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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
Core Viewpoint - The company, Jianyou Co., Ltd. (健友股份), has received approval from the U.S. Food and Drug Administration (FDA) for its propofol emulsion injection, which is expected to positively impact the company's operating performance [1] Group 1 - The FDA has issued an ANDA approval notification for Jianyou's propofol emulsion injection in three specifications: 200mg/20mL, 500mg/50mL, and 1000mg/100mL [1] - The newly approved product is scheduled to be launched in the U.S. market soon [1] - The approval is anticipated to have a positive effect on the company's business performance [1]
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
Core Viewpoint - The company, Jianyou Co., Ltd. (603707.SH), has received ANDA approval from the U.S. FDA for its propofol emulsion injection in various dosages [1] Group 1 - The approved dosages include 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL) [1]
健友股份:丙泊酚乳状注射液获美国FDA批准
Zheng Quan Shi Bao Wang· 2025-12-03 09:02
Core Viewpoint - The company, Jianyou Co., Ltd. (603707), has received ANDA approval from the U.S. FDA for its propofol emulsion injection products, which is expected to positively impact its operational performance [1] Group 1: Product Approval - The U.S. FDA has issued ANDA approval for propofol emulsion injection in three dosages: 200mg/20mL, 500mg/50mL, and 1000mg/100mL, all at a concentration of 10mg/mL [1] - The newly approved products are set to be launched in the U.S. market soon [1] Group 2: Impact on Company Performance - The approval is anticipated to have a positive effect on the company's business performance [1]
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。 ...