Workflow
阿普米司特片
icon
Search documents
力生制药:关于子公司中央药业药品阿普米司特片通过上市许可申请的公告
Zheng Quan Ri Bao· 2025-12-12 12:11
Core Viewpoint - Recently, the company announced that its subsidiary, Tianjin Central Pharmaceutical Co., Ltd., received drug registration certificates for Apremilast tablets in three different specifications: 10mg, 20mg, and 30mg, indicating successful approval for market entry [2]. Group 1 - The company has obtained the drug registration certificate for Apremilast tablets 10mg (Approval No. 2025S03538) [2] - The company has also received the drug registration certificate for Apremilast tablets 20mg (Approval No. 2025S03539) [2] - Additionally, the company secured the drug registration certificate for Apremilast tablets 30mg (Approval No. 2025S03540) [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]
力生制药(002393.SZ):子公司中央药业药品阿普米司特片通过上市许可申请
Ge Long Hui A P P· 2025-12-12 08:18
Core Viewpoint - The company, Lifesun Pharmaceutical (002393.SZ), announced that its subsidiary, Tianjin Central Pharmaceutical Co., Ltd., has received drug registration certificates from the National Medical Products Administration for Apremilast tablets in three dosages: 10mg, 20mg, and 30mg, indicating successful approval for market entry [1] Group 1 - The drug Apremilast is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy [1] - The registration certificates have the following batch numbers: 2025S03538 for 10mg, 2025S03539 for 20mg, and 2025S03540 for 30mg [1]
力生制药:阿普米司特片通过上市许可申请
Zhi Tong Cai Jing· 2025-12-12 08:10
Core Viewpoint - Company Tianjin Central Pharmaceutical Co., Ltd., a subsidiary of Lisheng Pharmaceutical, has received drug registration certificates from the National Medical Products Administration for Apremilast tablets in 10mg, 20mg, and 30mg specifications, indicating successful approval for market access [1] Group 1 - The drug Apremilast is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy [1]
力生制药(002393.SZ):阿普米司特片通过上市许可申请
智通财经网· 2025-12-12 08:09
Core Viewpoint - The company, Lifesun Pharmaceutical (002393.SZ), announced that its subsidiary, Tianjin Central Pharmaceutical Co., Ltd., has received drug registration certificates from the National Medical Products Administration for Apremilast tablets in 10mg, 20mg, and 30mg specifications, indicating successful approval for market entry [1]. Group 1 - The drug Apremilast is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy [1].
力生制药:子公司中央药业药品阿普米司特片通过上市许可申请
Ge Long Hui· 2025-12-12 08:09
Core Viewpoint - The company, Lifesun Pharmaceutical (002393.SZ), announced that its subsidiary, Tianjin Central Pharmaceutical Co., Ltd., has received drug registration certificates from the National Medical Products Administration for Apremilast tablets in three dosages: 10mg, 20mg, and 30mg, indicating successful approval for market entry [1] Group 1 - The drug Apremilast is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy [1] - The registration certificates have the following batch numbers: 2025S03538 for 10mg, 2025S03539 for 20mg, and 2025S03540 for 30mg [1]
力生制药:子公司药品阿普米司特片通过上市许可申请
Xin Lang Cai Jing· 2025-12-12 08:07
Core Viewpoint - The announcement indicates that the subsidiary of the company, Central Pharmaceutical, has received a drug registration certificate from the National Medical Products Administration for Apremilast tablets in 10mg, 20mg, and 30mg specifications, which has passed the marketing authorization application [1] Group 1 - The drug is classified as a Class 4 chemical drug and is intended for the treatment of moderate to severe plaque psoriasis in adult patients [1] - The approval will enrich the company's product line for psoriasis treatment and expand market sales [1] - The future performance impact is expected to be positive, although drug sales may be influenced by market conditions and other factors, leading to uncertainty [1]
北大医药前三季度净利润稳健增长 新产品矩阵持续完善
Core Viewpoint - The company reported a steady growth in net profit for the first three quarters of 2025, despite a decline in revenue, indicating resilience in its core operations and product development strategy [1] Financial Performance - The company achieved an operating revenue of approximately 1.231 billion yuan, a year-on-year decrease of 19.76% [1] - The net profit attributable to shareholders was 136 million yuan, reflecting a year-on-year increase of 4.31% [1] - Basic earnings per share stood at 0.23 yuan [1] Product Development and Pipeline - The company focuses on the fields of "anti-infection, analgesics, mental health, and chronic diseases," aiming to meet actual medication needs and enhance clinical efficacy [1] - The company has been actively pursuing consistency evaluations and independent research and development, introducing high-potential and high-value-added products [1] - A stable and mature core product lineup is being established through both internal and external growth strategies [1] Recent Product Approvals - On April 1, the company received a drug registration certificate for injectable cefoperazone sodium, enhancing its product line in the anti-infection sector [2] - On April 18, the company’s ondansetron hydrochloride tablets received approval, expanding its offerings in the gastrointestinal and metabolic fields [2] - On September 26, the company’s apremilast tablets were approved, which are recommended for the treatment of moderate to severe plaque psoriasis, further strengthening its position in the immunomodulator market [2]
北大医药股份有限公司关于获得《药品注册证书》的公告
Group 1: Drug Approval Announcement - North China Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for Apremilast Tablets, a PDE4 inhibitor, approved by the National Medical Products Administration [1][2][4] - The drug is indicated for the treatment of moderate to severe plaque psoriasis in adults and is recognized as a first-line systemic treatment in the 2023 Chinese Psoriasis Treatment Guidelines [4] Group 2: Impact on the Company - The approval of Apremilast Tablets enhances the company's product portfolio and competitiveness in the immunomodulator market, positively influencing future performance [4] Group 3: Dividend Distribution Announcement - The company has approved a cash dividend of 0.30 RMB per 10 shares, totaling approximately 17.88 million RMB, based on a total share capital of 595,987,425 shares [5][9] - The dividend distribution will occur on October 13, 2025, with the record date set for October 10, 2025 [10][11]
北大医药(000788.SZ):阿普米司特片获得《药品注册证书》
Ge Long Hui A P P· 2025-09-25 08:55
Core Viewpoint - Beida Pharmaceutical (000788.SZ) has received the Drug Registration Certificate from the National Medical Products Administration for Apremilast tablets, indicating a significant advancement in its product pipeline for treating moderate to severe plaque psoriasis in adults [1] Group 1: Product Information - Apremilast is a small molecule inhibitor specifically targeting phosphodiesterase-4 (PDE4), which regulates intracellular inflammatory signaling pathways [1] - The drug effectively inhibits the release of pro-inflammatory factors and increases the production of anti-inflammatory factors, allowing for precise control of inflammatory responses [1] - Apremilast tablets are recognized for their rapid onset of action, clear efficacy, and high safety profile, making them a first-line systemic treatment option as per the "Chinese Psoriasis Diagnosis and Treatment Guidelines (2023 Edition)" [1]