阿普米司特片
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北大医药前三季度净利润稳健增长 新产品矩阵持续完善
Zheng Quan Shi Bao Wang· 2025-10-30 13:23
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
Shang Hai Zheng Quan Bao· 2025-09-25 20:53
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]
北大医药:阿普米司特片获药品注册证书
Zheng Quan Shi Bao Wang· 2025-09-25 08:53
Core Viewpoint - The company received approval from the National Medical Products Administration for the drug Apremilast tablets, which are intended for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy [1] Company Summary - The approval of Apremilast tablets marks a significant milestone for the company, expanding its product portfolio in the dermatology sector [1] - This drug is specifically aimed at treating adult patients with moderate to severe plaque psoriasis, indicating a targeted approach to addressing this skin condition [1] Industry Summary - The approval aligns with the growing demand for effective treatments for psoriasis, a chronic skin condition affecting a substantial portion of the population [1] - The introduction of Apremilast tablets may enhance competition within the dermatology market, particularly among companies offering psoriasis treatments [1]
北大医药(000788.SZ)取得阿普米司特片药品注册证书
智通财经网· 2025-09-25 08:50
Core Viewpoint - The company, Beijing University Pharmaceutical (000788.SZ), has received approval from the National Medical Products Administration for the drug registration certificate of Apremilast tablets in two specifications (10mg and 30mg) [1] Group 1: Product Details - Apremilast is a specific small molecule inhibitor of phosphodiesterase-4 (PDE4) that regulates intracellular inflammatory signaling pathways [1] - The drug effectively inhibits the release of pro-inflammatory factors and increases the generation of anti-inflammatory factors, thereby precisely controlling inflammatory responses [1] - Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, characterized by rapid onset, clear efficacy, and high safety [1]
北大医药取得阿普米司特片药品注册证书
Zhi Tong Cai Jing· 2025-09-25 08:49
Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug registration certificate of Apremilast tablets in two specifications (10mg and 30mg) [1] Company Summary - Apremilast is a specific small molecule inhibitor of phosphodiesterase-4 (PDE4) that regulates intracellular inflammatory signaling pathways, effectively inhibiting the release of pro-inflammatory factors and increasing the production of anti-inflammatory factors [1] - The drug is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, characterized by rapid onset, clear efficacy, and high safety [1]
北大医药:阿普米司特片获得《药品注册证书》
Ge Long Hui· 2025-09-25 08:45
Core Viewpoint - North China 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 portfolio for treating moderate to severe plaque psoriasis in adults [1] Group 1: Product Details - 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 [1] Group 2: Clinical Guidelines - Apremilast has been included as a first-line systemic treatment option in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Edition)" for patients eligible for phototherapy or systemic therapy [1]
江西省药品生产监督检查结果公告(2025年第1号)
Zhong Guo Zhi Liang Xin Wen Wang· 2025-07-25 07:57
Core Viewpoint - The article discusses the results of drug production supervision inspections conducted by the Jiangxi Provincial Drug Supervision Administration from January to June 2025, highlighting compliance and non-compliance among various pharmaceutical companies [2][3][4]. Summary by Category Inspection Results - A total of 23 pharmaceutical companies were inspected during the first half of 2025, with most companies found to be compliant with the Good Manufacturing Practice (GMP) standards [2][3]. - Specific companies such as Jiangxi Ma Kang Pharmaceutical Co., Ltd. and Jiangxi Chengzhi Yongfeng Pharmaceutical Co., Ltd. were noted for their compliance in producing various drug forms including eye drops and traditional Chinese medicine [2][3]. Compliance Details - Companies like Jiangxi Qinfeng Pharmaceutical Co., Ltd. and Jiangxi Yichuan Pharmaceutical Technology Co., Ltd. were recognized for their adherence to GMP during inspections, covering a range of products from small volume injections to tablets [3][4]. - The inspections included checks on production lines for specific drugs, ensuring that companies met the required safety and quality standards [2][3]. Non-Compliance Issues - Some companies faced issues during inspections, although the article primarily focuses on those that complied with regulations [2][3]. - The inspections aimed to ensure that all pharmaceutical products manufactured in the province meet the necessary legal and quality standards [2][3][4].
周杰伦病情让自身免疫类药物受关注 和美药业能否借势闯关港股?核心产品还未上市,竞品集采已降价超93%
Mei Ri Jing Ji Xin Wen· 2025-06-25 12:43
Core Viewpoint - The rising public awareness of autoimmune diseases, particularly ankylosing spondylitis, has led to increased interest in the pharmaceutical company Ganzhou Hemei Pharmaceutical Co., Ltd. as it seeks to go public with its core drug Mufemilast targeting psoriasis and ankylosing spondylitis [1][6]. Company Overview - Ganzhou Hemei Pharmaceutical is preparing for an IPO under the Hong Kong Stock Exchange's 18A biotechnology rules, focusing on high investment and potential returns typical of biopharmaceutical companies [2]. - The company has not yet generated revenue and relies heavily on government subsidies and continuous financing to sustain operations [2][11]. Product Pipeline - The company has seven clinical-stage small molecule candidates aimed at addressing unmet medical needs in autoimmune diseases and oncology [2]. - Mufemilast is a dual-action PDE4 inhibitor that has entered the NDA priority review process, targeting multiple indications including psoriasis and ankylosing spondylitis [2][3]. Market Potential - The market for psoriasis drugs in China has seen rapid growth, with a compound annual growth rate (CAGR) of 30.4% from 2019 to 2023, reaching a market size of 13.9 billion yuan in 2023, projected to soar to 89.4 billion yuan by 2032 [3]. - The autoimmune disease drug market in China has expanded from $2.5 billion in 2019 to $4 billion in 2023, with expectations to reach $26.3 billion by 2032, reflecting a CAGR of 23.3% [6]. Competitive Landscape - The competitive environment for Mufemilast is intense, with existing competitors having undergone significant price reductions due to national procurement policies, with price drops exceeding 93% for some products [5]. - There are currently five approved small molecule targeted therapies for psoriasis in China, with 37 more in clinical development, indicating a crowded market for Mufemilast [5][8]. Financial Status - The company reported significant losses of 156 million yuan in 2023 and 123 million yuan in 2024, with minimal other income [11]. - The company has undergone multiple rounds of financing since 2021, raising over 500 million yuan to support its operations, with a post-investment valuation of 3.9 billion yuan [11]. Leadership - The founder and chairman, Zhang Hesheng, has over 20 years of experience in biopharmaceuticals and holds a significant voting power in the company [12].