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润都股份(002923.SZ):硫酸氨基葡萄糖氯化钠复盐获得化学原料药上市申请批准通知书
Ge Long Hui A P P· 2025-08-12 09:20
格隆汇8月12日丨润都股份(002923.SZ)公布,公司近日收到国家药品监督管理局签发的关于硫酸氨基葡 萄糖氯化钠复盐(以下简称:"本品")《化学原料药上市申请批准通知书》。本品适用于治疗原发性及继 发性骨关节炎。 ...
润都股份(002923) - 关于硫酸氨基葡萄糖氯化钠复盐获得化学原料药上市申请批准通知书的公告
2025-08-12 09:15
证券代码:002923 证券简称:润都股份 公告编号:2025-035 珠海润都制药股份有限公司 关于硫酸氨基葡萄糖氯化钠复盐 获得化学原料药上市申请批准通知书的公告 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。 珠海润都制药股份有限公司(以下简称"公司")近日收到国家药品监督管 理局签发的关于硫酸氨基葡萄糖氯化钠复盐(以下简称:"本品")《化学原料 药上市申请批准通知书》。现将有关情况公告如下: 一、药品基本情况 1、药品基本信息 原料药名称:硫酸氨基葡萄糖氯化钠复盐 申请人:珠海润都制药股份有限公司 申请事项:境内生产化学原料药上市申请 登记号:Y20230001261 通知书编号:2025YS00693 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册。质量标准、标签及生产工艺照所附执行。 2、其他相关情况 2024年2月,公司向国家药品监督管理局药品审评中心(CDE)递交硫酸氨基 葡萄糖氯化钠复盐境内生产化学原料药上市申请注册申报资料并获受理,2024年 10月收到CDE发出的补充研究通知,2025 ...
国产创新药发展:BD交易攀升、出海步伐加快、受投资者关注
Huan Qiu Wang· 2025-08-11 03:29
Group 1 - The innovative drug sector is a key focus in the pharmaceutical industry, with multiple companies successfully obtaining product approvals this year and ongoing business development (BD) projects in China [1] - China's share of global innovative drug BD transactions has been increasing, from 10.8% in 2015 to an estimated 30.6% in 2024, with a significant rise to 52.5% as of August 8 this year [3] - The market size for innovative drugs in China reached 679 billion yuan in 2022, projected to exceed 1 trillion yuan by 2026 and reach 1.12 trillion yuan by 2027 [3] Group 2 - The proportion of innovative drugs in China's pharmaceutical market was 41% in 2022, expected to rise to 50% by 2026 and 51% by 2027 [3] - The pace of domestic innovative drug companies expanding overseas is accelerating, with 81 pharmaceutical and biotech companies involved in innovative drug business, generating over 100 billion yuan in overseas revenue from 2022 to 2024 [3] - Companies like Betta Pharmaceuticals and Rundu Co. have reported significant overseas revenue, with some companies exceeding 70% of their revenue from international markets in the first half of 2025 [3] Group 3 - Investor interest in innovative drugs has surged, with over 2,000 interactions related to "innovative drugs" recorded this year, highlighting companies such as Betta Pharmaceuticals, Rundu Co., and Zhendong Pharmaceutical [3][4] - Betta Pharmaceuticals plans to commercialize its innovative drug, Tarecitinib, which is expected to be approved by June 30, 2025 [4] - Rundu Co. has completed phase IIIb clinical trials for its innovative drug, a heart load test medication, and plans to submit a marketing application by March 2024 [4]
创新药赛道火爆!机构密集调研+资金大幅加仓,仅13股
Core Viewpoint - China's innovative pharmaceuticals have transitioned from being followers to key players in global medical innovation, achieving significant breakthroughs in core treatment areas such as metabolic diseases and oncology, with a surge in new drug approvals and international progress [1][3]. Group 1: Market Trends - The attention of A-share investors towards innovative pharmaceuticals has significantly increased this year, with numerous companies actively disclosing their R&D and clinical progress [2]. - The total value of license-out transactions for innovative drugs in China is projected to exceed $60 billion by mid-2025, surpassing the total for 2024, with 16 transactions exceeding $1 billion each [3]. - The market size of China's innovative drugs reached 679 billion yuan in 2022, expected to exceed 1 trillion yuan by 2026 and reach 1.12 trillion yuan by 2027 [6]. Group 2: International Expansion - Chinese innovative drug companies are accelerating their international business, with 81 companies generating over 100 billion yuan in overseas revenue from 2022 to 2024, accounting for more than 14% of their total revenue [7]. - The proportion of China's innovative drug transactions in the global market has increased from 10.8% in 2015 to approximately 52.5% by August 2023 [6]. Group 3: Policy and Financial Support - The Chinese government has implemented policies to support the high-quality development of innovative drugs, significantly reducing the time from drug approval to inclusion in the medical insurance directory from about 5 years to approximately 1 year [8]. - From 2015 to 2024, the financing in China's innovative drug sector exceeded 1.23 trillion yuan, providing strong momentum for industry growth [9]. Group 4: R&D Investment - The number of companies in the pharmaceutical and biotechnology sector has increased from over 220 in 2015 to nearly 500 currently, with R&D investment in the sector exceeding 140 billion yuan in 2024, a fivefold increase since 2015 [9]. - Among the 81 innovative drug companies, R&D investment rose from approximately 8.8 billion yuan in 2015 to over 57.8 billion yuan in 2024, with R&D intensity increasing from 3.29% to 8.04% [9]. Group 5: Company Developments - Companies such as Betta Pharmaceuticals and Rundu Co. have reported significant advancements in their innovative drug pipelines, with Betta's drug expected to be approved by June 2025 and Rundu's drug completing phase III clinical trials [12]. - The stock performance of companies involved in innovative drugs has surged, with some companies experiencing average increases of over 50% since May 1, 2023 [13]. Group 6: Institutional Interest - 13 companies have received significant institutional interest this year, with some experiencing over 30% increase in financing, indicating strong market confidence in innovative drug investments [14]. - Companies like BeiGene and TaiGen Biotechnology are projected to see substantial profit growth in 2025 and 2026, with BeiGene potentially turning profitable this year [15].
化学制药板块8月8日涨0.24%,联环药业领涨,主力资金净流出2.3亿元
Market Overview - On August 8, the chemical pharmaceutical sector rose by 0.24% compared to the previous trading day, with Lianhuan Pharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 3635.13, down 0.12%, while the Shenzhen Component Index closed at 11128.67, down 0.26% [1] Stock Performance - Notable declines in individual stocks include: - Shanghai Yizhong: closed at 72.23, down 5.42% with a trading volume of 80,000 shares and a turnover of 573 million yuan - Yifang Bio: closed at 39.80, down 5.37% with a trading volume of 203,000 shares and a turnover of 818 million yuan - Qianhong Pharmaceutical: closed at 10.19, down 4.77% with a trading volume of 1,197,800 shares and a turnover of 1.23 billion yuan [1] Capital Flow Analysis - The chemical pharmaceutical sector experienced a net outflow of 230 million yuan from institutional investors and a net outflow of 93.16 million yuan from retail investors, while retail investors saw a net inflow of 323 million yuan [1] - Key stocks with significant capital flow include: - Meinuohua: net inflow of 236 million yuan from institutional investors, with a 18.01% share - Lianhuan Pharmaceutical: net inflow of 197 million yuan from institutional investors, with a 13.40% share [2] - Other notable stocks include Han Yu Pharmaceutical and Bo Rui Pharmaceutical, with net inflows of 171 million yuan and 131 million yuan from institutional investors, respectively [2]
化学制药板块8月7日跌1.88%,千红制药领跌,主力资金净流出37.8亿元
证券之星消息,8月7日化学制药板块较上一交易日下跌1.88%,千红制药领跌。当日上证指数报收于 3639.67,上涨0.16%。深证成指报收于11157.94,下跌0.18%。化学制药板块个股涨跌见下表: | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | | --- | --- | --- | --- | --- | --- | --- | | 002923 | 润都股份 | 15.54 | 9.98% | 19.83万 | | 3.01亿 | | 300584 | 海辰药业 | 47.95 | 7.22% | 25.11万 | | 12.11亿 | | 600200 | *ST苏吴 | 1.13 | 4.63% | 0 80.99万 | | 9014.77万 | | 002653 | 海思科 | 56.59 | 4.41% | 5.48万 | | 3.08亿 | | 000919 | 金陵药业 | 7.39 | 3.79% | 68.99万 | | 5.17亿 | | 301258 | 富士莱 | 36.33 | 2.45% | 5.07万 | | 1.83亿 | | ...
创新药概念股异动拉升 阳光诺和涨超10%
Group 1 - The innovative drug concept stocks experienced significant upward movement, with Rundu Co., Ltd. hitting the daily limit increase [1] - Haitian Pharmaceutical and Sunshine Nuohuo both rose over 10%, indicating strong market interest [1] - Other companies such as Huaren Health, Fuyuan Pharmaceutical, and Guangsheng Tang also saw notable gains, reflecting a broader trend in the sector [1]
8月4日晚间重要公告一览
Xi Niu Cai Jing· 2025-08-04 10:11
Group 1 - Weihai Guangtai reported a net profit of 83.32 million yuan for the first half of 2025, a year-on-year decrease of 22.41%, while total revenue reached 1.425 billion yuan, an increase of 10.91% [1] - Haowei Group expects a net profit increase of 39.43% to 49.67% for the first half of 2025, estimating a profit range of 1.906 billion to 2.046 billion yuan [1] - Tengda Construction won a bid for a project worth 118 million yuan, with a construction period of 500 calendar days [1] Group 2 - Shanda Power plans to use up to 520 million yuan of idle raised funds for cash management, investing in safe and liquid products with a term not exceeding 12 months [3] - Rundu Co., Ltd. received approval for the listing application of its chemical raw material drug, which is suitable for surgical treatment in adults and children over one month old [4] - Zhongyuan Qihua's subsidiary's clinical trial application for a drug aimed at treating pulmonary fibrosis has been accepted [4] Group 3 - Shanghai Xiba plans to establish a joint venture with Yuyuan Rare Earth, focusing on advanced materials for lithium-ion solid-state batteries, with a registered capital of 200 million yuan [6] - Aorite's senior management plans to reduce their holdings by up to 62,500 shares, accounting for 0.02% of the company's total equity [7] - Yipin Hong's subsidiary's clinical trial application for a new oral drug for endometriosis has been accepted [8] Group 4 - Haya Pharmaceutical plans to lease idle assets covering 22,671.39 square meters for a period of 10 years [9] - Southern Precision Engineering applied for a credit limit of 50 million yuan from a bank for operational purposes [11] - Jindawei's subsidiary established a joint venture with a registered capital of 5 million yuan, focusing on the sale of food additives and health products [12] Group 5 - Gaode Infrared signed a product order contract worth 307 million yuan, expected to account for 11.46% of the company's audited revenue for 2024 [13] - Xichang Electric will implement a low valley electricity price policy starting September 1, 2025, which is expected to reduce net profit by approximately 5.55 million yuan [14] - Huyou Pharmaceutical's first subject has been dosed in a Phase I clinical trial for a drug targeting advanced solid tumors [16] Group 6 - Chuanheng Co., Ltd. received a patent for a dust removal system in mining operations [17] - Spring Wind Power's application for issuing convertible bonds has been accepted by the Shanghai Stock Exchange [18] - Liuyao Group plans to repurchase shares worth between 100 million and 200 million yuan [19] Group 7 - Baiyun Electric has obtained a commitment letter for a stock repurchase loan of up to 18 million yuan [20] - Tonghe Pharmaceutical received a patent for a method of preparing an intermediate for a migraine treatment drug [21] - Tainkang's subsidiary's Phase II clinical trial for a drug for vitiligo has shown significant efficacy and safety [23] Group 8 - Yuhua Tian's secretary and deputy general manager resigned for personal reasons [24] - Heizhima's controlling shareholder is planning a change in control, leading to a temporary suspension of stock trading [25] - Keda Li's subsidiary completed a capital increase, raising its registered capital to 700 million yuan [26] Group 9 - Fangda Special Steel's shareholder plans to reduce holdings by up to 1% of the company's shares [28] - ST Pava's director is under investigation for alleged embezzlement, but the company's operations remain normal [29] - Jiachuan Video's controlling shareholder is planning a change in control, resulting in a temporary stock suspension [32] Group 10 - Danhua Technology will change its stock name to Jinmei Technology starting August 7, 2025, due to a relocation of its registered office [33] - Morning Wind Technology's shareholder plans to reduce holdings by up to 1% of the company's shares [34] - Leshan Electric will adjust residential gas prices starting September 1, 2025, which is expected to increase gross profit by approximately 2.7 million yuan [35] Group 11 - SAIC Motor reported a total vehicle sales of 337,500 units in July 2025, a year-on-year increase of 34.22%, with significant growth in new energy vehicle sales [36] - LIGONG Navigation's shareholders plan to reduce holdings by up to 3% of the company's shares [37] - United Imaging's employee stock ownership platform plans to reduce holdings by up to 1.62% of the company's shares [38] Group 12 - Beiqi Blue Valley's subsidiary reported a 6.38% decline in sales in July 2025 [39] - Watson Bio's clinical research application for an mRNA vaccine has been accepted [40]
润都股份:苯磺顺阿曲库铵获化学原料药上市申请批准
Zhi Tong Cai Jing· 2025-08-04 08:02
润都股份(002923)(002923.SZ)公告,公司全资子公司润都制药(荆门)有限公司(简称"润都荆门公司") 近日收到国家药品监督管理局签发的关于苯磺顺阿曲库铵《化学原料药上市申请批准通知书》。该药品 适用于成人及1个月及以上儿童的外科手术和其他操作治疗,亦可用于成人的重症监护治疗。可用作全 麻辅助,或者用作ICU中镇静以松弛骨骼肌,利于气管插管和机械通气。 ...
润都股份(002923.SZ):苯磺顺阿曲库铵获化学原料药上市申请批准
智通财经网· 2025-08-04 08:00
智通财经APP讯,润都股份(002923.SZ)公告,公司全资子公司润都制药(荆门)有限公司(简称"润都荆门 公司")近日收到国家药品监督管理局签发的关于苯磺顺阿曲库铵《化学原料药上市申请批准通知书》。 该药品适用于成人及1个月及以上儿童的外科手术和其他操作治疗,亦可用于成人的重症监护治疗。可 用作全麻辅助,或者用作ICU中镇静以松弛骨骼肌,利于气管插管和机械通气。 ...