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昂利康:关于获得药品注册证书及药品补充申请批准通知书的公告
Zheng Quan Ri Bao· 2025-12-12 12:10
证券日报网讯 12月12日晚间,昂利康发布公告称,近日,公司收到国家药品监督管理局签发的双氯芬 酸钠肠溶片《药品注册证书》和沙库巴曲缬沙坦钠片《药品补充申请批准通知书》。 (文章来源:证券日报) ...
12月12日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-12 10:41
Group 1 - Shouyao Holdings is planning to issue H-shares and list on the Hong Kong Stock Exchange, with discussions ongoing with intermediaries regarding the specifics of the listing [1] - Jiangsu Guoxin's subsidiary, Guoxin Mazhou, has completed the trial operation of a 1000MW coal-fired power unit, which is set to officially commence operations on December 12, 2025 [2] - Yuekang Pharmaceutical's mRNA tumor vaccine has received clinical trial approval from the National Medical Products Administration for treating advanced solid tumors [3] Group 2 - Dongli New Science plans to invest 666 million yuan in the restructuring of SAIC Hongyan, acquiring approximately 14.66% equity post-restructuring [4] - Longsheng Technology is set to invest approximately 350 million yuan in the establishment of an intelligent robot innovation center in Wuxi [5] - Shangwei Co. has received a government subsidy of 2.212 million yuan, which accounts for 13.53% of its audited net profit for 2024 [6] Group 3 - Anglikang has received drug registration certificates for Diclofenac Sodium Enteric-Coated Tablets and approval for a supplemental application for Sacubitril/Valsartan Sodium Tablets [7] - Guangzhou Development has received acceptance notices for the registration of 8 billion yuan in medium-term notes and 6 billion yuan in short-term financing bonds [8] - Kebo Da plans to increase capital by 21.2 million euros (approximately 174 million yuan) in its wholly-owned subsidiary in Germany [9][10] Group 4 - Changguang Huaxin has received a total of 11.6672 million yuan in government subsidies, including 8.0552 million yuan related to income [11] - Haizheng Pharmaceutical's subsidiary has received a European Pharmacopoeia suitability certificate for its raw material [12] - Qianjin Pharmaceutical's subsidiary has received a drug registration certificate for Lurasidone Hydrochloride Tablets, used for treating schizophrenia [13] Group 5 - Daimai Co. has received a warning letter from the Shanghai Securities Regulatory Bureau due to failure to timely disclose a significant event related to a fire incident [14] - ST Changyao's subsidiary has recently ceased production due to financial difficulties and competitive pressures in the photovoltaic industry [15] - Guodian Power is investing in the construction of a 2×1000MW expansion project at the Ganbi Power Plant, with a total dynamic investment of 7.218 billion yuan [16] Group 6 - Kaichuang International's subsidiary has completed the handover of a tuna purse seine vessel, expected to be operational by 2026 [16] - Tieke Rail plans to sign an energy management agreement for a distributed photovoltaic project, which is expected to save approximately 1.441 million yuan in electricity costs over 25 years [18] - Bailian Co. plans to sign a land compensation agreement with Friendship Logistics, with a total compensation of 103 million yuan [19] Group 7 - Dayu Water-saving's subsidiary has been pre-awarded two high-standard farmland construction projects, with total expected amounts of 137 million yuan and 135 million yuan respectively [20] - Tianma Technology reported a total eel output of approximately 1197.15 tons in November, with sales prices ranging from 53,000 yuan/ton to 89,000 yuan/ton [21] - Guorui Technology's subsidiary has been shortlisted for the GXLF project with a bid of 76 million yuan [22] Group 8 - Qingdao Food's deputy general manager has resigned for personal reasons [23] - Guosheng Zhike plans to use up to 900 million yuan of idle funds for cash management [24] - Guodian Nanrui plans to use up to 23 billion yuan of idle funds for entrusted wealth management [25] Group 9 - Jiahuan Energy plans to merge its wholly-owned subsidiary, Zhejiang Jiahuan Hydrogen Peroxide Co., Ltd., through an overall absorption merger [26] - Ganyue Expressway reported vehicle toll service revenue of 309 million yuan for November [27] - Jinling Hotel's chairman has resigned due to work changes [28] Group 10 - Lisheng Pharmaceutical's subsidiary has received drug registration certificates for Apremilast Tablets [29] - Baotai has received a positive opinion from the European Medicines Agency for Gotenfia® for various inflammatory conditions [30] - ST Zhisheng has been awarded a smart city governance project with a bid amount of 104 million yuan [31] Group 11 - Chenxi Aviation and its related personnel have received administrative regulatory measures from the Shaanxi Securities Regulatory Bureau due to financial reporting issues [32] - Portong Medical has appointed Xia Canglan as the new deputy general manager [33] - Maide Medical plans to repurchase shares with a total amount between 20 million and 40 million yuan [34] Group 12 - Jimin Health plans to establish a joint venture with a total investment of 600 million yuan, focusing on AI and software development [35] - Beilu Pharmaceutical has received a drug registration certificate for Pioglitazone Metformin Tablets [36] - Hainan Mining plans to entrust the overall management of the Shiluo Iron Mine to a construction company for three years, with a total contract amount of approximately 818 million yuan [38] Group 13 - Huiyu Pharmaceutical has received a drug registration certificate for Nicardipine Hydrochloride Injection [39] - Baoland has received a government subsidy of 10 million yuan related to income [40] - Qingdao Port has terminated the acquisition of 100% equity in an oil company and 50% equity in Rizhao Shihua due to regulatory concerns [41]
昂利康(002940.SZ):获得药品注册证书及药品补充申请批准通知书
Ge Long Hui· 2025-12-12 10:03
沙库巴曲缬沙坦钠片是治疗慢性心力衰竭药物,用于射血分数降低的慢性心力衰竭的成人患者和用于治 疗原发性高血压。该产品系公司与苏州鹏旭医药科技有限公司、苏州晶云药物科技股份有限公司共同合 作研发。公司沙库巴曲缬沙坦钠片(200mg)于2024年6月获批上市,此次公司申请增加100mg规格, 现已收到国家药监局核准签发的《药品补充申请批准通知书》。 格隆汇12月12日丨昂利康(002940.SZ)公布,公司收到国家药品监督管理局签发的双氯芬酸钠肠溶片 《药品注册证书》和沙库巴曲缬沙坦钠片《药品补充申请批准通知书》。 双氯芬酸钠肠溶片适用症如下:①炎性和退行性风湿病;②非关节性的各种软组织风湿性疼痛;③痛风 急性发作;④急性的轻、中度疼痛;⑤对耳、鼻、喉的严重痛性感染可作为辅助治疗药。 财经频道更多独家策划、专家专栏,免费查阅>> 责任编辑:钟离 ...
昂利康:获双氯芬酸钠肠溶片注册证书及沙库巴曲缬沙坦钠片补充申请批准
Xin Lang Cai Jing· 2025-12-12 09:25
昂利康公告称,近日收到国家药监局签发的双氯芬酸钠肠溶片《药品注册证书》和沙库巴曲缬沙坦钠片 《药品补充申请批准通知书》。双氯芬酸钠肠溶片规格25mg,批准文号有效期至2030年12月8日,视同 通过一致性评价;沙库巴曲缬沙坦钠片增加100mg规格,批准文号有效期至2029年6月27日。此次获批 将丰富公司产品管线及规格,但药品销售受政策、市场等因素影响,存在不确定性。 ...
昂利康:双氯芬酸钠肠溶片获得药品注册证书
Zheng Quan Shi Bao Wang· 2025-12-12 09:21
人民财讯12月12日电,昂利康(002940)12月12日公告,近日,公司收到国家药监局签发的双氯芬酸钠 肠溶片《药品注册证书》和沙库巴曲缬沙坦钠片《药品补充申请批准通知书》,本次双氯芬酸钠肠溶片 获得药品注册证书、沙库巴曲缬沙坦钠片100mg规格获批,将进一步丰富公司产品管线以及产品规格。 ...
昂利康(002940) - 关于获得药品注册证书及药品补充申请批准通知书的公告
2025-12-12 09:15
证券代码:002940 证券简称:昂利康 公告编号:2025-101 | 药品通用名称 | 双氯芬酸钠肠溶片 | | | --- | --- | --- | | 主要成份 | 双氯芬酸钠 | | | 剂型 | 片剂 | | | 申请事项 | 药品注册(境内生产) | | | 注册分类 | 化学药品 类 4 | | | 规格 | 25mg | | | 受理号 | CYHS2402146 | | | 药品批准文号 | 国药准字 H20256225 | | | 药品批准文号有效期 | 至 2030 12 月 08 日 | 年 | | 上市许可持有人 | 名称:浙江昂利康制药股份有限公司 | | | | 地址:浙江省嵊州市嵊州大道北 号 1000 | | | 生产企业 | 名称:浙江昂利康制药股份有限公司 | | | | 地址:绍兴市嵊州市嵊州大道北 号 1000 | | | 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,发 | | | | 给药品注册证书。 | | (一)药品注册证书主要内容 (二)药品补充申请批准通知书 1 | 药品通用名称 | 沙库巴曲 ...
创新综合实力获认可 昂利康入选2025年浙江省民营企业研发投入及发明专利200强
Quan Jing Wang· 2025-12-12 08:09
目前国内医药生产企业众多,竞争较为激烈,昂利康始终坚持将研发作为企业的核心发展动力,注重业 内合作,立足于开发具有临床价值的优质产品。经过多年的发展,在口服头孢类抗生素原料药、alpha 酮酸原料药、心血管类制剂、吸入用麻醉原料药、抗雄性激素中间体及植物源胆固醇系列产品上均具有 显著优势。公司是国内最早掌握酶法技术的口服头孢类原料药生产厂家之一;公司是国内最大的alpha 酮酸原料药生产厂家,也是费森尤斯卡比的核心原料药供应商之一;公司是国内钙拮抗剂类抗高血压制 剂的主要生产企业之一,苯磺酸左氨氯地平片在国内市场具有较高的市场占有率;公司是国内主要的吸 入用麻醉原料药和制剂一体化的生产企业;公司是国内较早以植物甾醇生物发酵所得产品为起始原料生 产甾体药物中间体的企业,是国内首家实现植物源胆固醇规模化生产的企业,在抗雄性激素中间体、植 物源胆固醇、植物源维生素D系列等细分领域已取得行业领先地位。 此次入选两项榜单,既是对昂利康创新工作的肯定,也将激励企业继续前进。未来,昂利康将继续坚持 研发投入,加强专利布局,推动更多优质医药产品上市,为浙江省民营经济高质量发展贡献力量,助力 公众健康事业发展。 昂利康主要从事 ...
昂利康(002940.SZ)取得恩格列净二甲双胍缓释片(II)药品注册证书
智通财经网· 2025-11-28 09:36
智通财经APP讯,昂利康(002940.SZ)公告,公司收到国家药品监督管理局签发的恩格列净二甲双胍缓释 片(II)《药品注册证书》。恩格列净二甲双胍缓释片(II)是恩格列净和盐酸二甲双胍的复方制剂,适用于 正在接受恩格列净和盐酸二甲双胍治疗的2型糖尿病成人患者,用于改善这些患者的血糖控制。 ...
昂利康(002940.SZ):获得药品注册证书
Ge Long Hui A P P· 2025-11-28 09:23
Core Viewpoint - The company, Anglikang (002940.SZ), has received a drug registration certificate from the National Medical Products Administration for its drug, Ertugliflozin Metformin Extended-Release Tablets (II), indicating a significant advancement in its product portfolio for diabetes treatment [1] Group 1: Drug Approval Details - The drug is a combination formulation of Ertugliflozin and Metformin Hydrochloride, aimed at improving blood sugar control in adult patients with type 2 diabetes who are already receiving treatment with these medications [1] - The company received the acceptance notice for the drug's marketing authorization application in June 2024 and has recently obtained approval from the National Medical Products Administration [1] - The issuance of the drug registration certificate is considered equivalent to passing the consistency evaluation as per national policy regulations [1]
昂利康(002940.SZ):子公司获得兽药产品批准文号
Ge Long Hui A P P· 2025-11-28 09:23
公司已按照《兽药管理条例》《兽药产品批准文号管理办法》等规定的要求取得硫糖铝片兽药产品批准 文号批件,该兽药具备生产上市销售条件。该兽药批准文号的取得可进一步丰富公司产品品类,对推动 宠物用药战略布局、促进公司发展具有积极意义。 子公司动保科技硫糖铝片用于治疗犬胃溃疡、十二指肠溃疡和胃炎。 格隆汇11月28日丨昂利康(002940.SZ)公布,近日,公司子公司浙江昂利康动保科技有限公司收到中华人 民共和国农业农村部核准签发的"硫糖铝片"兽药产品批准文号批件。通用名称:硫糖铝片兽药产品批准 文号,兽药字:111187075。 ...