Market Overview - The biopharmaceutical sector experienced a decline of 1.3% on January 29, with Hualan Vaccine leading the drop [1] - The Shanghai Composite Index closed at 4157.98, up 0.16%, while the Shenzhen Component Index closed at 14300.08, down 0.3% [1] Individual Stock Performance - Weigao Bio (002880) saw a closing price of 30.07, with an increase of 4.59% and a trading volume of 88,100 shares, totaling a transaction value of 266 million yuan [1] - Changchun High-tech (000661) closed at 98.30, up 0.92%, with a trading volume of 64,700 shares and a transaction value of 629 million yuan [1] - Other notable performers include Boya Bio (300294) and Zhifei Biological (300122), both with a closing price increase of 0.92% and 0.73% respectively [1] Declining Stocks - Hualan Bio (301207) reported a significant decline of 9.05%, closing at 22.62, with a trading volume of 300,600 shares and a transaction value of 689 million yuan [2] - Junshi Biosciences (688180) fell by 6.02%, closing at 36.82, with a trading volume of 266,100 shares and a transaction value of 1 billion yuan [2] - Other stocks such as Jinkang (688670) and Bohui Innovation (300318) also experienced declines of 5.81% and 4.95% respectively [2] Capital Flow Analysis - The biopharmaceutical sector saw a net outflow of 866 million yuan from institutional investors, while retail investors contributed a net inflow of 682 million yuan [2] - Notable net inflows from retail investors were observed in stocks like Shanghai Laishi (002252) and Weigao Bio (002880) [3] - Conversely, stocks such as Zhixiang Quantai (688443) and Weigao Bio (002880) experienced significant net outflows from institutional and speculative investors [3]

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a notice of acceptance from the National Medical Products Administration for the clinical trial application of Fuxin Qibai monoclonal antibody injection, aimed at treating non-infectious uveitis [1][2]. Group 1: Drug Information - The drug Fuxin Qibai monoclonal antibody injection is a fully human anti-IL-1β monoclonal antibody developed by Jinsai Pharmaceutical, intended for the treatment of non-infectious uveitis [1][2]. - The clinical trial application has been accepted under the registration numbers CXSL2600136 and CXSL2600137, indicating a positive step towards further development [1][2]. - There are currently no similar drugs approved for the same indication in the domestic and international markets, highlighting the potential market opportunity for Fuxin Qibai [1][2]. Group 2: Disease Context - Non-infectious uveitis is a heterogeneous inflammatory disease affecting the uveal tract and surrounding tissues, with a global annual incidence rate of 17 to 52 per 100,000 and a prevalence rate of 115 to 204 per 100,000, representing a significant public health burden [2]. - Existing biological agents approved for this indication are primarily anti-TNFα drugs, with many patients experiencing inadequate response or intolerance, indicating a strong demand for safer and more effective treatment options [2]. Group 3: Company Impact - If the clinical trial progresses smoothly, it will help the company expand its business structure, optimize its product portfolio, and enhance its core competitiveness [3]. - The company is committed to actively advancing the research and development projects and will fulfill its information disclosure obligations regarding the project's progress [4].

Group 1 - The core point of the article is that Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the clinical trial application of Fuxin Qibai monoclonal antibody injection [1] Group 2 - The acceptance of the clinical trial application indicates a significant step forward for the company's product development in the domestic market [1] - This development may enhance the company's position in the pharmaceutical industry, particularly in the monoclonal antibody segment [1] - The news reflects the ongoing regulatory support for innovative drug development in China [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a notice of acceptance from the National Medical Products Administration for the clinical trial application of Fuxin Qibai monoclonal antibody injection, which is intended for the treatment of non-infectious uveitis [1] Group 1 - The clinical trial application for Fuxin Qibai monoclonal antibody has been accepted, indicating progress in the drug development process [1] - Fuxin Qibai is a fully human anti-IL-1β monoclonal antibody developed by Changchun Jinsai Pharmaceutical, designed to specifically block the binding of IL-1β to its receptor IL-1R [1] - Currently, there are no similar drugs approved for the same disease area in both domestic and international markets, highlighting a potential market opportunity for the company [1]

证券代码：000661 证券简称：长春高新 公告编号：2026-005 长春高新技术产业（集团）股份有限公司 关于子公司伏欣奇拜单抗注射液境内生产药品注册临床试验申请 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。 获得受理的公告 近日，长春高新技术产业（集团）股份有限公司（以下简称"公司"）控股 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 监督管理局的《受理通知书》，金赛药业伏欣奇拜单抗注射液的境内生产药品注 册临床试验申请获得受理，现将相关情况公告如下： 批的生物制剂仅有抗 TNFα类药物，且仍有相当一部分患者应答不佳或不耐受， 因此，对于安全性更好、疗效更佳以及依从性更优的新机制药物始终存在需求。 综上所述，伏欣奇拜单抗具有潜在治疗非感染性葡萄膜炎的临床价值，本次 临床试验申请受理可以推动后续该产品针对非感染性葡萄膜炎人群的临床开发。 此前，伏欣奇拜单抗注射液（水剂）已获批开展子宫内膜异位症的临床试验， 其用于急性痛风性关节炎适应症的上市申请已于 2025 年 1 月获得受理；注射用 伏欣奇拜单抗（粉剂）已获批开展用于结缔组织 ...

Core Viewpoint - Changchun Gaoxin (000661) emphasizes its commitment to legal compliance and risk prevention as a state-controlled listed company, ensuring healthy development through robust internal controls and integrity mechanisms [1] Group 1 - The company adheres strictly to laws and regulations as well as state-owned asset supervision requirements [1] - It has established sound internal control and integrity mechanisms to conduct its operations in accordance with the law [1] - The company adopts a zero-tolerance approach to risk prevention to ensure its healthy development [1]

证券日报网讯1月27日，长春高新（000661）在互动平台回答投资者提问时表示，公司前期所聘请的金 融与专业领域的专家，主要目的是帮助公司在全面提升公司治理能力、市场竞争力和长期可持续发展能 力等方面开展工作，但不是专门的市值管理专家。 ...

Group 1 - The core viewpoint of the news highlights a recent pullback in the biopharmaceutical sector, with the Huatai-PineBridge Biopharmaceutical ETF (159839) declining by 2.08% while maintaining high trading volume, with nearly 600 million yuan in transactions for the day [1][4] - The ETF has seen continuous inflows, with a net subscription of over 54 million shares today and a total of over 73 million yuan in the last 10 days [1] - The ETF tracks the Guozheng Biopharmaceutical Index, which includes sectors such as CXO, vaccines, chemical drugs, blood products, and medical aesthetics, with the vaccine sector currently accounting for 15.1% of the index [6] Group 2 - A significant research breakthrough was reported by the Wuhan Institute of Virology, confirming that the oral nucleoside drug VV116 shows significant antiviral activity against the Nipah virus, providing new hope for the prevention and treatment of this high-mortality emerging infectious disease [3] - The biopharmaceutical ETF's major component stocks mostly experienced declines, with Watson Bio and Zhi Fei Bio dropping over 6%, while Sanofi Biopharma saw an increase of over 10% [4][5] - The latest performance forecast from Sanofi Biopharma indicates an expected net profit of approximately 2.9 billion yuan for 2025, representing a year-on-year growth of 311.35% [4] Group 3 - Data from Guoxin Securities indicates a decrease in pharmaceutical holdings among funds, with the overall pharmaceutical holding ratio at 7.97%, down by 1.71 percentage points from the previous quarter [7] - The largest sub-sector in pharmaceutical holdings is chemical preparations and other biological products, while the internet pharmacy and other biological products saw the most significant decline in holdings [9] - The JPM 2026 conference highlighted the acceleration of internationalization among Chinese pharmaceutical companies, with significant technological breakthroughs in areas such as ADC and GLP-1, leading to increased global competitiveness [10][11]

Core Viewpoint - The vaccine sector is experiencing strong performance due to the emergence of Nipah virus cases in India, leading to increased investment in related biopharmaceutical ETFs [1][3]. Group 1: Market Performance - The biopharmaceutical ETF Huatai (159839) saw a significant increase of 2.13% with a trading volume exceeding 60 million yuan, marking a 133% increase compared to the previous period [1]. - The ETF received a net subscription of 16.5 million shares today, accumulating nearly 40 million yuan in the last five days [1]. - Major component stocks of the ETF showed positive performance, with Zhifei Biological rising nearly 15%, Watson Bio increasing over 11%, and Hualan Biological up nearly 7% [3]. Group 2: Nipah Virus Impact - Five confirmed cases of Nipah virus infection have been reported in West Bengal, India, including healthcare workers, with nearly 100 individuals under home quarantine [3]. - The Nipah virus can attack the lungs and brain, with symptoms including fever, headache, drowsiness, and confusion, and a mortality rate of over 40% [3]. - There is currently no specific vaccine or effective treatment for the Nipah virus [3]. Group 3: Vaccine Development and Innovation - Hualan Biological received approval for clinical trials of its recombinant shingles vaccine, while Zhifei Biological's CA111 injection has entered Phase I clinical trials [7]. - The vaccine industry is focusing on technological upgrades and exploring new markets, particularly in the Middle East [8]. - The growth of the vaccine sector is expected to be driven by the increasing immunization needs of the aging population, shifting focus from children to a broader demographic [8]. Group 4: mRNA Vaccine Developments - Recent positive clinical data from mRNA vaccine leaders indicate a breakthrough development window for therapeutic cancer vaccines [9]. - mRNA technology offers significant advantages over traditional methods, including rapid production capabilities and enhanced safety profiles [9].

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, received approval for clinical trials of GenSci145 tablets, a novel selective PI3Kα inhibitor targeting PIK3CA mutation in advanced or metastatic solid tumors [1][2] Group 1: Product Development - GenSci145 is a first-class innovative chemical drug designed for treating locally advanced or metastatic solid tumors with PIK3CA mutations [1] - PIK3CA mutations are significant in breast cancer, accounting for 30%-40% of cases, and are crucial for tumor growth and resistance to treatments [1] Group 2: Clinical Need and Advantages - Existing PI3Kα inhibitors have poor targeting and can cause side effects like hyperglycemia, rash, and diarrhea, affecting long-term treatment adherence [2] - GenSci145 has shown selective inhibitory activity against various PIK3CA hotspot mutations and good blood-brain barrier penetration without traditional side effects, indicating its potential to meet clinical needs for patients with PIK3CA mutations and brain metastases [2] Group 3: Company Commitment - The company will actively advance the research and development of GenSci145 and comply with information disclosure obligations regarding project progress [2]