Core Viewpoint - Changchun High-tech announced that its subsidiary, Gensci Pharmaceutical, has received the Acceptance Notice from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a new selective PI3Kα inhibitor developed by Gensci [1] Group 1 - Gensci145 tablets have demonstrated strong selective inhibitory activity against various hotspot mutations in the PIK3CA helical and kinase domains during preclinical studies [1] - The drug has shown clear efficacy and good safety characteristics in animal models [1]

长春高新技术产业（集团）股份有限公司 证券代码：000661 证券简称：长春高新 公告编号：2025-154 申请人：长春金赛药业有限责任公司 审批结论：经审查，决定予以受理 适应症：携带 PIK3CA 突变的局部晚期或转移性实体瘤 关于子公司 GenSci145 片境内生产药品注册临床试验申请 获得受理的公告 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《受理通知书》，金赛药业 GenSci145 片注册临床试验申请获 得受理，现将相关情况公告如下： 一、药品的基本情况 产品名称：GenSci145 片 申请事项：境内生产药品注册临床试验 受理号：CXHL2501450、CXHL2501451、CXHL2501452 公司将积极推进上述研发项目，并严格按照有关规定及时对项目后续进展情 况履行信息披露义务。 二、药品的其它情况 在恶性肿瘤治疗领域，进展期（局部晚期或转移性）实体瘤患者常因疾病的 异质性与 ...

Core Viewpoint - The company is actively pursuing business development (BD) opportunities and diversifying its product pipeline, while facing various uncertainties in achieving these collaborations [2]. Group 1: Company Performance - As of December 23, 2025, the company's stock price closed at 93.69 yuan, down 1.58%, with a turnover rate of 1.35%, a trading volume of 54,000 shares, and a transaction amount of 508 million yuan [1]. Group 2: Business Development (BD) Efforts - The company is committed to enhancing its intrinsic value and promoting high-quality development through BD collaborations, although the success of these efforts is subject to multiple uncertainties [2]. - The company has ongoing discussions regarding potential BD projects, but specific details will be disclosed only when they meet legal disclosure standards [2]. - The company is focused on leveraging its strengths in brand, channels, and quality to adapt to regulatory requirements and enhance product sales [2]. Group 3: Market and Investor Relations - On December 23, there was a net outflow of 80.74 million yuan from institutional investors, while retail investors saw a net inflow of 48.95 million yuan [3][4]. - The company emphasizes the importance of investor relations and is utilizing various communication methods to maintain close contact with investors [2].

证券日报网讯 12月23日，长春高新（000661）在互动平台回答投资者提问时表示，公司高度重视投资 者关系管理工作，已通过券商策略会、电话、路演及现场调研等多种形式，与投资者保持密切沟通，后 续公司也将持续加强与资本市场的沟通交流，不断完善投资者关系管理，进一步提升信息披露透明度。 ...

Core Viewpoint - Changchun High-tech (000661) is committed to enhancing its intrinsic value to drive high-quality development and is actively pursuing BD cooperation and diversification transformation [1] Group 1 - The company emphasizes its dedication to high-quality development through intrinsic value enhancement [1] - Ongoing efforts are being made to advance BD cooperation matters [1] - The company will fulfill disclosure obligations in accordance with legal regulations when relevant information reaches disclosure standards [1]

Investment Rating - The report maintains a positive outlook on the pharmaceutical industry, indicating an "Overweight" rating for the sector [28]. Core Insights - The pharmaceutical sector has shown mixed performance, with the Shenwan Pharmaceutical and Biological Index down by 0.1% this week, while the Shanghai Composite Index increased by 0.03% [3][5]. - The overall valuation of the pharmaceutical sector stands at 29.2 times earnings, ranking 10th among 31 Shenwan primary industries [5][23]. Market Performance - The Shenwan Pharmaceutical and Biological Index ranked 22nd among 31 Shenwan primary sub-industries this week [3]. - The performance of various sub-sectors includes: - Raw materials (+0.5%) - Chemical preparations (-2.1%) - Traditional Chinese medicine (+0.2%) - Blood products (-0.3%) - Vaccines (-0.9%) - Other biological products (-0.7%) - Medical devices (+1.4%) - Medical consumables (+2.3%) - In vitro diagnostics (-0.8%) - Pharmaceutical distribution (+4.7%) - Offline pharmacies (+5.6%) - Medical research outsourcing (-0.9%) - Hospitals (+4.2%) [5][6]. Recent Key Events - Changchun High-tech signed an exclusive licensing agreement for GenSci098 with Yarrow, with potential milestone payments reaching up to $1.365 billion [10]. - Hansoh Pharmaceutical entered a multi-regional exclusive licensing agreement for Amivantamab with Glenmark, with potential payments exceeding $1 billion [12]. - Hengrui Medicine's subsidiary Kailera initiated three global Phase III clinical trials for HRS-9531, targeting obesity with and without diabetes [17]. - The FDA confirmed the legality of NMN as a dietary supplement, reversing a previous ban [15]. - The first invasive brain-machine interface for treating addiction-related mental disorders was approved in China [16]. Investment Opportunities - The report suggests focusing on domestic innovative drug companies due to the recovery of the CRO investment environment, highlighting companies such as Tigermed, Nossan, and others [2]. - As 2025 approaches its end, it is recommended to pay attention to valuation shifts in companies like WuXi AppTec, Hengrui Medicine, and others [2].

Investment Rating - The report maintains a positive outlook on the pharmaceutical industry, indicating an "Overweight" rating, suggesting that the industry is expected to outperform the overall market [30]. Core Insights - The report highlights recent developments in the pharmaceutical sector, including significant business development (BD) transactions involving companies like Changchun High-tech, Hansoh Pharmaceutical, and Hengrui Medicine, with potential milestone payments reaching billions of dollars [10][12][14]. - The approval of NMN as a dietary supplement in the U.S. and the submission of a new drug application for CagriSema, a GLP-1+Amylin combination therapy, are noted as key advancements in the industry [15]. - The report emphasizes the potential investment opportunities arising from the recovery of the domestic innovative drug environment, particularly in the CRO sector, with specific companies highlighted for consideration [2]. Market Performance - The report states that the Shenwan Pharmaceutical and Biological Index decreased by 0.1% this week, while the Shanghai Composite Index increased by 0.03% [3]. - Within the pharmaceutical sector, various sub-sectors showed mixed performance, with notable increases in medical supplies (+2.3%) and offline pharmacies (+5.6%), while chemical preparations (-2.1%) and blood products (-0.3%) declined [5][9]. Recent Key Events - Changchun High-tech signed an exclusive licensing agreement for GenSci098, with potential milestone payments of up to $1.365 billion [10]. - Hansoh Pharmaceutical entered into a multi-regional exclusive licensing agreement for Amivantamab, with potential payments exceeding $1 billion [12]. - The approval of a brain-machine interface for treating addiction marks a significant technological advancement in the industry [16]. Valuation Metrics - The overall valuation of the pharmaceutical sector is reported at 29.2 times earnings, ranking it 10th among 31 primary sectors [5][13]. - Specific companies within the sector have varying projected earnings per share (EPS) and price-to-earnings (PE) ratios, indicating diverse investment profiles [24].

Core Viewpoint - As of December 18, a total of 87 stocks in the Shanghai and Shenzhen markets have experienced net financing inflows for five consecutive days or more, indicating strong investor interest in these stocks [1] Group 1: Stocks with Longest Net Inflows - The stocks with the longest consecutive net inflows are AVIC Jonhon Optronic Technology and Liyuan Heng, both achieving net inflows for 11 consecutive trading days [1] - Other notable stocks with significant net inflows include China Ping An, Shengmei Shanghai, Chuangzhong Technology, Changchun High-tech, Trina Solar, Aerospace Electric, Nocera Health, and China Shipbuilding Special Gas [1]

Core Viewpoint - Changchun High-tech is shifting its reliance on growth hormone revenue by entering into a licensing agreement with Yarrow Bioscience, marking a strategic transition towards diversified revenue streams [1][2]. Group 1: Licensing Agreement Details - Changchun High-tech's subsidiary, Shanghai SaiZeng Medical Technology Co., Ltd., signed an exclusive licensing agreement with Yarrow Bioscience for the development, production, and commercialization rights of the monoclonal antibody GenSci098 outside Greater China [1]. - The agreement includes an upfront payment of $120 million, consisting of a non-refundable, non-deductible payment of $70 million and a subsequent milestone payment of $50 million [1]. - SaiZeng Medical is eligible for up to $1.365 billion in milestone payments related to specific R&D, regulatory, and commercialization achievements, along with over 10% sales royalties post-product launch [1]. Group 2: Financial Performance and Strategic Shift - Changchun High-tech's subsidiary, Jinsai Pharmaceutical, has historically contributed approximately 83% of the company's revenue and 99.5% of its net profit, but is facing performance challenges due to increased competition in the growth hormone market [2]. - In the first three quarters of 2025, Changchun High-tech reported a net profit decline of 58.23%, partly due to a nearly 50% drop in Jinsai Pharmaceutical's net profit [2]. - The licensing agreement represents a significant step in the company's strategic transformation towards a diversified business model, moving from a reliance on growth hormones to a triad of growth hormones, innovative drugs, and revenue from R&D licensing [2]. Group 3: Market Potential - The market for the indications of thyroid eye disease and Graves' disease is substantial, with North America and the Asia-Pacific region accounting for over 65% of the global market share [3]. - The collaboration aims to leverage both parties' strengths to accelerate global development and maximize the commercial potential of GenSci098, aligning with international R&D standards [3].

Core Viewpoint - Changchun High-tech (000661) has seen a significant stock price increase following the announcement of a licensing agreement for the GenSci098 injection project, indicating a strategic move towards internationalization and diversification in its product offerings [1][2]. Group 1: Licensing Agreement Details - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, has entered into an exclusive licensing agreement with Yarrow Bioscience, which includes an upfront payment of $120 million, with $70 million being non-refundable [1][2][3]. - The agreement allows Yarrow to develop and commercialize GenSci098 outside of China, while Changchun retains rights for development and commercialization within China [2][3]. Group 2: Financial Implications - The total potential milestone payments from the agreement could reach up to $1.365 billion, in addition to a sales commission exceeding 10% of net sales once the product is launched [3][4]. - The financial performance of Changchun High-tech has faced challenges, with a reported revenue decline of 7.55% and a net profit drop of 43.01% last year, primarily due to decreased sales of its short-acting growth hormone product [6][7]. Group 3: Strategic Focus and Market Position - Changchun High-tech is focusing on expanding its product lines beyond growth hormones, targeting areas such as pediatrics, women's health, and anti-aging [6][7]. - The company has increased its R&D investment by 17.32% year-on-year, indicating a commitment to innovation and product development [6][7]. - The company is also pursuing international market expansion, having submitted a listing application to the Hong Kong Stock Exchange to raise funds for global collaboration and development [7].