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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
Core Viewpoint - Recently, the company announced that it has received the drug registration certificate for Diclofenac Sodium Enteric-coated Tablets and the approval notice for the supplemental application of Sacubitril/Valsartan Tablets from the National Medical Products Administration [2] Group 1 - The company has been granted a drug registration certificate for Diclofenac Sodium Enteric-coated Tablets [2] - The company has also received an approval notice for the supplemental application of Sacubitril/Valsartan Tablets [2]
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
Core Viewpoint - Company received drug registration certificates for Diclofenac Sodium Enteric-Coated Tablets and approval for the supplemental application of Sacubitril/Valsartan Tablets from the National Medical Products Administration [1] Group 1: Product Approvals - Diclofenac Sodium Enteric-Coated Tablets are indicated for inflammatory and degenerative rheumatic diseases, various non-articular soft tissue rheumatic pain, acute gout attacks, acute mild to moderate pain, and as an adjunct treatment for severe pain infections in the ear, nose, and throat [1] - Sacubitril/Valsartan Tablets are indicated for the treatment of chronic heart failure in adults with reduced ejection fraction and for primary hypertension [1] Group 2: Collaboration and Market Launch - The Sacubitril/Valsartan Tablets were developed in collaboration with Suzhou Pengxu Pharmaceutical Technology Co., Ltd. and Suzhou Jingyun Pharmaceutical Technology Co., Ltd. [1] - The 200mg formulation of Sacubitril/Valsartan Tablets is set to be approved for market launch in June 2024, and the company has received approval for an additional 100mg specification [1]
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
Core Viewpoint - The company announced the receipt of drug registration certificates for Diclofenac Sodium Enteric-Coated Tablets and approval for a supplemental application for Sacubitril/Valsartan Sodium Tablets, indicating a positive development in its product pipeline [1] Group 1: Product Approvals - The National Medical Products Administration issued a drug registration certificate for Diclofenac Sodium Enteric-Coated Tablets, with a specification of 25mg and a validity period until December 8, 2030, which is considered equivalent to passing the consistency evaluation [1] - The company received approval for an additional specification of 100mg for Sacubitril/Valsartan Sodium Tablets, with the approval valid until June 27, 2029 [1] Group 2: Market Impact - The new approvals will enhance the company's product lineup and specifications, but the sales of these drugs may be influenced by policy and market factors, leading to uncertainties [1]
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
Core Insights - The company Anglikon (002940) has received regulatory approvals for two pharmaceutical products, enhancing its product pipeline and specifications [1] Group 1 - The company announced the receipt of a drug registration certificate for Diclofenac Sodium Enteric-Coated Tablets [1] - The company also received a supplemental approval notice for Sacubitril/Valsartan Sodium Tablets in the 100mg specification [1] - These approvals are expected to further enrich the company's product offerings [1]
重庆华森制药股份有限公司 关于公司获得奥利司他胶囊药品 补充申请批准通知书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-04-07 22:40
Group 1 - The core point of the announcement is that Chongqing Huason Pharmaceutical Co., Ltd. has received the Supplementary Application Approval Notice for Orlistat Capsules from the National Medical Products Administration, indicating a change in the marketing authorization holder [1][2] - Orlistat Capsules are currently the only approved oral treatment for obesity or overweight patients (BMI ≥ 24) in China, primarily working by reducing fat absorption from food [2][3] - The company has transitioned to self-branding "Quchang" for the sales operation of Orlistat Capsules after reaching an agreement with its partner to change the marketing authorization back to the partner while still allowing the company to produce the product [2][3] Group 2 - The company has also received re-registration approval notices for eight other drugs, ensuring their normal production and sales, which include Cang'erzi Nasal Inhalation Capsules and Spirulina Capsules among others [6][12] - Cang'erzi Nasal Inhalation Capsules are recognized as a classic medication for nasal diseases and are included in the national medical insurance list, indicating a strong market position [9] - Spirulina Capsules have shown significant effects in enhancing immunity and regulating blood lipids, supported by multiple clinical studies, which may enhance the company's product portfolio and market competitiveness [10][11]