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【长春高新(000661.SZ)】注射用伏欣齐拜单抗获批上市,创新转型持续深化——更新点评(王明瑞/黄素青)
光大证券研究· 2025-07-09 14:25
特别申明: 本订阅号中所涉及的证券研究信息由光大证券研究所编写,仅面向光大证券专业投资者客户,用作新媒体形势下研究 信息和研究观点的沟通交流。非光大证券专业投资者客户,请勿订阅、接收或使用本订阅号中的任何信息。本订阅号 难以设置访问权限,若给您造成不便,敬请谅解。光大证券研究所不会因关注、收到或阅读本订阅号推送内容而视相 关人员为光大证券的客户。 报告摘要 事件: 近日,控股子公司金赛药业申报的注射用伏欣奇拜单抗(曾用名注射用金纳单抗)经国家药监局批准上 市。该产品是生物制品1类新药,是国内首个获批用于治疗成人痛风性关节炎急性发作的 IL-1 抑制剂,丰 富了公司成人自免领域的产品布局,是公司创新转型的重要成果。 点评: 点击注册小程序 查看完整报告 24年公司研发投入金额为26.90亿元,同比+11.20%,占营业收入比例为19.97%,同比+3.36pp;其中费用 化研发投入为21.67亿元,资本化研发投入为5.23亿元。24H1重组人促卵泡激素注射液、黄体酮注射液 (II)等获批上市,后者被纳入《2024年国家医保目录》,成为辅助生殖领域第一个国谈药品。公司合作 引进的用于癌性厌食-恶病质综合征的美适亚 ...
三十载创新跨越,默克全程守护促“新生”
21世纪经济报道· 2025-07-01 15:09
人口战略作为影响国计民生的基础性要素,始终占据国家经济和社会发展的重要位置。过去 三 年 间 , 我 国 人 口 持 续 呈 现 负 增 长 态 势 。 辅 助 生 殖 是 帮 助 不 孕 不 育 群 体 进 行 生 育 的 终 极 手 段,自1 9 8 8年中国第一例试管婴儿诞生以来,我国辅助生殖技术已经走过近4 0个年头。从第 一代试管婴儿技术到第三代技术对遗传疾病的精准狙击,医学技术的升级与突破极大程度上 解决了"生不出"的难题;从单纯追求临床妊娠率到构建全生命周期健康管理体系,中国辅助 生殖领域正快速奔向"健康中国"战略目标。 作为辅助生殖领域的先行者和领导者,默克在全球范围内已成功帮助了超过6 0 0万辅助生 殖宝宝的顺利诞生。默克中国医药健康董事总经理张巍表示:"默克的全方位药物组合为 辅助生殖的各个阶段提供治疗方案。从全球首个获批的重组促性腺激素药物,到首个获 批的重组人促黄体激素药物,再到独家剂型的黄体酮阴道凝胶,默克致力于产品的创新 和剂型的优化,为中国不孕不育夫妇提供全面的解决方案。" 默克中国医药健康董事总经理 张巍 "默克的目标是孕育生命,一方面,我们积极投身于疾病教育科普宣传,提高公 ...
【科技日报】人工构建本草细胞高效合成甾体激素
Ke Ji Ri Bao· 2025-06-25 01:03
Core Viewpoint - The research team at the Tianjin Institute of Industrial Biotechnology has discovered an efficient biosynthetic pathway for progesterone in plants, marking a significant advancement in the synthesis technology of third-generation steroid hormones in China [1][2]. Group 1: Research Breakthrough - The team successfully constructed artificial herbal cells capable of producing steroid hormones, utilizing a more efficient "plant route" compared to the traditional "animal route" [1]. - The new method allows for the direct synthesis of steroid hormones from cholesterol-like substances in the endoplasmic reticulum, bypassing the complex mitochondrial transport steps required in the "animal route" [1]. Group 2: Economic Impact - Steroid hormones such as progesterone and hydrocortisone represent the second largest category of chemical drugs after antibiotics, with global annual sales exceeding $100 billion [1]. - The production yield of steroid hormones using the new method exceeds gram-level per liter, achieving over a tenfold increase compared to the "animal route" [1]. Group 3: Environmental Considerations - Traditional production methods rely on plant resources and can lead to environmental pollution, while the new approach offers a more efficient and environmentally friendly alternative for producing steroid hormone drugs [1][2]. Group 4: Broader Implications - This breakthrough provides new insights into the exploration of life's evolution and lays an important foundation for the efficient and environmentally friendly production of steroid hormone drugs based on heterologous biomimetic synthesis technology [2].
2025年中国妇科调经用药行业概览:“她经济”消费升级,聚焦女性健康需求
Tou Bao Yan Jiu Yuan· 2025-06-03 12:23
研究报告 2025/01 www.leadleo.com 2025年 中国妇科调经用药行业概览:"她经济"消 费升级,聚焦女性健康需求 2025 China Gynecological Menstrual Regulation Medications Industry 2025年中国妇科月経調節薬産業 报告标签:女性月经周期、月经失调 主笔人:钟琪 报告提供的任何内容(包括但不限于数据、文字、图表、图像等)均系头豹研究院独有的高度机密性 文件(在报告中另行标明出处者除外)。未经头豹研究院事先书面许可,任何人不得以任何方式擅自 复制、再造、传播、出版、引用、改编、汇编本报告内容,若有违反上述约定的行为发生,头豹研究 院保留采取法律措施、追究相关人员责任的权利。头豹研究院开展的所有商业活动均使用"头豹研究院 "或"头豹"的商号、商标,头豹研究院无任何前述名称之外的其他分支机构,也未授权或聘用其他任何 第三方代表头豹研究院开展商业活动。 研究报告 | 2025/04 中国妇科调经用药行业 摘要 中国妇科调经用药行业近年来呈现稳健增长 的态势,市场需求与政策红利共同推动行业 向多元化、专业化方向发展。受益于女性健 康 ...
2025年中国妇科经纬用药行业概览:“她经济”消费升级,聚焦女性健康需求
Tou Bao Yan Jiu Yuan· 2025-06-03 12:03
研究报告 2025/01 www.leadleo.com 2025年 中国妇科调经用药行业概览:"她经济"消 费升级,聚焦女性健康需求 2025 China Gynecological Menstrual Regulation Medications Industry 2025年中国妇科月経調節薬産業 报告标签:女性月经周期、月经失调 主笔人:钟琪 报告提供的任何内容(包括但不限于数据、文字、图表、图像等)均系头豹研究院独有的高度机密性 文件(在报告中另行标明出处者除外)。 ,任何人不得以任何方式擅自 复制、再造、传播、出版、引用、改编、汇编本报告内容,若有违反上述约定的行为发生,头豹研究 院保留采取法律措施、追究相关人员责任的权利。头豹研究院开展的所有商业活动均使用"头豹研究院 "或"头豹"的商号、商标,头豹研究院无任何前述名称之外的其他分支机构,也未授权或聘用其他任何 第三方代表头豹研究院开展商业活动。 研究报告 | 2025/04 中国妇科调经用药行业 摘要 中国妇科调经用药行业近年来呈现稳健增长 的态势,市场需求与政策红利共同推动行业 向多元化、专业化方向发展。受益于女性健 康意识的提升、慢性病管理需 ...
5月28日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-28 10:18
中国能建:中标145.86亿元重大煤电项目 5月28日晚,中国能建(601868)发布公告称,公司所属子公司组成的联合体中标中新建电力兵准园区 6×66万千瓦煤电项目(EPC),中标金额约145.86亿元。该项目包括6台66万千瓦超超临界燃煤发电机 组及配套环保设施,总工期约36.5个月。目前尚未正式签署合同。 资料显示,中国能建成立于2014年12月,主营业务是勘测设计及咨询、工程建设、工业制造、投资运 营。 所属行业:建筑装饰–基础建设–基建市政工程 友讯达:中标国家电网1.76亿元项目 5月28日晚,友讯达(300514)发布公告称,公司在国家电网有限公司2025年第三十一批采购(营销项 目第一次计量设备招标采购)中中标10个包,中标金额约为1.76亿元,占公司2024年经审计营业收入的 17.44%。 资料显示,友讯达成立于2002年9月,主营业务是各行业综合物联网问题的服务、帮助和解决。 所属行业:电力设备–电网设备–电工仪器仪表 岱勒新材:与专业机构共同设立投资基金 5月28日晚,岱勒新材(300700)发布公告称,公司与泰诺(深圳)私募股权基金管理有限公司等机构 签署协议,共同投资设立深圳泰诺协 ...
人福医药:黄体酮软胶囊获药品注册证书
news flash· 2025-05-28 08:02
人福医药(600079)公告,控股子公司武汉九珑人福药业有限责任公司近日收到国家药品监督管理局核 准签发的黄体酮软胶囊《药品注册证书》。黄体酮软胶囊用于治疗由黄体酮缺乏引起的机能障碍,也助 于妊娠。九珑人福于2023年12月提交上市许可申请并获得受理,截至目前该项目累计研发投入约为人民 币2900万元。根据米内网数据显示,2024年度黄体酮软胶囊全国销售额约为人民币3.72亿元,主要厂商 包括Besins HealthcareS.A.、浙江爱生药业有限公司、浙江医药(600216)股份有限公司新昌制药厂 等。 ...
5月21日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-21 10:14
汇宇制药:卡络磺钠注射液获药品注册证书 5月21日晚,汇宇制药(688553)发布公告称,全资子公司四川汇宇海玥医药科技有限公司收到国家药 品监督管理局核准签发的卡络磺钠注射液《药品注册证书》。该药品为化学药品3类,主要用于泌尿系 统、上消化道、呼吸道和妇产科出血疾病的治疗。此次获批视同通过仿制药质量和疗效一致性评价。 资料显示,汇宇制药成立于2010年10月,主营业务为肿瘤治疗领域药物和复杂注射剂药物的研发、生产 和国内外销售。 所属行业:医药生物–化学制药–化学制剂 百合股份:董事拟减持不超过42.4万股公司股份 5月21日晚,百合股份(603102)发布公告称,公司董事王文通计划通过集中竞价方式减持公司股份, 减持数量不超过42.4万股,占公司总股本的0.6625%。减持计划将于公告披露之日起15个交易日后的三 个月内进行。此次减持是基于王文通的个人资金需求。 资料显示,百合股份成立于2005年11月,主营业务是营养保健食品的研发、生产和销售。 所属行业:食品饮料–食品加工–保健品 金固股份:获全球龙头车企美国乘用车车轮项目定点 5月21日晚,金固股份(002488)发布公告称,公司近日收到某全球龙头车 ...
通化东宝精蛋白人胰岛素在尼加拉瓜获批;浩欧博回复年报信息披露监管工作函
Mei Ri Jing Ji Xin Wen· 2025-05-13 23:34
Group 1 - Tonghua Dongbao has received approval from Nicaragua's National Health Regulatory Authority for its recombinant human insulin injection, which is expected to enhance the company's international market presence and brand image [1] - The diabetes patient population in Nicaragua is projected to reach 377,000 by 2024, with an 8.7% prevalence rate among adults aged 20-79, indicating a significant market opportunity for the company [1] - The average annual expenditure per diabetes patient in Nicaragua is estimated at $587, highlighting the potential revenue generation from the new product [1] Group 2 - Haobor's response to the 2024 annual report inquiry reflects the company's commitment to regulatory compliance and transparency, addressing concerns regarding its distribution model and dealer management [2] - The detailed analysis of dealer numbers and management policies demonstrates the stability and rationality of the company's business model, which may alleviate investor concerns [2] - Continuous optimization of dealer management is expected to provide strong support for the company's long-term development [2] Group 3 - Kangji Medical has decided to terminate the sale of a subsidiary and has reached a settlement agreement with the buyer, which includes the return of company records and a refund of 5 million yuan [3] - The company expects to realize approximately 39.3 million yuan in gains from a land recovery agreement with government agencies, indicating effective management of complex transactions [3] - The resolution of this transaction is likely to stabilize investor confidence and positively impact the company's long-term growth prospects [3] Group 4 - Jincheng Pharmaceutical has signed a licensing and distribution agreement with UK-based Theramex HQ UK Limited for the hormone replacement therapy product Bijuva, aimed at addressing estrogen deficiency symptoms in postmenopausal women [4] - This collaboration aligns with the company's strategy to enhance its offerings in women's health and strengthen partnerships with international pharmaceutical firms [4] - The agreement is expected to expand the company's product portfolio in the women's health sector and improve its brand influence in this market [4]
仙琚制药(002332):利润短期承压 制剂端新品稳步推进
Xin Lang Cai Jing· 2025-05-06 06:43
Core Viewpoint - In 2024, the company achieved revenue of 4 billion yuan, a slight year-on-year decline, while net profit attributable to shareholders was significantly impacted by a fine related to sodium dexamethasone sales, with a stable growth in non-recurring net profit [1][2][3] - The impact of centralized procurement on the formulation segment has been largely digested, and new products are continuously being introduced, with expectations for accelerated growth in 2025 [1][4] - Revenue from the raw materials segment declined due to inventory destocking by overseas clients and price decreases, but sales volume remains stable, with a positive outlook for gradual recovery [1][5] Financial Performance - In 2024, the company reported operating revenue of 4.001 billion yuan, a year-on-year decrease of 2.98%, and a net profit attributable to shareholders of 397 million yuan, down 29.46% [2][3] - The non-recurring net profit for 2024 was 549 million yuan, reflecting a year-on-year increase of 2.15% [2][3] - For Q1 2025, the company achieved operating revenue of 1.01 billion yuan, a year-on-year decline of 2.9%, with a net profit of 140 million yuan, down 4.7% [2][3] Formulation Segment - In 2024, the formulation sales revenue reached 2.276 billion yuan, an increase of 8% year-on-year [4] - Key therapeutic areas showed varied performance, with gynecology and family planning sales at 450 million yuan, stable year-on-year; anesthetic muscle relaxants at 160 million yuan, up 55%; respiratory products at 880 million yuan, up 31%; and dermatology products at 230 million yuan, up 19% [4] - The company’s new products are expected to accelerate growth, with significant sales increases in new offerings such as sodium glucosamine injection [4][6] Raw Materials Segment - In 2024, revenue from raw materials and intermediates was 1.55 billion yuan, a year-on-year decline of 13% [5] - The decline was attributed to inventory destocking in the international market and increased competition leading to price drops [5][6] - The company is expected to see a recovery in the raw materials segment as prices stabilize and market share increases [5][6] Expense Analysis - In 2024, the company's sales, management, and R&D expense ratios were 25.84%, 7.74%, and 6.63%, respectively, with slight increases year-on-year [7] - The gross margin improved to 57.49%, up 4.61 percentage points, attributed to the clearing of centralized procurement impacts and operational efficiency [7] - The net profit margin was 10%, significantly impacted by a fine provision of 195 million yuan [7] Future Outlook - The company is expected to achieve stable growth in revenue and profit in 2025, with non-centralized procurement products anticipated to grow steadily [8] - Revenue projections for 2025-2027 are 4.35 billion, 4.81 billion, and 5.48 billion yuan, with year-on-year growth rates of 8.6%, 10.7%, and 13.8% respectively [8]