Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Baike Biological, received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration, allowing it to conduct clinical trials for a trivalent influenza virus split vaccine (BK-01 adjuvant) aimed at preventing influenza caused by related virus types [1] Group 1 - The approval is a significant step for the company in advancing its vaccine development pipeline [1] - The clinical trials will focus on the prevention of influenza caused by specific virus strains, indicating a targeted approach in vaccine development [1] - This development aligns with the growing demand for effective influenza vaccines in the market [1]

Group 1 - The core point of the article is that Changchun High-tech has received approval from the National Medical Products Administration for its trivalent influenza virus split vaccine, indicating a significant advancement in its pharmaceutical development [1] - As of October 13, Changchun High-tech's market capitalization is 53.9 billion yuan [2] - The revenue composition for Changchun High-tech in the first half of 2025 shows that the pharmaceutical sector accounts for 92.83%, real estate for 6.81%, and services for 0.36% [1]

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Changchun Baike Biotechnology Co., Ltd. (referred to as "Baike Biotechnology"), has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its trivalent influenza virus split vaccine (BK-01 adjuvant), allowing the company to conduct clinical trials for the vaccine aimed at preventing influenza caused by related strains of the virus [1] Group 1 - The approval from the National Medical Products Administration is a significant milestone for Baike Biotechnology in the development of its influenza vaccine [1] - The clinical trials will focus on the efficacy of the trivalent influenza virus split vaccine in preventing influenza outbreaks [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Baike Biotech, received the Clinical Trial Approval Notice from the National Medical Products Administration for its trivalent influenza virus split vaccine, allowing clinical trials to prevent influenza caused by related strains of the virus [1] Group 1 - The vaccine is targeted at individuals aged 60 and above [1] - The vaccine utilizes a split virus technology route and is combined with a self-developed adjuvant to ensure safety while enhancing immunogenicity [1] - Successful completion of clinical trials and subsequent approval for market launch will further enhance the company's influenza vaccine research pipeline and expand its coverage among the population [1]

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]