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仙琚制药:关于甲硫酸新斯的明注射液通过一致性评价的公告
2024-10-14 08:17
证券代码:002332 证券简称:仙琚制药 公告编号:2024-041 浙江仙琚制药股份有限公司 关于甲硫酸新斯的明注射液通过一致性评价的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有 虚假记载、误导性陈述或重大遗漏。 浙江仙琚制药股份有限公司(以下简称"公司")于近日收到国家药品 监督管理局核准签发的关于甲硫酸新斯的明注射液的《药品补充申请批准通 知书》(通知书编号:2024B04713 2024B04714),公司甲硫酸新斯的明注 射液通过仿制药质量和疗效一致性评价。现将相关情况公告如下: 申请内容:申报仿制药质量和疗效一致性评价。 审批结论:根据《中华人民共和国药品管理法》、《国务院关于改革药 品医疗器械审评审批制度的意见》(国发〔2015〕44号)、《关于仿制药质 量和疗效一致性评价工作有关事项的公告》(2017年第100号)和《国家药监 局关于开展化学药品注射剂仿制药质量和疗效一致性评价工作的公告》(2020 年第62号)的规定,经审查,本品通过仿制药质量和疗效一致性评价,并同 意批准本品增加4ml:2mg规格的补充申请,核发药品批准文号。 二、药品的其他相关情况 由于药品研发 ...
仙琚制药:制剂销售稳健增长,奥美克松钠申报在即
海通证券· 2024-10-14 06:41
Investment Rating - The investment rating for Xianju Pharmaceutical (002332) is "Outperform the Market" [1]. Core Insights - The company achieved a revenue of 2.183 billion yuan in the first half of 2024, with a year-on-year growth of 0.93%, and a net profit of 340 million yuan, reflecting a year-on-year increase of 12.56% [5]. - The sales of formulations showed steady growth, with a revenue of 1.215 billion yuan in the first half of 2024, up by 10.6% year-on-year. The company is preparing to submit a New Drug Application (NDA) for its new product, Omecamtiv Mecarbil Sodium [5]. - The raw material drug sales revenue was 910 million yuan, down by 9% year-on-year, but the company managed to overcome price declines through increased sales volume [5]. - The company is expected to see revenue growth of -3% in 2024, followed by 5% and 6% in 2025 and 2026, respectively, driven by stabilizing raw material drug demand and new product launches in formulations [5]. Financial Performance - The projected revenues for 2024, 2025, and 2026 are 4.453 billion yuan, 5.124 billion yuan, and 5.834 billion yuan, respectively, with net profits expected to be 700 million yuan, 846 million yuan, and 972 million yuan [6][10]. - The earnings per share (EPS) are forecasted to be 0.71 yuan, 0.86 yuan, and 0.98 yuan for the years 2024, 2025, and 2026 [6][10]. - The gross margin is expected to stabilize at around 55% from 2024 to 2026, with a net asset return rate projected to increase from 11.5% in 2024 to 14.0% in 2026 [10][11]. Business Segmentation - The company’s revenue from raw materials is projected to be 1.733 billion yuan in 2024, with a slight decline of 3%, while the chemical formulations are expected to generate 2.658 billion yuan, reflecting a growth of 17% [8]. - The company is focusing on three major innovation technology platforms for formulations: pulmonary inhalation platform, long-acting formulation technology platform, and suspension formulation technology platform [5].
仙琚制药:甾体类全链条龙头,制剂新品种商业化潜力可观
天风证券· 2024-10-11 06:30
Investment Rating - The report assigns a "Buy" rating for the company, with a target price of 17.37 CNY per share, based on a 20x PE for 2025 [6]. Core Insights - The company, Xianju Pharmaceutical, is a leading player in the steroid drug sector, focusing on both raw materials and formulations, with significant potential for new product commercialization [1][4]. - The steroid raw material market is broad, with stabilizing prices expected to boost the company's performance in the raw material segment [2]. - The company is gradually overcoming the impact of centralized procurement on its existing products, with a positive outlook for its main products [3]. - New product development is progressing well, with several innovative products expected to drive future growth [4][5]. Summary by Sections 1. Company Overview - Xianju Pharmaceutical specializes in steroid raw materials and formulations, maintaining an integrated business model [1][16]. - The company has a stable base of existing products and a promising pipeline of new products [1]. 2. Raw Materials - The steroid raw material market is characterized by high concentration and stabilizing prices, which are expected to enhance the company's performance [2][34]. - The company has a significant market share in the steroid raw material sector, with a broad application range for these drugs [31]. 3. Formulations - The company is gradually overcoming the negative effects of centralized procurement on its existing products, with sales of key products expected to recover [3][21]. - The main product, Mometasone Furoate nasal spray, is projected to grow by 30% in H1 2024, indicating a favorable competitive landscape [3][24]. 4. New Products - The company is advancing its innovative product pipeline, with several new products showing strong commercial potential [4][5]. - Key products in development include the combination of new respiratory drugs and gynecological products, with expected market launches in the coming years [4][5]. 5. Financial Forecast and Valuation - The company is expected to achieve revenues of 45.70 billion CNY, 52.10 billion CNY, and 59.95 billion CNY for 2024, 2025, and 2026, respectively, with corresponding net profits of 6.70 billion CNY, 8.59 billion CNY, and 10.64 billion CNY [5][6]. - The financial outlook reflects a recovery trajectory, with anticipated growth rates of 10.83%, 14.00%, and 15.07% for the respective years [5].
仙琚制药:上海市锦天城律师事务所关于仙琚制药2024年第一次临时股东大会法律意见书
2024-09-19 08:47
上海市锦天城律师事务所 关于浙江仙琚制药股份有限公司 2024 年第一次临时股东大会的 法律意见书 地址:上海市浦东新区银城中路 501 号上海中心大厦 9/11/12 楼 电话:021-20511000 传真:021-20511999 邮编:200120 上海市锦天城律师事务所 法律意见书 上海市锦天城律师事务所 关于浙江仙琚制药股份有限公司 2024 年第一次临时股东大会的 法律意见书 致:浙江仙琚制药股份有限公司 上海市锦天城律师事务所(以下简称"本所")接受浙江仙琚制药股份有限 公司(以下简称"公司"或"仙琚制药")委托,就公司召开 2024 年第一次临时 股东大会(以下简称"本次股东大会")的有关事宜,根据《中华人民共和国公 司法》(以下简称《公司法》)、《上市公司股东大会规则》等法律、法规、规章和 其他规范性文件以及《浙江仙琚制药股份有限公司章程》(以下简称"《公司章程》") 的有关规定,出具本法律意见书。 为出具本法律意见书,本所及本所律师依据《律师事务所从事证券法律业务 管理办法》和《律师事务所证券法律业务执业规则(试行)》等规定,严格履行 了法定职责,遵循了勤勉尽责和诚实信用原则,对本次股东 ...
仙琚制药:仙琚制药2024年第一次临时股东大会决议公告
2024-09-19 08:45
2024年第一次临时股东大会决议公告 本公司及董事会全体成员保证信息揭露的内容真实、准确、完整,没有虚假记 载、误导性陈述或重大遗漏。 特别提示: 1、本次股东大会未出现否决议案的情形; 2、本次股东大会不涉及变更前次股东大会已通过的决议。 一、会议召开和出席情况 (一)会议召开情况 股票代码:002332 股票简称:仙琚制药 公告编号:2024-040 浙江仙琚制药股份有限公司 1、会议召开时间: 现场会议召开时间为:2024年9月19日下午14:30 网络投票时间为:2024年9月19日 其中,通过深圳证券交易所交易系统进行网络投票时间为2024年9月19日 9:15-9:25,9:30-11:30 和 13:00-15:00;通过深圳证券交易所互联网投票系统开 始投票的时间为2024年9月19日9:15- 15:00。 2、现场会议召开地点:浙江仙琚制药股份有限公司会议室; 3、会议召集人:公司董事会; 4、会议方式:本次股东大会采取现场投票和网络投票相结合的方式; 5、现场会议主持人:公司董事长张宇松先生; 1、出席会议股东总体情况 参加本次股东大会现场会议及网络投票的股东及股东代理人共249人,代表 ...
仙琚制药:制剂放量恢复,费用管控提升盈利能力
广发证券· 2024-09-18 10:38
Investment Rating - The investment rating for the company is "Buy" with a current price of 11.71 CNY and a fair value of 13.73 CNY [1]. Core Insights - The company's formulation sales have stabilized after the impact of centralized procurement, with new products gradually gaining traction. In the first half of 2024, the company achieved operating revenue of 2.138 billion CNY, a year-on-year increase of 0.93%, and a net profit attributable to shareholders of 340 million CNY, up 12.56% year-on-year [2]. - The sales revenue from formulation products reached 1.215 billion CNY, reflecting a growth of 10.6% year-on-year, while the sales revenue from APIs and intermediates was 910 million CNY, down 9% year-on-year [2]. - The company is actively enhancing its core competitiveness, with a mature sales system. The growth in formulation products is primarily driven by overcoming the impact of centralized procurement, with new products showing significant growth [2]. Financial Performance Summary - For the first half of 2024, the company reported a net profit of 340 million CNY, with a year-on-year growth of 12.56%. The adjusted net profit was 331 million CNY, up 11.78% year-on-year [2]. - The company forecasts net profits of 679 million CNY, 808 million CNY, and 969 million CNY for 2024, 2025, and 2026 respectively, corresponding to PE ratios of 17, 14, and 12 times [2]. - The company’s operating revenue is projected to grow from 4.419 billion CNY in 2024 to 5.626 billion CNY in 2026, with growth rates of 7.2% and 14.6% respectively [3][5].
仙琚制药(002332) - 仙琚制药投资者关系管理信息
2024-09-04 01:37
证券代码:002332 证券简称:仙琚制药 浙江仙琚制药股份有限公司投资者关系活动记录表 编号:2024-08 | --- | --- | --- | --- | --- | --- | |-------------------------------|----------------------------------------------------------------|--------|----------|---------------------------------------------|----------------------------------------------------------| | 投资者关系活动 \n类别 \n | 特定对象调研 \n 媒体采访 \n□新闻发布会 □路演活动 \n□现场参观 | | | 现场会议□分析师会议 \n□业绩说明会 \n 其他 | 电话会议 | | 参与单位名称 | 中泰证券 | 祝嘉琦 | 中泰证券 | 李雨蓓 | 华泰证券 李奕玮 | | | 浙商医药 | 盖文化 | 浙商医药 | 郭双喜 | 永赢基金 单林 | | | 永赢基 ...
仙琚制药:利润环比加速增长,经营趋势不断向好
中泰证券· 2024-09-02 08:31
利润环比加速增长,经营趋势不断向好 [Table_Title] 评级:买入(维持) [Table_Finance] 公司盈利预测及估值 指标 2022A 2023A 2024E 2025E 2026E 营业收入(百万元) 4379.83 4123.42 4303.91 4783.73 5453.78 增长率 yoy% 0.52% -5.85% 4.38% 11.15% 14.01% 净利润(百万元) 749.41 563.08 678.44 821.28 1005.79 增长率 yoy% 21.00% -24.86% 20.49% 21.05% 22.47% 每股收益(元) 0.76 0.57 0.69 0.83 1.02 每股现金流量 0.62 0.60 0.86 0.98 1.12 净资产收益率 13.73% 9.73% 11.07% 12.15% 13.37% P/E 14.98 19.94 16.55 13.67 11.16 PEG 0.71 -0.80 0.81 0.65 0.50 P/B 2.06 1.94 1.83 1.66 1.49 备注:数据截至 2024.08.30 市场价格:11.50 ...
仙琚制药:制剂集采影响逐步出清,多重催化有望带来新一轮增长
德邦证券· 2024-09-01 12:01
[Table_Main] 证券研究报告 | 公司点评 仙琚制药(002332.SZ) 2024 年 09 月 01 日 望带来新一轮增长 买入(维持) 所属行业:医药生物/化学制药 当前价格(元):11.50 证券分析师 周新明 资格编号:S0120524060001 邮箱:zhouxm@tebon.com.cn 吴明华 资格编号:S0120524050002 邮箱:wumh3@tebon.com.cn 市场表现 -11% 0% 11% 23% 仙琚制药 沪深300 -23% | --- | --- | --- | --- | |--------------------------------|---------|---------|-------| | -34% 2023-09 | 2024-01 | 2024-05 | | | 沪深 300 对比 | 1M | 2M | 3M | | 绝对涨幅 (%) | -4.49 | 0.79 | -3.08 | | 相对涨幅 (%) | -0.98 | 4.84 | 4.14 | | 资料来源:德邦研究所,聚源数据 | | | | 相关研究 1.《仙琚制药(0023 ...
仙琚制药:2024年中报点评:盈利改善 制剂有望进入增长新周期
东方证券· 2024-09-01 11:11
盈利改善,制剂有望进入增长新周期 ——仙琚制药 2024 年中报点评 核心观点 ⚫ 上半年业绩稳定,盈利能力回升。公司发布 24 年中报,实现营业收入 21.38 亿元 (同比+0.93%),归母净利润 3.40 亿元(同比+12.56%),扣非归母净利润 3.31 亿元(同比+11.78%)。分季度来看,2024 年 Q2 单季度实现营业收入 11.00 亿元 (同比-5.25%),归母净利润 1.89 亿元(同比+11.80%),扣非归母净利润 1.86 亿 元(同比+13.35%)。公司 24H1 总体业绩维持稳定,盈利能力有所回升,主要系集 采影响逐步降低,运营效率提升,成本竞争力优化导致毛利率增加。 ⚫ 集采影响逐渐出清,制剂板块进入加速增长周期。24H1 公司制剂销售收入 12.15 亿 元(同比+10.6%),其中妇科计生类收入 2.33 亿元(同比-1%),麻醉肌松类收入 0.63 亿元(同比+28%),呼吸类收入 3.93 亿元(同比+30%),皮肤科产品收入 1.2 亿元(同比+26%),普药产品收入 3 亿元(同比-6%)。各领域产品集采影响 减弱,新产品放量叠加市场开拓驱动加速增长新周 ...