证券代码：000661 证券简称：长春高新 公告编号：2025-143 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"）收到国家药品监督 管理局核准签发的《药物临床试验批准通知书》，金赛药业 GenSci134 注射液的 境内生产药品注册临床试验申请获得批准，现将相关情况公告如下： 一、药品的基本情况 产品名称：GenSci134 注射液 申请事项：境内生产药品注册临床试验 受理号：CXSL2500737、CXSL2500738 申请人：长春金赛药业有限责任公司 审批结论：经审查，同意本品开展临床试验 适应症：特发性身材矮小（ISS） 二、药品的其它情况 长春高新技术产业（集团）股份有限公司 关于子公司 GenSci134 注射液境内生产药品注册临床试验申请获得 批准的公告 公司将积极推进上述研发项目，并严格按照有关规定及时对项目后续进展情 况履行信息披露义务。 GenSci134 注射液是金赛药业自主研发的一款治疗用生物制品 1 类药物， ...

Core Points - The Shenzhen State-owned Enterprises ESG Index (970055) closed at 1399.95 points, up 0.18%, with a trading volume of 40.636 billion yuan and a turnover rate of 1.2% [1] - Among the index constituents, 29 stocks rose, led by Newland Technology with a 10.01% increase, while 19 stocks fell, with China National Materials Technology leading the decline at 8.51% [1] Index Constituents Summary - The top ten constituents of the Shenzhen State-owned Enterprises ESG Index are as follows: - Hikvision (sz002415) holds a weight of 10.20%, latest price at 32.60 yuan, down 0.82%, with a market cap of 298.775 billion yuan, in the computer industry [1] - BOE Technology Group (sz000725) has a weight of 9.22%, latest price at 4.06 yuan, unchanged, with a market cap of 151.9 billion yuan, in the electronics sector [1] - Wuliangye Yibin (sz000858) has a weight of 8.57%, latest price at 118.98 yuan, down 0.01%, with a market cap of 461.834 billion yuan, in the food and beverage industry [1] - Weichai Power (sz000338) has a weight of 7.34%, latest price at 15.46 yuan, up 3.34%, with a market cap of 134.712 billion yuan, in the automotive sector [1] - Inspur Information (sz000977) has a weight of 6.49%, latest price at 63.78 yuan, down 2.22%, with a market cap of 93.893 billion yuan, in the computer industry [1] - Yun Aluminum (sz000807) has a weight of 4.62%, latest price at 24.29 yuan, up 5.65%, with a market cap of 84.237 billion yuan, in the non-ferrous metals sector [1] - Shenwan Hongyuan (sz000166) has a weight of 4.31%, latest price at 5.47 yuan, unchanged, with a market cap of 136.968 billion yuan, in the non-banking financial sector [1] - AVIC Optoelectronics (sz002179) has a weight of 3.87%, latest price at 35.01 yuan, down 0.26%, with a market cap of 74.161 billion yuan, in the defense and military industry [1] - Changchun High & New Technology (sz000661) has a weight of 3.27%, latest price at 108.22 yuan, down 3.60%, with a market cap of 44.147 billion yuan, in the pharmaceutical and biotechnology sector [1] - China Merchants Shekou (sz001979) has a weight of 3.13%, latest price at 9.36 yuan, down 0.95%, with a market cap of 84.809 billion yuan, in the real estate sector [1] Capital Flow Analysis - The index constituents experienced a net outflow of 1.386 billion yuan from institutional investors, while retail investors saw a net inflow of 1.387 billion yuan [1] - Specific stock capital flows include: - XJ Electric (000400) saw a net inflow of 259 million yuan from institutional investors, while retail investors had a net outflow of 167 million yuan [2] - Oriental Electronics (000682) had a net inflow of 207 million yuan from institutional investors, with retail investors experiencing a net outflow of 129 million yuan [2] - Yun Aluminum (000807) recorded a net inflow of 107 million yuan from institutional investors, while retail investors had a net outflow of 597,210 yuan [2] - Newland Technology (002912) had a net inflow of 86.2 million yuan from institutional investors, with retail investors seeing a net outflow of 54.581 million yuan [2]

Group 1 - The Biotech Index (970038) closed at 2277.73 points, down 0.07%, with a trading volume of 25.957 billion yuan and a turnover rate of 1.67% [1] - Among the index constituents, 26 stocks rose, led by Meiya Optoelectronics with a 3.74% increase, while 22 stocks fell, with Hualan Biological leading the decline at 3.87% [1] - The top ten constituents of the Biotech Index include major companies such as Mindray Medical, Changchun High-tech, and Kanglong Chemical, with varying weightings and market capitalizations [1] Group 2 - The net outflow of main funds from the Biotech Index constituents totaled 190 million yuan, while retail funds saw a net outflow of 143 million yuan, and speculative funds had a net inflow of 334 million yuan [3] - Specific stock fund flows indicate that Muyuan Foods had a main fund net inflow of 14.7 million yuan, while Mindray Medical experienced a main fund net inflow of 69.649 million yuan [3] - The data shows a mixed trend in fund flows, with some stocks attracting significant speculative interest while others faced outflows from both main and retail investors [3]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The rhythm of innovative drug licensing-out transactions has recovered, with a total of 103 transactions and a total amount of $92.03 billion in the first three quarters of 2025, representing a 77% increase compared to the total amount for 2024 [2] - The research and CXO sectors continue to lead the recovery in the pharmaceutical industry, with significant profit growth in these areas [4] - The medical device bidding market has shown a steady recovery, with a year-on-year growth of 29.8% in the third quarter of 2025 [5] - The self-immune field has seen breakthroughs in overseas licensing, indicating a growing alignment with global R&D trends [6] - The weight loss market is experiencing competitive mergers and acquisitions, highlighting its attractiveness and potential impact on Chinese companies [7] - Trends in respiratory infectious diseases are expected to influence the demand for detection and treatment medications [8] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 1.74 percentage points in the last week, ranking 9th among 31 primary industry indices [21] - In the last month, the pharmaceutical industry underperformed the CSI 300 index by 1.83 percentage points, ranking 24th [25] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index has a current PE (TTM) of 38.80, above the five-year historical average of 31.26 [42] 3. Recent Research Achievements - The report highlights various recent research outputs, including weekly industry reports and insights on innovative drug licensing trends [48] 4. Recent Industry Policies and News - The National Healthcare Security Administration has initiated reforms for immediate settlement of medical insurance funds, aiming for 80% coverage by the end of 2025 [50] - Recent news includes significant breakthroughs in GLP-1 therapies and the approval of new drugs for chronic hepatitis B [51][52] 5. Recommended Companies and Profit Forecasts - The report provides a list of recommended companies with their respective EPS and PE ratios, indicating a positive outlook for several firms in the pharmaceutical sector [10]

Core Insights - The company reported a significant decline in net profit despite a slight decrease in revenue, indicating a severe deterioration in profitability driven by rising costs and declining core business performance [2][3][4] Revenue Performance - For the first three quarters of 2025, the company achieved revenue of 9.807 billion yuan, a year-on-year decrease of 5.6%, with Q3 revenue dropping 14.55% to 3.204 billion yuan [2][4] - The core subsidiary, Jinsai Pharmaceutical, generated revenue of 8.213 billion yuan, a slight increase of 0.61%, but its net profit plummeted by 49.96% to 1.421 billion yuan, highlighting the challenge of maintaining revenue without profit growth [4] Cost Structure - Total expenses, including sales, management, and R&D, surged by 1.139 billion yuan, with sales expenses increasing by 620 million yuan to 3.764 billion yuan, reflecting aggressive marketing efforts [2][5] - The total of these expenses accounted for 48.87% of revenue, up 29.89% year-on-year, leading to a drop in net profit margin from 28.13% in 2024 to 10.81% [5][6] Market Challenges - The core product, growth hormone, faces multiple pressures, including a declining birth rate and increased competition from other companies, which has eroded its market dominance [5][10] - The company is experiencing a "difficult transformation" as it attempts to pivot towards innovative drugs, but current R&D investments are not yet yielding significant returns [9][10] Innovation Pipeline - The company has over 40 candidate drugs in its pipeline, with significant investments in R&D amounting to 1.733 billion yuan for the first three quarters, but these efforts are still in the early stages and unlikely to offset declines in core business in the short term [9][10] - Recently launched innovative drugs have contributed minimally to revenue, with total sales of less than 160 million yuan compared to the 8 billion yuan from the growth hormone business [9][10] Future Outlook - The company plans to raise funds through a Hong Kong listing to support R&D and international expansion, but the success of these initiatives remains uncertain and may not provide immediate relief to current performance pressures [12] - The ongoing challenges in the growth hormone market, coupled with high R&D costs and a lengthy commercialization timeline for new drugs, suggest that the company will continue to face significant headwinds in the near future [10][12]

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., received approval for the clinical trial application of GenSci134 injection for domestic production, aimed at treating pediatric growth hormone deficiency (PGHD) [1][2] Group 1: GenSci134 Injection - GenSci134 injection is a self-developed biological product intended for the treatment of growth hormone deficiency, specifically for children experiencing growth retardation due to endogenous growth hormone deficiency [1][2] - The clinical trial approval for GenSci134 is expected to facilitate further clinical development and address unmet clinical needs for PGHD patients, who require long-term growth hormone replacement therapy [2] Group 2: GenSci143 Injection - The company also announced that its subsidiary received approval for the clinical trial application of GenSci143 injection, which targets advanced solid tumors, including prostate and lung cancers [6][7] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) that targets B7-H3 and PSMA, potentially offering dual therapeutic effects and addressing the heterogeneity of tumors [7][8] - The clinical trial application for GenSci143 has been accepted both domestically and internationally, indicating a broad scope for its development [8][9] Group 3: Impact on the Company - Successful progress in clinical trials for both GenSci134 and GenSci143 is expected to enhance the company's business structure, optimize product offerings, and strengthen its core competitiveness in the pharmaceutical industry [3][9]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for clinical trials of GenSci143 in patients with advanced solid tumors [1] Group 1: Product Development - GenSci143 is an innovative biopharmaceutical developed by Jinsai Pharmaceutical, intended for the treatment of various advanced solid tumors, including prostate cancer and lung cancer [1] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, which offers dual potential therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering a broader patient population and producing more durable anti-tumor efficacy [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for clinical trials of GenSci143 in patients with advanced solid tumors [1] Group 1: Product Development - GenSci143 is an innovative biopharmaceutical developed by Jinsai Pharmaceutical, intended for the treatment of various advanced solid tumors, including prostate cancer and lung cancer [1] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, which offers dual potential therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering a broader patient population and providing more durable anti-tumor efficacy [1]

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial application of GenSci134 injection, a self-developed biological product aimed at treating growth hormone deficiency (GHD) [1] Company Summary - Changchun Jinsai Pharmaceutical's GenSci134 injection is classified as a Class 1 therapeutic biological product [1] - The drug is intended for the treatment of GHD, including adult growth hormone deficiency (AGHD), pediatric growth hormone deficiency (PGHD), and non-GHD conditions such as idiopathic short stature (ISS) [1] - The current application specifically targets children experiencing growth retardation due to endogenous growth hormone deficiency (PGHD) [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for clinical trials of its product, GenSci143, in patients with advanced solid tumors [1] Group 1: Product Development - GenSci143 is a first-class therapeutic biological product independently developed by Jinsai Pharmaceutical, intended for the treatment of various advanced solid tumors, including prostate cancer and lung cancer [1] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, which has the potential for both targeted chemotherapy and tumor immunotherapy [1] Group 2: Market Potential - The drug aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering a broader patient population and producing more durable anti-tumor efficacy [1]