安瑞克芬注射液

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海思科:定增募资调减至12.45亿元 为合规缩减补充流动资金
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-26 03:25
南方财经9月26日电, 报告期内(2022年至2025年1-6月),公司营业收入分别为30.15亿元、33.55亿元、37.21亿元、20.01亿 元;净利润分别为3.92亿元、2.96亿元、4.66亿元、1.29亿元,整体保持盈利。截至2025年6月末,研发 团队规模达920余人,硕士以上学历占比约44%。公司已有环泊酚注射液、苯磺酸克利加巴林胶囊、考 格列汀片及安瑞克芬注射液4款1类新药获批上市,另有13个在研1类新药处于临床阶段。 海思科(002653.SZ)9月24日公告,拟调整2025年度向特定对象发行A股股票方案,将募集资金总额上 限由原不超过136,525.67万元调整为不超过124,525.67万元。此次调整主要为满足《证券期货法律适用意 见第18号》中关于补充流动资金和偿还债务比例不得超过募集资金总额30%的监管要求。调整后募集资 金将主要用于新药研发项目及补充流动资金,其中新药研发项目拟投入96,525.67万元,补充流动资金金 额调整为28,000.00万元。 ...
医药太平洋医药日报:强生口服多肽 ICOTROKINRA向欧盟递交上市申请
Xin Lang Cai Jing· 2025-09-17 00:30
Market Performance - The pharmaceutical sector experienced a slight increase of +0.04% on September 15, 2025, underperforming the CSI 300 index by 0.20 percentage points, ranking 14th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, medical research outsourcing (+2.54%) and medical devices (+0.48%) performed well, while vaccines (-0.91%), medical consumables (-0.72%), and blood products (-0.51%) lagged behind [1] - Top three gainers in individual stocks were Furuide (+20.01%), Dezhan Health (+10.02%), and Zhaoyan New Drug (+10.01%), while the biggest losers were Nuocheng Jianhua (-8.20%), Yinkang Life (-5.21%), and Xinnuo Wei (-5.11%) [1] Industry News - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for the oral peptide therapy Icotrokinra (JNJ-2113), developed in collaboration with Protagonist, aimed at treating moderate to severe plaque psoriasis in patients aged 12 and older [2] - The ICONIC-LEAD pivotal Phase 3 study reported positive topline results, indicating that Icotrokinra significantly improved skin conditions in patients with moderate to severe plaque psoriasis and demonstrated good safety [2] Company News - Kanglong Chemical announced that its subsidiary, Kanglong Shaoxing, successfully passed the FDA's on-site quality inspection, marking the first time its Shaoxing active pharmaceutical ingredient production facility has passed the FDA's pre-approval inspection [3] - Haisco received a Class 1 innovative drug registration certificate from the National Medical Products Administration for Anruikefen injection, which has been approved for an additional indication to treat moderate to severe itching in adult patients with chronic kidney disease related to maintenance hemodialysis [3] - Yipinhong's subsidiary in Guangzhou received a drug registration certificate for Clindamycin Palmitate Granules, confirming compliance with registration requirements [3] - Shanghai Laishi announced that its controlling shareholder, Haiyingkang, has cumulatively increased its shareholding by 72,935,300 shares, representing 1.10% of the total share capital, with a total investment of approximately RMB 499.99 million from May 22, 2025, to September 15, 2025 [3]
9月16日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-16 10:15
Group 1 - China Shenhua reported coal sales of 37.5 million tons in August, a year-on-year decrease of 3.1%, with total sales for the first eight months at 280 million tons, down 9.2% year-on-year [1] - China Shenhua, established in November 2004, focuses on coal and electricity production and sales, as well as transportation and coal-to-olefins [1] - Huaren Shuanghe's subsidiary received a drug registration certificate for a new injection used in treating non-ST elevation acute coronary syndrome [1] - Huaren Shuanghe, founded in May 1997, operates in chronic disease management, specialty business, and infusion business [1] Group 2 - New Wufeng's subsidiary signed a property transaction contract for a 60% equity transfer at a price of 9.7 million yuan [1] - New Wufeng, established in June 2001, specializes in pig farming, meat sales, and feed processing [2] - Yaoshi Technology announced that its convertible bonds will stop conversion after September 17, with remaining bonds to be redeemed at 100.62 yuan per bond [3] - Yaoshi Technology, founded in December 2006, focuses on drug molecular building blocks and related services [3] Group 3 - Newhua Co. announced a board member's plan to reduce holdings by up to 75,200 shares, representing 0.039% of total shares [4] - Newhua Co., established in September 1997, specializes in fine chemical products [4] - Hefei Construction's subsidiary signed a land use rights transfer contract for residential land with a total price of 12.24 billion yuan [6] - Hefei Construction, founded in September 1999, is involved in real estate development and property management [6] Group 4 - Guoyao Modern's subsidiary received a drug registration certificate for an injection used in anesthesia and emergency treatment [7] - Guoyao Modern, established in November 1996, focuses on pharmaceutical product development and sales [7] - Maohua Shihua announced the resignation of its deputy general manager [8] - Maohua Shihua, founded in October 1988, specializes in petrochemical products [9] Group 5 - Zhejiang Xineng applied for enforcement of a civil mediation agreement, seeking 170 million yuan from a group for breach of contract [10] - Zhejiang Xineng, established in December 1991, focuses on renewable energy projects [10] - Zejing Pharmaceutical announced the initiation of key clinical trials for a new drug targeting DLL3 [11] - Zejing Pharmaceutical, founded in March 2009, specializes in the development and production of new chemical and biological drugs [12] Group 6 - Huayi Technology's deputy general manager resigned due to personal work arrangements [13] - Huayi Technology, established in December 1998, focuses on high polymer materials and equipment manufacturing [13] - Luxiao Technology's subsidiary signed a strategic cooperation agreement with a leading cross-border e-commerce company [14] - Luxiao Technology, founded in May 1989, operates in various sectors including photovoltaic power generation [14] Group 7 - Aoxiang Pharmaceutical's subsidiary received a drug registration certificate for a new cancer treatment [15] - Aoxiang Pharmaceutical, established in April 2010, focuses on the development and production of pharmaceutical products [15] - Baiyunshan's pharmaceutical factory received approval for five drug supplement applications [16] - Baiyunshan, founded in September 1997, specializes in the research and production of various pharmaceutical products [16] Group 8 - Renfu Pharmaceutical's subsidiaries received drug registration certificates for two new products [17] - Renfu Pharmaceutical, established in March 1993, focuses on drug research and production [18] - China Shipbuilding Technology signed a significant contract for green methanol sales, potentially worth up to 1.2 billion dollars [19] - China Shipbuilding Technology, founded in May 1997, specializes in wind and solar resource development [19] Group 9 - Haohua Technology received a project designation from a global automotive brand for its ADAS system [20] - Haohua Technology, established in January 2010, focuses on intelligent driving perception systems [20] - Hendi Pharmaceutical received approval for a new raw material drug [21] - Hendi Pharmaceutical, founded in December 1995, specializes in chemical raw materials and formulations [22] Group 10 - JX Communication's subsidiary received a temporary use permit for an air traffic communication system [23] - JX Communication, established in January 1995, focuses on communication technology applications [23] - Longyuan Technology's deputy general manager resigned due to work reasons [24] - Longyuan Technology, founded in December 1998, specializes in energy-saving and environmental protection [25] Group 11 - Jiuqiang Bio received a medical device registration for a gastrin-17 assay kit [26] - Jiuqiang Bio, established in January 2001, focuses on in vitro diagnostic testing platforms [26] - Rifei Co. received approval for a stock issuance to specific investors [27] - Rifei Co., founded in December 2009, specializes in special equipment cables and other electrical devices [27] Group 12 - Huayi Media received a subsidy for a micro-short drama project [28] - Huayi Media, established in August 1998, focuses on film and game content investment [28] - Huilong Pharmaceutical's subsidiary received overseas marketing approvals for multiple products [29] - Huilong Pharmaceutical, founded in October 2010, specializes in innovative and high-quality generic drugs [29] Group 13 - Junsheng Electronics' subsidiary received project designations from two major automotive brands [30] - Junsheng Electronics, established in August 1992, focuses on automotive parts [30] - Silek signed an investment cooperation agreement for a new energy project [31] - Silek, founded in January 2004, specializes in metal packaging equipment [31] Group 14 - ST Huhuwa received drug registration certificates for two new products [32] - ST Huhuwa, established in June 2005, focuses on drug research and production [32] - Canray Technology announced a share buyback plan of 20 to 40 million yuan [33] - Canray Technology, founded in September 2005, specializes in integrated circuits [33] Group 15 - Qilu Bank's directors plan to collectively increase their holdings by at least 3.5 million yuan [34] - Qilu Bank, established in June 1996, focuses on corporate and personal banking services [34] - China Overseas Land reported a significant decrease in contract sales in August [35] - China Overseas Land, founded in September 1997, specializes in tourism and real estate [35] Group 16 - Longjian Co. plans to acquire 100% of Guangdong Zhimao's equity for 40,000 yuan [36] - Longjian Co., established in January 1993, focuses on infrastructure construction [36] - Lichong Group's subsidiary received project designations from a luxury car brand [37] - Lichong Group, founded in July 1998, specializes in aluminum alloy products [37] Group 17 - Kanglong Huacheng's subsidiary passed an FDA inspection [38] - Kanglong Huacheng, established in July 2004, focuses on integrated drug research and development services [38] - Kangtai Bio received a drug registration certificate for a new polio vaccine [39] - Kangtai Bio, founded in September 1992, specializes in vaccine development and production [39] Group 18 - Baiyunshan's pharmaceutical factory's drug entered a key clinical trial phase [40] - Baiyunshan, established in September 1997, focuses on various pharmaceutical products [40] - Zhongyuan Home's chairman plans to reduce holdings by up to 3% [41] - Zhongyuan Home, founded in November 2001, specializes in furniture production [41] Group 19 - Shangluo Electronics plans to acquire 88.79% of Ligon Technology's equity for 709 million yuan [42] - Shangluo Electronics, established in August 1999, focuses on electronic components [42] - Shangluo Electronics also plans to issue convertible bonds to raise 1 billion yuan [43] - Shangluo Electronics, founded in August 1999, specializes in electronic products for various applications [43] Group 20 - HNA Holdings reported a 3.38% increase in passenger capacity in August [44] - HNA Holdings, established in December 1995, focuses on air transportation services [44] - Yipin Hong's subsidiary received a drug registration certificate for a new product [45] - Yipin Hong, founded in February 2002, specializes in pharmaceutical production [45] Group 21 - Haishi Ke's innovative drug received approval for a new indication [46] - Haishi Ke, established in August 2005, focuses on new drug development [46] - Huaxia Airlines plans to repurchase shares worth 80 to 160 million yuan [47] - Huaxia Airlines, founded in April 2006, specializes in air transportation services [47] Group 22 - Jingchen Co. plans to acquire 100% of Xinchip Microelectronics for 316 million yuan [48] - Jingchen Co., established in July 2003, focuses on semiconductor design [48] - Zhongxin Heavy Industry was recognized as an excellent smart factory by the Ministry of Industry and Information Technology [49] - Zhongxin Heavy Industry, founded in January 2008, specializes in large equipment and technology solutions [49]
海思科医药集团股份有限公司 关于1类创新药安瑞克芬注射液新适应症获批的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-16 02:16
登录新浪财经APP 搜索【信披】查看更多考评等级 本公司及董事会全体成员保证信息披露内容的真实、准确、完整,没有虚假记载、误导性陈述或重大遗 漏。 海思科医药集团股份有限公司(以下简称"公司")于近日收到国家药品监督管理局下发的1类创新药安 瑞克芬注射液(商品名称:思舒静?,研发代号:HSK21542)《药品注册证书》,现将相关情况公告如 下: 一、药品及申请基本信息 药品名称:安瑞克芬注射液 受理号:CXHS2400097 证书编号:2025S02878 批准文号:国药准字H20250014 注册分类:化学药品1类 剂 型:注射剂 规 格:1ml∶0.1mg 适 应 症:本品用于维持性血液透析的慢性肾脏疾病相关中重度瘙痒成人患者。 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品注册的有关要求, 批准增加适应症,新增适应症为"治疗成人维持性血液透析患者的慢性肾脏疾病相关的中度至重度瘙 痒",发给药品注册证书。 二、研发项目简介 HSK21542是我司自主研发的高选择性外周kappa 阿片受体(κ Opioid Receptor,KOR)激动剂。临床研 究结果表明,HSK21542注 ...
海思科(002653.SZ):1类创新药安瑞克芬注射液新适应症获批
Ge Long Hui A P P· 2025-09-15 11:40
格隆汇9月15日丨海思科(002653.SZ)公布,近日收到国家药品监督管理局下发的1类创新药安瑞克芬注 射液(商品名称:思舒静,研发代号:HSK21542)《药品注册证书》,HSK21542是我司自主研发的高 选择性外周kappa阿片受体(κOpioidReceptor,KOR)激动剂。临床研究结果表明,HSK21542注射液能 显著缓解瘙痒,主要疗效指标和次要疗效指标均显著优于安慰剂组,且HSK21542注射液安全性良好可 控。该新获批适应症于2024年7月被纳入优先审评审批程序,现获批上市,有望为患者提供更好的止痒 选择。 ...
海思科:安瑞克芬注射液新适应症获批
Zheng Quan Shi Bao Wang· 2025-09-15 11:28
人民财讯9月15日电,海思科(002653)9月15日晚间公告,公司于近日收到国家药品监督管理局下发的 1类创新药安瑞克芬注射液(商品名称:思舒静,研发代号:HSK21542)《药品注册证书》。新增适应症 为"治疗成人维持性血液透析患者的慢性肾脏疾病相关的中度至重度瘙痒"。 ...
海思科安瑞克芬注射液新适应症获批
Zhi Tong Cai Jing· 2025-09-15 11:20
海思科(002653)(002653.SZ)公告,公司近日收到国家药品监督管理局下发的1类创新药安瑞克芬注射 液(商品名称:思舒静,研发代号:HSK21542)《药品注册证书》,本次新增适应症为"治疗成人维持性 血液透析患者的慢性肾脏疾病相关的中度至重度瘙痒"。 ...
海思科:1类创新药安瑞克芬注射液新适应症获批
Ge Long Hui· 2025-09-15 11:14
格隆汇9月15日|海思科(002653.SZ)公告称,公司收到国家药品监督管理局下发的1类创新药安瑞克芬 注射液《药品注册证书》,批准增加适应症为"治疗成人维持性血液透析患者的慢性肾脏疾病相关的中 度至重度瘙痒"。该新获批适应症于2024年7月被纳入优先审评审批程序,现获批上市。此外,安瑞克芬 注射液已于2025年5月首次获批"用于治疗腹部手术后的轻、中度疼痛"适应症,且用于骨科手术术后镇 痛适应症的Ⅲ期临床研究正在顺利进行中。 ...
国信证券晨会纪要-20250827
Guoxin Securities· 2025-08-27 01:50
Macro and Strategy - The equity market is currently in an accelerating upward phase, prompting discussions on how to adjust positions to prepare for potential market fluctuations [8] - Investors are advised to consider right-side position reduction as a more reasonable choice, given the current market dynamics [8] - Historical data suggests that low-priced convertible bonds (priced between 110-115 yuan) tend to be more resilient during market downturns [8] Company and Industry Analysis - **Dengkang Dental (001328.SZ)**: The company reported a stable growth in Q2 2025, with revenue reaching 842 million yuan, a year-on-year increase of 19.72%, and a net profit of 85 million yuan, up 17.59% [10][11] - **Marubi Biotechnology (603983.SH)**: The company achieved a revenue of 1.769 billion yuan in H1 2025, a 30.83% increase year-on-year, while net profit grew by 5.21% to 186 million yuan [13][14] - **Haidi Lao (06862.HK)**: The company reported a revenue of 20.7 billion yuan in H1 2025, a decrease of 3.7%, with core operating profit down 14% [17][18] - **Green Tea Group (06831.HK)**: The company achieved a revenue of 2.29 billion yuan in H1 2025, a 23.1% increase, with adjusted net profit rising by 40% [19][20] - **Haisco Pharmaceutical (002653.SZ)**: The company reported a revenue of 2 billion yuan in H1 2025, an 18.6% increase, with anesthetic product revenue growing by 54% [22][23] - **Furui Co., Ltd. (300049.SZ)**: The company achieved a revenue of 713 million yuan in H1 2025, an 11.02% increase, while net profit was impacted by foreign exchange losses [26][27] - **Kaili Medical (300633.SZ)**: The company reported a revenue of 964 million yuan in H1 2025, a decrease of 4.78%, with net profit down 72.43% due to high initial investments in new product lines [29][30] - **Yuyue Medical (002223.SZ)**: The company reported a revenue of 4.659 billion yuan in H1 2025, an 8.2% increase, with net profit rising by 7.4% [31][32]
海思科(002653):公司信息更新报告:持续加大研发投入,创新转型成效显著
KAIYUAN SECURITIES· 2025-08-25 02:56
Investment Rating - The investment rating for the company is "Buy" (maintained) [1][6][16] Core Views - The company achieved a significant increase in non-recurring net profit, with a growth of 90.84% year-on-year, indicating strong operational performance despite a decline in net profit [6] - The company is expected to maintain a robust growth trajectory in its innovative pipeline, with projected net profits of 5.33 billion, 7.35 billion, and 10.31 billion for 2025, 2026, and 2027 respectively [6][9] - The current price-to-earnings (P/E) ratios are projected to decrease from 123.6 in 2025 to 63.9 in 2027, suggesting potential for valuation improvement [6][9] Financial Performance Summary - In H1 2025, the company reported operating revenue of 2.001 billion (up 18.63% year-on-year) and a gross margin of 72.96% (up 1.01 percentage points) [6][9] - The company’s R&D investment reached 497 million in H1 2025, reflecting a year-on-year increase of 43.02% [7] - The projected operating revenues for the years 2025 to 2027 are 4.364 billion, 5.312 billion, and 6.863 billion respectively, with corresponding year-on-year growth rates of 17.3%, 21.7%, and 29.2% [9][12] Innovative Pipeline and Market Position - The company has successfully maintained a leading market share of 22.3% in the intravenous anesthesia market with its product环泊酚, which is currently used in over 2,500 hospitals [7] - The company has several innovative products in various stages of development, including a first-class new drug for diabetic peripheral neuropathic pain and a high-selectivity peripheral κ-opioid receptor agonist [7] - The company’s innovative transformation is expected to drive future growth and enhance its market valuation [7]