Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received written notification from the U.S. Food and Drug Administration (FDA) approving the clinical trial application for GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicating significant progress in its oncology pipeline [1]. Group 1 - Jinsai Pharmaceutical's GenSci143 is a self-developed drug with dual potential therapeutic effects, targeting both chemotherapy and tumor immunotherapy [1]. - GenSci143 is classified as a Class 1 biological product intended for the treatment of advanced solid tumors, including prostate cancer and lung cancer [1].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), received written notification from the U.S. Food and Drug Administration (FDA) approving the clinical trial application for its injectable GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] Group 1 - Jinsai Pharmaceutical's GenSci143 is a self-developed drug aimed at treating various advanced solid tumors, including prostate cancer and lung cancer [1] - The drug is classified as a Class 1 biological product for therapeutic use [1] - The approval from the FDA marks a significant milestone for the company in the oncology drug development space [1]

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Changchun Jinsai Pharmaceutical, received written notification from the FDA regarding the approval of the clinical trial application for GenSci143, a therapeutic biological product intended for the treatment of advanced solid tumors such as prostate cancer and lung cancer [1] Group 1 - The FDA approval pertains to the clinical trial application for GenSci143, which is classified as a Class 1 therapeutic biological product [1] - GenSci143 is designed for the treatment of multiple advanced solid tumors, including prostate cancer and lung cancer [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, has received approval for the clinical trial application of GenSci143 in the United States, which is a bispecific antibody-drug conjugate developed for the treatment of advanced solid tumors such as prostate cancer and lung cancer [1] Group 1 - GenSci143 is independently developed by Jinsai Pharmaceutical [1] - The drug has already been approved for clinical trials in China for advanced solid tumors [1]

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]

Investment Rating - The report maintains an "Outperform" rating for the company, with a target price of 38.26 RMB and a 2026 PE of 41X [4][9]. Core Insights - The company's core product, dust mite drops, is steadily growing, while the new product, artemisia annua drops, is rapidly gaining market share. The prick test solution product line is also expanding, and there are multiple advancements in the R&D pipeline [1][4]. - In the first three quarters of 2025, the company achieved a revenue of 0.85 billion RMB, representing a growth of 16.86%, and a net profit attributable to shareholders of 0.35 billion RMB, which is an increase of 26.67% [4][9]. - The company has effectively controlled costs, leading to profit growth that outpaces revenue growth, primarily due to a decrease in expense ratios and refined sales management [4][9]. Financial Summary - The company’s projected financials show a revenue increase from 848 million RMB in 2023 to 1.525 billion RMB in 2027, with a CAGR of approximately 18.9% [3][5]. - Net profit attributable to shareholders is expected to grow from 310 million RMB in 2023 to 595 million RMB in 2027, reflecting a CAGR of about 21.7% [3][5]. - The earnings per share (EPS) forecast is adjusted to 0.77 RMB for 2025, 0.93 RMB for 2026, and 1.14 RMB for 2027 [4][9]. Product Performance - By product, dust mite revenue reached 0.79 billion RMB (+13.38%), artemisia annua revenue was 44.76 million RMB (+117.58%), and prick test solution revenue was 11.05 million RMB (+94.10%) in the first three quarters of 2025 [4][9]. - In Q3 2025 alone, the company reported a revenue of 0.37 billion RMB (+22.64%) and a net profit of 0.17 billion RMB (+36.44%) [4][9]. R&D Pipeline - The company is advancing its allergen product development, with several products in various stages of clinical trials, including the artemisia annua pollen sublingual drops and dermatitis diagnostic patches [4][9]. - Current R&D products include the house dust mite membrane agent in Phase I, and two dermatitis diagnostic patches in Phase I and II clinical trials [4][9].

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]