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长春高新(000661) - 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
2026-01-08 08:30
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 ...
长春高新(000661) - 关于子公司褪黑素颗粒上市申请获得受理的公告
2026-01-08 08:30
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 ...
生长激素行业要变了
3 6 Ke· 2026-01-08 08:10
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].
生物制品板块1月6日涨0.55%,辽宁成大领涨,主力资金净流出4.26亿元
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]
生物制品板块1月5日涨3.12%,康弘药业领涨,主力资金净流入1.91亿元
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% ...
2025中国创新药出海一年狂揽1356亿美元,2026年能否持续?
Jing Ji Guan Cha Wang· 2026-01-01 02:55
Core Insights - The surge in BD (business development) transactions in China's innovative pharmaceutical sector is a reflection of the industry's maturation and increasing global recognition, with 2025 marking a significant year for License-out agreements [3][4][5] Group 1: BD Transactions Overview - In December 2025, several Chinese pharmaceutical companies, including Ganli Pharmaceutical and Heng Rui Medicine, announced significant BD agreements, indicating a trend towards increased collaboration and innovation in the sector [2] - The total value of BD transactions for Chinese innovative drugs reached $135.655 billion in 2025, with upfront payments totaling $7 billion, marking a historical high in both transaction volume and value [3] - The number of BD transactions involving Chinese companies and top multinational corporations (MNCs) increased from 3 in 2015 to 35 in 2025, highlighting the growing interest from global players [3] Group 2: Market Dynamics and Future Outlook - The BD transaction boom is expected to continue into 2026, with industry experts predicting sustained high activity levels, although the focus may shift from quantity to value [5][14] - The NewCo model, which allows for "technology equity + capital cooperation," is emerging as a new pathway for Chinese pharmaceutical companies to engage in international markets, although its prevalence may decrease in 2026 [14][15] - The overall trend indicates a shift from isolated transactions to a more collaborative ecosystem, where companies leverage partnerships to enhance their global market presence [16][20] Group 3: Transaction Structures and Strategies - The structure of BD transactions is evolving, with companies increasingly engaging in co-development and co-commercialization agreements, allowing for shared risks and benefits [10][11] - The pricing of BD transactions is becoming more rational, with companies focusing on the clinical value and market potential of their products, which influences upfront payment amounts [19][18] - Legal and advisory services are becoming integral to BD transactions, reflecting the increasing complexity and importance of these deals in the pharmaceutical landscape [17]
明天起,有产品降价75%,患儿一年治疗费可从12万降至3万元!
Mei Ri Jing Ji Xin Wen· 2025-12-31 07:48
Group 1 - The recent inclusion of long-acting growth hormone in the national medical insurance directory is expected to significantly reduce treatment costs for families, with prices dropping from approximately 4000-5000 yuan per month to around 2000 yuan after January 2026 [1][2] - Two long-acting growth hormone products, namely Yipei and Jinsai, have been included in the national medical insurance directory, with Yipei's price reduced by about 53% from 1798 yuan to 853.2 yuan, and Jinsai's price reduced by approximately 75% from 3500 yuan to around 900 yuan [2][3] - The annual treatment cost for patients with growth hormone deficiency is projected to decrease from about 120,000 yuan to 30,000 yuan after the price reduction, with further reductions possible through local insurance reimbursements [2][3] Group 2 - The growth hormone market in China has rapidly expanded, with the market size increasing from 4 billion yuan in 2018 to 12 billion yuan in 2022, making China the largest market globally for growth hormone [7][8] - The competitive landscape is evolving, with multiple companies, including Jinsai and Yipei, as well as new entrants like Anke Bio and Tianjing Bio, actively developing long-acting growth hormone products [8][9] - The approval of international long-acting growth hormone products, such as Novo Nordisk's product, is expected to intensify competition in the domestic market [8][9]
有患儿年费用从12万降至3万元!长效生长激素纳入医保明起执行 一产品降价75%
Mei Ri Jing Ji Xin Wen· 2025-12-31 06:10
Core Insights - The recent inclusion of long-acting growth hormones in the national medical insurance directory is expected to significantly reduce treatment costs for families with children suffering from growth hormone deficiency [1][2][3] Pricing and Cost Impact - The two long-acting growth hormone products included in the insurance directory are Teva's Yipei and Jinsai's Jinsai Zeng, with prices dropping from 1798 yuan to 853.2 yuan for Yipei and from approximately 3500 yuan to about 900 yuan for Jinsai Zeng, representing reductions of approximately 53% and 75% respectively [2][3] - For a child weighing 30 kg, the annual treatment cost with Jinsai Zeng is projected to decrease from around 120,000 yuan to 30,000 yuan after the price reduction [2][3] Market Dynamics - The Chinese growth hormone market has rapidly expanded from 4 billion yuan in 2018 to 12 billion yuan in 2022, making China the largest market for growth hormone treatments globally [7] - The market is expected to grow at a compound annual growth rate of 15.7% from 2018 to 2030, driven by increasing awareness and diagnosis of growth hormone deficiency [7] - The competitive landscape is evolving, with multiple companies, including Jinsai and Teva, actively developing long-acting growth hormone products, alongside new entrants like Novo Nordisk [8][9] Clinical and Regulatory Considerations - The use of growth hormones is strictly regulated, requiring a confirmed diagnosis of growth hormone deficiency for insurance coverage, which limits the potential patient base [4][5] - The recent price reductions are not expected to cause significant fluctuations in supply and demand due to the nature of the product as a prescription medication and the relatively low prevalence of growth hormone deficiency [5][6]
长春高新:公司会持续跟进各研发管线的进展、竞争力、技术先进性、持续研发成功可能性等情况
Core Viewpoint - The company emphasizes that drug development is a high-investment, long-term, and high-risk process, and it will continuously monitor the progress of its research pipelines and make informed decisions regarding their continuation or cessation based on various factors [1] Group 1 - The company is committed to tracking the progress of its research pipelines [1] - The company will assess the competitiveness and technological advancement of its projects [1] - The company will evaluate the likelihood of continued success in research and development [1]
长春高新:对于公司主动组织发起的投资者交流会,公司会按照要求发布相关提示性公告、文件等
Zheng Quan Ri Bao· 2025-12-30 12:07
(文章来源:证券日报) 证券日报网讯 12月30日,长春高新在互动平台回答投资者提问时表示,对于公司主动组织发起的投资 者交流会,公司会按照要求发布相关提示性公告、文件等;对于参加的由相关证券机构等发起的会议, 如有达到信息披露标准的情况,公司会在会后及时发布相关交流纪要。 ...