Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. ("Jinsai Pharmaceutical"), has received the Acceptance Notice from the National Medical Products Administration for the clinical trial application of its injectable GenSci136, aimed at treating Immunoglobulin A Nephropathy (IgAN) [1] Group 1 - The clinical trial application for GenSci136 has been accepted, indicating progress in the drug development process [1] - The targeted indication for GenSci136 is Immunoglobulin A Nephropathy (IgAN), a significant condition affecting kidney function [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, has received the acceptance notice from the National Medical Products Administration for the registration application of melatonin granules, indicating progress in the development of a product aimed at addressing sleep difficulties in children with neurodevelopmental disorders [2]. Company Summary - Jinsai Pharmaceutical's melatonin granules are developed for the pediatric neuropsychiatric field and are classified as a Class 4 chemical drug [2]. - The product works by activating the MT1 and MT2 receptors in the suprachiasmatic nucleus, demonstrating sleep-inducing effects [2]. - The completion of the bioequivalence study comparing the test formulation with the reference formulation has been reported, and a generic drug application (ANDA) has been submitted [2]. Industry Summary - The approval of melatonin granules is expected to enhance the options available for treating sleep difficulties in children, thereby better meeting clinical needs [2].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received the Acceptance Notice from the National Medical Products Administration for the domestic production drug registration application of melatonin granules, a product developed for the pediatric neuropsychiatric field [1] Group 1 - Jinsai Pharmaceutical's melatonin granules are classified as a Class 4 chemical drug [1] - The product aims to improve sleep difficulties associated with neurodevelopmental disorders in children [1] - The mechanism of action involves activating the MT1 and MT2 receptors in the suprachiasmatic nucleus to regulate neural activity, demonstrating sleep-inducing effects [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the registration application of melatonin granules, indicating progress in the approval process for this pediatric product [1] Group 1: Company Developments - The melatonin granules are developed by Jinsai Pharmaceutical and are intended for use in the pediatric neuropsychiatric field [1] - This product is classified as a Class 4 chemical drug and aims to improve sleep difficulties associated with neurodevelopmental disorders in children [1] - The mechanism of action involves activating the MT1 and MT2 receptors in the suprachiasmatic nucleus to regulate neural activity, demonstrating sleep-inducing effects [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, has had its clinical trial application for the domestically produced injectable GenSci136 accepted by the National Medical Products Administration [1] Group 1: Product Development - Injectable GenSci136 is a Class 1 therapeutic biological product independently developed by Jinsai Pharmaceutical, intended for the treatment of Immunoglobulin A Nephropathy (IgAN) [1] - The drug functions as a B-cell maturation antigen (BCMA) trimeric fusion protein, capable of binding to B lymphocyte stimulator (BlyS) and a proliferation-inducing ligand (APRIL) [1] - GenSci136 has the potential to block the interaction between BlyS, APRIL, and B cell membrane receptors, which may help in treating various autoimmune diseases characterized by fluid immune disorders and tissue damage caused by pathogenic antibodies [1]

证券代码：000661 证券简称：长春高新 公告编号：2026-001 长春高新技术产业（集团）股份有限公司 关于子公司注射用 GenSci136 境内生产药品注册临床试验申请 获得受理的公告 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，长春高新技术产业（集团）股份有限公司（以下简称"公司"）控股 子公司——长春金赛药业有限责任公司（以下简称"金赛药业"）收到国家药品 监督管理局核准签发的《受理通知书》，金赛药业注射用 GenSci136 的境内生产 药品注册临床试验申请获得受理，现将有关情况公告如下： 一、药品的基本情况 产品名称：注射用 GenSci136 申请事项：境内生产药品注册临床试验 受理号：CXSL2600033 申请人：长春金赛药业有限责任公司 审批结论：经审查，决定予以受理 适应症：用于免疫球蛋白 A 肾病（IgAN） 二、药品的其它情况 注射用 GenSci136 是金赛药业自主研发的一款治疗用生物制品 1 类药物，拟 用于治疗免疫球蛋白 A 肾病（IgAN）。作为一种 B 细胞成熟抗原（BCMA）三聚体 融合蛋白，注射用 Gen ...

证券代码：000661 证券简称：长春高新 公告编号：2026-002 长春高新技术产业（集团）股份有限公司 关于子公司褪黑素颗粒上市申请获得受理的公告 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，长春高新技术产业（集团）股份有限公司（以下简称"公司"）控股 子公司——长春金赛药业有限责任公司（以下简称"金赛药业"）收到国家药品 监督管理局核准签发的《受理通知书》，金赛药业褪黑素颗粒的境内生产药品注 册上市许可申请获得受理，现将相关受理事项公告如下： 一、药品的基本情况 产品名称：褪黑素颗粒 申请事项：境内生产药品注册上市许可 受理号：CYHS2600108 申请人：长春金赛药业有限责任公司 充足的睡眠是保证儿童尤其是婴幼儿生长发育、能量代谢的必要条件，对儿 童的体格、情绪、认知等各方面的发育具有重要作用。若睡眠问题在儿童期得不 到恰当治疗，则可能会发展为慢性睡眠障碍。相关研究显示，有睡眠问题的儿童 比例介于 11%和 40%之间，神经发育障碍儿童尤其自闭症谱系障碍患者共患失 眠达 50~80%。 金赛药业研发的褪黑素颗粒已经完成了受试制剂与参比制剂 ...

Core Viewpoint - The new National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog will be implemented on January 1, 2026, leading to price reductions for several drugs, including long-acting growth hormone products from Jinsai Pharmaceutical and Tebao Biological [1][6]. Group 1: Market Impact - The inclusion of long-acting growth hormones in the national medical insurance will fundamentally change the market dynamics by significantly lowering annual treatment costs, thus releasing previously suppressed demand [7][18]. - The annual treatment cost for a child weighing 30 kg will drop to around 30,000 yuan after the inclusion of long-acting growth hormones in the insurance [6][10]. - The domestic growth hormone market size has grown from 4 billion yuan in 2018 to 11.6 billion yuan in 2023, with a compound annual growth rate (CAGR) of 23.9%, expected to reach 28.6 billion yuan by 2030 [14]. Group 2: Product Competition - Jinsai Pharmaceutical's Jinsai Growth Hormone and Tebao Biological's Yipeisheng are the only two long-acting products included in the new insurance catalog, leading to direct competition [20][21]. - Jinsai Growth Hormone's price has reportedly dropped to approximately 900 yuan per 9 mg after negotiations, a reduction of about 75% from its previous price of 3,500 yuan [6][10]. - Tebao Biological's Yipeisheng has seen a price reduction of about 53%, with new insurance payment prices ranging from 418.11 yuan to 853.20 yuan [5][6]. Group 3: Future Trends - The long-acting growth hormone market is expected to capture 73.8% of the overall growth hormone market by 2030, while short-acting products are projected to decline [17]. - The market penetration of long-acting growth hormones is anticipated to increase significantly due to their improved patient compliance and lower injection frequency [10][18]. - New entrants, such as Novo Nordisk and Weisheng Pharmaceutical, are expected to face challenges in gaining market share due to the already low pricing established by Jinsai Growth Hormone [23][24].

Market Performance - The biopharmaceutical sector increased by 0.55% on January 6, with Liaoning Chengda leading the gains [1] - The Shanghai Composite Index closed at 4083.67, up by 1.5%, while the Shenzhen Component Index closed at 14022.55, up by 1.4% [1] Individual Stock Performance - Liaoning Chengda (600739) closed at 12.27, with a rise of 7.16% and a trading volume of 530,500 shares, amounting to a transaction value of 633 million yuan [1] - Dongbao Biological (300239) closed at 6.18, up by 5.64%, with a trading volume of 454,500 shares and a transaction value of 278 million yuan [1] - Olin Biological (616889) closed at 27.66, increasing by 3.83%, with a trading volume of 74,400 shares and a transaction value of 204 million yuan [1] - Kanghong Pharmaceutical (002773) closed at 33.75, up by 2.37%, with a trading volume of 249,700 shares and a transaction value of 838 million yuan [1] Capital Flow Analysis - The biopharmaceutical sector experienced a net outflow of 426 million yuan from institutional investors, while retail investors saw a net inflow of 323 million yuan [2] - The net inflow from speculative funds was 104 million yuan [2] Detailed Capital Flow for Selected Stocks - Liaoning Chengda had a net inflow of 34.37 million yuan from institutional investors, while it faced a net outflow of 18.32 million yuan from retail investors [3] - Dongbao Biological saw a net inflow of 21.29 million yuan from institutional investors, with a net outflow of 13.16 million yuan from retail investors [3] - Tian Tan Biological (600161) had a net inflow of 18.06 million yuan from institutional investors, with a net outflow of 10.02 million yuan from retail investors [3]

从资金流向上来看，当日生物制品板块主力资金净流入1.91亿元，游资资金净流出2.73亿元，散户资金净 流入8203.94万元。生物制品板块个股资金流向见下表： | 代码 | 名称 | 主力净流入(元) | 主力净占比 游资净流入(元) | | 游资净占比 散户净流入 (元) | | 散户净占比 | | --- | --- | --- | --- | --- | --- | --- | --- | | 002773 康弘药业 | | 1.18 Z | 18.31% | -3021.77万 | -4.70% | -8748.13万 | -13.61% | | 000661 | 长春高新 | 7444.34万 | 9.43% | -4755.38万 | -6.02% | -2688.95万 | -3.40% | | 688331 荣昌生物 | | 6982.31万 | 10.14% | -2366.87万 | -3.44% | -4615.43万 | -6.71% | | 300122 智飞生物 | | 3724.35万 | 9.83% | 85.58万 | 0.23% | -3809.93万 | -10.05% ...