ApicHope(300723)
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一品红(300723) - 关于全资子公司创新药APH03621 片获得临床试验注册申请受理的公告
2025-08-04 08:00
证券代码:300723 证券简称:一品红 公告编号:2025-051 近日,一品红药业集团股份有限公司(以下简称"公司")全资子公司广州 一品红制药有限公司自主研发的创新药物 APH03621 片的药物临床试验申请获得 国家药品监督管理局受理,并收到《受理通知书》。现将相关情况公告如下: 一、《受理通知书》主要内容 | 药品名称 | 申请事项 | 适应症 | 规格 | 受理号 | | --- | --- | --- | --- | --- | | APH03621 片 | 境内生产药品注 | 子 宫 内 膜 异 | 5mg | CXHL2500802 | | | 册临床试验 | 位症 | 40mg | CXHL2500803 | 一品红药业集团股份有限公司 关于全资子公司创新药 APH03621 片获得临床试验注册申请受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 目前,国内暂无获批上市的 GnRH 口服小分子拮抗剂。 根据《中华人民共和国行政许可法》第三十二条的规定,经审查,决定予以 受理。 二、药品研发及相关情况 APH03621 是公司研制的 ...
一品红:痛风创新药氘泊替诺雷(AR882)国内Ⅲ期临床试验已入组超过50%的受试者
Zheng Quan Shi Bao Wang· 2025-08-04 03:33
Core Viewpoint - Yipinhong's innovative gout drug, AR882, has made significant progress in its clinical trials, with over 50% of participants enrolled in the Phase III trial, indicating a major advancement in its global development [1][3]. Group 1: Clinical Trial Progress - The Phase III clinical trial for AR882 is a multi-center, randomized, double-blind, parallel-controlled study aimed at evaluating the efficacy and safety of AR882 compared to febuxostat in treating gout patients with hyperuricemia in China [1]. - The global Phase III trial, REDUCE2, has successfully enrolled 750 participants ahead of schedule, primarily consisting of patients with inadequate response to previous uric acid-lowering therapies [2]. Group 2: Drug Mechanism and Efficacy - AR882 is a highly selective URAT1 inhibitor that promotes urate excretion, thereby lowering serum uric acid (sUA) levels without increasing the burden on the kidneys [1]. - Previous Phase II clinical trial data indicate that AR882 demonstrates superior efficacy and safety compared to existing therapies, significantly reducing sUA levels, gout stone formation, and the frequency of acute gout attacks [1]. Group 3: Industry Context - Gout, an inflammatory arthritis caused by urate crystal deposition, affects over 55.8 million people globally, with more than 90% of patients experiencing insufficient urate excretion [2]. - AR882 received Fast Track designation from the FDA in 2024 and was highlighted for its breakthrough efficacy in dissolving gout stones at the American College of Rheumatology annual meeting [2].
一品红在研痛风创新药氘泊替诺雷(AR882)国内Ⅲ期临床试验已入组超过50%的受试者
Zheng Quan Shi Bao Wang· 2025-08-03 12:49
Core Viewpoint - Yipinhong (300723) has successfully enrolled over 50% of participants in the Phase III clinical trial for its innovative gout treatment, Deuterated Parnate (AR882) [1] Group 1: Company Overview - Yipinhong is developing Deuterated Parnate (AR882), a potent and highly selective URAT1 inhibitor aimed at promoting urate excretion and lowering serum uric acid (sUA) levels [1] Group 2: Clinical Trial Progress - The Phase III clinical trial for Deuterated Parnate (AR882) has surpassed the 50% enrollment mark for participants [1]
一品红(300723)8月1日主力资金净流入3192.02万元
Sou Hu Cai Jing· 2025-08-01 11:32
Group 1 - The core viewpoint of the news is that Yipin Hong (300723) has experienced a decline in stock price and significant decreases in revenue and profit in its latest financial report [1] - As of August 1, 2025, Yipin Hong's stock closed at 75.72 yuan, down 2.37%, with a trading volume of 111,400 hands and a transaction amount of 868 million yuan [1] - The company's latest quarterly report shows total revenue of 377 million yuan, a year-on-year decrease of 39.48%, and a net profit attributable to shareholders of 56.59 million yuan, down 43.70% year-on-year [1] Group 2 - Yipin Hong has made investments in 12 companies and participated in 2 bidding projects, indicating active engagement in business expansion [2] - The company holds 308 trademark registrations and 16 patents, reflecting its focus on intellectual property [2] - Yipin Hong has 9 administrative licenses, which may enhance its operational capabilities [2]
一品红股价创新高
Mei Ri Jing Ji Xin Wen· 2025-08-01 02:26
(文章来源:每日经济新闻) 每经AI快讯,一品红涨4.98%,报81.42元/股,股价再创新高,总市值突破367.76亿元,成交额达3.51亿 元。 ...
一品红:关于全资子公司获得西咪替丁注射液注册证书的公告
Zheng Quan Ri Bao· 2025-07-31 12:39
Group 1 - The core point of the article is that Yipinhong announced the approval of its subsidiary Guangzhou Lianrui Pharmaceutical Co., Ltd. for the registration of Cimetidine injection by the National Medical Products Administration [2] Group 2 - The approval signifies a regulatory milestone for the company, potentially enhancing its product portfolio in the pharmaceutical market [2] - Cimetidine is commonly used for treating conditions related to excess stomach acid, indicating a strategic focus on gastrointestinal therapies [2] - This development may lead to increased revenue opportunities for the company as it expands its offerings in the pharmaceutical sector [2]
一品红:关于全资子公司获得复方聚乙二醇电解质散(Ⅲ)注册证书的公告
Zheng Quan Ri Bao· 2025-07-31 12:39
Group 1 - The core point of the article is that Yipinhong has received a drug registration certificate for its product, Compound Polyethylene Glycol Electrolyte Powder (III), from the National Medical Products Administration [2] Group 2 - Yipinhong's wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., is the entity that received the approval [2]
7月31日晚间重要公告一览
Xi Niu Cai Jing· 2025-07-31 10:18
Group 1 - Jiejia Weichuang expects a net profit of 1.7 billion to 1.96 billion yuan for the first half of 2025, representing a year-on-year increase of 38.65% to 59.85% [1] - Micron Biotech's CS231295 clinical trial application has been approved by the FDA for treating advanced solid tumors [1] - Sinopec anticipates a net profit of 20.1 billion to 21.6 billion yuan for the first half of 2025, a decrease of 39.5% to 43.7% year-on-year [2] Group 2 - High Energy Environment has obtained a loan commitment letter from a financial institution for share repurchase [2] - Electric Power Investment Energy received a warning letter from the Inner Mongolia Securities Regulatory Bureau for inadequate disclosure in its semi-annual report [3] - Zhejiang University Net New won a bid for an intelligent engineering project worth 94.2712 million yuan [5] Group 3 - Daodaoquan reported a net profit of 181 million yuan for the first half of 2025, a year-on-year increase of 563.15% [8] - New Light Optoelectronics expects a net loss of 19 million to 23 million yuan for the first half of 2025 [9] - Aihua Pharmaceutical's two probiotic powder registration applications have been accepted [10] Group 4 - Xinhui Electric's subsidiary signed a product sales framework contract for commercial and household robots [11] - Baida Precision Engineering's subsidiary obtained 134,500 square meters of industrial land use rights [12] - Haiyang Technology's chief engineer resigned for personal reasons [13] Group 5 - Tianhe Magnetic Materials received a project filing notice for a 12,000-ton magnetic material deep processing project [22] - Wanlima is the pre-selected unit for a procurement project worth 43.835 million yuan from China Southern Airlines [24] - Yipin Hong's subsidiaries obtained two drug registration certificates [25] Group 6 - Zhejiang Jiaoke's subsidiary signed new construction projects worth 4.783 billion yuan in the second quarter [27] - Shenglan Co. received approval for issuing convertible bonds [29] - Jimi Technology expects a net profit of 88.6622 million yuan for the first half of 2025, a year-on-year increase of 2062.33% [31] Group 7 - Dingtong Technology reported a net profit of 115 million yuan for the first half of 2025, a year-on-year increase of 134.06% [32] - Huaheng Biological is planning to list on the Hong Kong Stock Exchange [34] - Yuntian Lihui submitted an application for H-share issuance and listing on the Hong Kong Stock Exchange [36] Group 8 - Nanchip Technology expects a net profit of 108.8 million to 133.1 million yuan for the first half of 2025, a decrease of 35.09% to 47.03% year-on-year [43] - Anglikang's Mesobam injection has received a drug registration certificate [44] - Jida Zhengyuan's shareholder plans to reduce their stake by up to 0.998% [45]
午间公告:浙江交科子公司二季度建筑业新中标且签约金额47.83亿元
Zheng Quan Shi Bao Wang· 2025-07-31 04:21
Group 1 - Shenglan Co., Ltd. has received approval from the China Securities Regulatory Commission for the issuance of convertible bonds to unspecified objects [1] - Yipin Hong's wholly-owned subsidiary, Guangzhou Yipin Pharmaceutical, has obtained the registration certificate for Compound Polyethylene Glycol Electrolyte Powder (III), qualifying it to sell this specification of drug in the domestic market [1] - Zhejiang Jiaokao disclosed its second-quarter construction industry operating situation, reporting that its subsidiary, Zhejiang Jiaogong, won and signed 207 new projects in the second quarter, amounting to 4.783 billion yuan; for the first half of the year, a total of 539 new projects were won and signed, totaling 21.355 billion yuan [1] Group 2 - Weilon Co., Ltd. is approaching the final half trading day before the "Weilon Convertible Bonds" stop conversion and redemption; after the market closes on July 31, unconverted "Weilon Convertible Bonds" will cease conversion, and the remaining convertible bonds will be forcibly redeemed at a price of 100.485 yuan per bond, which may result in losses for investors [1]
一品红子公司获得复方聚乙二醇电解质散(Ⅲ)注册证书
Zhi Tong Cai Jing· 2025-07-31 04:03
此次公司获得复方聚乙二醇电解质散(Ⅲ)注册证书,标志着公司具备了在国内市场销售该规格药品的资 格,将进一步丰富公司产品管线和产品品类,增强了公司的核心竞争力。 一品红(300723)(300723.SZ)发布公告,公司全资子公司广州一品红制药有限公司于近日收到国家药 品监督管理局核准签发的关于复方聚乙二醇电解质散(Ⅲ)的《药品注册证书》,复方聚乙二醇电解质散 (Ⅲ)适应症为:用于以下情况之前的患者结肠清洁准备:--内窥镜或放射检查--结肠手术,本品适用于成 人。 ...