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拓新药业子公司新乡制药收到药品GMP符合性检查告知书
Zhi Tong Cai Jing· 2026-01-20 10:53
拓新药业(301089)(301089.SZ)公告,公司全资子公司新乡制药股份有限公司(简称"新乡制药")近日收 到河南省药品监督管理局分别核发的两份《药品GMP符合性检查告知书》。新乡制药本次原料药(奥拉 帕利)(抗肿瘤药)、原料药(胞磷胆碱)相关车间及生产线通过药品GMP符合性检查,标志着公司相应生产 设施与管理体系满足药品生产质量管理规范要求。 ...
拓新药业(301089.SZ)子公司新乡制药收到药品GMP符合性检查告知书
智通财经网· 2026-01-20 10:49
智通财经APP讯,拓新药业(301089.SZ)公告,公司全资子公司新乡制药股份有限公司(简称"新乡制药") 近日收到河南省药品监督管理局分别核发的两份《药品GMP符合性检查告知书》。新乡制药本次原料 药(奥拉帕利)(抗肿瘤药)、原料药(胞磷胆碱)相关车间及生产线通过药品GMP符合性检查,标志着公司 相应生产设施与管理体系满足药品生产质量管理规范要求。 ...
拓新药业(301089.SZ):子公司收到药品GMP符合性检查告知书
Ge Long Hui A P P· 2026-01-20 09:45
HNGMP26015、编号:豫GMP202503049)。新乡制药本次原料药(奥拉帕利)(抗肿瘤药)、原料药 (胞磷胆碱)相关车间及生产线通过药品GMP符合性检查,标志着公司相应生产设施与管理体系满足 药品生产质量管理规范要求。原料药(胞磷胆碱)即可上市销售,原料药(奥拉帕利)由于涉及地址变 更,待通过国家药品监督管理局备案后,即可上市销售。本次通过药品GMP符合性检查,将助力公司 持续保障产品质量稳定性与生产供应能力,更好地满足相关药品的市场需求,将有力推动公司未来的业 务拓展。 格隆汇1月20日丨拓新药业(301089.SZ)公布,全资子公司新乡制药股份有限公司(简称"新乡制药")近 日收到河南省药品监督管理局分别核发的两份《药品GMP符合性检查告知书》(编号: ...
拓新药业:子公司收到药品GMP符合性检查告知书
Ge Long Hui· 2026-01-20 09:34
HNGMP26015、编号:豫GMP202503049)。新乡制药本次原料药(奥拉帕利)(抗肿瘤药)、原料药 (胞磷胆碱)相关车间及生产线通过药品GMP符合性检查,标志着公司相应生产设施与管理体系满足 药品生产质量管理规范要求。原料药(胞磷胆碱)即可上市销售,原料药(奥拉帕利)由于涉及地址变 更,待通过国家药品监督管理局备案后,即可上市销售。本次通过药品GMP符合性检查,将助力公司 持续保障产品质量稳定性与生产供应能力,更好地满足相关药品的市场需求,将有力推动公司未来的业 务拓展。 格隆汇1月20日丨拓新药业(301089.SZ)公布,全资子公司新乡制药股份有限公司(简称"新乡制药")近 日收到河南省药品监督管理局分别核发的两份《药品GMP符合性检查告知书》(编号: ...
Nature:蔡立慧团队揭示ABCA7基因突变增加阿尔茨海默病风险的机制,并提出逆转方法
生物世界· 2025-09-12 04:07
Core Viewpoint - The research highlights the significant role of the ABCA7 gene in Alzheimer's disease risk, particularly through its rare functional loss mutations and their impact on phosphatidylcholine metabolism and mitochondrial function in neurons [3][4][10]. Group 1: Genetic Risk Factors - APOE4 is identified as the strongest genetic risk factor for Alzheimer's disease, increasing the risk by 3 times with one copy and 8-12 times with two copies [3]. - ABCA7 gene mutations, particularly those causing functional loss, double the risk of developing Alzheimer's compared to non-carriers [3]. Group 2: Mechanisms of ABCA7 - ABCA7 protein is crucial for lipid transport and maintaining membrane asymmetry in the brain, with its dysfunction linked to amyloid protein deposition and increased neuroinflammation [6]. - The study utilized brain tissue samples from the ROSMAP study, focusing on 12 patients with ABCA7 functional loss mutations to explore the genetic impact on Alzheimer's risk [6][7]. Group 3: Cellular Impact and Interventions - Single-nucleus RNA sequencing revealed extensive gene expression changes in various neuronal cell types associated with ABCA7 mutations, affecting lipid metabolism and mitochondrial function [7]. - Supplementation with cytidine diphosphate-choline (CDP-choline) was shown to reverse the negative effects of ABCA7 mutations on neurons, restoring mitochondrial function and reducing oxidative stress [8][10].
拓新药业:专注于核苷(酸)类医药中间体及原料药的研发、生产及销售
Core Viewpoint - The company focuses on the research, production, and sales of nucleoside (acid) pharmaceutical intermediates and active pharmaceutical ingredients, primarily in the fields of antiviral, antitumor, and neurological medications [1] Company Overview - The main products of the company include: - Cytidine sodium - Cytidine - Acyclidine - Cytarabine hydrochloride - Adefovir dipivoxil - Ribavirin - Inosine - Acyclovir - Cytosine - 5-Fluorouracil - Cytidine - Uridine [1] Market Focus - The company is currently not involved in the development of vaccines or treatments related to the epidemic of Chikungunya virus [1]
科伦药业(002422):一季度业绩承压 全年季度环比望迎改善
Xin Lang Cai Jing· 2025-05-05 08:37
Core Viewpoint - The company reported mixed financial results for 2024 and Q1 2025, with a slight increase in annual revenue but a significant decline in quarterly performance due to high base effects from the previous year [1][2]. Financial Performance - In 2024, the company achieved operating revenue of 21.812 billion yuan, a year-on-year increase of 1.67%, and a net profit attributable to shareholders of 2.936 billion yuan, up 19.53% [1]. - For Q1 2025, the company reported operating revenue of 4.390 billion yuan, a year-on-year decrease of 29.42%, and a net profit of 584 million yuan, down 43.07% [2]. Profitability Metrics - The overall gross margin for 2024 was 51.69%, a decrease of 0.74 percentage points year-on-year, while the expense ratio was 32.27%, down 3.95 percentage points [3]. - In Q1 2025, the gross margin dropped to 48.67%, a decline of 7.17 percentage points year-on-year, with the expense ratio slightly increasing to 32.38% [3]. Business Segments - The infusion business generated sales of 8.912 billion yuan in 2024, a decrease of 11.85%, with sales volume of 4.347 billion bottles/bags, down 0.70% [4]. - Non-infusion drug sales increased by 5.41% to 4.169 billion yuan, driven by strong performance in the plastic water needle business [4]. - The antibiotic intermediates and raw materials segment achieved revenue of 5.856 billion yuan, a year-on-year increase of 20.90%, benefiting from increased market demand [4]. Innovation and Pipeline - The company launched its innovative drug, Lukanosatuzumab (佳泰莱), in November 2024, marking the beginning of a new era in innovative drug commercialization [5]. - Ongoing clinical trials for various ADC therapies are being conducted in collaboration with Merck, targeting multiple cancer types [5][6]. Future Projections - Revenue projections for 2025 to 2027 are estimated at 21.9 billion, 23.36 billion, and 23.98 billion yuan, with corresponding net profits of 3.02 billion, 3.35 billion, and 3.41 billion yuan [7]. - The company is expected to maintain a valuation of 19X for 2025 and 17X for 2026 and 2027 [7]. Investment Rating - The investment rating is maintained at "Buy" based on the company's growth potential and ongoing innovation efforts [8].