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仙琚制药(002332) - 关于收到炔雌醇环丙孕酮片一致性评价受理通知书的公告
2025-05-07 08:15
证券代码:002332 证券简称:仙琚制药 公告编号:2025-022 浙江仙琚制药股份有限公司 关于收到炔雌醇环丙孕酮片一致性评价受理通知书的公告 炔雌醇环丙孕酮片一致性评价申请被国家药品监督管理局受理,标志着该 品种一致性评价工作进入了审评阶段,公司将积极推进后续相关工作,如顺利 1 产品名称 剂型 规格 申请事项 受理号 炔雌醇环丙孕 酮片 片剂 每片含醋酸 环 丙 孕 酮 2mg 和炔雌 醇 0.035mg 境内生产药品一致性评价申 请:国家药品监管部门规定需 要审批的补充申请事项(一致 性评价)。 CYHB2550185 一、受理通知书主要内容 通过一致性评价将增加其市场竞争力。药品一致性评价工作流程有一定时间周 期,存在不确定性因素,敬请广大投资者审慎决策,注意投资风险。 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 管理局下发的炔雌醇环丙孕酮片一致性评价受理通知书,现将相关情况公告如下: 二、炔雌醇环丙孕酮片的相关情况 本次申报的炔雌醇环丙孕酮片每片含醋酸环丙孕酮 2mg 和炔 ...
仙琚制药被罚没1.95亿疑延迟披露 营收止步40亿净利两连降股价跌40%
Chang Jiang Shang Bao· 2025-05-06 23:27
对于这一重大信息,投资者质疑仙琚制药存在延迟披露问题。 仙琚制药在4月23日披露的2024年年报中进行了披露,并确认了预计负债和相关损失。 而早在4月21日,仙琚制药就收到了相关部门拟处罚的告知书。对此,仙琚制药没有进行单独披露。 受上述事项影响,2024年,仙琚制药归属于母公司股东的净利润(简称"归母净利润")同比下降近30%, 为3.97亿元。这已是公司归母净利润连续两年快速下降。 仙琚制药是一家老牌制药企业,公司的发展愿景为"成为全世界前十名的甾体药物供应商"。 不过,公司经营业绩处于止步不前状态。2020年至2024年的五个年度,公司营业收入在40亿元左右波 动,增长乏力。 垄断原料药被罚没近2亿 垄断原料药,仙琚制药(002332)(002332.SZ)收到了大额罚单。 5月5日晚,仙琚制药发布公告称,4月30日,公司收到天津市市场监督管理委员会下发的《行政处罚决 定书》,公司因涉及垄断地塞米松磷酸钠原料药价格,被罚没约1.95亿元。 在2024年业绩说明会上,多名参会投资者质疑"收到近2亿元的处罚通知,不公告,暗箱操作"。对此, 仙琚制药相关负责人没有作出具体解释。 仙琚制药在公告中表示,本次行政 ...
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]
Neuralink脑机接口设备获FDA“突破性设备”认证;恒瑞医药通过港交所上市聆讯丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-05-05 23:35
Group 1 - Heng Rui Pharmaceutical has officially passed the Hong Kong Stock Exchange listing hearing, with the potential to be listed as early as May [1] - The listing represents a significant step in Heng Rui's internationalization strategy, following its IPO in the A-share market [1] - The company aims to leverage the larger growth opportunities in overseas markets as part of its "innovation + internationalization" dual-driven strategy [1] Group 2 - Neuralink's brain-computer interface device Link has received FDA "breakthrough device" designation, aimed at providing communication solutions for patients with severe speech impairments [2] - This designation will expedite the review process, marking a significant advancement for Neuralink in the brain-computer interface field [2] - However, this certification does not equate to market approval, and further clinical validation and safety assessments are required [2] Group 3 - Novo Nordisk's oral version of the weight loss drug Wegovy has had its application accepted by the FDA, with a decision expected in Q4 [3] - If approved, it will be the first oral GLP-1 receptor agonist for chronic weight management globally, potentially enhancing Novo Nordisk's competitive position in the weight loss market [3] - The oral formulation addresses issues of injection adherence among patients, indicating a broad market opportunity if approved [3] Group 4 - Xianju Pharmaceutical has received an administrative penalty of 195 million yuan for engaging in price-fixing agreements that restricted competition in the market for dexamethasone phosphate raw materials [4] - This significant fine reflects the increasing regulatory scrutiny and enforcement against anti-competitive practices in the pharmaceutical sector [4] - The penalty is expected to have a substantial negative impact on Xianju's short-term performance and highlights weaknesses in the company's compliance framework [4] Group 5 - Yong'an Pharmaceutical's chairman Chen Yong is under investigation and has been detained, although the company states that its operations and management remain stable [5] - The investigation may affect the market's perception of the company's credibility and management stability [5] - Despite assurances of normal operations, there may be short-term pressure on the company's stock price due to the uncertainty surrounding the investigation [5]
Wind风控日报 | 特朗普拟对在外国制作的电影征收100%关税
Wind万得· 2025-05-05 22:30
Group 1: Corporate Investigations and Issues - China Copper Industry Co., Ltd. director Li Lianbing is under investigation for serious violations of discipline and law [3] - Yong'an Pharmaceutical's actual controller and chairman Chen Yong is under investigation and has been detained [6] - Xianju Pharmaceutical received an administrative penalty of 195 million yuan for price-fixing agreements with competitors [10] Group 2: Corporate Transactions and Financial Warnings - AVIC Capital plans to transfer shares of AVIC Xi'an Aircraft Industry Group and AVIC Avionics to its controlling shareholder for 4.067 billion yuan [7] - Jiangsu Wuzhong's stock will be subject to additional risk warnings due to an audit report with no opinion and non-operational fund occupation by related parties [8] - Tianmao Group and Jinlitai are both unable to disclose their periodic reports on time, leading to stock suspensions [10][11] Group 3: Industry Trends and Changes - Several automotive companies, including Li Auto, Xiaomi, NIO, and Xpeng, are shifting their marketing language from "smart driving" to "assisted driving" [21]
兴业银锡拟收购大西洋锡业有限公司;永安药业实控人陈勇被实施留置 | 公告精选
Mei Ri Jing Ji Xin Wen· 2025-05-05 13:34
Mergers and Acquisitions - Xingye Yinxin plans to acquire Atlantic Tin Company for approximately 4.54 billion RMB, with a total investment of about 0.98 million AUD at a price of 0.24 AUD per share [1] - Electric Power Investment Energy is undergoing an asset restructuring with its actual controller, State Power Investment Corporation, involving the acquisition of Inner Mongolia Baiyin Hua Coal Power equity [2] - Huibo Yuntong intends to purchase control of Baode Computer System Co., Ltd. through a combination of share issuance and cash payment, with details to be disclosed in a restructuring report [3] Share Buybacks and Increases - Kesi Technology plans to repurchase shares worth between 30 million and 50 million RMB, using self-owned funds for employee stock ownership plans or capital reduction [4] - Fuchuang Precision's major shareholder, Shenyang Advanced Manufacturing Technology Industry Co., Ltd., aims to increase its stake in the company by 1.2 billion to 2.4 billion RMB over the next 12 months [5] Regulatory and Compliance Issues - Yong'an Pharmaceutical's actual controller and chairman, Chen Yong, is under investigation and has been detained, with the company monitoring the situation closely [6] - *ST Gongzhi received a notice of termination of listing due to financial reporting issues, including an audit report with no opinion expressed for the 2024 fiscal year [8] - Xianju Pharmaceutical was fined 195 million RMB for engaging in monopolistic practices related to the pricing of dexamethasone phosphate sodium raw materials [9] - *ST Hengli failed to disclose periodic reports within the legal timeframe, leading to potential termination of its stock listing [10] - Tianmao Group also failed to disclose its periodic reports on time, resulting in stock suspension [11]
仙琚制药,被罚没1.95亿元
Zhong Guo Ji Jin Bao· 2025-05-05 12:08
Core Viewpoint - Xianju Pharmaceutical has been fined a total of 195 million yuan due to a monopoly agreement with competitors, which significantly impacts its net profit for 2024, accounting for nearly 50% of the projected net profit [2][5][6]. Financial Impact - The total penalty of 195 million yuan includes the confiscation of illegal gains of 23.7467 million yuan and a fine of 171.6 million yuan, which is 8% of the company's 2023 sales [2][5]. - This penalty represents 4.88% of the company's audited revenue for 2024, which is 4.007 billion yuan, and 49.17% of the net profit attributable to shareholders, which is 397 million yuan [5][6]. Company Performance - For the year 2024, Xianju Pharmaceutical reported a revenue of 4.007 billion yuan, a decrease of 2.98% year-on-year, and a net profit of 397 million yuan, down 29.46% year-on-year [8]. - The net profit excluding non-recurring gains and losses was 549 million yuan, reflecting a year-on-year increase of 2.15% [8]. - The net cash flow from operating activities was 399 million yuan, a decrease of 33.05% year-on-year [8]. Compliance and Remediation - Xianju Pharmaceutical has implemented several corrective measures, including stopping the illegal pricing behavior, adjusting the prices of dexamethasone phosphate sodium raw materials, and enhancing internal compliance management [9]. - The company has established an antitrust compliance management guideline and conducted comprehensive risk assessments and specialized training to strengthen compliance [2][9]. Market Position - As of April 30, the stock price of Xianju Pharmaceutical was 8.98 yuan, with a total market capitalization of 8.883 billion yuan [9].
仙琚制药:收到行政处罚决定书 被罚没1.95亿元
news flash· 2025-05-05 07:58
Core Viewpoint - Xianju Pharmaceutical has been fined a total of 195 million yuan due to anti-competitive practices related to the pricing of dexamethasone phosphate sodium raw materials, which involved collusion with competitors [1] Summary by Relevant Sections Administrative Penalty - The company received an administrative penalty decision from the Tianjin Municipal Market Supervision Administration on April 30, 2025 [1] - The total penalty includes the confiscation of illegal gains amounting to 23.7467 million yuan and a fine of 171 million yuan, which is 8% of the company's sales in 2023, leading to a total of 195 million yuan in penalties [1] Impact on Company Operations - The main responsible person of the company, Zhang Yusong, has been fined 600,000 yuan [1] - The company confirmed that this penalty does not trigger any major illegal circumstances that would lead to forced delisting, although it will have a negative impact on the current financial statements [1] - Despite the penalty, the company asserts that it will not affect normal operations and development [1] Compliance Measures - In response to the penalty, the company has developed antitrust compliance management guidelines and an employee compliance manual [1] - The company has initiated a comprehensive risk assessment and specialized training to strengthen antitrust compliance management [1]
仙琚制药(002332) - 关于公司收到行政处罚决定书的公告
2025-05-05 07:45
证券代码:002332 证券简称:仙琚制药 公告编号:2025-021 浙江仙琚制药股份有限公司 关于公司收到行政处罚决定书的公告 政府申请复议;或者自收到本行政处罚决定书之日起六个月内,依法向天津市第 三中级人民法院提起行政诉讼。行政复议或者行政诉讼期间,本行政处罚决定不 停止执行。 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚 假记载、误导性陈述或重大遗漏。 浙江仙琚制药股份有限公司(以下简称"公司")于2025年4月30日收到天津 市市场监督管理委员会下发的《行政处罚决定书》(津市监垄处[2025]2号), 现将相关情况公告如下: 一、 决定书主要内容 天津市市场监督管理委员会认为,公司与具有竞争关系的其他经营者,以垄 断协议形式变更、固定地塞米松磷酸钠原料药价格,排除限制了地塞米松磷酸钠 原料药销售领域的竞争,违反了《中华人民共和国反垄断法》第十七条第(一) 项的规定,属于达成并实施"固定或者变更商品价格"垄断协议的行为,应当依 据《反垄断法》第五十六条的规定依法追究法律责任。张宇松作为公司主要负责 人,全面主持工作及战略部署,应当依法合规开展经营,严格遵守《反垄断法》 的规定,主 ...
仙琚制药(002332):业绩短期承压 成长动力充足
Xin Lang Cai Jing· 2025-04-29 02:43
Core Insights - The company faced revenue pressure but significantly improved profitability, with a 2024 revenue of 4.001 billion yuan (down 2.98% year-on-year) and a net profit of 397 million yuan (down 29.46% year-on-year) [1] - The company reported a gross margin of 57.49% for 2024, an increase of 4.61 percentage points, attributed to a higher proportion of high-margin formulations and optimized raw material costs [1] Revenue Breakdown - In 2024, the formulation sales revenue was 2.415 billion yuan (up 6.02% year-on-year), with significant growth in anesthetic muscle relaxants (up 55%) and respiratory products (up 31%), while generic drug formulation revenue decreased by 19% [2] - Raw material and intermediate revenue fell to 1.547 billion yuan (down 13.4% year-on-year), primarily due to intensified competition and price declines in the non-standard market [2] Growth Potential - The company has a strong pipeline with four new generic drug approvals in 2024, including the first domestic generic version of estradiol valerate tablets [3] - The company is expanding internationally, with raw materials like medroxyprogesterone acetate receiving WHO PQ certification and prednisone receiving PMDA certification in Japan [3] - Earnings per share forecasts for 2025-2027 have been adjusted to 0.69, 0.80, and 0.97 yuan, respectively, with a target price of 11.04 yuan based on a 16x P/E ratio for 2025 [3]