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华海药业:关于获得药品注册证书的公告
Zheng Quan Ri Bao· 2026-02-24 12:43
证券日报网讯 2月24日,华海药业发布公告称,公司于近日收到国家药品监督管理局核准签发的马来酸 曲美布汀片的《药品注册证书》。 (文章来源:证券日报) ...
华海药业取得一项药品注册证书
Zhi Tong Cai Jing· 2026-02-24 12:19
华海药业(600521)(600521.SH)公告,公司近日收到国家药品监督管理局核准签发的马来酸曲美布汀 片的《药品注册证书》。马来酸曲美布汀片用于胃肠道运动功能紊乱引起的食欲不振、恶心、呕吐、嗳 气、腹胀、腹鸣、腹痛、腹泻、便秘等症状的改善和肠易激综合征。 ...
华海药业:获得马来酸曲美布汀片《药品注册证书》
Xin Lang Cai Jing· 2026-02-24 08:29
华海药业公告称,近日收到国家药监局核准签发的马来酸曲美布汀片的《药品注册证书》,批准文号为 国药准字H20263372。该药品用于改善胃肠道运动功能紊乱症状和肠易激综合征,2025年国内市场销售 金额预计约3.4亿元。截至目前,公司在该药品研发上已投入约1010万元。获批产品可视同通过一致性 评价,将丰富产品线、提升竞争力,但生产和销售易受政策、市场等因素影响。 ...
华海药业(600521.SH)取得一项药品注册证书
智通财经网· 2026-02-24 08:23
智通财经APP讯,华海药业(600521.SH)公告,公司近日收到国家药品监督管理局核准签发的马来酸曲 美布汀片的《药品注册证书》。马来酸曲美布汀片用于胃肠道运动功能紊乱引起的食欲不振、恶心、呕 吐、嗳气、腹胀、腹鸣、腹痛、腹泻、便秘等症状的改善和肠易激综合征。 ...
“膏药大王”豪掷4亿元进军镇痛领域
Shen Zhen Shang Bao· 2025-12-12 07:41
Group 1 - Company JiuDian Pharmaceutical (九典制药) announced an investment of up to 400 million yuan to acquire technology for a new analgesic drug YJ2301 from Suzhou Yuanju Pharmaceutical Technology Co., Ltd. This acquisition aims to enrich the product pipeline and promote the transformation into innovative drugs [1] - The transaction includes a milestone payment of up to 11 million yuan, with the total transfer fee not exceeding 400 million yuan, structured through milestone payments and sales commissions [1] - The YJ2301 project has completed part of its preclinical research and has submitted relevant patent applications, with the goal of enhancing the company's R&D capabilities and long-term core competitiveness [1] Group 2 - JiuDian Pharmaceutical received a drug registration certificate for Trimebutine Maleate Tablets from the National Medical Products Administration, which is used to improve symptoms of irritable bowel syndrome [2] - The sales figures for Trimebutine Maleate Tablets are projected to be 276 million yuan, 292 million yuan, and 266 million yuan for the years 2022, 2023, and 2024, respectively [2] - The company has a strong presence in the chemical drug patch market, with its two core products, Loxoprofen Sodium Gel Patch and Ketoprofen Gel Patch, ranking first in sales in public hospitals in urban and county-level areas in 2023 and 2024 [2] Group 3 - JiuDian Pharmaceutical faced increased sales pressure due to competition, with operating expenses reaching 1.229 billion yuan in the first three quarters of the year, resulting in a cost ratio of 54.20% [3] - The company reported total revenue of 2.268 billion yuan, a year-on-year increase of 5.69%, while net profit attributable to shareholders decreased by 9.64% to 406 million yuan [3] - For 2024, the company anticipates revenue of 2.931 billion yuan, an increase of 8.85%, and a net profit of 512 million yuan, reflecting a growth of 39.13% [3] Group 4 - As of the market close on December 12, JiuDian Pharmaceutical's stock price was 15.61 yuan per share, with a total market capitalization of 7.81 billion yuan [4]
九典制药:产品取得注册证,产品名称为“马来酸曲美布汀片”
Sou Hu Cai Jing· 2025-12-11 13:33
Company Overview - JiuDian Pharmaceutical (SZ 300705) announced on December 11 that it has received a drug registration certificate from the National Medical Products Administration for its product "Malaise Acid Trimebutine Tablets" [1] - As of the announcement, JiuDian Pharmaceutical has a market capitalization of 7.8 billion yuan [1] Revenue Composition - For the first half of 2025, the revenue composition of JiuDian Pharmaceutical is as follows: - Pharmaceutical preparations account for 82.47% - Raw materials account for 7.65% - Pharmaceutical excipients account for 6.03% - Plant extracts and others account for 3.16% - Technology transfer and services account for 0.63% [1]
九典制药获得马来酸曲美布汀片药品注册证书
Zhi Tong Cai Jing· 2025-12-11 13:29
Core Viewpoint - JiuTian Pharmaceutical (300705.SZ) has received the drug registration certificate for Trimebutine Maleate Tablets from the National Medical Products Administration, indicating a significant step in expanding its product portfolio in the gastrointestinal treatment market [1] Group 1: Product Information - Trimebutine Maleate Tablets are indicated for the treatment of irritable bowel syndrome and gastrointestinal motility disorders, addressing symptoms such as loss of appetite, nausea, vomiting, belching, bloating, abdominal rumbling, abdominal pain, diarrhea, and constipation [1] - The drug was first approved for market release in France in 1970 and is currently available in various forms including tablets, capsules, and dry mixed suspensions in both domestic and international markets [1]
九典制药(300705.SZ)获得马来酸曲美布汀片药品注册证书
智通财经网· 2025-12-11 13:29
Core Viewpoint - The company, Jiutian Pharmaceutical, has received the drug registration certificate for Maleate Trimebutine Tablets from the National Medical Products Administration, indicating a significant regulatory approval for a product aimed at treating gastrointestinal disorders [1] Group 1: Product Information - Maleate Trimebutine Tablets are indicated for the treatment of irritable bowel syndrome and gastrointestinal motility disorders, addressing symptoms such as loss of appetite, nausea, vomiting, belching, bloating, abdominal rumbling, abdominal pain, diarrhea, and constipation [1] - The drug was first approved for market release in France in 1970 and is currently available in various forms, including tablets, capsules, and dry mixed suspensions, both domestically and internationally [1]
九典制药(300705.SZ):马来酸曲美布汀片获得药品注册证书
Ge Long Hui A P P· 2025-12-11 13:28
Core Viewpoint - Jiutian Pharmaceutical (300705.SZ) has received the Drug Registration Certificate from the National Medical Products Administration for its drug, Trimebutine Maleate Tablets, which is indicated for the treatment of symptoms related to irritable bowel syndrome and gastrointestinal motility disorders [1] Group 1 - The drug Trimebutine Maleate Tablets is used to improve symptoms such as loss of appetite, nausea, vomiting, belching, abdominal distension, borborygmi, abdominal pain, diarrhea, and constipation [1] - Trimebutine Maleate was first approved for marketing in France in 1970 and is currently available in various forms including tablets, capsules, and dry mixed suspensions in both domestic and international markets [1]
挪用募资、信披违规被罚,亏损中的东亚药业转型路在何方?
Bei Ke Cai Jing· 2025-10-23 10:03
Core Viewpoint - Zhejiang Dongya Pharmaceutical Co., Ltd. is facing regulatory scrutiny due to discrepancies in the use of raised funds compared to what was disclosed in its IPO prospectus, leading to a warning for its former board secretary and ongoing financial challenges for the company [1][2][3]. Group 1: Regulatory Issues - Zhejiang Securities Regulatory Bureau found that Dongya Pharmaceutical's actual use of raised funds did not align with the disclosures made in its IPO prospectus, and the company failed to follow internal review procedures for these changes [2]. - The company has been ordered to rectify these issues, and the violations will be recorded in the securities market's integrity archives [2][3]. Group 2: Financial Performance - Dongya Pharmaceutical's revenue for 2022, 2023, 2024, and the first half of 2025 were reported at 1.18 billion, 1.36 billion, 1.20 billion, and 416 million respectively, with year-on-year growth rates of 65.62%, 15.00%, -11.66%, and -35.85% [4]. - The net profit attributable to shareholders for the same periods was 104 million, 121 million, -101 million, and -30.23 million, with year-on-year growth rates of 52.46%, 16.11%, -183.02%, and -193.09% [4]. - The company's debt-to-asset ratio has increased from 25.56% in 2022 to 47.70% in the first half of 2025, indicating rising financial leverage [4]. Group 3: Business Challenges - Dongya Pharmaceutical's core antibacterial drug business is under significant pressure due to the government's "antibiotic restriction orders," which have limited the market space for antibacterial drugs [5][6]. - The company has attempted to implement a "raw material drug formulation integration" strategy, but progress has been slow, with only one of over ten submitted formulations receiving approval [7]. - The existing product structure remains heavily reliant on antibacterial drugs, exposing the company to substantial market and policy risks [7].