证券代码：000661 证券简称：长春高新 公告编号：2025-134 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 ——长春百克生物科技股份公司（以下简称"百克生物"）收到国家药品监督管理 局对其三价流感病毒裂解疫苗（BK-01 佐剂）下发的《药物临床试验批准通知书》。 现将相关情况公告如下： 一、《药物临床试验批准通知书》的主要信息 受理号：CXSL2500608 通知书编号：2025LP02679 药品名称：三价流感病毒裂解疫苗（BK-01 佐剂） 结论：同意开展预防疫苗相关型别流感病毒引起的流行性感冒的临床试验。 批准日期：2025 年 10 月 13 日 长春高新技术产业（集团）股份有限公司 关于子公司三价流感病毒裂解疫苗（BK-01 佐剂） 临床试验申请获得批准的公告 自 2020 年 3 月以来，自然环境中尚未发现确证的 B/Yamagata 系流感病毒，WHO 于 2024 年 2 月 19 日针对 2024～2025 年度北半球流感疫苗组分召开的重要会议中， 建议从北半球 ...

Core Viewpoint - The Biotech Index (970038) closed at 2325.47 points, down 1.85%, with a trading volume of 31.496 billion yuan and a turnover rate of 2.07% [1] Group 1: Index Performance - On the day, 6 out of the index's constituent stocks rose, with Huace Testing leading with a 2.51% increase, while 44 stocks declined, with Boteng Co. leading the decline at 6.27% [1] - The top ten constituent stocks of the Biotech Index are primarily in the pharmaceutical and biotechnology sectors, with notable declines in major stocks like Mindray Medical and Changchun High-tech [1] Group 2: Stock Details - The top ten constituent stocks by weight include: - Mindray Medical (13.81% weight) at 235.20 yuan, down 2.81%, with a market cap of 285.166 billion yuan [1] - Changchun High-tech (5.41% weight) at 132.06 yuan, down 3.11%, with a market cap of 53.872 billion yuan [1] - Kanglong Chemical (4.66% weight) at 31.76 yuan, down 3.99%, with a market cap of 56.475 billion yuan [1] - Other notable stocks include Taige Pharmaceutical and Aimeike, both showing declines [1] Group 3: Capital Flow - The Biotech Index constituent stocks experienced a net outflow of 722 million yuan from main funds, while retail investors saw a net inflow of 534 million yuan [3] - Specific stocks like Mindray Medical and Changchun High-tech had varying levels of net inflow and outflow from different investor categories, indicating mixed investor sentiment [3]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The trend of Chinese innovative drugs going overseas is a long-term phenomenon, with external environmental changes having limited impact. In the first half of 2025, there were 72 License-out transactions, exceeding half of the total for 2024, with a total transaction amount 16% higher than in 2024. Notably, there were 16 transactions exceeding $1 billion each [2] - The small nucleic acid drug sector has seen significant breakthroughs, particularly in the treatment of chronic diseases such as hypertension and hyperlipidemia, with major collaborations and potential milestone payments indicating a robust commercial outlook [3] - The trend towards oral autoimmune drugs is gaining attention, with significant partnerships and clinical advancements in this area, highlighting the importance of oral formulations in autoimmune therapies [4] - Recent clinical data on long-acting insulin analogs shows promising weight loss results, with ongoing developments in combination therapies for metabolic diseases, indicating a growing market potential [5] - The CXO sector is gradually recovering, with an increase in License-out transactions serving as a vital funding source for biotech companies, leading to a resurgence in innovation and clinical development [6] - The 2025 national medical insurance negotiations and the commercial insurance innovative drug directory are crucial for companies involved, with a focus on orphan drugs and imported PD-1/L-1 products [7] Summary by Sections Industry Tracking - The pharmaceutical sector has underperformed compared to the CSI 300 index, with a recent weekly decline of 1.20% and a monthly decline of 3.38%, ranking 25th among 31 industry indices [22][26] Industry Trends and Valuation - The pharmaceutical industry index currently has a PE ratio of 39.05, above the five-year historical average of 31.36, indicating a higher valuation compared to historical trends [48][50] Recent Research Achievements - The research team has published several in-depth reports on various pharmaceutical topics, including the growth of the blood products industry and the potential of GLP-1 drugs in chronic disease management [53] Important Policies and News - Recent regulations have been introduced to standardize clinical research and ensure drug traceability, which will impact the pharmaceutical landscape significantly [55][56]

Investment Rating - The report maintains a positive outlook on the innovative drug sector, suggesting it will continue to show high revenue growth and reduce losses [4][16]. Core Insights - The pharmaceutical sector experienced a decline of 1.2% this week, ranking 25th among 31 sub-industries [5][7]. - The overall valuation of the pharmaceutical sector is at 30.9 times earnings, placing it 10th among 31 primary industries [8][15]. - Notable transactions include the licensing agreement between Innovent Biologics and Zenas BioPharma, valued at over $2 billion, which includes a $100 million upfront payment [4][14]. - The report highlights the importance of monitoring the performance of innovative drug companies in the upcoming quarterly reports, particularly those showing consistent high growth [4][16]. Market Performance - The pharmaceutical index decreased by 1.2%, while the Shanghai Composite Index increased by 0.4% during the same period [5][7]. - The performance of various sub-sectors includes: - Raw materials: -0.7% - Chemical preparations: -2.5% - Traditional Chinese medicine: +1.5% - Blood products: +1.4% - Vaccines: +0.7% - Other biological products: -1.7% - Medical devices: -0.2% - Medical consumables: +0.2% - In vitro diagnostics: -0.6% - Pharmaceutical distribution: +0.8% - Offline pharmacies: +0.3% - Medical R&D outsourcing: -5.3% - Hospitals: +1.8% [8][12]. Key Events - The National Medical Products Administration released a draft for further promoting post-marketing research and evaluation of traditional Chinese medicine injections [4][16]. - The report notes the upcoming IPOs in the sector, including He Yuan Biology and Biotech [19].

Investment Rating - The report maintains a strong confidence in the pharmaceutical sector's potential for a reversal in 2025, particularly focusing on innovative drugs and the recovery of left-side sectors as the biggest investment opportunities for the year [5][14]. Core Insights - The innovative drug sector is expected to continue its upward trend, with BD (business development) activities anticipated to catalyze market movements. The upcoming ESMO conference (October 17-21) is highlighted as a key event for clinical data disclosures from domestic innovative drug companies [2][13]. - The report emphasizes the importance of recent Nobel Prize discoveries related to peripheral immune tolerance, which are relevant to the development of new therapies in oncology and autoimmune diseases. This underscores the significance of innovation in these fields [40][50]. - The report notes that the CXO industry in China is entering a recovery phase, with improvements expected in industry orders, capacity utilization, and performance metrics due to enhanced domestic investment and financing data [2][5]. Summary by Sections Innovative Drugs - The innovative drug sector has seen a recent pullback, but the long-term upward trend remains intact. The report suggests that the market is awaiting further BD catalysts and highlights the importance of upcoming clinical data from the ESMO conference [2][13]. - The report indicates that the overall sentiment in the innovative drug sector is still positive, with a focus on potential breakthroughs in cancer and autoimmune therapies following the recent Nobel Prize discoveries [40][50]. Biologics - Novo Nordisk announced an agreement to acquire Akero for $4.7 billion, with Akero's FGF21 analog EFX showing promise as a leading therapy for metabolic dysfunction-related fatty liver disease (MASH) [3][51]. - The report suggests that EFX is the only drug in Phase 2 trials demonstrating significant fibrosis regression in F4 patients, highlighting the need for continued attention to developments in this area [51][57]. Medical Devices - The commercialization of innovative products is accelerating, with domestic replacements making significant progress. For instance, MicroPort's Tumi laparoscopic surgical robot has surpassed 100 global orders and is leading the domestic market share [4][58]. - The report notes that the Tumi robot has received market access in over 60 countries and regions, with a strong presence in high-end markets such as Europe [60][62]. Traditional Chinese Medicine - There has been a continuous increase in new drug IND and NDA applications for traditional Chinese medicine, with 92 new IND applications and 42 NDA applications reported in the first nine months of 2025 [3][64]. - The report highlights ongoing policy support for traditional Chinese medicine, which is expected to drive further innovation and development in this sector [64][65].

Core Viewpoint - The innovative drug concept has seen a significant surge in the market, with several companies experiencing notable stock price increases [1] Group 1: Company Performance - Changchun High-tech has risen over 8% [1] - Xinghao Pharmaceutical and Wanbangde have both increased by over 5% [1] - Other companies such as Tibet Pharmaceutical, Rongchang Bio, Xinlitai, Guangsheng Tang, and Nuocheng Jianhua have also shown upward movement in their stock prices [1]

(a) The publication of this announcement on the Exchange's website does not give rise to any obligation of the Company, its sole sponsor, overall coordinators, advisers or members of the underwriting syndicate to proceed with an offering or a placing in Hong Kong or any other jurisdiction. There is no assurance that the Company will proceed with the offering or the placing; (b) The application to which this announcement relates has not been approved for listing and the Exchange and the Commission may accept ...

登录新浪财经APP 搜索【信披】查看更多考评等级 长春高新技术产业（集团）股份有限公司于2024年11月14日召开第十一届董事会第六次会议，审议通过 回购股份方案。公司计划使用自有资金及金融机构股票回购专项贷款资金，以集中竞价交易方式回购部 分已在境内发行的人民币普通股（A股）股票。 此次回购资金总额不低于3亿元（含）、不超过5亿元（含），回购价格不超过160元/股。回购的股份将 全部用于后续实施公司及子公司核心团队股权激励或员工持股计划。相关公告于2024年11月16日、2024 年11月21日分别在《中国证券报》《证券时报》《上海证券报》《经济参考报》及巨潮资讯网披露。 根据相关法规，公司需在回购期间每月前三个交易日内公告截至上月末的回购进展情况。截至2025年9 月30日，相比前次披露，回购股份进展情况无变化。 公司强调，此次回购符合相关法律、法规规定及A股回购方案要求。在回购时间、数量、价格及集中竞 价交易委托时段等方面，均符合《深圳证券交易所上市公司自律监管指引第9号——回购股份》相关规 定。公司未在可能影响股价的重大事项发生至依法披露期间回购股票，且以集中竞价交易方式回购股份 时，委托价格、交易时 ...

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Baike Biotechnology Co., Ltd. (referred to as "Baike Biotechnology"), received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its acellular pertussis-diphtheria-tetanus combined vaccine with Hib [1] Group 1 - The approved vaccine, referred to as "DTP-Hib combined vaccine," is designed to simultaneously prevent whooping cough, diphtheria, tetanus, and infections caused by Haemophilus influenzae type b [1] - The target recipients of the vaccine are infants aged 2 months and older, and it is intended to stimulate the immune response to prevent invasive infections caused by these pathogens [1]

Summary of Conference Call Notes Industry Overview - The focus remains on the innovative drug sector, benefiting from business development (BD) transactions and data catalysts, with companies like Heng Rui continuing to push forward despite recent large transactions not meeting expectations [1][2] - The CRO (Contract Research Organization), CDMO (Contract Development and Manufacturing Organization), and upstream supply chain are benefiting from anticipated interest rate cuts in the U.S. and recovering order performance [1][2] - Medical devices, particularly high-consumption and equipment sectors, are showing signs of reversing performance difficulties, with Q3 expected to show improvement [1][2] Key Investment Strategies - Emphasis on the innovative drug line, with catalysts from the ESMO conference and BD transactions, alongside Q3 performance improvements [1][5] - Attention to the impact of basic drug directory policies and adjustments in traditional Chinese medicine companies, which may provide short-term catalysts [1][5] - Portfolio adjustments in October 2025 included increasing positions in companies like Changchun High-tech, Xianju Pharmaceutical, Betta Pharmaceuticals, and Tengke Pharmaceuticals, as well as companies showing performance inflection points [1][6] Core Recommendations - Recommended stocks based on three criteria: vertical extension capability in the supply chain, realization capability, and systematic early-stage R&D platform capability [9] - Specific recommendations include Changchun High-tech, Betta Pharmaceuticals, Amgen Pharmaceuticals, and Xiansheng Pharmaceuticals [9] - Notable mentions include Amgen, WuXi Biologics, and Miaomei Helian, expected to benefit from strong Taiji business, recovery in monoclonal antibody business, and high growth in ADC projects, with significant earnings growth anticipated in 2025 [1][19] Sector-Specific Insights - The innovative drug sector is viewed as the strongest and most fundamentally sound segment, with a focus on recovery from previous difficulties and policy changes [3][4] - CROs are showing early signs of recovery, with significant performance from WuXi and similar companies [3][4] - Medical devices are also recovering, with various companies performing well across different segments [4] Company-Specific Developments - **Betta Pharmaceuticals**: Notable for strong financial performance and ongoing business development, including an IPO process in Hong Kong expected to bring positive momentum [10] - **Amgen Pharmaceuticals**: Recently introduced strategic investment from Haizheng Pharmaceuticals, enhancing future growth prospects [11] - **Miaomei Helian**: Positioned as a leader in the ADC CRDMO sector, with significant growth expected from backend projects [20] - **Tianyu Co.**: Anticipated to maintain strong growth due to a diverse product pipeline and CDMO business expansion [25] - **Lianbang Pharmaceuticals**: Focused on innovative drugs, with several promising projects in clinical trials expected to drive future growth [26][27] Market Performance - The recommended portfolio showed an average increase of 5.5 percentage points in September, outperforming the broader pharmaceutical sector by 7.2 percentage points [6] - Specific stocks like Changchun High-tech and WuXi Biologics saw significant price increases of 26% and 23%, respectively [6] Conclusion - The innovative drug sector remains a key focus for investment, with several companies showing promising signs of recovery and growth potential. The overall sentiment is positive, with expectations for continued performance improvements in Q3 and beyond, driven by strategic investments and favorable market conditions [1][2][5]