Core Viewpoint - The company has received approval from the National Medical Products Administration for its product, which is now authorized for use in pediatric and adolescent anesthesia induction and maintenance [1] Group 1: Company Announcement - Subsidiary Shenyang Haishi Pharmaceutical Co., Ltd. has been granted a Supplementary Application Approval Notice for the drug, Ropivacaine Injection (Sishuning) [1] - The approval aligns with the drug registration requirements and includes revisions to the safety information in the product's instructions [1]

本公司及董事会全体成员保证信息披露内容的真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 证券代码：002653 证券简称：海思科 公告编号：2025-103 海思科医药集团股份有限公司 关于创新药环泊酚注射液获得拓展儿童人群批准 的公告 海思科医药集团股份有限公司（以下简称"公司"）子公司沈阳 海思科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《药 品补充申请批准通知书》，现将相关情况公告如下： 一、 药品基本信息 药品名称：环泊酚注射液 受 理 号：CYHB2402078 通知书编号：2025B04334 原药品批准文号：国药准字 H20200013 剂 型：注射剂 规 格：20ml:50mg 审批结论：经审查，本品此次申请事项符合药品注册的有关要求。 批准本品如下补充申请事项：1、用于儿童/青少年全身麻醉诱导和维 持的用法用量；2、修订说明书安全性信息。 二、 研发项目简介 环泊酚注射液（思舒宁 ®）（以下简称"环泊酚"或"该产品"） 是公司开发的全新的具有自主知识产权的 1 类静脉麻醉药物，于 2020 年 12 月国内获批上市，在国内已获得"非气管插管手术/操作中的镇 静和麻醉"、"全 ...

证券代码：002653 证券简称：海思科 公告编号：2025-104 | | | | | | | | 已质押股份情况 | | 未质押股份情况 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东 | 持股 | 持股 | 本次质押前 | 本次质押后 | 占其所 | 占公司 | | | | | | | 数量 | | 质押股份数 | 质押股份数 | 持股份 | 总股本 | 已质押股 | 占已 | 未质押股 | 占未 | | 名称 | （万股） | 比例 | 量（万股） | 量（万股） | 比例 | 比例 | 份限售和 | 质押 | 份限售和 | 质押 | | | | | | | | | 冻结数量 | 股份 | 冻结数量 | 股份 | 1 股东 名称 是否为控 股股东或 第一大股 东及其一 致行动人 本次质押 数量 (万股) 占其 所持 股份 比例 占公 司总 股本 比例 是否 为限 售股 是否 为补 充质 押 质押 起始日 质押 到期日 质权人 质押 用途 范秀莲 否 490 2.25% 0.44% 否 否 2025 ...

Market Performance - The pharmaceutical sector experienced a slight increase of +0.04% on September 15, 2025, underperforming the CSI 300 index by 0.20 percentage points, ranking 14th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, medical research outsourcing (+2.54%) and medical devices (+0.48%) performed well, while vaccines (-0.91%), medical consumables (-0.72%), and blood products (-0.51%) lagged behind [1] - Top three gainers in individual stocks were Furuide (+20.01%), Dezhan Health (+10.02%), and Zhaoyan New Drug (+10.01%), while the biggest losers were Nuocheng Jianhua (-8.20%), Yinkang Life (-5.21%), and Xinnuo Wei (-5.11%) [1] Industry News - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for the oral peptide therapy Icotrokinra (JNJ-2113), developed in collaboration with Protagonist, aimed at treating moderate to severe plaque psoriasis in patients aged 12 and older [2] - The ICONIC-LEAD pivotal Phase 3 study reported positive topline results, indicating that Icotrokinra significantly improved skin conditions in patients with moderate to severe plaque psoriasis and demonstrated good safety [2] Company News - Kanglong Chemical announced that its subsidiary, Kanglong Shaoxing, successfully passed the FDA's on-site quality inspection, marking the first time its Shaoxing active pharmaceutical ingredient production facility has passed the FDA's pre-approval inspection [3] - Haisco received a Class 1 innovative drug registration certificate from the National Medical Products Administration for Anruikefen injection, which has been approved for an additional indication to treat moderate to severe itching in adult patients with chronic kidney disease related to maintenance hemodialysis [3] - Yipinhong's subsidiary in Guangzhou received a drug registration certificate for Clindamycin Palmitate Granules, confirming compliance with registration requirements [3] - Shanghai Laishi announced that its controlling shareholder, Haiyingkang, has cumulatively increased its shareholding by 72,935,300 shares, representing 1.10% of the total share capital, with a total investment of approximately RMB 499.99 million from May 22, 2025, to September 15, 2025 [3]

Core Viewpoint - The stock of Haishike experienced a decline of 2.02% on September 16, with a trading price of 55.31 yuan per share and a total market capitalization of 61.943 billion yuan. The company has seen a year-to-date stock price increase of 67.71% but has faced recent declines over the past five and twenty trading days [1]. Financial Performance - As of June 30, Haishike reported a revenue of 2.001 billion yuan for the first half of 2025, reflecting a year-on-year growth of 18.63%. However, the net profit attributable to shareholders decreased by 21.79% to 129 million yuan [2]. - Cumulatively, Haishike has distributed 3.673 billion yuan in dividends since its A-share listing, with 687 million yuan distributed over the past three years [3]. Shareholder Structure - The number of shareholders for Haishike increased by 25.93% to 11,400 as of June 30, with an average of 42,147 circulating shares per shareholder, a decrease of 28.64% [2]. - Notable institutional shareholders include China Europe Medical Health Mixed A, which increased its holdings by 5.3574 million shares, and Industrial Bank's Frontier Medical Stock A, which increased its holdings by 5.4 million shares [3].

Core Viewpoint - The company has received approval from the National Medical Products Administration for its innovative drug, Anruikefen Injection (HSK21542), which is indicated for treating moderate to severe pruritus in adult patients undergoing maintenance hemodialysis [1][2]. Group 1: Drug and Application Information - Drug Name: Anruikefen Injection - Acceptance Number: CXHS2400097 - Certificate Number: 2025S02878 - Approval Number: National Drug Standard H20250014 - Application: Drug registration (domestic production) - Registration Category: Class 1 chemical drug - Dosage Form: Injection - Specification: 1ml: 0.1mg - Indication: For moderate to severe pruritus in adult patients with chronic kidney disease undergoing maintenance hemodialysis [1]. Group 2: R&D Project Overview - HSK21542 is a highly selective peripheral kappa opioid receptor agonist developed by the company - Clinical research indicates that HSK21542 Injection significantly alleviates pruritus, with primary and secondary efficacy indicators showing significant improvement over the placebo group - The safety profile of HSK21542 Injection is reported to be good and controllable - The newly approved indication was included in the priority review and approval process in July 2024 and is now approved for market release, providing better options for patients suffering from pruritus - Anruikefen Injection was first approved in May 2025 for treating mild to moderate pain after abdominal surgery, and a Phase III clinical study for its use in postoperative pain relief in orthopedic surgery is ongoing [2].

Core Viewpoint - The recent share reduction by a significant shareholder of Haishike (002653.SZ) indicates personal financial needs, while the company continues to pursue a private placement to raise funds for new drug development and working capital [2][4]. Group 1: Shareholder Actions - On September 14, Haishike announced that shareholder Shen Ping plans to reduce her holdings by 1.25 million shares, representing 0.11% of the total share capital, between September 1 and September 12, 2025 [1]. - Following this reduction, the combined shareholding of Shen Ping and her husband Wang Junmin decreased from 4.49 billion shares to 4.48 billion shares, with their total ownership percentage dropping from 40.11% to 40.00% [1][3]. - Shen Ping's previous reductions included over 6 million shares earlier this year, and she has plans to further reduce her holdings by up to 10.37 million shares in the coming months [3][4]. Group 2: Financial Performance - In the first half of the year, Haishike reported revenue of 2 billion yuan, an increase of 18.63% year-on-year, while net profit attributable to shareholders fell by 21.79% to 129 million yuan [5]. - The core product,环泊酚注射液, contributed significantly to sales, achieving approximately 800 million yuan in revenue, a 55% increase year-on-year [5]. - As of the mid-year report, Haishike had 17 innovative drug products in clinical stages, with total R&D expenses amounting to 342 million yuan [5]. Group 3: Fundraising Activities - Haishike is actively pursuing a private placement, with the Shenzhen Stock Exchange having accepted its application to issue up to 70 million shares, aiming to raise a maximum of 1.365 billion yuan [4]. - The funds raised are intended for new drug development (approximately 965 million yuan) and to supplement working capital (400 million yuan) [4].

Core Viewpoint - The company has received approval from the National Medical Products Administration for its innovative drug, HSK21542, which is expected to provide better options for patients suffering from itching [1] Company Summary - HSK21542, marketed as Anruikefen Injection (brand name: Sishujing), is a highly selective peripheral kappa opioid receptor agonist developed independently by the company [1] - Clinical research indicates that HSK21542 significantly alleviates itching, with both primary and secondary efficacy indicators showing substantial improvement over the placebo group [1] - The safety profile of HSK21542 injection is reported to be good and controllable [1] Industry Summary - The newly approved indication for HSK21542 will be included in the priority review and approval process in July 2024, highlighting the drug's potential impact on the market [1] - The approval of HSK21542 is expected to enhance treatment options for patients, indicating a positive development in the pharmaceutical industry focused on innovative therapies [1]

Core Viewpoint - The company Haishi Ke (002653) has received a Class 1 innovative drug registration certificate from the National Medical Products Administration for its injection drug Anruikefen (brand name: Sishujing, R&D code: HSK21542), which is indicated for the treatment of moderate to severe itching associated with chronic kidney disease in adult patients undergoing maintenance hemodialysis [1]. Group 1 - The drug Anruikefen has been approved for a new indication related to chronic kidney disease [1]. - The approval highlights the company's ongoing commitment to developing innovative treatments for patients with specific medical needs [1].

Core Viewpoint - The company has received a Class 1 innovative drug registration certificate from the National Medical Products Administration for Anruikefen injection (brand name: Sishujing, R&D code: HSK21542), with a new indication for treating moderate to severe itching related to chronic kidney disease in adult patients undergoing maintenance hemodialysis [1] Group 1 - The drug Anruikefen is now approved for a new indication, expanding its potential market [1] - The approval highlights the company's commitment to developing innovative treatments for chronic conditions [1] - This development may enhance the company's competitive position in the pharmaceutical industry [1]