证券代码：000661 证券简称：长春高新 公告编号：2025-136 长春高新技术产业（集团）股份有限公司 关于子公司注射用 GenSci139 境内生产药品临床试验获批的公告 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》，同意注射用 GenSci139 单药在 晚期实体瘤患者中开展临床试验。现将相关情况公告如下： 1 解连接子，与一种强效拓扑异构酶 I 抑制剂类有效载荷共价连接，可特异性识别 并结合表达 EGFR 和/或 HER2 的肿瘤细胞，通过阻断 EGFR 同源二聚体、HER2 同源二聚体和 EGFR-HER2 异源二聚体的信号传导，抑制肿瘤细胞的生长。同时， 本品可与表达 EGFR 和/或 HER2 的肿瘤细胞结合后内化，释放有效载荷，从而 杀伤肿瘤细胞。 GenSci139 采用自主研发的接头技术，具有毒素活性强和连接子血浆稳定性 高等特性，在产生更强肿瘤杀伤作用 ...

Core Points - The Bioeconomy Index (970038) closed at 2262.82 points, up 0.08%, with a trading volume of 19.253 billion yuan and a turnover rate of 1.3% [1] - Among the index constituents, 27 stocks rose, with Iwubio leading at a 10.07% increase, while 22 stocks fell, with Yifan Pharmaceutical leading the decline at 4.45% [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 223.47, down 0.90%, and a market cap of 270.944 billion yuan [1] - Changchun High-tech (sz000661) with a weight of 5.41%, latest price at 121.12, down 0.12%, and a market cap of 49.409 billion yuan [1] - Kanglong Chemical (sz300759) with a weight of 4.66%, latest price at 30.56, up 1.76%, and a market cap of 54.342 billion yuan [1] - Shizhu Aoshi (sz002252) with a weight of 4.52%, latest price at 6.67, up 0.15%, and a market cap of 44.275 billion yuan [1] - Biao Ge Shi Medicine (sz300347) with a weight of 4.23%, latest price at 54.08, up 0.95%, and a market cap of 46.564 billion yuan [1] - Shenzhen Technology (sz000021) with a weight of 4.08%, latest price at 27.24, down 0.58%, and a market cap of 42.693 billion yuan [1] - Muyuan Foods (sz002714) with a weight of 3.66%, latest price at 49.48, down 2.25%, and a market cap of 270.298 billion yuan [1] - Aimeike (sz300896) with a weight of 3.44%, latest price at 167.03, down 1.49%, and a market cap of 50.542 billion yuan [1] - Kailai Ying (sz002821) with a weight of 3.23%, latest price at 105.80, up 2.72%, and a market cap of 38.151 billion yuan [1] - Color Egg Therapy (sz002223) with a weight of 3.19%, latest price at 36.65, down 1.24%, and a market cap of 36.741 billion yuan [1] Capital Flow Summary - The Bioeconomy Index constituents experienced a net outflow of 599 million yuan from institutional investors and 215 million yuan from retail investors, while retail investors saw a net inflow of 814 million yuan [3] - Notable capital flows include: - Kanglong Chemical saw a net inflow of 74.766 million yuan from institutional investors, while retail investors experienced a net outflow of 49.703 million yuan [3] - Hualan Biological had a net inflow of 42.164 million yuan from institutional investors, with retail investors seeing a net outflow of 33.5328 million yuan [3] - Lepu Medical had a net inflow of 40.927 million yuan from institutional investors, while retail investors had a net outflow of 32.1814 million yuan [3] - Kailai Ying had a net inflow of 38.867 million yuan from institutional investors, with retail investors experiencing a net outflow of 16.4533 million yuan [3] - Iwubio had a net inflow of 23.192 million yuan from institutional investors, while retail investors saw a net outflow of 5.9208 million yuan [3]

Investment Rating - The report maintains a "Buy" rating for key companies in the pharmaceutical and biotechnology sector, including WuXi AppTec, WuXi Biologics, and Changchun High-tech [5][28]. Core Insights - The report expresses a strong outlook on the innovation theme and emphasizes the importance of capturing Q3 performance. The pharmaceutical sector has shown a decline, with the Shanghai Composite Index down 2.73% and the pharmaceutical sector down 3.65% [12][16]. - The report highlights the active participation of Chinese biopharmaceutical companies in global business development (BD) transactions, which have reached 38% of the global total since 2025. This trend is expected to boost investment sentiment in the sector [12][16]. - The report suggests focusing on companies with improving performance metrics, particularly in the CRO/CDMO and upstream segments, as well as in medical devices and traditional Chinese medicine [12][16]. Summary by Sections Industry Overview - The pharmaceutical industry comprises 515 listed companies with a total market capitalization of approximately 731.59 billion yuan and a circulating market value of about 666.30 billion yuan [2]. Market Dynamics - The pharmaceutical sector has experienced a year-to-date return of 18.85%, outperforming the Shanghai Composite Index by 4.13 percentage points. However, recent weeks have seen a decline in various sub-sectors, with traditional Chinese medicine being the only one to show an increase [16][18]. Valuation Metrics - The current valuation of the pharmaceutical sector is approximately 26.2 times PE based on 2025 earnings forecasts, which is a premium of 17.3% compared to the overall A-share market (excluding financials). The TTM valuation stands at 30.1 times PE, below the historical average of 34.9 times PE [18][20]. Key Company Performance - The report lists several companies with strong performance metrics, including WuXi AppTec, WuXi Biologics, and Changchun High-tech, all rated as "Buy." The average decline for recommended stocks in the month was 10.08%, with a weekly decline of 7.43% [28][29]. Business Development Activity - The report notes that several pharmaceutical companies have engaged in overseas licensing agreements, indicating a growing recognition of Chinese companies' capabilities in the global market [12][16]. Regulatory Updates - Recent regulatory announcements from the National Medical Insurance Administration and the National Medical Products Administration are aimed at improving drug pricing transparency and enhancing the approval process for innovative drugs [12][29]. Price Trends - The report tracks the price movements of various vitamins, noting slight decreases in some and stability in others, which may impact the cost structure for companies in the sector [31][32].

Investment Rating - The report indicates a current overall valuation of the pharmaceutical sector at 30.1 times earnings, ranking it 10th among 31 primary sectors in the market [5][8]. Core Insights - The pharmaceutical sector experienced a decline of 2.5% this week, underperforming compared to the Shanghai Composite Index, which fell by 1.5% [3][5]. - The report highlights significant corporate activities, including BMS's acquisition of Orbital Therapeutics for $1.5 billion, which includes a promising CAR-T therapy candidate and proprietary RNA platform technology [4][13]. - The report emphasizes the importance of the 2025 ESMO conference, where multiple Chinese pharmaceutical companies are expected to present clinical data, suggesting a focus on innovative drug sectors and companies with improving performance in medical devices and upstream sectors [4][19]. Market Performance Summary - The pharmaceutical sector's performance this week ranked 16th among 31 sub-industries, with various segments showing mixed results: - Raw materials (-2.3%) - Chemical preparations (-1.7%) - Traditional Chinese medicine (+0.4%) - Medical devices (-5.4%) [3][8]. - The report notes that the pharmaceutical sector's index has seen a decline of 2.5%, while the overall market (excluding financials and oil) dropped by 4.2% [3][5]. Key Events Recap - BMS's acquisition of Orbital Therapeutics is a notable event, as it aims to enhance its capabilities in CAR-T therapies [4][13]. - The approval of new indications for Pegasys by Teva Biopharma is expected to strengthen its market position in hepatitis treatment [4][15]. - Mindray Medical announced plans to issue H shares and list on the Hong Kong Stock Exchange to support its international strategy [4][15]. Clinical Data Highlights - The report includes a summary of clinical data presented at the 2025 ESMO conference, showcasing various drugs and their efficacy in treating different cancers, which may present investment opportunities [19][22].

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., received written notification from the FDA regarding the acceptance of the clinical trial application for the injectable GenSci143, a dual-target antibody-drug conjugate aimed at treating advanced solid tumors [1][2]. Group 1: Drug Information - Product Name: Injectable GenSci143 [1] - Indication: Advanced solid tumors [2] - Application Details: The clinical trial application has been accepted by the FDA with acceptance number 177763 [1]. Group 2: Mechanism and Technology - GenSci143 targets B7-H3 and PSMA, which are highly expressed in various malignancies, including non-small cell lung cancer, pancreatic cancer, and prostate cancer [2]. - The drug utilizes a proprietary linker technology that enhances the potency and stability of the toxin, aiming to provide a new treatment avenue for tumors expressing B7-H3 and/or PSMA [3]. Group 3: Development Timeline - The clinical trial application for GenSci143 is also set to be accepted in China by the National Medical Products Administration by August 2025 [3]. Group 4: Company Commitment - The company will actively advance the research and development of GenSci143 and will fulfill its information disclosure obligations regarding the project's progress [5].

Group 1 - The core viewpoint of the article highlights the increasing trend of A-share companies seeking to list on the Hong Kong Stock Exchange (HKEX), driven by the need to broaden financing channels and accelerate internationalization of Chinese assets [1][3][4] - As of September, over 20 A-share companies have announced plans or progress towards listing in Hong Kong, with more than 10 companies already completing the "A+H" listing this year, including industry leaders like CATL and Heng Rui Medicine [2][4] - The internationalization strategy is a key motivation for A-share companies to pursue HKEX listings, as it allows them to access a more global capital market and enhance their overseas business operations [3][4] Group 2 - The Hong Kong IPO market is expected to remain strong, with projections indicating over 80 new listings and total fundraising between 250 billion to 280 billion HKD for the year [5] - The active secondary market in Hong Kong, along with favorable conditions such as improved liquidity and valuation recovery, has made it more attractive for companies to issue new shares [4][5] - The "A+H" listing model has become a significant part of fundraising in Hong Kong, accounting for 70% of total fundraising in the first half of the year [4]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. ("Jinsai Pharmaceutical"), has received written notification from the U.S. Food and Drug Administration (FDA) that the clinical trial application for its injectable GenSci143 has been accepted, targeting advanced solid tumors [1] Group 1 - The clinical trial application for GenSci143 has been accepted by the FDA [1] - The indication for GenSci143 is advanced solid tumors [1]

Core Viewpoint - Changchun Gaoxin announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received written notification from the FDA regarding the acceptance of the clinical trial application for its drug GenSci143, which is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicating potential dual therapeutic effects in chemotherapy and tumor immunotherapy [1]. Company Summary - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical, has developed GenSci143, which is a novel drug designed to target specific cancer markers [1]. - The acceptance of the clinical trial application by the FDA is a significant milestone for the company, potentially paving the way for further development and commercialization of GenSci143 [1]. Industry Summary - The drug GenSci143 represents advancements in the field of targeted cancer therapies, particularly in the area of dual-specific antibody-drug conjugates, which may enhance treatment efficacy [1]. - The FDA's acceptance of clinical trial applications is a critical step in the drug development process, reflecting regulatory confidence in innovative cancer therapies [1].

Core Viewpoint - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, has received written notification from the FDA regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate aimed at treating tumors expressing B7-H3 and PSMA [1][2] Group 1: Product Development - GenSci143 is a self-developed drug that targets B7-H3 and PSMA, combining chemotherapy and tumor immunotherapy potential [1] - The drug utilizes a proprietary linker technology, providing strong cytotoxic activity and high plasma stability, which enhances its safety profile while effectively killing tumor cells [1] - The dual-target design of GenSci143 aims to overcome tumor heterogeneity and resistance, potentially benefiting a broader patient population [1] Group 2: Regulatory Progress - The clinical trial application for GenSci143 has also been accepted by the National Medical Products Administration in China, indicating progress in both U.S. and Chinese markets [2] - The company has received multiple approvals for other clinical trial applications, including GS3-007a and GenSci140, showcasing a robust pipeline of innovative drug candidates [2] Group 3: Strategic Focus - The company has undertaken strategic adjustments and increased investment in innovation, establishing core technology platforms with independent intellectual property rights and international competitiveness [3] - There is a focus on high-demand therapeutic areas, particularly in endocrine metabolism and pediatric fields, aligning with the company's sustainable development and internationalization goals [3]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a written notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate [1] Group 1: Product Details - GenSci143 is a self-developed dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The mechanism of GenSci143 involves internalization into lysosomes upon binding to B7-H3 or PSMA, releasing TOPO-I inhibitor toxins to kill B7-H3 positive, PSMA positive, and dual-positive tumor cells [1] - The dual-target approach of B7-H3 and PSMA can overcome tumor heterogeneity and resistance caused by reduced expression of a single target, thereby covering more patients and producing more durable anti-tumor efficacy [1] Group 2: Technical Advantages - GenSci143 utilizes self-developed linker technology, which features strong toxin activity and high plasma stability of the linker, resulting in enhanced tumor-killing effects and improved safety [1] - The innovative dual-target design, stable linker technology, efficient cell-killing mechanism, and broad anti-tumor spectrum of GenSci143 may provide new treatment directions for various solid tumors expressing B7-H3 and/or PSMA [1]