每经AI快讯，9月8日，长春高新(000661.SZ)公告称，公司控股子公司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GS3-007a干混悬剂境内生产药品注册临床试验申请获得受 理。截至目前，国内尚无同类产品上市。该产品为口服小分子生长激素促分泌药物，拟用于因内源性生 长激素缺乏所引起的儿童生长缓慢的治疗。 ...

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GS3-007a, an orally administered small molecule growth hormone secretagogue, aimed at treating pediatric growth hormone deficiency (PGHD) [1] Group 1 - The clinical trial application for GS3-007a has been accepted, which is a significant step in the product's clinical development [1] - GS3-007a is classified as a Class 1 chemical drug and is intended for the treatment of children with growth retardation due to endogenous growth hormone deficiency [1] - Currently, there are no similar products available in the domestic market, indicating a potential unmet clinical need [1]

Market Overview - In the first week of September (September 1 to September 5), the A-share market experienced wide fluctuations, with the solid-state battery concept driving the rise of the new energy sector, leading to over 10% gains in related indices such as CS Battery and Innovative Energy [1][2] - The A-share innovation and entrepreneurship sector saw increased volatility, with the leading products in related ETFs actively traded, and the ChiNext ETF (159915) recording a trading volume exceeding 40 billion yuan [1][4] Sector Performance - The solid-state battery sector saw significant gains, with companies like Xian Dao Intelligent rising over 50%, and other firms such as Sunshine Power, Jinlang Technology, and Yiwei Lithium Energy increasing by over 30% [2] - More than 20 related thematic ETFs in the battery, new energy, and photovoltaic sectors collectively rose over 10%, with the Easy Fund New Energy ETF (516090) and the Energy Storage Battery ETF (159566) tracking indices that also saw gains exceeding 10% [2] ETF Trading Activity - The trading activity of thematic ETFs related to innovation and entrepreneurship was notably high, with the ChiNext ETF (159915) and the Sci-Tech 50 ETF (588080) recording trading volumes of over 40 billion yuan and 10 billion yuan, respectively [4] - In the Hong Kong market, the innovation drug sector remained active, attracting significant trading volumes, with some leading ETFs surpassing 60 billion yuan in trading volume [4] Fund Flows - Recent inflows into ETFs tracking sectors such as securities, chemicals, batteries, and gold stocks were substantial, with ETFs tracking securities companies seeing net inflows exceeding 8 billion yuan [5][6] - Conversely, the innovation and entrepreneurship thematic ETFs experienced net outflows, with the ChiNext ETF (159915) and the Sci-Tech 50 ETF (588080) seeing combined net outflows exceeding 6 billion yuan [5][6] New ETF Launches - Fund managers have accelerated the launch of new related ETF products, including the Easy Fund Shanghai Stock Exchange Sci-Tech Board New Energy ETF and various other thematic ETFs focused on artificial intelligence and software [8] - The Easy Fund Shanghai Stock Exchange Sci-Tech Board New Energy ETF completed its fundraising on September 5, tracking an index composed of 50 large-cap stocks in the photovoltaic, wind power, and new energy vehicle sectors [8]

Investment Rating - The report maintains an "Overweight" rating for the industry [6]. Core Insights - The report emphasizes the significant potential of innovative drugs in extending overall survival (OS) for cancer patients, with a growing focus on improving quality of life (QoL) through palliative care solutions [10][14]. - The pharmaceutical sector has shown resilience amid market fluctuations, with innovative drugs and their supply chains leading the performance [12][38]. - The report highlights the increasing competitiveness of domestic innovative drugs and the positive outlook for the innovation-driven industry chain [12][38]. Summary by Sections Industry Overview - The pharmaceutical industry consists of 494 listed companies with a total market capitalization of approximately 78,182.34 billion [3]. - The industry has demonstrated a 27.26% return since the beginning of 2025, outperforming the Shanghai Composite Index by 13.91 percentage points [38]. Market Dynamics - Recent market trends indicate a 1.40% increase in the pharmaceutical sector, while the broader market (CSI 300) decreased by 0.81% [12][38]. - The report notes a divergence in sub-sector performance, with chemical pharmaceuticals and biological products showing gains of 3.92% and 1.93%, respectively [12][38]. Innovative Drug Development - The report discusses the advancements in innovative therapies such as dual antibodies, antibody-drug conjugates (ADC), and small molecule targeted therapies, which are crucial for improving OS and QoL for cancer patients [10][14]. - Specific companies like Changchun High-tech and Lee's Pharmaceutical are highlighted for their innovative treatments targeting cancer cachexia and breakthrough cancer pain [10][29]. Investment Recommendations - The report recommends focusing on companies with strong innovative drug pipelines and those that are likely to benefit from upcoming data catalysts, particularly in the context of the WCLC conference [12][38]. - Key companies to watch include WuXi AppTec, Innovent Biologics, and others involved in the innovative drug supply chain [12][38]. Valuation Metrics - The current valuation of the pharmaceutical sector is approximately 28.1 times PE based on 2025 earnings forecasts, indicating a premium over the broader A-share market [41][42]. - The report notes that the sector's valuation is below its historical average, suggesting potential for growth [41][42].

Group 1 - The core announcement is that Changchun High-tech Industry (Group) Co., Ltd.'s subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., has received acceptance for the clinical trial application of the injectable GenSci140 from the National Medical Products Administration [1][2] - GenSci140 is a novel dual-target antibody-drug conjugate specifically designed to target the folate receptor alpha (FRα), which is expressed in various tumors, including ovarian cancer [2][3] - The drug utilizes a unique linker technology and is expected to enhance tumor cell killing while maintaining a favorable safety profile, making it a potential best treatment option for FRα-positive cancer patients, particularly those with low to medium expression levels [3] Group 2 - If the clinical trial progresses smoothly, it will help the company expand its business scope, optimize its product structure, and enhance its core competitiveness [4] - The pharmaceutical product development process is characterized by high technology, high risk, and long timelines, which may be influenced by various uncertainties [4][5] - The company will actively promote the research and development of this project and fulfill its information disclosure obligations regarding subsequent progress [5]

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Jinsai Pharmaceutical, has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci140, a new targeted antibody-drug conjugate developed independently by the company [1] Group 1 - Jinsai Pharmaceutical's GenSci140 is a novel targeted antibody-drug conjugate that specifically targets the folate receptor alpha subtype [1] - The acceptance of the clinical trial application marks a significant step in the development of GenSci140, indicating progress in the company's research and development efforts [1]

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received the acceptance notice for the clinical trial application of GenSci140 from the National Medical Products Administration, indicating progress in the development of a new targeted therapy for cancer [1][2]. Group 1 - GenSci140 is a novel dual-target antibody-drug conjugate that targets the folate receptor alpha (FRα), designed to enhance binding and internalization in tumor cells [1]. - The drug combines Fab fragments targeting different epitopes of FRα with a single-domain heavy chain antibody (VHH), utilizing a cleavable linker and a topoisomerase I (TOPOI) inhibitor payload [1]. - GenSci140 has shown significant anti-tumor effects in various models, including ovarian cancer, regardless of FRα expression levels [2]. Group 2 - Preclinical studies indicate that GenSci140 possesses strong tumor cell binding and internalization activity, along with high plasma stability of the linker technology developed in-house [2]. - The innovative dual-epitope design and effective cytotoxic mechanism suggest that GenSci140 could become a potential best treatment option for FRα-positive cancer patients, particularly those with low to medium FRα expression [2].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received the Acceptance Notice from the National Medical Products Administration for the clinical trial application of GenSci140, a new targeted drug developed by the company [1] Group 1 - GenSci140 is a novel bispecific antibody-drug conjugate targeting the folate receptor alpha (FRα), composed of Fab fragments binding to different epitopes of FRα and a single-domain heavy chain antibody (VHH) [1] - The drug utilizes a cleavable linker and is loaded with a topoisomerase I (TOPOI) inhibitor, enhancing its therapeutic potential [1] - GenSci140 can bind to two different epitopes expressed on tumor cells, increasing antibody binding and internalization, which promotes the delivery of the TOPOI cytotoxic payload into the cells, leading to direct tumor cell killing [1]

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd.'s subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice for the clinical trial application of GenSci140 from the National Medical Products Administration, indicating progress in the development of a new targeted therapy for cancer patients [1][2]. Group 1 - GenSci140 is a novel dual-target antibody-drug conjugate that targets the folate receptor alpha (FRα), designed to enhance binding and internalization in tumor cells, thereby improving the delivery of the cytotoxic agent [1]. - The drug utilizes a cleavable linker and is loaded with a topoisomerase I (TOPOI) inhibitor, which directly kills tumor cells and enhances anti-tumor effects through a bystander killing effect [1][2]. Group 2 - Preclinical studies have demonstrated that GenSci140 exhibits strong tumor cell binding and internalization activity, showing significant anti-tumor effects across various models, including ovarian cancer, regardless of FRα expression levels [2]. - The innovative dual-target design and stable linker technology of GenSci140 suggest it may become a potential best treatment option for FRα-positive cancer patients, particularly those with low to medium FRα expression [2].

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the registration application of the injectable GenSci140, a novel targeted antibody-drug conjugate for treating advanced solid tumors [1] Group 1: Product Details - GenSci140 is a new type of dual-target antibody-drug conjugate developed independently by Jinsai Pharmaceutical, targeting the folate receptor alpha (FRα) [1] - The drug consists of Fab fragments binding to different epitopes of FRα and a single-domain heavy chain antibody (VHH), utilizing a cleavable linker and carrying a topoisomerase I (TOPO I) inhibitor payload [1] - GenSci140 can bind to two different epitopes expressed on tumor cells, enhancing antibody binding and internalization, which promotes the cytotoxic payload's entry into cells to directly kill tumor cells [1] Group 2: Mechanism of Action - The drug not only directly kills tumor cells but also enhances the anti-tumor effect through a bystander killing effect [1] - Indicated for the treatment of advanced solid tumors, GenSci140 aims to improve therapeutic outcomes in this challenging patient population [1]