PKU HealthCare (000788)
Search documents
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(000788) - 关于获得《药品注册证书》的公告
2025-09-25 08:45
证券代码:000788 证券简称:北大医药 公告编号:2025-074 北大医药股份有限公司 关于获得《药品注册证书》的公告 剂型:片剂 规格:10mg 注册分类:化学药品4类 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 近日,北大医药股份有限公司(以下简称"公司")收到国家药品监督管理 局核准签发的《药品注册证书》。现将相关情况公告如下: 一、药品基本情况 药品批准文号:国药准字H20255527 上市许可持有人:北大医药股份有限公司 药品生产企业:北大医药股份有限公司 1、药品通用名称:阿普米司特片 英文名/拉丁名:Apremilast Tablets 阿普米司特片的获批进一步丰富了公司现有产品布局,有利于提升公司在 免疫制剂领域产品市场的竞争力,对公司未来业绩提升有积极作用。 审批主要结论: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。 2、药品通用名称:阿普米司特片 英文名/拉丁名:Apremilast Tablets 剂型:片剂 规格:30mg 注册分类:化学药品4类 药品批准文号: ...
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]
北大医药股份有限公司 关于全资子公司变更名称、法定代表人暨完成工商变更登记的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-23 09:25
Group 1 - The company has officially changed the name of its wholly-owned subsidiary from "Beijing Peking University Medicine Co., Ltd." to "Beijing New Advantage Pharmaceutical Commercial Co., Ltd." [2] - The legal representative has been changed from Mr. Yuan Pingdong to Ms. Cheng Hong [2] - The new business license has been issued by the Market Supervision Administration of Changping District, Beijing [2] Group 2 - The registered capital of the new entity is 100 million RMB [2] - The company was established on June 10, 1998 [2] - The business scope includes drug wholesale, sales of disinfecting equipment, and various medical device operations [2]
北大医药:关于全资子公司变更名称、法定代表人暨完成工商变更登记的公告
Zheng Quan Ri Bao· 2025-09-22 14:04
证券日报网讯 9月22日晚间,北大医药发布公告称,公司全资子公司"北京北医医药有限公司"根据公司 战略规划及经营业务发展需要,已正式更名为"北京新优势医药商业有限公司",法定代表人由袁平东先 生变更为成红女士,并于近日完成更名及法定代表人变更事项的工商变更登记手续,取得了北京市昌平 区市场监督管理局换发的《营业执照》。 (文章来源:证券日报) ...
北大医药(000788) - 关于全资子公司变更名称、法定代表人暨完成工商变更登记的公告
2025-09-22 09:30
证券代码:000788 证券简称:北大医药 公告编号:2025-073 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 一、基本情况 北大医药股份有限公司(以下简称"公司")全资子公司"北京北医医药有 限公司"根据公司战略规划及经营业务发展需要,已正式更名为"北京新优势医 药商业有限公司",法定代表人由袁平东先生变更为成红女士,并于近日完成更 名及法定代表人变更事项的工商变更登记手续,取得了北京市昌平区市场监督管 理局换发的《营业执照》。更名后的营业执照基本情况如下: 公司名称:北京新优势医药商业有限公司 统一社会信用代码:91110108700012272M 公司类型:有限责任公司(法人独资) 法定代表人:成红 注册资本:10,000 万元人民币 北大医药股份有限公司 关于全资子公司变更名称、法定代表人 暨完成工商变更登记的公告 住所:北京市昌平区回龙观镇生命园路 8 号院一区 6 号-2 至 12 层 101(3 层 301)(昌平示范园) 经营范围:许可项目:药品批发;消毒器械销售;道路货物运输(不含危险 货物);第三类医疗器械经营。(依法须经批准的项目 ...
北大医药全资子公司更名、换法定代表人并完成工商登记
Xin Lang Cai Jing· 2025-09-22 09:22
北大医药股份有限公司公告,其全资子公司"北京北医医药有限公司"因战略规划及业务发展需要,更名 为"北京新优势医药商业有限公司",法定代表人由袁平东变更为成红。近日已完成工商变更登记,取得 北京市昌平区市场监督管理局换发的《营业执照》。新公司注册资本 10000 万元,成立于 1998 年 6 月 10 日,经营范围包括药品批发、医疗器械销售等许可项目及多类一般项目。公告附有《营业执照》作 为备查文件,发布时间为 2025 年 9 月 23 日。 ...