雌二醇片/雌二醇地屈孕酮片复合包装
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证券代码:002332 证券简称:仙琚制药 公告编号:2025-057
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-19 10:16
Core Viewpoint - The company has received a drug registration acceptance notice from the National Medical Products Administration for its combined packaging of estradiol tablets and estradiol/dydrogesterone tablets, marking a significant step in the domestic production registration process [1][2]. Group 1: Drug Registration Acceptance - The acceptance notice indicates that the registration work for the combined packaging of estradiol tablets and estradiol/dydrogesterone tablets has entered the evaluation stage [2]. - The reference formulation for the combined packaging is the original imported product, Femoston?, developed by Abbott B.V., which has been approved for sale in several countries including the Netherlands, Portugal, and Germany [1]. Group 2: Product Details - The combined packaging is indicated for the treatment of perimenopausal syndrome caused by natural or surgical menopause [1]. - The specifications of the company's application for the combined packaging are consistent with those of the already approved reference product [1]. Group 3: Impact on the Company - If the approval process is successful, it will enrich the company's product line and enhance its market competitiveness [2]. - The drug registration approval process has a certain time cycle and uncertainty, which the company acknowledges [2].
今日晚间重要公告抢先看——中金公司2025年半年度共计派发现金红利4.34亿元;海天味业特别分红预案,拟10派3元;西部矿业全资子公司取得采矿许可证,矿区拥有金金属量2.86吨
Jin Rong Jie· 2025-12-18 14:55
Group 1 - CICC announced a cash dividend distribution of 434 million yuan for the first half of 2025, with a per-share dividend of 0.09 yuan [10] - Haitian Flavoring proposed a special dividend plan, distributing 3 yuan for every 10 shares, totaling 1.754 billion yuan [16] - Xibu Mining's subsidiary obtained a mining license for a polymetallic mine with a gold metal content of 2.86 tons [2] Group 2 - Qibin Group's subsidiary plans to invest 600 million yuan to establish a new energy company in Shenzhen [2] - Jiangnan New Materials intends to invest 300 million yuan in a high-end copper-based core material R&D and industrialization project [4] - Tibet Pharmaceutical plans to repurchase shares worth 170 million to 200 million yuan for employee stock ownership plans [5] Group 3 - Nanjing Pharmaceutical plans to invest 120 million yuan to establish a medical device investment company [6] - Baotai received acceptance for the marketing application of BAT5906, a drug for wet age-related macular degeneration [7] - Nanhua Futures set the public offering price for H-shares at 12 HKD per share [8] Group 4 - Visionox plans to invest 3.918 billion yuan in the second phase of the Hefei Guoxian AMOLED production line project [9] - Dafu Technology intends to transfer 49% of Daosheng Graphite's equity at a base price of 206 million yuan [9] - Aorite passed the GMP compliance inspection for its production lines [9] Group 5 - Sichuan Road and Bridge reported that China Post Insurance increased its stake to 5% [11] - Huicheng Environmental Protection received approval for a private placement from the CSRC [12] - Junwei Electronics announced a joint venture with Placo New Materials in Hong Kong [13] Group 6 - Huayi Fragrance appointed Gao Ming as the deputy general manager [14] - Yongmota received a government subsidy of 17.2242 million yuan [15] - *ST Shuangcheng's injection of boron substituent has been approved by the FDA [19] Group 7 - Jiemai Technology invested in Beijing Critical Field Technology Co., focusing on high-temperature superconducting materials [20] - Xianju Pharmaceutical's drug registration application for a combination packaging product was accepted [21] - Qinglong Pipe Industry signed a contract worth 55.2671 million yuan for a water diversion project [31]
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]
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]
奥锐特:关于全资子公司获得药品注册批件的公告
Zheng Quan Ri Bao· 2025-11-25 12:46
Group 1 - The core point of the article is that Aorite has received a drug registration certificate for a combined packaging of estradiol tablets and estradiol/dydrogesterone tablets from the National Medical Products Administration [2] Group 2 - Aorite's wholly-owned subsidiary, Yangzhou Aorite Pharmaceutical Co., Ltd., is the entity that received the approval [2]
奥锐特(605116.SH):全资子公司获得药品注册批件
Ge Long Hui A P P· 2025-11-25 09:09
Core Viewpoint - Aorite (605116.SH) has received approval from the National Medical Products Administration for the registration of a combined packaging of estradiol tablets and dydrogesterone tablets, which is expected to enhance the company's market competitiveness and positively impact its operating performance [1] Group 1 - Aorite's wholly-owned subsidiary, Yangzhou Aorite, has been granted a drug registration certificate for the combined packaging of estradiol tablets and dydrogesterone tablets [1] - The drug, developed by Abbott B.V., is intended for the treatment of menopausal syndrome caused by natural or surgical menopause [1] - The combined packaging was initially approved for import in 2015 under the brand name "Feminine" [1] Group 2 - The new drug registration is classified under the new registration method for chemical drugs, which is expected to improve the company's competitive position in the pharmaceutical market [1] - The approval of this product for domestic sales is anticipated to have a positive effect on the company's financial performance [1]
奥锐特(605116.SH):雌二醇片/雌二醇地屈孕酮片复合包装获得药品注册批件
Ge Long Hui A P P· 2025-11-25 09:09
Core Viewpoint - The company, Aorite (605116.SH), has received approval from the National Medical Products Administration for a combined packaging of estradiol tablets and estradiol-dydrogesterone tablets, which is expected to enhance its market competitiveness and positively impact its financial performance [1]. Group 1 - Aorite's wholly-owned subsidiary, Yangzhou Aorite Pharmaceutical Co., Ltd., has obtained a drug registration certificate for the combined packaging of estradiol tablets and estradiol-dydrogesterone tablets [1]. - The approved product is intended for the treatment of perimenopausal syndrome caused by natural or surgical menopause [1]. - The registration of the product under the new classification method for chemical drugs is expected to improve the company's market position in this therapeutic area [1].
奥锐特:产品取得注册证
Sou Hu Cai Jing· 2025-11-25 08:57
Group 1 - The core point of the article is that Aorite Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for a new drug registration certificate for a combination packaging of estradiol tablets and estradiol-dydrogesterone tablets [1] - Aorite's revenue composition for the first half of 2025 is as follows: 85.12% from self-produced raw materials and intermediates, 11.64% from formulations, 2.74% from trade, and 0.5% from other businesses [1] - As of the report date, Aorite's market capitalization is 8.9 billion yuan [1] Group 2 - The article also mentions that another company, identified by its stock code 688496, is under investigation by the China Securities Regulatory Commission due to a significant loss exceeding 100 million yuan shortly after its IPO, with its main customer reducing purchases [1]
奥锐特子公司获雌二醇片/雌二醇地屈孕酮片复合包装注册批件
智通财经网· 2025-11-25 08:14
Core Viewpoint - Aorite (605116.SH) announced that its wholly-owned subsidiary, Yangzhou Aorite Pharmaceutical Co., Ltd., received a drug registration certificate from the National Medical Products Administration for a combination packaging of estradiol tablets and estradiol/dydrogesterone tablets, which is intended for the treatment of perimenopausal syndrome caused by natural or surgical menopause [1] Group 1 - The newly approved product, branded as "Aoshutong," is classified under the new registration category for chemical drugs, which enhances the company's market competitiveness in this pharmaceutical area [1] - The approval of this product is expected to have a positive impact on the company's operational performance due to its anticipated domestic market launch [1]