证券代码：000661 证券简称：长春高新 公告编号：2025-145 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 验申请获得批准，现将相关情况公告如下： 一、药品的基本情况 二、药品的其它情况 GenSci143 是金赛药业自主研发的一款靶向 B7-H3 与 PSMA 的双特异性抗 体偶联药物（BsADC），具有靶向化疗和肿瘤免疫双重潜在治疗作用。是一款 治疗用生物制品 1 类药物，拟用于前列腺癌、肺癌等多种晚期实体肿瘤治疗。 GenSci143 通过结合 B7-H3 或 PSMA，内化至溶酶体，释放 TOPO-I 抑制剂 毒素，实现对 B7-H3 阳性、PSMA 阳性及双阳性肿瘤细胞的杀伤。B7-H3 和 PS ...

Core Insights - The Shenzhen Leading Index (399653) closed at 3104.35 points, up 1.73%, with a trading volume of 105.65 billion yuan and a turnover rate of 0.96% [1] - Among the index constituents, 36 stocks rose while 12 fell, with Ruida Futures leading the gainers at an increase of 8.07%, and Binjiang Group leading the decliners with a drop of 3.33% [1] Index Constituents Summary - The top ten constituents of the Shenzhen Leading Index include: - Ningde Times (20.44% weight) at 415.60 yuan, up 7.56%, with a market cap of 1896.42 billion yuan [1] - Zhongji Xuchuang (8.35% weight) at 481.00 yuan, down 2.19%, with a market cap of 534.45 billion yuan [1] - Midea Group (7.67% weight) at 79.60 yuan, up 0.14%, with a market cap of 611.73 billion yuan [1] - Luxshare Precision (6.06% weight) at 57.38 yuan, down 0.68%, with a market cap of 417.85 billion yuan [1] - Sungrow Power (5.67% weight) at 190.51 yuan, up 1.53%, with a market cap of 394.97 billion yuan [1] - BYD (5.25% weight) at 99.83 yuan, up 2.11%, with a market cap of 910.17 billion yuan [1] - Wugong Liquor (4.41% weight) at 121.20 yuan, up 0.68%, with a market cap of 470.45 billion yuan [1] - Gree Electric (3.53% weight) at 41.00 yuan, down 0.36%, with a market cap of 229.66 billion yuan [1] - ZTE Corporation (2.83% weight) at 40.35 yuan, up 1.56%, with a market cap of 193.02 billion yuan [1] - Yuanlefang A (2.75% weight) at 4.04 yuan, unchanged, with a market cap of 151.15 billion yuan [1] Capital Flow Analysis - The net inflow of main funds into the Shenzhen Leading Index constituents totaled 3.862 billion yuan, while retail investors experienced a net outflow of 684 million yuan [1] - Notable capital flows include: - Ningde Times saw a net inflow of 2.655 billion yuan from main funds, while retail investors had a net outflow of 448 million yuan [2] - BYD had a net inflow of 607 million yuan from main funds, with retail investors experiencing a net outflow of 208 million yuan [2] - Zhongji Xuchuang had a net inflow of 409 million yuan from main funds, while retail investors had a negligible outflow [2]

Core Insights - The biopharmaceutical sector experienced a rise of 1.06% on November 13, with BoHui Innovation leading the gains [1] - The Shanghai Composite Index closed at 4029.5, up 0.73%, while the Shenzhen Component Index closed at 13476.52, up 1.78% [1] Stock Performance - BoHui Innovation (300318) closed at 8.17, with a significant increase of 13.47% and a trading volume of 1.4092 million shares [1] - Other notable performers included: - Sanofi (688336) at 73.00, up 6.57% with a trading volume of 137,200 shares [1] - Jinke (688670) at 23.36, up 5.23% with a trading volume of 124,300 shares [1] - Rongchang Bio (688331) at 89.00, up 3.37% with a trading volume of 68,500 shares [1] Capital Flow - The biopharmaceutical sector saw a net outflow of 211 million yuan from institutional investors, while retail investors contributed a net inflow of 86.65 million yuan [2] - The capital flow for specific stocks included: - Sanofi (688336) with a net inflow of 35.23 million yuan from institutional investors [3] - Junshi Biosciences (688180) with a net inflow of 29.67 million yuan from institutional investors [3] - Long Spring High-tech (000661) experienced a net outflow of 59.78 million yuan from institutional investors [3]

Healthcare Policy - National Healthcare Security Administration held a series of discussions on the adjustment of the disease-based payment grouping scheme 3.0, involving over 70 representatives from medical institutions and industry associations [1] Drug and Medical Device Approvals - Shijiazhuang Pharmaceutical Group's application for the listing of Pertuzumab injection has been accepted by the National Medical Products Administration, targeting HER2-positive breast cancer [1] - Huason Pharmaceutical received a registration certificate for its special medical purpose formula food, Ganyimei®, designed for patients over 10 years old with strict fat restrictions and digestive absorption disorders [2] - United Imaging Healthcare's subsidiary obtained a medical device registration certificate for its color Doppler ultrasound diagnostic system, enhancing its product range across various market segments [3] - Yiling Pharmaceutical's application for the listing of Memantine Hydrochloride, a drug for treating moderate to severe Alzheimer's disease, has been approved [4] - Zhifei Biological's clinical trial application for a freeze-dried varicella inactivated vaccine has been accepted by the National Medical Products Administration [10] - Changchun High-tech's subsidiary received approval for a clinical trial of an acellular pertussis-diphtheria-tetanus combined vaccine for adolescents and adults [11] Capital Market Activities - Peking University Pharmaceutical announced the release of 34,615,386 shares from pledge, representing 51.52% of the pledged shares and 5.81% of the total share capital [5] - Kelun Pharmaceutical received approval for a registration of 4 billion yuan in ultra-short-term financing bonds, with a validity period of 2 years [6][7] - Baili Tianheng decided to delay its global offering and listing of H-shares due to current market conditions [8] - Aipeng Medical announced a plan for a shareholder to reduce holdings by up to 1% of total shares, citing personal funding needs [12] - Hendi Pharmaceutical's shareholders plan to collectively reduce their holdings by up to 2.33% of total shares for personal financial planning [13] Financial Adjustments - Baihua Pharmaceutical plans to use 1.91 billion yuan from its capital reserve to cover losses, primarily due to goodwill impairment from a previous major asset restructuring [14]

Core Points - Changchun High-tech announced that its subsidiary, Changchun Baike Biotechnology Co., has received the clinical trial approval notice from the National Medical Products Administration for its adsorbed acellular combined vaccine for adults and adolescents [1] Group 1 - The company has made significant progress in vaccine development with the approval of a clinical trial for a new vaccine [1]

Group 1 - Longjian Co., Ltd. won a bid for a highway maintenance project in Heilongjiang with a contract value of 483 million yuan, accounting for 2.64% of the company's expected revenue for 2024 [1] - Transsion Holdings plans to issue H-shares and list on the main board of the Hong Kong Stock Exchange [1] - Good Home's controlling shareholder intends to reduce its stake by up to 2.7%, equivalent to no more than 39.4468 million shares [1][2] Group 2 - Xinhua Insurance reported a cumulative premium income of 181.973 billion yuan from January to October, representing a year-on-year growth of 17% [2][4] - Zhejiang Jiaokao is part of a consortium that plans to bid for a new urbanization project with an estimated total investment of 11.103 billion yuan [4] Group 3 - Changchun High-tech received approval for clinical trials of a vaccine for adolescents and adults [6] - XinNuoWei's application for the listing of Pertuzumab injection has been accepted, targeting HER2-positive breast cancer [8] - Dash Smart won a bid for an intelligent project at the new Huanggang Port inspection building, valued at 55.056 million yuan, which is 1.74% of its expected revenue for 2024 [8] Group 4 - Electronic City is involved in a lawsuit for debt recovery, with the amount in dispute estimated at 777 million yuan [9] - Haibo Technology signed a strategic cooperation agreement with CATL for a cumulative procurement of no less than 200 GWh of electricity from 2026 to 2028 [10] Group 5 - Renfu Pharmaceutical's HW231019 tablets have entered the second phase of clinical trials for postoperative pain relief [11] - Tonghua Dongbao received a drug registration certificate for Aspart Insulin injection from the Dominican Republic [11] Group 6 - Shaanxi Construction reported winning major projects worth a total of 1.016 billion yuan in October [12] - Fuzhou Environmental Protection plans to change its stock name to "Fuzhou Technology" [12] Group 7 - Panlong Pharmaceutical's gel patch for knee osteoarthritis has received approval for clinical trials [15] - Zhongyida's application for a specific stock issuance has been terminated by the Shanghai Stock Exchange [16] Group 8 - Zhizhong Home's controlling shareholder reduced its holdings of convertible bonds by 905,000 units, accounting for 13.51% of the total issued [19] - Haibo Co., Ltd. plans to establish a subsidiary with an investment of 1 billion yuan for high-end component projects [21] Group 9 - Caina Co. plans to use 57 million yuan of idle funds to purchase structured deposits [23] - Zhendong Pharmaceutical's new drug for acute ischemic stroke has entered the IIa phase of clinical trials [25] Group 10 - Weiman Sealing's overseas subsidiary plans to lease a factory in Saudi Arabia for 5 years at a total rent of approximately 54.039 million yuan [26] - Yiling Pharmaceutical's application for Memantine Hydrochloride has been approved for market entry [28] Group 11 - Dongfang Zhizao plans to acquire 70% of Saifu Machinery for 27.4887 million yuan [30] - JianKai Technology's actual controller intends to transfer 3% of the company's shares through inquiry [31] Group 12 - Rejing Bio plans to repurchase shares worth between 100 million and 200 million yuan [32] - Bangji Technology has decided to terminate a major asset restructuring project due to failure to reach an agreement [34] Group 13 - Huadong Pharmaceutical's application for the marketing license of a new drug has been accepted [36] - Zhonggu Logistics' shareholder plans to reduce its stake by up to 3% [38] Group 14 - Bohui Innovation's subsidiary received approval for a clinical trial of a vaccine for invasive infections [40] - Shannon Chip's shareholder pledged 0.27% of the company's shares for financing [42] Group 15 - Shanghai Petrochemical appointed a new general manager [44] - Jiaojian Co. plans to reduce the holdings of some directors and executives by up to 0.35% [46] Group 16 - Weiting Electric plans to raise no more than 300 million yuan through a private placement [47] - Zhongjin Irradiation plans to invest approximately 200 million yuan in an electronic accelerator manufacturing project [49] Group 17 - Tongxing Technology signed a framework agreement to invest 3.2 billion yuan in a sodium battery project [50] - Hongri Da plans to establish a subsidiary focused on semiconductor packaging [51] Group 18 - Shanghai Kaibao's new drug for acute ischemic stroke has received approval for clinical trials [53] - Yitong Century announced a change in its control structure, becoming a company without a controlling shareholder [55]

格隆汇11月12日｜长春高新(000661.SZ)公告称，公司子公司百克生物收到国家药品监督管理局对其吸 附无细胞百(二组分)白破联合疫苗(成人及青少年用)的《药物临床试验批准通知书》。该疫苗是一种可 以同时预防青少年及成人百日咳、白喉、破伤风的疫苗，接种对象为10周岁及以上人群。若该疫苗顺利 完成临床试验并获批上市，将进一步完善公司疫苗研发管线，丰富公司联合疫苗产品矩阵，有助于公司 优化产品结构和主营业务的全面发展。 ...

Core Viewpoint - Changchun High-tech's subsidiary, Baike Biological, has received approval from the National Medical Products Administration for clinical trials of an acellular combined vaccine for adolescents and adults, aimed at preventing whooping cough, diphtheria, and tetanus [1][2] Group 1: Vaccine Approval and Market Context - The approved vaccine is designed for individuals aged 10 and above, stimulating immune response to prevent invasive infections caused by whooping cough, diphtheria, and tetanus [1] - There has been an increasing incidence of whooping cough among adolescents and adults in recent years, prompting the recommendation for vaccination every 10 years in developed countries [1] - Currently, China's immunization program primarily targets infants, with no approved combined vaccine for adolescents and adults [1] Group 2: Technological Advancements and Business Implications - The vaccine developed by Baike Biological utilizes a new acellular technology, replacing the traditional co-purification process, and includes inactivated components of whooping cough toxin, filamentous hemagglutinin, diphtheria toxin, and tetanus toxin [2] - The vaccine's formulation with an aluminum-CpG adjuvant system enhances immune response, offering high purity and consistency [2] - Successful completion of clinical trials and subsequent market approval will enhance the company's vaccine development pipeline, diversify its product offerings, and create new growth opportunities for the company's performance [2]

Core Viewpoint - Changchun High-tech's subsidiary, Baike Biological, has received approval from the National Medical Products Administration for clinical trials of its acellular combined diphtheria, tetanus, and pertussis vaccine for adolescents and adults, addressing the rising incidence of whooping cough among this demographic [1][2]. Group 1 - The approved vaccine is designed to prevent whooping cough, diphtheria, and tetanus in individuals aged 10 and above, stimulating immune responses to prevent invasive infections [1]. - There has been an increasing trend in the incidence of whooping cough among adolescents and adults both domestically and internationally, prompting recommendations for vaccination every 10 years in developed countries [1]. - Currently, China's immunization program primarily targets infants, with no approved combined diphtheria, tetanus, and pertussis vaccine for adolescents and adults [1]. Group 2 - The vaccine developed by Baike Biological utilizes a new formulation that includes inactivated pertussis toxin, filamentous hemagglutinin, diphtheria toxin, and tetanus toxin, along with an aluminum-CpG adjuvant system to enhance immune response [2]. - If the clinical trials are successful and the vaccine is approved for market release, it will enhance the company's vaccine research pipeline and diversify its product offerings, contributing to overall business growth and providing high-quality vaccination options to the public [2].

Core Viewpoint - Changchun High-tech's subsidiary, Baike Bio, has received approval for clinical trials of an acellular combined vaccine for adolescents and adults, which aims to prevent whooping cough, diphtheria, and tetanus [1] Group 1 - The vaccine is intended for individuals aged 10 years and older [1] - Successful completion of clinical trials and subsequent approval for market launch will enhance the company's vaccine research pipeline [1] - This development will enrich the company's portfolio of combined vaccines, aiding in optimizing product structure and overall business growth [1]