海曲泊帕乙醇胺片

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医药生物行业周报:业绩密集披露,关注超预期标的-20250822
BOHAI SECURITIES· 2025-08-22 13:12
行 行业周报 业 业绩密集披露,关注超预期标的 研 究 分析师: 侯雅楠 SAC NO: S1150524120001 2025 年 08 月 22 日 houyn@bhzq.com (1)国家医疗保障局印发《医疗保障按病种付费管理暂行办法》; 医药生物 投资要点: 证券分析师 侯雅楠 行业要闻 022-23839211 (2)司美格鲁肽获美国食品药品监督管理局(FDA)批准治疗 MASH。 研究助理 公司公告 近三月行业指数走势图 (1)恒瑞医药:①公布 2025 年半年度报告;②药品上市许可申请获受理; 证 券 (2)百利天恒:①公布 2025 年半年度报告;②关于 iza-bren(EGFR×HER3 双抗 ADC)用于治疗晚期 EGFR 突变的非小细胞肺癌获得美国 FDA 突破性 疗法认定; 研 (3)荣昌生物:①NMPA 药品审评中心(CDE)授予 RC148 突破性治疗药 物认定用于治疗非小细胞肺癌;②签署授权许可协议; 报 相关研究报告 医疗器械关注度提升,关注相 (4)百奥泰:①公布 2025 年半年度报告;②与 STADA 就 BAT1806(托珠 单抗)注射液签署授权许可与商业化协议;③U ...
行业投资策略周报:司美MASH适应症获批-20250819
CAITONG SECURITIES· 2025-08-19 11:11
Core Insights - The report highlights the approval of semaglutide (Wegovy) for the treatment of metabolic dysfunction-associated steatotic liver disease (MASH) by the FDA, which is expected to enhance the market penetration of related products and diagnostic tools [7][10][15] - The report suggests that companies like Furuya Co., Ltd. will benefit from the growth opportunities in the MASH indication market due to the increasing prescription rates of semaglutide and the rising demand for diagnostic instruments [15][5] Industry Performance Review - As of August 15, 2025, the pharmaceutical and biotechnology sector's TTM-PE stands at 51.31 times, which is 110% higher than its historical low of 24.38 times [16] - The healthcare sector has shown a relative premium of 281% compared to the CSI 300 index, which is significantly above the average premium rate of 241% over the past decade [16] - The pharmaceutical and biotechnology sector experienced a 3.08% increase in the week from August 11 to August 15, 2025, ranking 10th among 27 sub-industries [20][24] Company Dynamics - Furuya Co., Ltd. is noted for its FibroScan series of liver fibrosis diagnostic instruments, which are the first globally to utilize transient elastography technology for non-invasive liver stiffness measurement [15] - The report emphasizes the strategic collaborations between Furuya and leading pharmaceutical companies to promote the clinical application and commercialization of new drugs [15] - The report identifies several companies that could be key players in the MASH treatment landscape, including innovative drug and device companies such as Furuya, Anglikon, and others [15]
港股开盘:恒指涨0.26%、科指涨0.24%,科网股走势分化,影视股走强橙天嘉禾涨15%
Jin Rong Jie· 2025-08-19 01:37
Market Overview - The Hong Kong stock market opened slightly higher, with the Hang Seng Index rising by 0.26% to 25,241.29 points, the Hang Seng Tech Index up by 0.24% to 5,592.3 points, the National Enterprises Index increasing by 0.23% to 9,054.09 points, and the Red Chip Index gaining 0.18% to 4,373.41 points [1] Company Performance - Sinopec Oilfield Services reported revenue of approximately 37.051 billion yuan, a year-on-year increase of 0.6%, and a net profit of approximately 492 million yuan, up 9% [2] - Leap Motor achieved revenue of 24.25 billion yuan, a significant year-on-year growth of 174%, and a net profit of 30 million yuan, turning around from a loss of 2.21 billion yuan in the same period last year [2] - Wanwu Cloud reported revenue of 18.137 billion yuan, a year-on-year increase of 3.11%, and a net profit of 792 million yuan, up 3.88% [3] - China Biopharmaceuticals recorded revenue of 17.57 billion yuan, a year-on-year increase of 10.7%, and a net profit of 3.39 billion yuan, up 140.2% [3] - Tongcheng Travel reported revenue of 9.05 billion yuan, a year-on-year increase of 11.5%, with adjusted EBITDA of 2.34 billion yuan, up 35.2%, and a net profit of 1.56 billion yuan, up 28.6% [3] - Hansoh Pharmaceutical reported revenue of 7.434 billion yuan, a year-on-year increase of 14.27%, and a net profit of 3.135 billion yuan, up 15.02% [4] - Meitu reported revenue of 1.82 billion yuan, a year-on-year increase of 12.3%, and a net profit of 397 million yuan, up 30.8% [5] - Huabao International reported revenue of 1.621 billion yuan, a year-on-year increase of 2.5%, and a net profit of 118 million yuan, up 298.1% [6] - Andeli Juice reported revenue of 948 million yuan, a year-on-year increase of 50%, and a net profit of 201 million yuan, up 50.3% [6] Earnings Warnings and Surprises - Road King issued a profit warning, expecting a mid-term net loss of approximately 1.9 to 2.1 billion HKD [7] - Hui Kee Group also issued a profit warning, anticipating a mid-term net loss of approximately 800 to 900 million HKD, a year-on-year increase [8] - Yunfeng Financial issued a profit alert, expecting a mid-term net profit of approximately 480 million HKD, a significant year-on-year increase of about 139% [9] - Heung Kong Holdings issued a profit warning, expecting a mid-term net loss of 130 to 160 million HKD [10] - JS Global Life issued a profit warning, expecting a mid-term net loss of no more than 56 million USD, turning from profit to loss [11] - United Pharmaceutical issued a profit alert, expecting a mid-term net profit of approximately 1.85 billion yuan, a year-on-year increase [12] - Orange Sky Golden Harvest issued a profit alert, expecting a net profit exceeding 125 million HKD, turning from loss to profit [13] - Ximei Resources issued a profit alert, expecting a mid-term net profit of approximately 81.8 to 100 million HKD, a year-on-year increase [14] - International Resources issued a profit alert, expecting a mid-term net profit of approximately 59 million USD, a year-on-year increase [15] - Siheng Holdings issued a profit alert, expecting a mid-term net profit exceeding 50 million HKD, turning from loss to profit [16] Insurance Sector - New China Life Insurance reported cumulative original premium income of 137.806 billion yuan for the first seven months, a year-on-year increase of 23% [17] Automotive Sector - Leap Motor delivered 50,129 vehicles in July [18]
恒瑞医药(01276.HK):海曲泊帕乙醇胺片的药品上市许可申请获国家药监局受理
Ge Long Hui· 2025-08-18 10:37
Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Haiqubopai Ethanolamine Tablets from the National Medical Products Administration, aimed at treating chemotherapy-induced thrombocytopenia in adult patients [1][2] Group 1: Drug Approval and Clinical Trials - The National Medical Products Administration has issued an acceptance notice for the drug application of Haiqubopai Ethanolamine Tablets, which is indicated for adult patients with chemotherapy-induced thrombocytopenia [1] - The Phase III clinical trial (SHR8735-301) for Haiqubopai Ethanolamine Tablets achieved its primary endpoint in May 2025, demonstrating significant efficacy compared to the control group with good safety and tolerability [1] Group 2: Existing Approvals and Market Context - Haiqubopai Ethanolamine Tablets have previously been approved for two indications: chronic primary immune thrombocytopenia in adults with poor response to corticosteroids and immunoglobulins, and severe aplastic anemia in adults with poor response to immunosuppressive therapy [2] - The drug is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production through the activation of TPO-R mediated STAT and MAPK signaling pathways [2] - Similar products available in the international market include Eltrombopag, Avatrombopag, and Lusutrombopag, with a combined global sales forecast of approximately $2.59 billion for 2024 [2] - The cumulative R&D investment for Haiqubopai Ethanolamine Tablets has reached approximately 445.87 million yuan [2]
恒瑞医药:海曲泊帕乙醇胺片药品上市许可申请获国家药监局受理
Mei Ri Jing Ji Xin Wen· 2025-08-18 08:49
Core Viewpoint - Heng Rui Medicine (600276.SH) has received a notice from the National Medical Products Administration (NMPA) regarding the acceptance of its drug listing application for Haequparib Ethanolamine Tablets, which are intended for the treatment of chemotherapy-induced thrombocytopenia in adult patients [2] Company Summary - The drug application is specifically aimed at addressing thrombocytopenia caused by chemotherapy, indicating a focus on oncology treatments [2] - The acceptance of the application marks a significant step for the company in expanding its product portfolio in the oncology sector [2]
港股异动丨恒瑞医药涨超4% 海曲泊帕乙醇胺片上市许可申请获受理
Ge Long Hui· 2025-08-13 07:53
恒瑞医药(1276.HK)涨4.11%,报78.45港元,暂成交3.8亿港元,最新市值5207亿港元。恒瑞医药公告,近日,江苏恒瑞医药股份有限公司收到国家药品监督 管理局下发的《受理通知书》,公司海曲泊帕乙醇胺片的药品上市许可申请获国家药监局受理,适应症为:适用于既往对糖皮质激素、免疫球蛋白等治疗反 应不佳的持续性及慢性原发免疫性血小板减少症(ITP)成人及≥6岁的儿童患者。 中金发研报指,国家医保局发布基本医疗保险、生育保险和工伤保险药品目录以及商保创新药目录调整初步形式审查公告,534个药品通过初步形式审查, 预期当局启动双目录机制,可为医保形成清晰分工,基本医保目录覆盖临床必需的基础药品,而商保创新目录则重点纳入未被医保覆盖、但具有重大临床价 值的高价值药品。该行建议关注恒瑞医药等股票。(格隆汇) ...
港股异动 | 恒瑞医药(01276)涨超3% 海曲泊帕乙醇胺片药品上市许可申请获国家药监局受理
智通财经网· 2025-08-13 03:17
消息面上,恒瑞医药发布公告,近日,公司收到国家药品监督管理局下发的《受理通知书》,公司海曲 泊帕乙醇胺片的药品上市许可申请获国家药监局受理,适应症为:适用于既往对糖皮质激素、免疫球蛋 白等治疗反应不佳的持续性及慢性原发免疫性血小板减少症(ITP)成人及≥6岁的儿童患者。 2025年3月,海曲泊帕乙醇胺片Ⅲ期临床试验(HR-TPO-ITP-Ⅲ-PED)达到了方案预设的主要研究终点。 该研究是一项在儿童和青少年原发免疫性血小板减少症患者中评价海曲泊帕乙醇胺片的有效性和安全性 的多中心、随机、双盲及开放性的Ⅲ期研究,由首都医科大学附属北京儿童医院王天有教授担任主要研 究者,共入组100例6岁及以上儿童和青少年原发免疫性血小板减少症患者。试验组在主要终点上显著优 于对照组,且长期治疗的安全性、有效性良好。 智通财经APP获悉,恒瑞医药(01276)涨超3%,截至发稿,涨3.19%,报77.75港元,成交额1.46亿港元。 ...
江苏恒瑞医药股份有限公司关于药品上市许可申请获受理的提示性公告
Shang Hai Zheng Quan Bao· 2025-08-12 20:41
Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance from the National Medical Products Administration for the marketing authorization application of its drug, HAIQUPOLPA Ethanolamine Tablets, aimed at treating adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to previous treatments [1][2]. Drug Basic Information - Drug Name: HAIQUPOLPA Ethanolamine Tablets - Dosage Form: Tablets - Acceptance Number: CXHS2500092, CXHS2500093, CXHS2500094 - Application Stage: Marketing - Indication: For adults and children aged ≥6 years with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to corticosteroids and immunoglobulins [1][2]. Clinical Trial Information - The Phase III clinical trial (HR-TPO-ITP-III-PED) for HAIQUPOLPA Ethanolamine Tablets achieved its primary endpoint in March 2025. The study evaluated the efficacy and safety of the drug in children and adolescents with primary immune thrombocytopenia, involving 100 participants aged 6 and above. The treatment group showed significant improvement over the control group, with good long-term safety and efficacy [1][2]. Approved Indications - HAIQUPOLPA Ethanolamine Tablets have already been approved for two indications: 1. Treatment of chronic primary immune thrombocytopenia in adults with inadequate response to corticosteroids and immunoglobulins (approved in June 2021). 2. Treatment of severe aplastic anemia in adults with poor response to immunosuppressive therapy [2]. Disease Context - ITP is an acquired autoimmune bleeding disorder characterized by skin and mucosal bleeding, with severe cases leading to internal bleeding and even intracranial hemorrhage. It is the most common bleeding disorder in children and adolescents, with an annual incidence rate of 1.6-5.3 per 100,000 for primary ITP in children aged 1 month to 18 years. Approximately 80% of cases resolve within 12 months, but about 20% persist for over a year, indicating a significant clinical treatment demand [2][3]. Market Context - HAIQUPOLPA Ethanolamine Tablets are a non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production. Similar products available internationally include Eltrombopag, Avatrombopag, and Lusutrombopag. The global sales of these similar products are approximately $2.59 billion. In China, Eltrombopag was approved in 2017, Avatrombopag in 2020, and Lusutrombopag in 2023 [3][4].
格隆汇公告精选(港股)︱毛戈平(01318.HK)盈喜:预期中期净利润增长35.0%至37.0%
Ge Long Hui· 2025-08-12 14:37
Group 1 - The core viewpoint of the article highlights that Mao Geping (01318.HK) anticipates a mid-term net profit growth of 35.0% to 37.0% for the six months ending June 30, 2025, with expected revenue between RMB 25.7 billion and RMB 26.0 billion, representing a year-on-year increase of 30.4% to 31.9% [1] - The board attributes the growth in performance to the company's commitment to creating value for consumers, providing high-quality products and services, and enhancing brand recognition as a high-end brand, which translates into long-term business growth [1] Group 2 - China Unicom (00762.HK) reported a revenue exceeding RMB 200 billion for the first half of the year, reflecting a year-on-year growth of 1.5% [2] - Tencent Music-SW (01698.HK) showed steady growth in both revenue and profit in the second quarter, with an increase in the number of paying users and average revenue per paying user [2] - Wan Zhou International (00288.HK) reported a mid-term operating profit increase of 10.4% to USD 1.259 billion [2] - FIT HON TENG (06088.HK) achieved mid-term revenue of USD 2.305 billion, marking an 11.5% year-on-year increase [2] - Shanghai Industrial Environment (00807.HK) reported a net profit attributable to shareholders of RMB 344 million for the first half of the year, a 7.1% increase compared to the previous year [2]
恒瑞医药海曲泊帕乙醇胺片上市许可申请获受理
Bei Jing Shang Bao· 2025-08-12 14:03
Core Viewpoint - Heng Rui Medicine has received acceptance from the National Medical Products Administration for its drug application of Haequparib Ethanolamine Tablets, aimed at treating patients with chronic immune thrombocytopenia (ITP) who have had poor responses to previous treatments [1] Group 1 - The drug Haequparib Ethanolamine Tablets is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production by activating the STAT and MAPK signaling pathways [1] - The drug has already been approved for two indications prior to this application [1] - The target patient population includes adults and children aged 6 years and older with persistent and chronic primary immune thrombocytopenia [1]