchased 890 million HKD worth of shares at prices ranging from 2.21 to 2.27 HKD [3]
石药集团:受托人根据股份奖励计划购买300万股公司股份
Zhi Tong Cai Jing· 2025-10-13 12:13
石药集团(01093)公布,于2025年10月13日,受托人根据股份奖励计划的条款及条件在市场上购买合共 300万股公司股份,并为获选参与者的利益以信托方式持有该等股份。 ...
石药集团(01093):受托人根据股份奖励计划购买300万股公司股份
智通财经网· 2025-10-13 12:10
智通财经APP讯,石药集团(01093)公布,于2025年10月13日,受托人根据股份奖励计划的条款及条件在 市场上购买合共300万股公司股份,并为获选参与者的利益以信托方式持有该等股份。 ...
石药集团(01093) - 自愿公告 - 根据本公司股份奖励计划在市场上购买股份
2025-10-13 12:00
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份內容而產 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 謹此 提述 石藥 集團 有限 公司(「本 公司」)於 2018 年8 月 20 日 有關 刊發 採納 本公 司限 制性 股份 獎勵計劃(「該計劃」)之公告(「該公告」)。誠如本公司日期為2024年5月21日之自願公告所披 露,該計劃之條款其後已作出修訂。除本公告另有界定外,本公告所用詞彙與該公告所界 定者具有相同涵義。 於2025年10月13日,受託人根據該計劃之條款及條件在市場上購買合共3,000,000股本公司 股份,並為獲選參與者之利益以信託方式持有該等股份。受託人於2025年10月13日所購買 及以信託方式持有之股份詳情如下: | 所購買股份總數: | 3,000,000股股份 | | --- | --- | | 所購買股份佔目前已發行股份總數百分比: | 約0.026 % | | 每股平均價格: | 約9.3251港元 | | ...
石药集团:依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理
Zhi Tong Cai Jing· 2025-10-13 11:05
Core Viewpoint - The announcement highlights the acceptance of a new drug application for the product Icodextrin α injection by the National Medical Products Administration of China, aimed at long-term weight management in overweight or obese adults [1] Group 1: Product Details - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered weekly [1] - It selectively binds and activates GLP-1 receptors to suppress appetite and reduce food intake, leading to weight loss while also lowering blood glucose levels and improving cardiovascular and metabolic indicators [1] Group 2: Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results showed significant weight reduction compared to placebo, along with reductions in waist circumference, blood glucose, blood pressure, and blood lipids, providing cardiovascular and metabolic benefits [1] - The product demonstrated good safety and tolerability, with lower rates of gastrointestinal adverse events compared to similar marketed drugs, and a quicker, simpler dose escalation regimen that reaches the target maintenance dose in just four weeks [1] Group 3: Ongoing Research - Currently, two Phase III clinical trials are actively progressing for the product in patients with type 2 diabetes, aiming to benefit a larger patient population [2]
石药集团(01093):依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理
智通财经网· 2025-10-13 11:03
Core Viewpoint - The application for the new drug, Idaglutide α injection, developed by the subsidiary of the company, has been accepted by the National Medical Products Administration of China for long-term weight management in overweight or obese adults [1] Group 1: Product Details - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered once a week [1] - It selectively binds and activates GLP-1 receptors to suppress appetite and reduce food intake, leading to weight loss, while also lowering blood glucose levels in a glucose-dependent manner and improving cardiovascular and metabolic indicators [1] Group 2: Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results showed significant weight reduction compared to placebo, along with notable decreases in waist circumference, blood glucose, blood pressure, and blood lipids, providing cardiovascular and metabolic benefits [1] - The product demonstrated good safety and tolerability, with lower incidence rates of gastrointestinal adverse events compared to similar marketed drugs, and a quicker, simpler dose escalation regimen that reaches the target maintenance dose in just four weeks [1] Group 3: Ongoing Research - Currently, two Phase III clinical trials are actively progressing for the product in patients with type 2 diabetes, aiming to benefit more patients [2]
石药集团:他克莫司缓释胶囊获药品注册批件
Zhi Tong Cai Jing· 2025-10-13 10:58
石药集团(01093)发布公告,集团开发的他克莫司缓释胶囊(0.5mg、1mg)已获得中华人民共和国国家药 品监督管理局颁发的药品注册批件,并视同通过仿制药质量和疗效一致性评价。 他克莫司是一种大环内酯类免疫抑制剂,属于钙调神经磷酸霉抑制剂。体内外研究均证实,他克莫司具 有强效的免疫抑制作用,能抑制引起移植物排斥反应的细胞毒淋巴细胞的形成,其作用机制主要包括抑 制T细胞的活化和T辅助细胞依赖型B细胞的增殖,并抑制淋巴因子的形成(如白介素-2,白介素-3及γ-干 扰素)和白介素-2受体的表达。该产品适用于预防肾脏移植术后的移植物排斥反应,预防肝脏移植术后 维持期的移植物排斥反应,以及治疗肾脏或肝脏移植术后应用其他免疫抑制药物无法控制的移植物排斥 反应。 该产品的获批将进一步丰富集团在免疫排斥治疗领域的产品线。 ...
石药集团(01093.HK):依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理
Ge Long Hui· 2025-10-13 10:58
Core Viewpoint - The new drug application for the injection of Idaglutide α developed by Stone Pharmaceutical Group has been accepted by the National Medical Products Administration of China, targeting long-term weight management in overweight or obese adults [1] Company Summary - Stone Pharmaceutical Group's subsidiary, Stone Pharmaceutical Group Baike (Shandong) Biopharmaceutical Co., Ltd., is responsible for the development of the new drug [1] - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered once a week [1] Product Details - The drug is classified as a Class 1 new drug for therapeutic biological products, aimed at weight management alongside diet control and increased physical activity [1] - It selectively binds and activates GLP-1 receptors, leading to appetite suppression and reduced food intake, while also lowering blood glucose levels in a glucose-dependent manner [1] - The product shows benefits in cardiovascular and metabolic indicators [1] Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results indicate that the product significantly reduces weight compared to a placebo, along with reductions in waist circumference, blood glucose, blood pressure, and blood lipids [1] - The safety and tolerability of the product are reported to be good, with lower rates of gastrointestinal adverse events compared to similar marketed drugs [1] Dosing and Administration - The dosing regimen is noted to be quicker and simpler, achieving the target maintenance dose within just four weeks [1]