智通财经APP讯，长春高新(000661.SZ)公告，公司子公司——长春金赛药业有限责任公司("金赛药业") 收到美国食品药品监督管理局("FDA")书面通知，金赛药业注射用GenSci143临床试验申请获得受理，适 应症为：晚期实体瘤。 ...

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, has received acceptance from the US FDA for the clinical trial application of GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA [1] Group 1: Product Development - GenSci143 is independently developed by Jinsai Pharmaceutical and is designed to target both chemotherapy and tumor immunity, offering dual potential therapeutic effects [1] - The innovative dual-target design, stable linker technology, and efficient cell-killing mechanism of GenSci143 may provide new treatment options for various solid tumors expressing B7-H3 and/or PSMA [1] Group 2: Regulatory Milestones - The clinical trial application for GenSci143 intended for advanced solid tumors has also been accepted by the National Medical Products Administration in China, with a planned submission date in August 2025 [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, has received acceptance from the US FDA for the clinical trial application of GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA for the treatment of advanced solid tumors [1] Group 1 - GenSci143 is independently developed by Jinsai Pharmaceutical [1] - The clinical trial application for GenSci143 has also been accepted by the National Medical Products Administration in China [1]

证券代码：000661 证券简称：长春高新 公告编号：2025-135 长春高新技术产业（集团）股份有限公司 关于子公司注射用 GenSci143 境外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"）子公 司——长春金赛药业有限责任公司（以下简称"金赛药业"）收到美国食品药品 监督管理局（以下简称"FDA"）书面通知，金赛药业注射用 GenSci143 临床试 验申请获得受理，现将相关情况公告如下： 一、药品的基本情况 产品名称：注射用 GenSci143 申请事项：临床试验申请 受理号：177763 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：晚期实体瘤 二、药品的其它情况 B7 同源物 3（B7 homologue 3，B7-H3）是一种Ⅰ型跨膜糖蛋白，其在多种 恶性肿瘤中呈现显著高表达，包括非小细胞肺癌、胰腺癌、肝细胞癌、结直肠癌、 乳腺癌、前列腺癌、头颈部鳞癌及黑色素瘤等。前列腺特异性膜抗原 （Prostate-spe ...

Group 1: Company Overview - Changchun High-tech Industry (Group) Co., Ltd. is located in Changchun, Jilin Province, and was established on June 10, 1993, with its listing date on December 18, 1996 [2] - The company primarily engages in the research, production, and sales of biopharmaceuticals and traditional Chinese medicine, with real estate development and property management as supplementary businesses [2] - The revenue composition of the company is as follows: pharmaceuticals 92.83%, real estate 6.81%, and services 0.36% [2] Group 2: Financial Performance - For the first half of 2025, the company achieved operating revenue of 6.603 billion yuan, a year-on-year decrease of 0.54%, and a net profit attributable to shareholders of 983 million yuan, a year-on-year decrease of 42.85% [2] - The company has cumulatively distributed dividends of 4.791 billion yuan since its A-share listing, with 3.259 billion yuan distributed in the last three years [3] Group 3: Stock Performance and Market Activity - As of October 16, the stock price of Changchun High-tech fell by 2.01% to 124.61 yuan per share, with a trading volume of 453 million yuan and a turnover rate of 0.90% [1] - Year-to-date, the stock price has increased by 28.62%, but it has decreased by 3.59% in the last five trading days [1] - The company has appeared on the "Dragon and Tiger List" twice this year, with the most recent appearance on September 2, where it recorded a net purchase of 275 million yuan [1]

Core Viewpoint - Changchun High-tech has submitted an application for overseas listing (H shares) on the Hong Kong Stock Exchange, following a significant decline in its stock price, which has dropped over 70% since 2021 due to price reductions in its core product, growth hormone, resulting in a projected decline in revenue and net profit for 2024 and the first half of 2025 [2][10]. Financial Performance - In 2024, Changchun High-tech's revenue is expected to be 13.466 billion yuan, a year-on-year decrease of 7.55%, while net profit is projected at 2.583 billion yuan, down 43.01% [4]. - For the first half of 2025, the company anticipates revenue of 6.603 billion yuan, a slight decline of 0.54%, and a net profit of 983 million yuan, down 42.85% [4]. - The gross profit margin from drug sales has decreased from 91.6% in 2022 to 88.6% in the first half of 2025 [6]. Core Business Impact - The main revenue and profit contributions come from the growth hormone business of Jinsai Pharmaceutical, which saw a revenue of 10.671 billion yuan in 2024, down 3.73%, and a net profit of 2.678 billion yuan, down 40.67% [10]. - In the first half of 2025, Jinsai Pharmaceutical's revenue was 5.469 billion yuan, a year-on-year increase of 6.17%, but net profit decreased by 37.35% to 1.108 billion yuan [10]. - The vaccine business of Baike Biotechnology also faced challenges, with revenue dropping to 1.229 billion yuan in 2024, down 32.64%, and a net profit of 232 million yuan, down 53.67% [11]. Market Challenges - The growth hormone product has been included in centralized procurement in several provinces since 2022, leading to significant price reductions and increased competition from similar products [10]. - The company's international revenue remains low, with only 130 million yuan in 2024, accounting for 0.97% of total revenue, and 1.13% in the first half of 2025 [12].

Core Viewpoint - Changchun High-tech has submitted an application for overseas listing (H shares) on the Hong Kong Stock Exchange, following a significant decline in its stock price, which has dropped over 70% since 2021 [2][3]. Financial Performance - In 2024, Changchun High-tech's revenue and net profit are expected to decline for the first time in nearly 20 years, with projected revenue of 13.466 billion yuan, a decrease of 7.55%, and net profit of 2.583 billion yuan, down 43.01% [6][7]. - For the first half of 2025, the company is projected to report revenue of 6.603 billion yuan, a slight decrease of 0.54%, and a net profit of 983 million yuan, down 42.85% [8]. - The gross margin for drug sales has decreased from 91.6% in 2022 to 88.6% in the first half of 2025 [10]. Core Business Impact - The main revenue and profit contributions come from two subsidiaries: Jinsai Pharmaceutical and Baike Biological, both of which have experienced declining gross margins from 93.5% to 90.9% and from 87.2% to 78.4%, respectively, from 2022 to the first half of 2025 [12][13]. - Jinsai Pharmaceutical's revenue is projected to be 10.671 billion yuan in 2024, down 3.73%, with a net profit of 2.678 billion yuan, a decrease of 40.67% [16]. - Baike Biological is expected to report revenue of 1.229 billion yuan in 2024, down 32.64%, and a net profit of 232 million yuan, down 53.67% [17]. Market Challenges - The decline in revenue and profit is attributed to the inclusion of growth hormone products in centralized procurement programs across various provinces, leading to significant price reductions [16]. - The company faces increased competition as similar products from other companies have entered the market, disrupting its previous monopoly [16]. - The international expansion of Changchun High-tech remains in its early stages, with overseas revenue accounting for only 0.97% in 2024 and 1.13% in the first half of 2025 [17].

Group 1 - The Shenzhen State-Owned Enterprises Shareholder Return Index (470064) closed at 2334.29 points, up 1.05%, with a trading volume of 39.892 billion yuan and a turnover rate of 1.5% on October 15 [1] - Among the index constituents, 31 stocks rose, with Shenhuo Co., Ltd. leading with a 5.9% increase, while 11 stocks fell, with Fuan Energy leading the decline at 3.99% [1] - The top ten constituents of the index include BOE Technology Group (9.64% weight), Wuliangye Yibin (7.95% weight), and Hikvision (7.72% weight), with total market capitalizations of 153.397 billion yuan, 473.828 billion yuan, and 305.832 billion yuan respectively [1] Group 2 - The net inflow of main funds into the index constituents totaled 0.987 billion yuan, while retail investors experienced a net outflow of 0.882 billion yuan [1] - Detailed fund flow data shows that Chang'an Automobile had a net inflow of 0.651 billion yuan from main funds, while retail investors had a net outflow of 0.386 billion yuan [2] - Other notable stocks include BOE Technology Group with a net inflow of 0.221 billion yuan from main funds and a net outflow of 0.735 billion yuan from retail investors [2]

Core Points - The Bioeconomy Index (970038) closed at 2319.65 points, up 1.32%, with a trading volume of 23.929 billion yuan and a turnover rate of 1.64% [1] - Among the index constituents, 39 stocks rose while 11 fell, with Boteng Co., Ltd. leading the gainers at 6.85% and Dabo Medical leading the decliners at 2.94% [1] Index Constituents Summary - The top ten constituents of the Bioeconomy Index include: - Mindray Medical (sz300760) with a weight of 13.81%, latest price at 230.50, and a market cap of 279.468 billion yuan [1] - Changchun High-tech (sz000661) with a weight of 5.41%, latest price at 127.16, and a market cap of 51.873 billion yuan [1] - Kanglong Chemical (sz300759) with a weight of 4.66%, latest price at 31.35, and a market cap of 55.746 billion yuan [1] - Other notable constituents include Taige Pharmaceutical, Deep Technology, and Muyuan Foods, each with varying weights and market caps [1] Capital Flow Analysis - The Bioeconomy Index constituents experienced a net inflow of 265 million yuan from institutional investors, while retail investors saw a net outflow of 72.932 million yuan [3] - Key stocks with significant capital flow include: - Mindray Medical with a net inflow of 79.5868 million yuan from institutional investors [3] - Xintai (002294) with a net inflow of 66.974 million yuan, but a net outflow of 87.6434 million yuan from retail investors [3] - Changchun High-tech also saw a net inflow of 66.9424 million yuan from institutional investors, with a notable outflow from retail investors [3]

Core Insights - The Medical Health Index (980016) closed at 6759.45 points, up 1.78%, with a trading volume of 27.946 billion yuan and a turnover rate of 1.0% [1] - Among the index constituents, 40 stocks rose, with Huahai Pharmaceutical leading at a 7.59% increase, while 9 stocks fell, with BGI Genomics leading the decline at 2.93% [1] Index Performance - The Medical Health Index saw a net inflow of 1.063 billion yuan from main funds, while retail investors experienced a net outflow of 392 million yuan [1] - The top ten constituents of the index include major companies such as WuXi AppTec, Hengrui Medicine, and Mindray Medical, with varying market capitalizations and price changes [1] Fund Flow Analysis - Huahai Pharmaceutical had a main fund net inflow of 163 million yuan, while retail investors saw a net outflow of 76.6 million yuan [2] - Other notable companies with significant fund flows include Aier Eye Hospital and Hengrui Medicine, both experiencing mixed inflows and outflows from different investor categories [2]