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上海吸纳生物医药等企业加入“探索者计划”;迈威生物董事长被罚
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-05 00:13
Group 1: Pharmaceutical Regulations - Starting from August 1, all retail pharmacies in Foshan will implement a real-name registration system for the sale of 47 key controlled drugs, primarily for treating symptoms of Chikungunya fever [1] - The list of controlled drugs includes common medications such as Ibuprofen, Compound Cold Medicine, and Lianhua Qingwen capsules [1] Group 2: Clinical Trials and Drug Approvals - Kangning Jereh's innovative drug JSKN022, a PD-L1/αvβ6 dual-specific antibody drug conjugate, has received acceptance for clinical trial application from the National Medical Products Administration [3] - Yipin Hong's innovative drug APH03621 for endometriosis treatment has also received clinical trial registration acceptance from the National Medical Products Administration [5] - Lianhua Pharmaceutical's subsidiary has passed the consistency evaluation for the generic drug Lincomycin Hydrochloride Injection [4] Group 3: Financial Performance - China Resources Medical expects a profit decline of 20% to 25% for the first half of the year, with a significant drop of 55% to 60% when excluding one-time gains [6] - Zhenghai Bio reported a net profit of 46.49 million yuan for the first half of 2025, a decrease of 45.97% year-on-year, with revenue of 188 million yuan, down 5.14% [8] Group 4: Corporate Actions - Kexing Bio has spent 47.38 million yuan to repurchase 1.27 million shares, representing 0.63% of its total share capital [8] - WuXi AppTec has repurchased 6.51 million A-shares for a total of 497 million yuan [10] - Tian Tan Bio has decided to abandon the acquisition opportunity of Pailin Bio due to potential competition with its core business [9] Group 5: Industry Developments - Significant progress has been made in HIV vaccine research in China, with the completion of the first phase clinical trial for a replicating Tian Tan smallpox vaccine carrier HIV vaccine [11][13] - Sanofi announced the discontinuation of its PCSK9 inhibitor drug Alirocumab in China due to global supply issues and a strategic shift in its cardiovascular product line [12]
联环药业: 联环药业关于控股子公司药品通过仿制药一致性评价的公告
Zheng Quan Zhi Xing· 2025-08-04 16:23
Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. announced that its subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., has successfully passed the consistency evaluation for the quality and efficacy of Lincomycin Hydrochloride Injection, which is expected to enhance the product's market share and competitiveness [1][3]. Drug Basic Information - Drug Name: Lincomycin Hydrochloride Injection - Dosage Form: Injection - Registration Classification: Chemical Drug - Specification: 2ml:0.6g - Original Drug Approval Number: Guoyao Zhunzi H41020229 - Drug Registration Standard Number: YBH18522025 - Acceptance Number: CYHB2450458 - Approval Conclusion: The product has passed the consistency evaluation for quality and efficacy [1]. Market Impact - The sales revenue for Lincomycin Hydrochloride Injection (2ml:0.6g) in domestic sample hospitals for 2024 is reported to be 10.82 million yuan [1]. - The successful consistency evaluation is anticipated to expand the market share of the drug, although it is noted that the approval is not expected to have a significant impact on the company's recent operating performance [3]. R&D Investment - As of the date of the announcement, the R&D investment for the consistency evaluation of Lincomycin Hydrochloride Injection by Changle Pharmaceutical is approximately in RMB [2]. - In 2025, Changle Pharmaceutical has obtained 2 production licenses [2].
联环药业(600513.SH):公司盐酸林可霉素注射液通过仿制药质量和疗效一致性评价
Xin Lang Cai Jing· 2025-08-04 09:42
Core Viewpoint - The announcement highlights that the company's subsidiary, Changle Pharmaceutical, has successfully passed the consistency evaluation for the quality and efficacy of Lincomycin Hydrochloride Injection, indicating a significant milestone in its product development and market potential [1] Group 1: Product Development - Changle Pharmaceutical's Lincomycin Hydrochloride Injection (specification: 2ml:0.6g) is classified as a lincosamide antibiotic, suitable for treating respiratory infections, skin and soft tissue infections, and bone and joint infections caused by sensitive bacteria [1] - In 2025, Changle Pharmaceutical received two production approvals for its products, reflecting its ongoing commitment to expanding its pharmaceutical offerings [1] Group 2: Financial Performance - The research and development investment for the consistency evaluation of Lincomycin Hydrochloride Injection amounted to approximately 2.328 million yuan [1] - In 2024, the domestic sales revenue for Lincomycin Hydrochloride Injection in sample hospitals reached 10.8176 million yuan, indicating a strong market presence and demand for the product [1]
联环药业(600513) - 联环药业关于控股子公司药品通过仿制药一致性评价的公告
2025-08-04 09:30
证券代码:600513 证券简称:联环药业 公告编号:2025—053 江苏联环药业股份有限公司 关于控股子公司药品通过仿制药一致性评价的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 注册分类:化学药品 规格:2ml:0.6g 原药品批准文号:国药准字 H41020229 药品注册标准编号:YBH18522025 受理号:CYHB2450458 通知书编号:2025B03431 审批结论:经审查,本品通过仿制药质量和疗效一致性评价。 二、药品的其他情况 江苏联环药业股份有限公司(以下简称"公司")控股子公司新乡常乐制药 有限责任公司(以下简称"常乐制药")于近日收到国家药品监督管理局核准签 发的关于盐酸林可霉素注射液(以下简称"本品")《药品补充申请批准通知 书》,批准常乐制药本品通过仿制药质量和疗效一致性评价(以下简称"一致性 评价")。现将相关情况公告如下: 一、药品基本信息 药品名称:盐酸林可霉素注射液 剂型:注射剂 截至本公告披露日,2025 年常乐制药共获得 2 个生产批件。 三、对公司的影响及风险提示 公司 ...
联环药业子公司盐酸林可霉素注射液通过仿制药一致性评价
Zhi Tong Cai Jing· 2025-08-04 09:28
Core Viewpoint - The company, Lianhuan Pharmaceutical, announced that its subsidiary, Xinxiang Changle Pharmaceutical, received approval from the National Medical Products Administration for the supplement application of Lincomycin Hydrochloride Injection, indicating successful consistency evaluation of the generic drug [1] Group 1: Company Developments - Lianhuan Pharmaceutical's subsidiary, Xinxiang Changle Pharmaceutical, has been approved for Lincomycin Hydrochloride Injection, which is a significant milestone for the company [1] - The approved product is a Lincomycin class antibiotic, indicated for respiratory infections, skin and soft tissue infections, and bone and joint infections caused by sensitive bacteria [1] Group 2: Market Insights - The sales revenue for Lincomycin Hydrochloride Injection (2ml:0.6g) in domestic sample hospitals is projected to be 10.82 million yuan in 2024 [1]
联环药业(600513.SH)子公司盐酸林可霉素注射液通过仿制药一致性评价
智通财经网· 2025-08-04 09:22
Group 1 - Company Lianhuan Pharmaceutical (600513.SH) announced that its subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the supplemental application of Lincomycin Hydrochloride Injection [1] - The approved product, Lincomycin Hydrochloride Injection (specification: 2ml:0.6g), is classified as a lincosamide antibiotic, indicated for respiratory infections, skin and soft tissue infections, and bone and joint infections caused by sensitive bacteria [1] - According to the MoSheng Medical Database, the sales revenue of Lincomycin Hydrochloride Injection (specification: 2ml:0.6g) in domestic sample hospitals is projected to be 10.82 million yuan in 2024 [1]
联环药业(600513.SH):控股子公司药品通过仿制药一致性评价
Ge Long Hui A P P· 2025-08-04 09:15
Core Viewpoint - The company, Lianhuan Pharmaceutical (600513.SH), announced that its subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the supplemental application of Lincomycin Hydrochloride Injection, which has passed the consistency evaluation for generic drug quality and efficacy [1] Group 1 - The approved product, Lincomycin Hydrochloride Injection (specification: 2ml:0.6g), is classified as a lincosamide antibiotic and is clinically used for treating respiratory infections, skin and soft tissue infections, and bone and joint infections caused by sensitive bacteria [1] - The approval for the consistency evaluation is expected to help expand the market share of this drug and enhance its market competitiveness [1] - The receipt of the supplemental approval notification is not anticipated to have a significant impact on the company's recent operating performance [1]
联环药业:盐酸林可霉素注射液通过仿制药一致性评价
Xin Lang Cai Jing· 2025-08-04 09:07
Group 1 - The core point of the article is that Lianhuan Pharmaceutical's subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., has successfully passed the consistency evaluation for the quality and efficacy of Lincomycin Hydrochloride Injection [1] - In 2025, Changle Pharmaceutical obtained a total of 2 production licenses [1] - The research and development investment for the consistency evaluation has reached approximately 2.328 million yuan [1] Group 2 - In 2024, the domestic sales revenue of Lincomycin Hydrochloride Injection in sample hospitals amounted to 10.8176 million yuan [1]
国企改革板块8月4日涨0.37%,东杰智能领涨,主力资金净流入4亿元





Sou Hu Cai Jing· 2025-08-04 08:56
Market Overview - On August 4, the state-owned enterprise reform sector rose by 0.37% compared to the previous trading day, with Dongjie Intelligent leading the gains [1] - The Shanghai Composite Index closed at 3583.31, up 0.66%, while the Shenzhen Component Index closed at 11041.56, up 0.46% [1] Top Gainers in State-Owned Enterprise Reform Sector - Dongjie Intelligent (300486) closed at 66.91, with a gain of 19.99% and a trading volume of 487,500 shares, amounting to a transaction value of 803 million yuan [1] - Feile Audio (600651) closed at 6.12, up 10.07%, with a trading volume of 1,221,200 shares and a transaction value of 724 million yuan [1] - Great Wall Electric (600192) closed at 10.86, gaining 10.03%, with a trading volume of 437,300 shares and a transaction value of 465 million yuan [1] - Other notable gainers include Guojijinggong (002046), Changcheng Military Industry (601606), and Construction Industry (002265), all showing gains around 10% [1] Top Losers in the Market - Shili Monitoring (300528) saw a decline of 11.33%, closing at 18.93, with a trading volume of 723,800 shares and a transaction value of 1.411 billion yuan [2] - Zhonghua Equipment (600579) fell by 9.18%, closing at 9.10, with a trading volume of 572,500 shares and a transaction value of 527 million yuan [2] - Shanghai Film (601595) decreased by 7.87%, closing at 36.39, with a trading volume of 352,400 shares and a transaction value of 1.299 billion yuan [2] Capital Flow Analysis - On the same day, the state-owned enterprise reform sector experienced a net inflow of 400 million yuan from institutional investors, while retail investors saw a net inflow of 1.119 billion yuan [2] - However, speculative funds recorded a net outflow of 1.518 billion yuan [2] Individual Stock Capital Flow - Construction Industry (002265) had a net inflow of 716 million yuan from institutional investors, while it faced a net outflow of 342 million yuan from speculative funds [3] - Changcheng Military Industry (601606) saw a net inflow of 547 million yuan from institutional investors, with a net outflow of 292 million yuan from speculative funds [3] - Aerospace Electronics (600879) recorded a net inflow of 459 million yuan from institutional investors, but faced a net outflow of 233 million yuan from speculative funds [3]
化学制药板块8月4日涨0.48%,海辰药业领涨,主力资金净流入9700.43万元
Zheng Xing Xing Ye Ri Bao· 2025-08-04 08:30
Group 1 - The chemical pharmaceutical sector increased by 0.48% on August 4, with Hai Chen Pharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 3583.31, up 0.66%, while the Shenzhen Component Index closed at 11041.56, up 0.46% [1] - Hai Chen Pharmaceutical's stock price rose by 20.01% to 41.27, with a trading volume of 285,300 shares and a transaction value of 1.101 billion [1] Group 2 - The top gainers in the chemical pharmaceutical sector included Han Yu Pharmaceutical, which rose by 19.98% to 24.32, and Guangsheng Tang, which increased by 18.18% to 120.90 [1] - The sector saw a net inflow of 97.0043 million in main funds, while retail investors contributed a net inflow of 1.279 billion [2] - The main funds showed significant net outflows in several companies, including Hai Chen Pharmaceutical, which had a net inflow of 182 million, but retail investors had a net outflow of 579.696 million [3]