仙琚制药
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仙琚制药:雌二醇片/雌二醇地屈孕酮片复合包装药品注册申请获受理
Zheng Quan Ri Bao Wang· 2025-12-18 13:13
Core Viewpoint - Xianju Pharmaceutical (002332) has received a drug registration acceptance notice from the National Medical Products Administration for the combined packaging of estradiol tablets and estradiol-dydrogesterone tablets, indicating progress in its product development and regulatory approval process [1] Group 1 - The company announced the receipt of a drug registration acceptance notice for estradiol tablets and estradiol-dydrogesterone tablets [1] - The specifications of the combined packaging submitted by the company are consistent with those of the original approved products [1] - The application is classified under Category 4 of chemical drugs [1]
12月18日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-18 10:30
Group 1 - Shandong Zhanggu received administrative regulatory measures from the Shandong Securities Regulatory Commission due to issues related to related party transactions, information disclosure violations, improper use of raised funds, and non-compliance in corporate governance [1] - Nanjing Pharmaceutical plans to invest 120 million yuan to establish a medical device investment company, holding a 59.9% stake, which will focus on investing in Ningbo Jiangfeng Biological Information Technology Co., Ltd. [2] - ST Mingjia's stock will be suspended for one day on December 19 due to the implementation of its restructuring plan [3] Group 2 - Baotai's application for the marketing authorization of BAT5906 has been accepted by the National Medical Products Administration [4] - Nanhua Futures has set the final price for its H-share public offering at 12 HKD per share, with trading expected to begin on December 22 [5] - Visionox plans to invest 3.918 billion yuan in the second phase of capital contribution to Hefei Guoxian, increasing its shareholding to 37.73% [6] Group 3 - Dafu Technology intends to transfer 49% of its stake in Dasheng Graphite at a base price of 206 million yuan [7] - Aorite has passed the GMP compliance inspection for its production lines [8] - CICC announced a cash dividend distribution of 434 million yuan for the first half of 2025, with a dividend of 0.09 yuan per share [9][10] Group 4 - Sichuan Road and Bridge received a stake increase from Zhongyou Insurance, raising its holding to 5% [11] - Jinhua Co. plans to apply for a comprehensive credit line of 185 million yuan from Guangfa Bank [12] - Huicheng Environmental Protection's private placement has been approved by the China Securities Regulatory Commission [13] Group 5 - Junwei Electronics has established a joint venture with Placo New Materials in Hong Kong [14] - Huaye Fragrance appointed Gao Ming as the deputy general manager [15] - Yongmaotai received a government subsidy of 17.2242 million yuan, accounting for 45.92% of its net profit for the last audited fiscal year [16] Group 6 - Haitian Flavoring plans a special dividend of 3 yuan per 10 shares, totaling 1.754 billion yuan [17] - Haizheng Pharmaceutical's subsidiary received a new veterinary drug registration certificate [18] - Hailianxun's share swap merger with Hangzhou Qilun has been approved by the CSRC [19] Group 7 - ST Shuangcheng's injection of bortezomib ANDA has been approved by the US FDA [20] - Tibet Pharmaceutical plans to repurchase shares worth between 170 million and 200 million yuan [21] - Jiayuan Technology has set a preliminary transfer price of 39.93 yuan per share for its inquiry transfer [22] Group 8 - Jiemai Technology has invested in Beijing Critical Field Technology Co., Ltd. [23] - Zotye Auto plans to reach a settlement with SAIC Transmission Company regarding a contract dispute [24] - Xianju Pharmaceutical's application for the registration of estradiol tablets has been accepted [25] Group 9 - Xinya Electronics has established a subsidiary focused on urban rail transit technology [26] - Southern Precision has received a total credit line of 179 million yuan from ICBC and CCB [27] - Ningbo Construction's subsidiary won a 747 million yuan engineering project [28] Group 10 - Whirlpool plans to sign a supplementary agreement regarding component procurement with Whirlpool Corporation [29] - Haixiang New Materials intends to sell part of its under-construction factory for 41.3774 million yuan [30] - Menohua's subsidiary's atorvastatin calcium raw material drug application has been approved [31] Group 11 - Beilu Pharmaceutical plans to use up to 500 million yuan of idle funds for cash management [32] - Jiangnan New Materials plans to invest 300 million yuan in a high-end copper-based core material project [33] - Jinqilin's CRH380D train brake pads have passed small-scale trials [34] Group 12 - China Chemical signed contracts worth 352.569 billion yuan from January to November 2025 [35] - Guanghuan New Network plans to apply for an additional credit line of 300 million yuan [36] - Zhengye Technology signed a 120 million yuan equipment procurement contract [38] Group 13 - Xinno's subcutaneous injection of secukinumab has achieved primary endpoint success in its Phase III clinical trial [39] - Qinglong Pipe Industry signed a procurement contract worth 55.2671 million yuan [40]
仙琚制药(002332.SZ):雌二醇片/雌二醇地屈孕酮片复合包装药品注册申请获得受理
智通财经网· 2025-12-18 08:17
Core Viewpoint - The company, Xianju Pharmaceutical, has received a production registration acceptance notice from the National Medical Products Administration for its combined packaging of estradiol tablets and estradiol-dydrogesterone tablets, indicating progress in its product development and regulatory approval process [1] Group 1 - The company has announced the receipt of a production registration acceptance notice for estradiol tablets and estradiol-dydrogesterone tablets [1] - The combined packaging specifications submitted by the company are consistent with those of the original research products that have already been approved for market [1] - The application is classified under Category 4 of chemical drugs [1]
仙琚制药:雌二醇片/雌二醇地屈孕酮片复合包装药品注册申请获得受理
Xin Lang Cai Jing· 2025-12-18 08:16
Core Viewpoint - The company has received a drug registration acceptance notice from the National Medical Products Administration for a combined packaging of estradiol tablets and estradiol/dydrogesterone tablets, indicating a significant step towards market entry for these products [1] Group 1 - The product name is estradiol tablets/estradiol/dydrogesterone tablets combined packaging, with dosage forms including tablets [1] - Specifications include estradiol tablets containing 1mg and estradiol/dydrogesterone tablets containing 1mg of estradiol and 10mg of dydrogesterone, as well as estradiol tablets containing 2mg and estradiol/dydrogesterone tablets containing 2mg of estradiol and 10mg of dydrogesterone [1] - The application is for domestic production drug registration and marketing authorization, with acceptance numbers CYHS2504314 and CYHS2504315 [1]
仙琚制药(002332) - 关于雌二醇片、雌二醇地屈孕酮片复合包装药品注册申请获得受理的公告
2025-12-18 08:15
证券代码:002332 证券简称:仙琚制药 公告编号:2025-057 1 产品名称 剂型 规格 申请事项 受理号 雌二醇片/雌二醇 地屈孕酮片复合 包装 片剂 雌二醇片含雌二醇 1mg; 雌二醇地屈孕酮片含雌 二醇 1mg 和地屈孕酮 10mg 境内生产药品注 册上市许可 CYHS2504314 雌二醇片/雌二醇 地屈孕酮片复合 包装 片剂 雌二醇片含雌二醇 2mg; 雌二醇地屈孕酮片含雌 二醇 2mg 和地屈孕酮 10mg 境内生产药品注 册上市许可 CYHS2504315 一、受理通知书主要内容 多个国家上市销售。 本次公司申报的雌二醇片/雌二醇地屈孕酮片复合包装规格与原研已批准上 市的规格一致,按化学药品 4 类进行申报。 浙江仙琚制药股份有限公司 关于雌二醇片/雌二醇地屈孕酮片复合包装药品注册申请获得受 理的公告 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 管理局下发的雌二醇片/雌二醇地屈孕酮片复合包装境内生产药品注册受理通知 书,现将相关情况公告如下: 二、药品的相关情况 雌二 ...
仙琚制药:公司与奥默医药共同研发的新药奥美克松纳近期已递交相关制剂及原料药补充资料
Zheng Quan Ri Bao Wang· 2025-12-18 08:10
证券日报网讯12月17日,仙琚制药(002332)在互动平台回答投资者提问时表示,据了解,公司与奥默 医药共同研发的新药奥美克松纳近期已递交相关制剂及原料药补充资料,敬请投资者注意投资风险。 ...
仙琚制药:董事会换届选举人选综合考量合规性、专业性与治理效能等
Zheng Quan Ri Bao· 2025-12-18 07:49
证券日报网讯 12月17日,仙琚制药在互动平台回答投资者提问时表示,董事会换届选举人选综合考量 合规性、专业性与治理效能,兼顾性别、年龄、专业背景多元化,同时对履职能力要求能投入足够时间 精力,具备决策、统筹、公司治理等能力,兼顾管理团队稳定性。 (文章来源:证券日报) ...
仙琚制药(002332.SZ):克拉司酮原料药尚在国内申报准备阶段
Ge Long Hui· 2025-12-17 08:39
格隆汇12月17日丨仙琚制药(002332.SZ)在投资者互动平台表示,克拉司酮原料药尚在国内申报准备阶 段。 (原标题:仙琚制药(002332.SZ):克拉司酮原料药尚在国内申报准备阶段) ...
避孕药免税取消在即,解读来了
凤凰网财经· 2025-12-14 12:51
Core Viewpoint - The article discusses the potential price increase of contraceptive pills due to the adjustment of the VAT policy in China, effective from January 1, 2026, which will no longer exempt contraceptive products from VAT [2][4]. Group 1: VAT Policy Changes - The exemption from VAT for contraceptive drugs and devices has been in place since the 1990s, aimed at supporting family planning policies. The new VAT law will end this exemption, reflecting the government's shift towards encouraging childbirth and optimizing population structure [4]. - The removal of the VAT exemption will impact companies by increasing their cost structure, as they will no longer be able to deduct input VAT on raw materials and production equipment, leading to potential price increases for consumers [4][5]. Group 2: Market Impact and Pricing Strategies - Experts suggest that the increased tax burden may lead to a price hike in contraceptive products, but companies must balance consumer acceptance with their business goals. A differentiated pricing strategy is recommended, where products with high repurchase rates may see a controlled price increase of 3%-5% [6]. - The competitive landscape in the reproductive health industry is expected to intensify, with larger companies benefiting from economies of scale and better cost management, while smaller firms may struggle to maintain profitability [9]. Group 3: Market Trends and Projections - The contraceptive market is projected to reach 8.5 billion yuan by 2025, with a compound annual growth rate of 11.3%. The cancellation of the VAT exemption is anticipated to reshape market dynamics, favoring larger firms with scale advantages [9]. - The article highlights that the sales of the emergency contraceptive "Levonorgestrel" have seen a decline, with sales in physical pharmacies reaching 72 million yuan in the first half of 2025, a year-on-year decrease of 17.08% [7].
避孕药免税取消在即,解读来了
21世纪经济报道· 2025-12-14 04:35
Core Viewpoint - The upcoming adjustment in the value-added tax (VAT) policy for contraceptive drugs in China, effective January 1, 2026, is expected to impact pricing strategies and cost structures within the industry, potentially leading to price increases for these products [2][4][9]. Group 1: Tax Policy Changes - The exemption from VAT for contraceptive drugs and devices, in place since the 1990s, will be lifted, reflecting a shift in national policy aimed at encouraging childbirth and optimizing population structure [4][9]. - The new VAT law will allow companies to deduct input VAT but will also impose output VAT, creating cost pressures for manufacturers [4][5]. Group 2: Market Impact and Pricing Strategies - Experts suggest that the removal of the VAT exemption may lead to price increases, but companies will need to balance consumer acceptance with business objectives when adjusting prices [5][9]. - A differentiated pricing strategy is recommended, where products with high repurchase rates, like emergency contraceptives, could see limited price increases of 3%-5% to retain customer loyalty [5][9]. Group 3: Industry Dynamics - The contraceptive drug market is projected to grow to 8.5 billion yuan by 2025, with a compound annual growth rate of 11.3%, driven by policy and consumer demand [9]. - The competitive landscape is expected to shift, favoring larger companies that can leverage economies of scale and better manage costs, while smaller firms may struggle with price sensitivity and market consolidation pressures [9].