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奥赛康(002755.SZ):子公司注射用德拉沙星葡甲胺获得药品注册证书
Ge Long Hui· 2025-12-22 13:23
格隆汇12月22日丨奥赛康(002755.SZ)公布,全资子公司江苏奥赛康药业有限公司于近日收到国家药品 监督管理局核准签发的注射用德拉沙星葡甲胺《药品注册证书》,根据国家相关政策规定,本次获得 《药品注册证书》视同通过一致性评价。注射用德拉沙星葡甲胺独家获批上市后,将进一步丰富公司在 抗感染治疗领域的产品组群,在ABSSSI和CABP等适应症中形成差异化竞争优势,并为临床多重耐药 菌感染提供新的治疗选择,将对公司及子公司未来的经营产生积极影响。 财经频道更多独家策划、专家专栏,免费查阅>> 责任编辑:钟离 ...
奥赛康(002755.SZ):注射用德拉沙星葡甲胺获得药品注册证书
智通财经网· 2025-12-22 11:40
德拉沙星作为一种新型广谱抗生素,对革兰氏阳性菌(G+)、革兰氏阴性菌(G-)以及厌氧菌均显示广泛而 强大的抗菌活性。与其他氟喹诺酮类抗菌药物相比,德拉沙星具有阴离子特性,能够增强酸性环境中的 抗菌活性,且在酸性环境下的药物累积量可达其他氟喹诺酮类药物的10倍,对甲氧西林耐药金黄色葡萄 球菌(MRSA)以及其他病原菌的抗菌活性更强。德拉沙星具有新型结构特征,抗菌活性显著增强且不易 耐药,其临床疗效和安全性已获国内外临床研究实践验证,是目前唯一被美国外科感染学会(SIS)《复 杂皮肤软组织感染的管理指南》纳入推荐用于MRSA治疗的喹诺酮类药物,与传统喹诺酮类药物不推荐 用于MRSA感染形成显著差异。其安全性良好,相关治疗未见QT间期延长、光毒性等传统喹诺酮类药 物常见风险的报道。 智通财经APP讯,奥赛康(002755.SZ)发布公告,公司全资子公司江苏奥赛康药业有限公司(以下简称"子 公司")于近日收到国家药品监督管理局(以下简称"药监局")核准签发的注射用德拉沙星葡甲胺《药品注 册证书》。 ...
奥赛康(002755) - 关于子公司注射用德拉沙星葡甲胺获得药品注册证书的公告
2025-12-22 11:15
证券代码:002755 证券简称:奥赛康 公告编号:2025-062 北京奥赛康药业股份有限公司 关于子公司注射用德拉沙星葡甲胺 获得药品注册证书的公告 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。 德拉沙星(Delafloxacin)是新一代广谱抗菌药物,2017年6月,美国食品药 品监督管理局(FDA)批准注射用德拉沙星(规格:0.3g)上市,用于治疗敏感 菌引起的成人急性细菌性皮肤及皮肤结构感染(ABSSSI);2019年10月,新增 适应症为成人社区获得性细菌性肺炎(CABP)。2021年,德拉沙星在欧洲药品 管理局(EMA)获得前述两项适应症的完全批准。 公司研发的注射用德拉沙星完成验证性临床研究,于2024年3月申报注册生 产,于近日国内独家获批上市,用于急性细菌性皮肤及皮肤结构感染和社区获得 性细菌性肺炎适应症的治疗,填补了国内市场空白。 德拉沙星作为一种新型广谱抗生素,对革兰氏阳性菌(G+)、革兰氏阴性菌 (G-)以及厌氧菌均显示广泛而强大的抗菌活性。与其他氟喹诺酮类抗菌药物相 比,德拉沙星具有阴离子特性,能够增强酸性环境中的抗菌活性,且在酸 ...
奥赛康:子公司注射用德拉沙星葡甲胺获药品注册证书
Xin Lang Cai Jing· 2025-12-22 11:02
奥赛康公告称,其全资子公司江苏奥赛康近日收到药监局核准签发的注射用德拉沙星葡甲胺《药品注册 证书》。该药品为国内独家获批上市,用于急性细菌性皮肤及皮肤结构感染和社区获得性细菌性肺炎治 疗,填补国内市场空白。德拉沙星抗菌活性强、不易耐药、安全性好。2024年喹诺酮类抗菌药销售额约 49亿元,市场潜力大。此次获批将丰富公司抗感染产品组群,对经营产生积极影响,但产品销售情况有 不确定性。 ...
奥赛康:截至12月10日公司股东人数为30683户
Zheng Quan Ri Bao Wang· 2025-12-22 08:42
证券日报网讯12月22日,奥赛康(002755)在互动平台回答投资者提问时表示,截至12月10日,公司的 股东人数为30683户。 ...
奥赛康:公司聚焦主营业务
(编辑 任世碧) 证券日报网讯 12月22日,奥赛康在互动平台回答投资者提问时表示,基于对公司未来发展前景的坚定 信心,公司聚焦主营业务,秉持全体股东价值最大化的宗旨,以多种方式促进上市公司的可持续发展。 ...
【价值发现】239.59%最佳任期回报!鹏华基金经理金笑非如何用“三维决策框架”打造投资闭环?
Sou Hu Cai Jing· 2025-12-17 02:54
Core Insights - The A-share market has shown a fluctuating upward trend since 2025, with the pharmaceutical and biotechnology sector performing exceptionally well, dominating the top ten stock fund rankings in the first half of the year [2] - Jin Xiaofei, a representative mid-generation fund manager at Penghua Fund, has achieved remarkable performance with his managed funds, utilizing a unique "dual-line resonance" framework to navigate crowded sectors [2][3] Investment Performance - Jin Xiaofei has been with Penghua Fund since July 2012, accumulating a tenure of 9 years and 174 days, managing assets totaling 5.375 billion yuan, with a best-term return of 239.59% [3] - The Penghua Medical Technology Stock A fund, under Jin's management, has shown significant excess returns, with a total return of 74.19% since its inception on June 2, 2015, and a return of 73.03% this year [5] - The Penghua Innovation Upgrade Mixed A fund has also performed well, with a year-to-date return of 88.72% and a one-year return of 74.60% [15] Investment Strategy - Jin's investment strategy is centered on "fundamental trend investing," integrating a dual-dimensional analysis framework that focuses on both visible driving factors and market sentiment [3][4] - The "bright line" strategy emphasizes significant industry changes, while the "dark line" strategy identifies undervalued opportunities through reverse analysis of market emotions and capital flows [4] - Jin's approach includes a three-dimensional decision-making framework that considers long-term, mid-term, and short-term performance metrics to ensure robust investment logic [14][16] Stock Holdings and Performance - The fund has made strategic purchases in various stocks, including: - 1,126,260 shares of Nuocheng Jianhua, which saw a price increase of 213% during the holding period [7] - 217,760 shares of Dizhe Pharmaceutical, with a price increase of 90.49% [9] - 119,040 shares of Baijishenzhou, which appreciated by 257% [11] - 211,230 shares of Rongchang Bio, with a price increase of 121% [13] - The fund's holdings in stocks like Hailan Pharmaceutical and Zexing Pharmaceutical also demonstrated significant price increases during their respective holding periods [18][20] Market Outlook - Jin Xiaofei anticipates a new investment cycle in the pharmaceutical sector, with institutional holdings recovering from historical lows, and emphasizes the importance of beta opportunities in the current market [5][16] - The need for continuous optimization of risk control systems is highlighted, as the industry faces increasing competition and innovation [25]
医药生物行业2026年度投资策略报告:十年创新,踏出海征程-20251214
Orient Securities· 2025-12-14 05:16
Core Insights - The pharmaceutical industry is experiencing a surge in innovative products, with clear domestic demand and significant potential for international expansion [4][14][25] - Investment opportunities are concentrated in innovative drugs and their supply chains, with a notable performance from CRO/CMO and chemical pharmaceuticals [9][15][17] - The report emphasizes the importance of innovation as the primary solution to industry challenges, driven by stable demand and supportive policies [26][32][41] Industry Overview - The pharmaceutical sector has faced revenue declines, with a 0.9% year-on-year decrease in revenue for the first three quarters of 2025, and net profit down by 2.2% [15][16] - The innovative drug sector has outperformed, with CRO/CMO and chemical pharmaceuticals showing net profit growth of 31.0% and 16.6% respectively [17][18] - The overall market is characterized by low fund holdings and historical valuation bottoms, indicating high investment value [20][25] Demand and Payment Dynamics - The demand for healthcare services is steadily increasing, with a projected 5% growth in total medical visits and hospital admissions in 2024 [26][28] - The aging population is expected to drive long-term demand, with 220 million people aged 65 and above by 2050 [28][30] - The medical insurance fund's income growth has outpaced expenditure growth, leading to a significant increase in fund reserves [32][36] Financing and Market Trends - The IPO market for healthcare has rebounded, with 28 IPOs in the first three quarters of 2025, a 100% increase from the previous year [42][43] - License-out transactions have surged, with transaction numbers increasing by 41% and total amounts reaching $92 billion, indicating a robust market for innovative drug licensing [48][50] - The number of IND applications and new clinical trials for innovative drugs has been steadily increasing, with a notable rise in NDA approvals [53][57] Technological Advancements - The report highlights the emergence of new technologies such as ADC and small nucleic acids, with domestic companies leading in these areas [60] - The focus on dual antibodies and GLP-1 drugs is expected to drive significant growth, with multiple development directions emerging [9][60] - The report notes that domestic companies are increasingly recognized for their innovative capabilities, particularly in the ADC space [60]
2025年医保谈判结果点评:医保平稳商保可期,国产创新药龙头胜出
Orient Securities· 2025-12-10 00:45
Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry, indicating an expected return that is stronger than the market benchmark by over 5% [5]. Core Insights - The National Medical Insurance Administration is strongly encouraging the high-quality development of innovative drugs, with clear policies supporting the payment side for innovative drugs. Domestic leading innovative drug companies are entering a commercial realization phase [3][7]. - The 2025 National Medical Insurance Drug List includes 127 products, with 114 successfully added, of which 50 are innovative drugs, marking a historical high. The overall negotiation success rate reached 90%, the highest in nearly seven years [7]. - The report highlights that the domestic innovative drug market is becoming increasingly concentrated, with leading companies like Heng Rui and Xin Da Biotech significantly benefiting from the new insurance policies [7]. Summary by Sections Investment Recommendations and Targets - Recommended stocks include Heng Rui Pharmaceutical (600276, Buy), Ke Lun Pharmaceutical (002422, Buy), Xin Li Tai (002294, Hold), Ao Sai Kang (002755, Buy), Jing Xin Pharmaceutical (002020, Buy), and others [3]. Market Dynamics - The report notes that the introduction of the commercial insurance directory marks the beginning of a "new golden decade" for Chinese innovative drugs, with a focus on high clinical efficacy and value innovation [7]. - The report emphasizes that the competition in the GLP-1 market remains clear, with the entry of new drugs not significantly altering the competitive landscape for existing treatments [7].
奥赛康(002755) - 持股5%以上股东减持计划期限届满暨实施结果的公告
2025-12-09 10:19
证券代码:002755 证券简称:奥赛康 公告编号:2025-061 北京奥赛康药业股份有限公司 持股 5%以上股东减持计划期限届满 暨实施结果的公告 持股 5%以上的股东中亿伟业控股有限公司保证向本公司提供的 信息内容真实、准确、完整,没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供 的信息一致。 北京奥赛康药业股份有限公司(以下简称"公司")于 2025 年 8 月 16 日披露 了《关于持股 5%以上股东减持计划的预披露公告》(公告编号:2025-042),公 司股东中亿伟业控股有限公司(以下简称"中亿伟业")计划以集中竞价和大宗交 易方式减持本公司股份不超过 18,563,200 股,不超过本公司总股本的 2%。 近日,公司收到中亿伟业出具的告知函,中亿伟业本次减持计划已期限届满, 通过集中竞价和大宗交易方式累计减持本公司股份 14,351,603 股,占本公司总股 本的 1.55%。 本次股份变动后,中亿伟业持有本公司股份 105,840,430 股,占本公司总股 本的 11.40%。现将有关情况公告如下: 一、股东减持情况 1、 减持股份来源:中亿伟业参 ...