证券代码：000661 证券简称：长春高新 公告编号：2025-142 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 境内生产药品注册临床试验申请 获得批准的公告 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》，同意本品在晚期实体瘤患者中 开展临床试验。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：境内生产药品注册临床试验 受理号：CXSL2500728 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：晚期实体瘤 二、药品的其它情况 GenSci143 是金赛药业自主研发的一款治疗用生物制品 1 类药物，拟用于前 列腺癌和肺癌等多种晚期实体肿瘤治疗。作为一款靶向 B7-H3 与 PSMA 的双特 异性抗体偶联药物（BsADC），GenSci143 具有靶向化疗和肿瘤免疫双 ...

证券代码：000661 证券简称：长春高新 公告编号：2025-141 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 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 PGHD 是由于垂体前叶分泌的生长激素不足所导致的一种内分泌代谢性疾 病。PGHD 是导致儿童身材矮小的原因之一，持续存在且未治疗的 GHD 还可以 引起患儿成年期代谢紊乱、心血管疾病等症状，影响生活质量和寿命。基于治疗 现状，PGHD 患者需要长期接受 GH 替代治疗，存在未被满足的临床需求。 综上所述，GenSci134 注射液具有潜在治疗 PGHD 的成药性，本次临床试验 1 申请的获批可推动该产品后续临床开发，也符 ...

Core Viewpoint - Changchun High-tech's subsidiary, GenSci, has received approval for the clinical trial application of GenSci134 injection for domestic production, which is aimed at treating children with growth retardation due to endogenous growth hormone deficiency [1] Group 1: Company Developments - The clinical trial application for GenSci134 injection has been approved by the National Medical Products Administration [1] - The drug is classified as a Class 1 therapeutic biological product and is intended for children with growth issues [1] - GenSci134 has previously been approved for clinical trials in adults with growth hormone deficiency, indicating a potential expansion of its application [1] Group 2: Industry Implications - Successful progress in the clinical trials could help the company diversify its business structure and enhance its core competitiveness [1] - The development of pharmaceutical products is inherently uncertain, and there are risks associated with the clinical trial process [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd. (referred to as "JinSai Pharmaceutical"), has received the Clinical Trial Approval Notification from the National Medical Products Administration for its GenSci134 injection, marking a significant step in the development of a treatment for growth hormone deficiency (GHD) [1] Company Summary - JinSai Pharmaceutical's GenSci134 injection is an independently developed Class 1 biological product intended for the treatment of GHD, including adult growth hormone deficiency (AGHD), pediatric growth hormone deficiency (PGHD), and non-GHD patients [1] - The current application specifically targets the treatment of pediatric growth retardation (PGHD) caused by endogenous growth hormone deficiency [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, has received approval from the National Medical Products Administration for the clinical trial of GenSci143 in patients with advanced solid tumors [1] Group 1: Company Developments - Jinsai Pharmaceutical has been granted a Clinical Trial Approval Notice for GenSci143, a first-class therapeutic biological product developed independently by the company [1] - The clinical trial will focus on advanced solid tumors, specifically targeting prostate cancer and lung cancer among other indications [1]

Core Viewpoint - Changchun High-tech reported a decline in both revenue and net profit for the first three quarters of the year, indicating significant challenges in its financial performance [1] Financial Performance - For the first three quarters, the company achieved operating revenue of 9.807 billion, a year-on-year decrease of 5.60% [1] - The net profit attributable to shareholders was 1.165 billion, down 58.23% year-on-year [1] - In Q3 alone, operating revenue was 3.204 billion, reflecting a 14.55% year-on-year decline [1] - The net profit for Q3 was 182 million, a substantial decrease of 82.98% year-on-year [1] Subsidiary Performance - The net profit of subsidiary Jinsai Pharmaceutical decreased by 49.96% year-on-year [1] - The net profit of subsidiary Baike Biological plummeted by 164.76% year-on-year [1] Investment Activities - The company's long-term equity investments increased by 435 million compared to the beginning of the year, marking a growth of 149.56% [1] - This increase was primarily due to Baike Biological's second-phase capital increase in Chuanxin Biological, with an additional investment of 200 million, raising the company's ownership stake to 33.3241% [1]

Core Insights - The Biotech Index (970038) closed at 2279.35 points, up 0.77%, with a trading volume of 28.709 billion yuan and a turnover rate of 1.85% [1] - Among the index constituents, 41 stocks rose, with Hualan Vaccine leading at a 17.88% increase, while 8 stocks fell, with Deep Technology leading the decline at 6.38% [1] Index Performance - The Biotech Index saw a net inflow of 140 million yuan from institutional investors, while retail investors contributed a net inflow of 210 million yuan, and there was a net outflow of 350 million yuan from speculative funds [1] Top Constituents - The top ten constituents of the Biotech Index include: - Mindray Medical (sz300760) with a weight of 13.81%, latest price at 215.04, and a decrease of 0.76% [1] - Changchun High-tech (sz000661) with a weight of 5.41%, latest price at 112.26, and a decrease of 2.55% [1] - Kanglong Chemical (sz300759) with a weight of 4.66%, latest price at 33.51, and an increase of 1.12% [1] - Other notable constituents include Muyuans (sz002714) and Aimeike (sz300896) with respective weights of 3.66% and 3.44% [1] Capital Flow Details - Detailed capital flow for key stocks includes: - Mindray Medical saw a net inflow of 26.2 million yuan from institutional investors [2] - Muyuans had a net inflow of 203 million yuan from institutional investors [2] - Hualan Vaccine experienced a net inflow of 74.8 million yuan from institutional investors [2]

Core Points - The Shenzhen State-owned Enterprise ESG Index (970055) closed at 1397.41 points, down 1.17%, with a trading volume of 45.284 billion yuan and a turnover rate of 1.32% [1] - Among the index constituents, 19 stocks rose while 30 stocks fell, with Mango Excellent Media leading the gainers at 3.67% and China Tungsten High-tech leading the decliners at 10.0% [1] Index Constituents Summary - The top ten constituents of the Shenzhen State-owned Enterprise ESG Index include Hikvision, BOE Technology Group, Wuliangye Yibin, Inspur Information, Weichai Power, AVIC Optoelectronics, Shenwan Hongyuan, Yun Aluminum, Changchun High-tech, and China Merchants Shekou [1] - Hikvision holds a weight of 9.64% with a latest price of 32.87 yuan, down 1.05% [1] - BOE Technology Group has a weight of 9.31% with a latest price of 4.06 yuan, down 0.73% [1] - Wuliangye Yibin has a weight of 8.62% with a latest price of 66.81 yuan, up 0.44% [1] - Inspur Information has a weight of 7.30% with a latest price of 65.23 yuan, down 5.97% [1] - Weichai Power has a weight of 6.78% with a latest price of 14.96 yuan, up 3.60% [1] - AVIC Optoelectronics has a weight of 4.48% with a latest price of 35.10 yuan, down 0.23% [1] - Shenwan Hongyuan has a weight of 4.14% with a latest price of 5.47 yuan, up 0.37% [1] - Yun Aluminum has a weight of 4.08% with a latest price of 22.99 yuan, down 2.50% [1] - Changchun High-tech has a weight of 3.73% with a latest price of 112.26 yuan, down 2.55% [1] - China Merchants Shekou has a weight of 3.31% with a latest price of 9.45 yuan, up 1.61% [1] Capital Flow Analysis - The index constituents experienced a net outflow of 3.372 billion yuan from institutional investors, while retail investors saw a net inflow of 2.508 billion yuan [1] - Notable net inflows from retail investors were observed in Wuliangye Yibin, Weichai Power, and Mango Excellent Media, while significant outflows were noted in Hikvision and China Merchants Shekou [2]

Core Points - The Medical Health R Index (480016) closed at 7755.61 points, up 1.68%, with a total transaction volume of 40.103 billion yuan and a turnover rate of 1.25% [1] - Among the index constituents, 43 stocks rose, with Zai Jian Pharmaceutical leading with a 16.14% increase, while 6 stocks fell, with Kailai Ying leading the decline at 4.33% [1] Index Constituents Summary - The top ten constituents of the Medical Health R Index include: - WuXi AppTec (603259) with a weight of 14.37%, latest price at 99.40 yuan, and a 2.41% increase, total market value of 296.585 billion yuan [1] - Hengrui Medicine (600276) with a weight of 11.45%, latest price at 64.15 yuan, and a 2.02% increase, total market value of 425.776 billion yuan [1] - Mindray Medical (300760) with a weight of 8.07%, latest price at 215.04 yuan, and a 0.76% decrease, total market value of 260.723 billion yuan [1] - United Imaging Healthcare (688271) with a weight of 4.32%, latest price at 139.92 yuan, and a 0.79% decrease, total market value of 115.316 billion yuan [1] - Pianzai Shou (600436) with a weight of 3.59%, latest price at 178.13 yuan, and a 0.64% increase, total market value of 107.469 billion yuan [1] - Aier Eye Hospital (300015) with a weight of 3.21%, latest price at 12.25 yuan, and a 1.16% increase, total market value of 114.236 billion yuan [1] - Kelun Pharmaceutical (002422) with a weight of 2.54%, latest price at 35.00 yuan, and a 2.19% increase, total market value of 55.932 billion yuan [1] - Changchun High-tech (000661) with a weight of 2.35%, latest price at 112.26 yuan, and a 2.55% decrease, total market value of 45.795 billion yuan [1] - Fosun Pharma (600196) with a weight of 2.28%, latest price at 29.20 yuan, and a 2.46% increase, total market value of 77.977 billion yuan [1] - New Hope Liuhe (002001) with a weight of 2.22%, latest price at 24.30 yuan, and a 0.04% increase, total market value of 74.684 billion yuan [1] Capital Flow Summary - The net inflow of main funds into the Medical Health R Index constituents totaled 406 million yuan, while speculative funds saw a net outflow of 644 million yuan, and retail investors had a net inflow of 237 million yuan [1] - Specific capital flow details for key stocks include: - Mindray Medical (300760) with a main fund net inflow of 262 million yuan and a speculative fund net outflow of 127 million yuan [2] - BeiGene (688235) with a main fund net inflow of 233 million yuan and a speculative fund net outflow of 225 million yuan [2] - Haizhi Pharmaceutical (002653) with a main fund net inflow of 92.778 million yuan and a retail net outflow of 95.916 million yuan [2] - New Hope Liuhe (002001) with a main fund net inflow of 90.378 million yuan and a speculative fund net outflow of 43.538 million yuan [2] - Renfu Pharmaceutical (600079) with a main fund net inflow of 71.683 million yuan and a speculative fund net outflow of 41.302 million yuan [2]

Core Insights - The assisted reproductive concept sector saw a rise of 3.23%, ranking 8th among concept sectors, with 69 stocks increasing in value, including notable gains from companies like Caina Co., Ltd. (20% limit up), Zhongsheng Pharmaceutical (limit up), and Kangzhi Pharmaceutical, which rose by 17.47%, 10.99%, and 9.98% respectively [1][6] - The sector experienced a net inflow of 811 million yuan from main funds, with 38 stocks receiving net inflows, and 23 stocks seeing inflows exceeding 10 million yuan. Zhongsheng Pharmaceutical led with a net inflow of 305 million yuan, followed by Guangsheng Pharmaceutical and Anke Bio, with net inflows of 272 million yuan and 88 million yuan respectively [1][2] Sector Performance - The assisted reproductive concept sector was among the top gainers, with a daily increase of 3.23%, while other sectors like recombinant proteins and cell immunotherapy also performed well, increasing by 3.72% and 3.58% respectively [1] - Conversely, sectors such as cultivated diamonds and national big fund holdings faced declines, both dropping by 2.96% [1] Fund Flow Analysis - The leading stocks in terms of fund inflow ratios included Zhongsheng Pharmaceutical (20.95%), Tianyao Pharmaceutical (10.99%), and Caina Co., Ltd. (10.65%) [2][3] - The top stocks by main fund flow included Zhongsheng Pharmaceutical with 304.73 million yuan, Guangsheng Pharmaceutical with 272.34 million yuan, and Anke Bio with 88.06 million yuan [2][3] Notable Stock Movements - Significant stock movements included Zhongsheng Pharmaceutical and Caina Co., Ltd. achieving limit up status, while companies like Changchun High-tech and *ST Suwu experienced declines of 2.55% and 1.98% respectively [1][5] - Other notable gainers included Kangzhi Pharmaceutical and Nanjing Momo Biological, which rose by 17.47% and 9.98% respectively [1][4]