11月21日，国家药监局发布《药品生产企业出口药品检查和出口证明管理规定》。其中提出，拓宽出口 证明出证范围，对于药品生产企业按照药品GMP生产的出口药品，无论是否在中国批准上市，均可以 申请出具出口证明；统筹出口证明的有效期，《药品出口销售证明》有效期由2年调整为3年，与《出口 欧盟原料药证明文件》一致。限定证明出具时限，《规定》明确要求各省级药品监督管理部门设定的工 作细则中，出口证明的办理时限最长不超过20个工作日，但药品监督管理部门开展技术审查和评定、现 场检查以及企业整改等所需时间不计入时限。 政策动向 药械审批 国家药监局：拓宽药品出口证明出证范围统筹出口证明的有效期 恒瑞医药：获得多款药物临床试验批准通知书 常山药业：控股股东高树华拟协议转让5%股份给元素基金 11月21日，常山药业(300255.SZ)公告称，公司控股股东、实际控制人高树华拟通过协议转让方式将其 持有的4600万股无限售流通股（占公司总股本5.0051%）转让给重庆元素私募证券投资基金管理有限公 11月21日，恒瑞医药(600276.SH)公告称，公司及子公司近期收到国家药监局核准签发关于注射用SHR- 9839(sc)、注射 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 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。 人福医药集团股份公司（以下简称"公司"）控股子公司宜昌人福药业有限责任公司（以下简称"宜昌人 福"，公司持有其80%的股权）近日收到国家药品监督管理局核准签发的二甲磺酸利右苯丙胺胶囊的药 品注册上市许可申请《受理通知书》，现将相关情况公告如下： 一、药物名称：二甲磺酸利右苯丙胺胶囊 二、剂型：胶囊剂 三、申请事项：境内生产药品注册上市许可 四、注册分类：化学药品3类 五、申请人：宜昌人福药业有限责任公司 六、审查结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查，决定予以受理。受理 号：CYHS2504001、CYHS2504003、CYHS2504004、CYHS2504006。 人福医药集团股份公司董事会 二甲磺酸利右苯丙胺胶囊原研最早于美国获批上市，用于治疗成人和6岁及以上儿科患者的注意缺陷多 动障碍（ADHD），以及成人中度至重度暴食症（BED）。宜昌人福本次提交本品的上市许可申请申报 的适应症为成人和6岁及以 ...

·商务部：1-10月全国新设立外商投资企业53782家同比增长14.7% ·21日，国务院国资委以"现场+视频"形式举行中央企业专业化整合推进会暨重点项目集中签约仪式。当 日，17家包括中央企业、地方国有企业、民营企业等在内的单位就8组专业化整合项目开展集中签约， 项目涉及新材料、人工智能、检验检测、航空物流等领域。（新华社） ·11月21日，农业农村部部常务会议要求，要加强生猪产能综合调控，加快构建供需动态适配、规模结 构合理、产业链协同提升的生猪产业高质量发展格局。要加强生产和市场监测预警，动态调整全国能繁 母猪正常保有量目标，提早开展逆周期调节，防止出现大的波动。（新华财经） ·住房城乡建设部部长倪虹21日表示，城市更新是推动城市高质量发展的综合性、系统性战略行动，要 着力在规划、资金、运营、治理四方面下功夫，因地制宜、探索创新，持续推进城市更新行动。（新华 社） ·财政部和中国人民银行日前发布的《关于储蓄国债（电子式）纳入个人养老金产品范围有关事宜的通 知》提出，为支持多层次多支柱养老保险体系发展，将储蓄国债（电子式）纳入个人养老金产品范围。 开办机构应当按照规定，自2026年6月起，开办个人养老金储 ...

人福医药集团股份公司 关于子公司药品上市许可申请获受理的提示性公告 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。 人福医药集团股份公司（以下简称"公司"）控股子公司宜昌人福药业有限责任公司（以下简称"宜昌人 福"，公司持有其80%的股权）近日收到国家药品监督管理局核准签发的二甲磺酸利右苯丙胺胶囊的药 品注册上市许可申请《受理通知书》，现将相关情况公告如下： 登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：600079 证券简称：人福医药 编号：临2025-122 六、审查结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查，决定予以受理。受理 号：CYHS2504001、CYHS2504003、CYHS2504004、CYHS2504006。 二甲磺酸利右苯丙胺胶囊原研最早于美国获批上市，用于治疗成人和6岁及以上儿科患者的注意缺陷多 动障碍（ADHD），以及成人中度至重度暴食症（BED）。宜昌人福本次提交本品的上市许可申请申报 的适应症为成人和6岁及以上儿科患者的注意缺陷多动障碍（ADHD）。根据国家药 ...

二甲磺酸利右苯丙胺胶囊原研最早于美国获批上市，用于治疗成人和6岁及以上儿科患者的注意缺陷多 动障碍（ADHD），以及成人中度至重度暴食症（BED）。宜昌人福本次提交本品的上市许可申请申报 的适应症为成人和6岁及以上儿科患者的注意缺陷多动障碍（ADHD）。根据国家药品监督管理局官网 显示，国内目前暂无二甲磺酸利右苯丙胺胶囊上市，也无相关产品获批进口。截至目前，宜昌人福在该 项目上的累计研发投入约9000万元人民币。 11月21日，人福医药（600079）公告表示，控股子公司宜昌人福药业有限责任公司（以下简称"宜昌人 福"，公司持有其80%的股权）近日收到国家药品监督管理局核准签发的二甲磺酸利右苯丙胺胶囊的药 品注册上市许可申请《受理通知书》。 （人福医药公告） ...

Group 1: Shareholding Changes - Company Zhaoyi Innovation announced that several directors and senior management personnel plan to reduce their holdings by a total of 249,000 shares, with specific reductions from the vice chairman and general manager, as well as other vice presidents [1] - Company Super Aerospace announced a stock suspension due to its controlling shareholders planning a significant matter that may lead to a change in control [2] - Company Haosai is under investigation by the China Securities Regulatory Commission (CSRC) for suspected violations of information disclosure laws [5] Group 2: Major Contracts and Projects - Company Dajin Heavy Industry's wholly-owned subsidiary signed a contract worth approximately 1.339 billion yuan for a European offshore wind farm project, which represents 35.41% of the company's audited revenue for 2024 [3] - Company Ruifeng New Materials plans to increase capital by 200 million yuan in a related party to advance a lithium hexafluorophosphate project [6] Group 3: Regulatory Actions - Company Jushi Chemical received a notice from the CSRC regarding an investigation for suspected violations of information disclosure laws [4] - Company Huosai is also under investigation by the CSRC for similar reasons [5] Group 4: Investment and Acquisitions - Company Gao Neng Environment plans to acquire 45.2% equity in three mining companies [7] - Company Aerospace Electric intends to purchase 32% equity in Shenzhen Aerospace Electric Motor System Co., Ltd. through public bidding [8]

Group 1 - Central Plaza received a warning letter from Jiangsu Securities Regulatory Commission due to failure to timely disclose significant litigation progress and accounting treatment, affecting the accuracy of the 2025 semi-annual report [4] - Jiaron Technology announced a stock suspension as it plans a major asset restructuring through share issuance and fundraising, with the suspension expected to last no more than 10 trading days [5] - Maiwei Co. is undergoing a debt restructuring involving accounts receivable totaling 371 million yuan, with an estimated loss of 85.465 million yuan, aimed at accelerating cash flow recovery and reducing receivables risk [6] Group 2 - New World plans to use up to 850 million yuan of idle fundraising to purchase financial products or deposits, having previously used 575 million yuan for similar purposes [7] - Huyou Pharmaceutical's HYP-6589 tablet clinical trial application for treating advanced non-small cell lung cancer has been accepted by the National Medical Products Administration [8] - Sunshine Nuohuo's lawsuit against Hengsheng Pharmaceutical has entered the second instance, with the original claim amounting to 20 million yuan and a counterclaim of 740.73 thousand yuan [9] Group 3 - Guolian Aquatic received a warning letter from Guangdong Securities Regulatory Commission for non-operating fund occupation by its controlling shareholder, with a total borrowing of 7.8 million yuan [10] - Renfu Pharmaceutical's application for the marketing authorization of Dexmethylphenidate capsules has been accepted, targeting ADHD treatment [11] - Jindi Co. signed a strategic cooperation letter with Dongpei Co. to explore collaboration on humanoid robot harmonic reducer assemblies [12] Group 4 - Yuyuan Co. repurchased 1 million A-shares for a total payment of approximately 5.386 million yuan, as part of a broader repurchase plan of 200-300 million yuan [13] - Yuheng Pharmaceutical's executives increased their holdings by 1.12% through a judicial auction, acquiring 25 million shares [14] - Zhonghuan Co. shareholders plan to reduce their holdings by 1.02% and 0.24% respectively, citing personal funding needs [15] Group 5 - Huibo Co. won a contract for the Iraq NaftKhana oilfield restoration project worth approximately 1.596 billion yuan, expected to significantly impact 2026-2027 performance [17] - Dajin Heavy Industry's subsidiary signed a contract for a European offshore wind farm project valued at approximately 1.339 billion yuan, representing 35.41% of the company's 2024 audited revenue [18]

Group 1 - Daikin Heavy Industries' subsidiary signed a contract worth approximately 1.339 billion yuan for an offshore wind farm project in Europe, accounting for 35.41% of the company's audited revenue for 2024 [1] Group 2 - Zhaoyi Innovation announced that several board members and senior management plan to reduce their holdings by a total of 249,000 shares, due to personal financial needs, with the reduction period set from December 15, 2025, to March 14, 2026 [2] Group 3 - Jushi Chemical received a notice from the China Securities Regulatory Commission regarding an investigation for suspected violations of information disclosure laws, while the company's operations continue normally [3][6] Group 4 - Chaozhuo Aerospace announced a stock suspension due to major matters being planned by its controlling shareholders, which may lead to a change in control [4] Group 5 - Heng Rui Medicine received approval for clinical trials of SHR-1139 injection, a biopharmaceutical with no similar products approved for sale domestically or internationally, with a cumulative R&D investment of approximately 100.13 million yuan [5] Group 6 - Huayou Pharmaceutical's HYP-6589 tablet for treating advanced non-small cell lung cancer received a clinical trial application acceptance notice, with no similar products approved for sale [8] Group 7 - Renfu Pharmaceutical's application for the marketing license of Dexamethasone L-amphetamine capsules was accepted, aimed at treating ADHD, with a cumulative R&D investment of approximately 90 million yuan [10] Group 8 - Huibo Group won a bid for a 1.596 billion yuan project for the restoration of an oil field in Iraq [10]

证券日报网讯 11月21日晚间，人福医药发布公告称，公司控股子公司宜昌人福药业有限责任公司（公 司持有其80%的股权）近日收到国家药品监督管理局核准签发的二甲磺酸利右苯丙胺胶囊的药品注册上 市许可申请《受理通知书》。 （文章来源：证券日报） ...

Regulatory Actions - Haosai is under investigation by the China Securities Regulatory Commission for suspected violations of information disclosure, but the company states that its operations remain normal and the investigation will not significantly impact management [2] - Central Plaza and its executives received a warning letter from the Jiangsu Securities Regulatory Bureau for failing to timely disclose significant litigation progress, which led to inaccurate financial reporting [3] - Guolian Aquatic received a warning letter from the Guangdong Securities Regulatory Bureau for non-operating fund occupation by its controlling shareholder, which was not disclosed in a timely manner [9] Corporate Actions - Jiarong Technology is planning a major asset restructuring and has suspended trading of its shares, expected to last no more than 10 trading days [4] - Maiwei Co. announced a debt restructuring totaling 371 million yuan, with an expected loss of 85.465 million yuan, aimed at improving cash flow and reducing receivables risk [5] - New World plans to use up to 850 million yuan of idle fundraising to purchase financial products or deposits, with a total of 575 million yuan already invested in such products [6] Legal Matters - Sunshine Nuohuo's lawsuit against Hengsheng Pharmaceutical has entered the second instance, with the original claim amounting to 20 million yuan and a counterclaim of 7.4073 million yuan [8] Product Development - Huyou Pharmaceutical's HYP-6589 tablet has received acceptance for clinical trial applications for treating advanced non-small cell lung cancer [7] - Renfu Pharmaceutical's application for the marketing license of a new ADHD treatment has been accepted, with no similar products currently available in the domestic market [10] Strategic Partnerships - Jindi Co. signed a strategic cooperation letter of intent with Dongpei Co. to explore collaboration on humanoid robot harmonic reducer assemblies and key components [11] Share Buybacks and Holdings - Yuyuan Co. has repurchased 1 million A-shares for a total of approximately 5.3864 million yuan as part of a buyback plan [12] - Yuheng Pharmaceutical's executives increased their holdings by 1.12%, acquiring a total of 25 million shares [13] Major Contracts - Huayou Huibo has been awarded a contract worth 225 million USD for the Iraq NaftKhana oilfield project, which is expected to significantly impact future earnings [16] - Dajin Heavy Industry's subsidiary signed a contract worth approximately 1.339 billion yuan for a European offshore wind farm project, representing 35.41% of the company's expected annual revenue [17]