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贵州百灵实控人被证监会立案;健友股份丙泊酚乳状注射液获FDA批准|医药早参
Mei Ri Jing Ji Xin Wen· 2025-12-03 23:12
Group 1 - Guizhou BaiLing's actual controller Jiang Wei has been investigated by the China Securities Regulatory Commission (CSRC) for insider trading and information disclosure violations, indicating a focus on regulatory enforcement against key individuals [1] - The investigation may exacerbate operational uncertainties for Guizhou BaiLing, which has faced performance pressures in recent years, raising concerns about corporate governance and information disclosure risks [1] Group 2 - Jianyou Co., Ltd. has received ANDA approval from the FDA for its propofol emulsion injection, marking a significant step in the company's internationalization of its formulations [2] - The product, commonly used for sedation during surgeries, has substantial market potential in the U.S., which is expected to contribute to revenue growth for Jianyou [2] Group 3 - Shenzhen Xinlitai Pharmaceutical Co., Ltd. has been granted clinical trial approval for its innovative small molecule drug SAL0140, aimed at treating chronic kidney disease (CKD) [3] - SAL0140, an aldosterone synthase inhibitor, targets multiple significant chronic disease areas, including uncontrolled hypertension and CKD, presenting considerable market potential for the company [3] Group 4 - Junshi Biosciences reported a decrease in the shareholding percentage of Greenland Financial Investment Group and its affiliates from 5.0051% to 4.7129% due to share lending, falling below the 5% disclosure threshold [4] - This change is primarily a technical operation rather than an active reduction in holdings, but the market will need to monitor the future actions of these shareholders [4] Group 5 - Sichuang Medical Technology has elected Wei Naixu as the new chairman following the resignation of Xu Yiran, who stepped down to facilitate governance structure optimization [5] - Xu Yiran will remain on the board, indicating that the adjustment aims to clarify responsibilities and strengthen governance rather than signaling a crisis [5]
12月3日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-03 10:19
Group 1 - Dongfang Electric announced that three executives plan to reduce their holdings by a total of no more than 30,000 shares due to personal financial needs [1] - Yahu Pharmaceutical's APL-1401 clinical trial data was presented at the 19th European Colorectal Congress, indicating progress in treating moderate to severe ulcerative colitis [1] - Guizhou Bai Ling's actual controller is under investigation by the China Securities Regulatory Commission for insider trading and information disclosure violations [3] Group 2 - Bairen Medical's ePTFE pericardial membrane product has been approved for registration, ending the reliance on imports for this product in the domestic market [4] - Qianxin received approval for a total of 2 billion yuan in technology innovation bonds, with plans to issue medium-term notes and short-term financing bonds [6] - Tengjing Technology's shareholder plans to reduce holdings by no more than 1.96% of the company's shares [7] Group 3 - Yuntianhua's subsidiary is required to pay 386 million yuan in overdue taxes and penalties, which will impact the company's net profit for 2025 [8] - Jianyou Pharmaceutical's propofol emulsion injection has received FDA approval in the United States [9] - Suzhou Gaoxin successfully acquired land use rights for a residential project for 360 million yuan [9] Group 4 - Chalco International's subsidiary won a bid for a 3.03 billion yuan electrolytic aluminum project [11] - Tai Long Pharmaceutical's stock will continue to be suspended due to potential changes in control as the major shareholder is planning a share transfer [12] - Qianli Technology reported a 63.44% year-on-year increase in automobile sales for November, although new energy vehicle sales decreased by 43.98% [13] Group 5 - Fosun Pharma's innovative drug FXS0887 has received approval for a Phase I clinical trial for advanced malignant solid tumors [14] - Guoen Co. has obtained approval for a project to produce 20,000 square meters of aviation-grade acrylic glass, with a total investment of 560 million yuan [15] - Guofa Co.'s chairman resigned due to personal reasons [17] Group 6 - Shanghai Construction won a bid for a state-owned construction land use right for 264 million yuan [18] - Weixin Kang's subsidiary received approval for a clinical trial of lidocaine cream for local anesthesia [20] - Sanxing Medical's subsidiary is a candidate for a 152 million yuan transformer procurement project for the State Grid [20] Group 7 - People's Daily announced the resignation of its president due to work changes, while retaining other leadership roles [21] - Beibu Gulf Port reported a 0.29% year-on-year increase in cargo throughput for November [22] - Chongqing Construction won three engineering projects with a total value of approximately 2.773 billion yuan [23] Group 8 - Xingyu Co. is planning to issue H-shares and list on the Hong Kong Stock Exchange [24] - Huajian Group signed a design contract worth 160 million yuan for a comprehensive project [25] - Wankai New Materials plans to invest 350 million yuan in a technical transformation project for producing 100,000 tons of adipic acid [26] Group 9 - Kaipuyun received a government subsidy of 18 million yuan, which is 87.43% of its net profit for the last audited fiscal year [28] - Ningbo Port expects a 10.8% year-on-year increase in container throughput for November [30] - An Cai High-Tech plans to invest 498 million yuan to upgrade its photovoltaic glass production line [32] Group 10 - Shunhao Co. stated that its existing business has not generated synergies with the rail business, which faces various risks [34] - Yihualu plans to publicly transfer 35% of its stake in Liaoyun Company [35] - ST Wanfang's shareholder plans to reduce holdings by no more than 3% of the company's shares [36] Group 11 - Youyou Food's shareholder plans to reduce holdings by no more than 110,000 shares [38] - Hengtong Optic-Electric's incentive fund has spent 49.98 million yuan to purchase company shares [41] - Zoli Pharmaceutical plans to issue convertible bonds to raise no more than 1.556 billion yuan for various projects [42]
健友股份丙泊酚乳状注射液获得美国FDA批准
Bei Jing Shang Bao· 2025-12-03 10:04
健友股份表示,新批准产品近期将安排在美国上市销售,有望对公司经营业绩产生积极影响。 北京商报讯(记者 丁宁)12月3日晚间,健友股份(603707)发布公告称,公司于近日收到美国食品药 品监督管理局签发的丙泊酚乳状注射液的ANDA批准通知,规格包括200mg/20mL、500mg/50mL和 1000mg/100mL。 ...
健友股份(603707.SH):丙泊酚乳状注射液获得美国FDA批准
智通财经网· 2025-12-03 09:05
智通财经APP讯,健友股份(603707.SH)发布公告,公司于近日收到美国食品药品监督管理局(以下简 称"美国FDA")签发的丙泊酚乳状注射液,200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), 1,000 mg/100 mL(10 mg/mL)的 ANDA批准通知(ANDA号:217945)。 ...
健友股份:丙泊酚乳状注射液获美国FDA批准
人民财讯12月3日电,健友股份(603707)12月3日公告,公司近日收到美国食品药品监督管理局(简 称"美国FDA")签发的丙泊酚乳状注射液200mg/20mL(10mg/mL)、500mg/50mL(10mg/mL)、 1000mg/100mL(10mg/mL)的ANDA批准通知。新批准产品近期将安排在美国上市销售,有望对公司经营 业绩产生积极影响。 ...
健友股份(603707) - 健友股份关于公司产品丙泊酚乳状注射液获得美国FDA批准的公告
2025-12-03 09:00
证券代码:603707 证券简称:健友股份 公告编号:2025-089 债券代码:113579 债券简称:健友转债 南京健友生化制药股份有限公司 (三)剂 型:注射剂 (四)规 格:200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), 1,000 mg/100 mL(10 mg/mL) (五)ANDA 号:217945 (六)申 请 人:南京健友生化制药股份有限公司 二、药品其他相关情况 关于产品丙泊酚乳状注射液获得美国 FDA 批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别及连带责任。 南京健友生化制药股份有限公司(以下简称"健友股份"或"公司")于近日收 到美国食品药品监督管理局(以下简称"美国 FDA")签发的丙泊酚乳状注射 液,200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), 1,000 mg/100 mL(10 mg/mL)的 ANDA 批准通知(ANDA 号:217945)。现将相关情况公告如下: 一、药品的基本情 ...
健友股份:丙泊酚乳状注射液获得美国FDA批准
Mei Ri Jing Ji Xin Wen· 2025-12-03 08:41
Core Viewpoint - The company, Jianyou Co., Ltd. (603707.SH), has received ANDA approval from the US FDA for its propofol emulsion injection, which is expected to positively impact its operational performance [2]. Group 1: Product Approval - The US FDA has granted ANDA approval for propofol emulsion injection in three specifications: 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL [2]. - The reference product is held by FRESENIUS KABI USA LLC [2]. Group 2: Financial Investment - The company has invested approximately RMB 73.66 million in research and development for this product [2]. Group 3: Market Impact - The newly approved product is set to be launched in the US market soon, which is anticipated to have a positive effect on the company's business performance [2].
健友股份(603707) - 健友股份关于股份回购进展的公告
2025-12-02 08:32
| | | 债券代码:113579 债券简称:健友转债 南京健友生化制药股份有限公司 关于股份回购进展的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 二、回购股份的进展情况 根据《上市公司股份回购规则》《上海证券交易所上市公司自律监管指引第 7 号——回购股份》等相关规定,公司在回购期间,应于每个月的前 3 个交易日内 披露截至上月末的回购进展情况。现将公司回购股份进展情况公告如下: 截至 2025 年 11 月 30 日,公司通过上海证券交易所交易系统以集中竞价交易 方式已累计回购股份137.9995万股,已累计回购股份占公司总股本的比例为0.09%, 成交最低价为 9.56 元/股,成交最高价为 11.66 元/股,支付的总金额为人民币 1500.85 万元(不含交易费用及印花税)。 上述回购股份符合法律法规及公司回购股份方案的规定。 重要内容提示: | 回购方案首次披露日 | 2025/4/29,由董事长唐咏群先生提议 | | | | | | | | --- | --- | --- | --- | --- | - ...
健友股份:已累计回购1500.85万元股份
Ge Long Hui· 2025-12-02 08:15
格隆汇12月2日丨健友股份(603707.SH)公布,截至2025年11月30日,公司通过上海证券交易所交易系统 以集中竞价交易方式已累计回购股份137.9995万股,已累计回购股份占公司总股本的比例为0.09%,成 交最低价为9.56元/股,成交最高价为11.66元/股,支付的总金额为人民币1500.85万元(不含交易费用及 印花税)。 ...
健友股份:累计斥资1500.85万元回购0.09%股份
Xin Lang Cai Jing· 2025-12-02 08:08
健友股份公告称,2025年4月28日,公司董事会审议通过回购议案,预计金额2000万元至4000万元,回 购股份用于员工持股计划或股权激励。实施期限为2025年5月20日至2026年5月19日。截至2025年11月30 日,公司累计回购137.9995万股,占总股本0.09%,支付总金额1500.85万元,成交价格在9.56元/股至 11.66元/股之间。 ...