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]

Core Viewpoint - Changchun Gaoxin announced that its subsidiary, Changchun Jinsai Pharmaceutical, received approval from the National Medical Products Administration for the clinical trial of GenSci145 tablets, a new selective PI3Kα inhibitor for treating advanced or metastatic solid tumors with PIK3CA mutations [1]. Group 1 - Changchun Jinsai Pharmaceutical has developed GenSci145 tablets, classified as a first-class innovative chemical drug [1]. - The drug is intended for patients with locally advanced or metastatic solid tumors carrying PIK3CA mutations [1].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a novel selective PI3Kα inhibitor intended for the treatment of locally advanced or metastatic solid tumors with PIK3CA mutations [1] Group 1 - The clinical trial approval for GenSci145 marks a significant milestone for Jinsai Pharmaceutical in the development of innovative drugs [1] - GenSci145 is classified as a Class 1 innovative chemical drug, indicating its potential to address unmet medical needs in oncology [1] - The drug targets specific mutations (PIK3CA) associated with certain types of cancer, highlighting its specialized therapeutic application [1]

Core Viewpoint - Changchun Gaoxin (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a novel selective PI3Kα inhibitor intended for the treatment of locally advanced or metastatic solid tumors with PIK3CA mutations [1] Group 1 - Jinsai Pharmaceutical's GenSci145 tablets are classified as a Class 1 innovative chemical drug [1] - The drug is specifically developed for patients carrying PIK3CA mutations [1] - The approval marks a significant milestone in the company's drug development pipeline [1]

证券代码：000661 证券简称：长春高新 公告编号：2026-004 长春高新技术产业（集团）股份有限公司 关于子公司 GenSci145 片境内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。 二、药品的其它情况 GenSci145 片是金赛药业开发的一款新型突变选择性 PI3Kα抑制剂，属 1 类创新型化学药品，拟用于携带 PIK3CA 突变的局部晚期或转移性实体瘤的治疗。 PIK3CA 基因突变在乳腺癌中占 30%～40%，是乳腺癌发生和进展的重要因 素。PIK3CA 基因编码 PI3Kα的催化亚基 p110α是 PI3K-AKT-mTOR 信号通路 的核心，PIK3CA 基因突变可导致该通路异常激活，促进肿瘤细胞的生长和抗凋 亡能力，并且可导致乳腺癌内分泌治疗、化疗和靶向治疗的耐药。对于携带 PIK3CA 突变的患者，开发针对性的 PI3K 通路抑制剂，将有助于改善患者的疗 效和预后。 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 ...

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for the clinical trial application of its drug GenSci145 tablets, which is a novel selective PI3Kα inhibitor intended for the treatment of locally advanced or metastatic solid tumors with PIK3CA mutations [1]. Group 1 - Jinsai Pharmaceutical's GenSci145 tablets are classified as a Class 1 innovative chemical drug [1]. - The drug is specifically designed for patients carrying PIK3CA mutations [1]. - The approval marks a significant milestone in the development of targeted therapies for specific cancer mutations [1].