智通财经APP讯，长春高新(000661.SZ)发布公告，近日，公司子公司长春金赛药业有限责任公司(以下 简称"金赛药业")收到国家药品监督管理局核准签发的《药品注册证书》，其申报的替勃龙片已在境内 获批上市。 替勃龙片是金赛药业研发的一种组织选择性雌性激素活性调节剂，属于化学药品4类口服片剂，用于治 疗妇女自然绝经和手术绝经所引起的低雌激素症状。替勃龙是一种人工合成的类固醇激素，主要成分为 替勃龙。替勃龙本身激素活性很弱，主要依赖于组织局部酶的活性和组织的特异性代谢机制，在不同组 织发挥不同的效应。替勃龙口服后迅速代谢成三种化合物而发挥其药理作用。3α-OH-替勃龙和3β-OH- 替勃龙两个代谢物具有雌激素样活性，而第三个代谢物替勃龙的Δ4–异构体具有孕激素和雄激素样活 性，进而改善绝经后女性由于雌激素水平下降而引起的一系列临床症状，如潮热等。 替勃龙片原研由N.V.Organon研发。金赛药业研发的替勃龙片是针对当前未满足的市场和临床需求研发 的一款仿制药。根据已完成的一项"中国绝经后健康女性受试者空腹/餐后单次口服替勃龙片和利维爱® 的单中心、随机、开放、两序列、四周期、完全重复交叉设计的生物等效性试验 ...

9月26日，据CDE官网显示，太极集团旗下西南药业提交的盐酸托莫西汀胶囊4类仿制上市申请已获受理，该产品原研于2024年1 月停止中国市场供应。据摩熵医药数据库显示，目前盐酸托莫西汀在国内主要有胶囊剂和口服溶液，其中，持有胶囊剂生产批 文的药企（进口+国产）达10家。 | 【神经系统药物】【2024】全终端医院销售额-正亚分析TOP10 | | | | --- | --- | --- | | O TOP10 O TOP50 | 数量降序 | 维度:MAH/生产企业 | 截图来源：CDE 盐酸托莫西汀（择思达）原研为礼来，2002年在美国上市，主要用于治疗儿童和青少年的注意缺陷/多动障碍（ADHD）的非兴 奋型药物，也是美国儿童青少年精神病协会（AACAP）推荐的治疗ADHD的一线药物。2007年，盐酸托莫西汀胶囊在中国获批 上市，与再普乐、百优解及欣百达并称为礼来在中国中枢神经产品线中的四大核心药品。摩熵医药数据显示，盐酸托莫西汀胶 囊在2021年全终端医院市场的销售额突破3亿元，同比增长率达46.64%，2025年（截至Q2）其销售额已超1亿元。 | 会播音 | 药品名称 | 药品类型 | 申请类型 | 注 ...

近日，上海市浦东新区人民政府官网发布了关于齐鲁制药创新药物全球研发总部项目设计方案公示。 根据此前签订的合作协议，齐鲁制药集团将在张江科学城建设齐鲁制药创新药物全球研发总部，项目选 址张江科学城民营经济总部园，总投资约30亿元。该总部将聚焦肿瘤、自身免疫、代谢、神经系统性疾 病等治疗领域，建立小分子药化精准设计、单抗/双特异性抗体、ADC、siRNA等创新平台。 齐鲁制药集团是中国大型综合性现代制药企业，专业从事治疗肿瘤、心脑血管、抗感染、精神系统、神 经系统、眼科疾病的制剂及其原料药的研制、生产与销售。集团总部位于山东省济南市，全国有十一大 生产基地、全球五大研发中心，下设12家子公司，形成药物研发、原料合成、制剂加工、产品包装、市 场销售的完整产业价值链。 建设单位上海齐鲁制药研究中心有限公司是齐鲁制药创新药物研究、人才培养、国际合作交流的综合平 台，负责齐鲁创新药研发的整体规划、创新药项目研发、以及与齐鲁海外研发公司的协同。 研发投入超43亿把药卖向全球 齐鲁制药是首批国家食品药品监督管理局GMP认证企业，其产品质量管控体系不仅符合国内高标准， 更与国际接轨。其中非无菌原料药(发酵、化学合成)、无菌原料 ...

Core Viewpoint - The company, Anglikang (002940), is focusing on optimizing its research and development (R&D) team to support the advancement of its innovative drug pipeline while primarily relying on a license-in strategy for the next 2-3 years [1] Group 1: R&D Strategy - The current R&D team is primarily structured for generic drug development [1] - The company has initiated recruitment and formation of clinical and medical teams to facilitate the clinical work of its innovative drug pipeline [1] - There are no plans for large-scale establishment of an innovative drug R&D team in the short term [1] Group 2: Collaboration and Talent Acquisition - The company maintains an open collaboration attitude and may consider bringing in strong professionals and teams that align with its philosophy [1] - The focus remains on enhancing the overall R&D capabilities of the company through strategic partnerships [1]

Core Viewpoint - Fujian Haixi New Drug Creation Co., Ltd. is seeking to list on the Hong Kong Stock Exchange after previously attempting to list on the Shenzhen Stock Exchange, indicating a strategic shift in its IPO plans [1][9]. Group 1: Company Background - Haixi New Drug was founded in 2012 by Kang Xinshan and Feng Yan, supported by state-owned shareholders [5][6]. - The company has a diverse product portfolio, primarily focusing on generic drugs for various diseases [9]. Group 2: Financial Performance - The company has achieved a remarkable compound annual growth rate (CAGR) of 48.4% in revenue over the past three years [2][10]. - Revenue figures for the years 2022 to 2024 are reported as 212 million, 317 million, and 467 million, with net profits of 69 million, 117 million, and 136 million respectively [10]. - The net profit margin has remained around 30%, with gross margins exceeding 81% for three consecutive years, reaching 84% in the first five months of 2025 [10]. Group 3: Product Pipeline and R&D - Haixi New Drug has received approval for 14 generic drugs from the National Medical Products Administration, with additional drugs in the ANDA stage expected to be approved by 2025 or 2026 [9][10]. - The company is developing four innovative drugs and holds a global patent portfolio of 36 patents [10]. Group 4: Financial Needs and IPO Purpose - As of May 31, 2025, the company had cash and cash equivalents of only 46.259 million, indicating a need for capital [11]. - The funds raised from the IPO will be used for R&D investment, enhancing commercialization capabilities, and improving operational systems [11].

Group 1: Company Overview - The company has seen significant revenue growth and steady profit improvement in its GNC China business, but there is still room for optimization in expense management [1] - The company plans to actively explore the potential of commercial contract promotion and implement various measures to reduce costs and improve efficiency, focusing on precise allocation of sales expenses [1] - The company aims to strengthen brand value and promote compliant, high-quality development of its GNC China business while closely monitoring market dynamics [1] Group 2: Market and Product Development - The orthopedic external patch market in China has exceeded 10 billion, with a compound annual growth rate of 9.55% driven by aging population and chronic disease management awareness [2] - The company is focusing on the development of traditional Chinese medicine combined with modern transdermal technology for its key prescription product, the wind-dispelling pain gel [2] - The company plans to continue digital and intelligent transformation of its traditional Chinese medicine production lines to enhance efficiency and responsiveness to national policy [2] Group 3: Future Product Pipeline - The company has received approval for a generic drug, lactulose oral solution, and is progressing with two other products through consistency evaluation [2] - Upcoming products expected to be approved in the next two years include oseltamivir phosphate dry suspension and iron protein succinate oral solution, among others [2] - The company will focus on major disease areas such as cardiovascular, digestive metabolism, respiratory, anti-infection, and anti-tumor, with an emphasis on developing medications for the elderly and children [2] Group 4: Financial Management - The company disclosed that its interest income comes solely from bank deposits, with no involvement in financial products or lending for interest income [3] - The company emphasizes a scientific and reasonable financial planning approach to maintain sufficient debt repayment capacity and a reasonable capital structure [3] - The company has established a budget management system to ensure that every expense has a responsible party and approval process, with regular evaluations and adjustments [3][4]

Investment Rating - The investment rating for the company is "Buy/Maintain" with a target price of 19, compared to the last closing price of 15.35 [1]. Core Insights - The company reported a revenue of 830 million yuan in Q1 2025, representing a year-on-year growth of 3.46%. However, the net profit attributable to shareholders decreased by 1.47% to 131 million yuan [4][5]. - The gross profit for Q1 2025 was 553 million yuan, with a gross margin of 66.64%, an increase of 0.60 percentage points compared to the same period last year. The sales expense ratio improved to 36.84%, down by 0.41 percentage points year-on-year [5]. - The company has a rich pipeline of generic drugs under development, with 87 projects as of last year-end. It is expected to submit a record number of generic drug applications this year, with an anticipated 20-30 new products approved annually, contributing to incremental revenue [5]. Financial Performance Summary - For the years 2025 to 2027, the company is projected to achieve revenues of 3.853 billion, 4.238 billion, and 4.662 billion yuan, respectively, with growth rates of 11.82%, 9.99%, and 10.00% [6][7]. - The net profit attributable to shareholders is expected to be 543 million, 632 million, and 728 million yuan for the same years, with growth rates of 11.19%, 16.32%, and 15.24% [6][7]. - The projected price-to-earnings (PE) ratios for 2025, 2026, and 2027 are 14, 12, and 10 times, respectively [6].