Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., received written notification from the FDA regarding the acceptance of the clinical trial application for the injectable GenSci143, a dual-target antibody-drug conjugate aimed at treating advanced solid tumors [1][2]. Group 1: Drug Information - Product Name: Injectable GenSci143 [1] - Indication: Advanced solid tumors [2] - Application Details: The clinical trial application has been accepted by the FDA with acceptance number 177763 [1]. Group 2: Mechanism and Technology - GenSci143 targets B7-H3 and PSMA, which are highly expressed in various malignancies, including non-small cell lung cancer, pancreatic cancer, and prostate cancer [2]. - The drug utilizes a proprietary linker technology that enhances the potency and stability of the toxin, aiming to provide a new treatment avenue for tumors expressing B7-H3 and/or PSMA [3]. Group 3: Development Timeline - The clinical trial application for GenSci143 is also set to be accepted in China by the National Medical Products Administration by August 2025 [3]. Group 4: Company Commitment - The company will actively advance the research and development of GenSci143 and will fulfill its information disclosure obligations regarding the project's progress [5].

Core Viewpoint - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, has received written notification from the FDA regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate aimed at treating tumors expressing B7-H3 and PSMA [1][2] Group 1: Product Development - GenSci143 is a self-developed drug that targets B7-H3 and PSMA, combining chemotherapy and tumor immunotherapy potential [1] - The drug utilizes a proprietary linker technology, providing strong cytotoxic activity and high plasma stability, which enhances its safety profile while effectively killing tumor cells [1] - The dual-target design of GenSci143 aims to overcome tumor heterogeneity and resistance, potentially benefiting a broader patient population [1] Group 2: Regulatory Progress - The clinical trial application for GenSci143 has also been accepted by the National Medical Products Administration in China, indicating progress in both U.S. and Chinese markets [2] - The company has received multiple approvals for other clinical trial applications, including GS3-007a and GenSci140, showcasing a robust pipeline of innovative drug candidates [2] Group 3: Strategic Focus - The company has undertaken strategic adjustments and increased investment in innovation, establishing core technology platforms with independent intellectual property rights and international competitiveness [3] - There is a focus on high-demand therapeutic areas, particularly in endocrine metabolism and pediatric fields, aligning with the company's sustainable development and internationalization goals [3]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a written notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate [1] Group 1: Product Details - GenSci143 is a self-developed dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The mechanism of GenSci143 involves internalization into lysosomes upon binding to B7-H3 or PSMA, releasing TOPO-I inhibitor toxins to kill B7-H3 positive, PSMA positive, and dual-positive tumor cells [1] - The dual-target approach of B7-H3 and PSMA can overcome tumor heterogeneity and resistance caused by reduced expression of a single target, thereby covering more patients and producing more durable anti-tumor efficacy [1] Group 2: Technical Advantages - GenSci143 utilizes self-developed linker technology, which features strong toxin activity and high plasma stability of the linker, resulting in enhanced tumor-killing effects and improved safety [1] - The innovative dual-target design, stable linker technology, efficient cell-killing mechanism, and broad anti-tumor spectrum of GenSci143 may provide new treatment directions for various solid tumors expressing B7-H3 and/or PSMA [1]

Core Viewpoint - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical Co., has received written notification from the FDA regarding the acceptance of the clinical trial application for GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicating potential dual therapeutic effects in chemotherapy and tumor immunotherapy [1] Company Summary - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical, is advancing its clinical trial for GenSci143, which is a self-developed drug [1] - The drug GenSci143 is designed to target both B7-H3 and PSMA, showcasing its innovative approach in cancer treatment [1] Industry Summary - The acceptance of the clinical trial application by the FDA highlights the growing interest and investment in dual-specific antibody-drug conjugates within the pharmaceutical industry [1] - The potential dual therapeutic effects of GenSci143 may position it favorably in the competitive landscape of cancer therapies [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a written notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate [1][2] Group 1: Product Development - GenSci143 is a self-developed dual-specificity antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug works by binding to B7-H3 or PSMA, internalizing into lysosomes, and releasing TOPO-I inhibitor toxins to kill B7-H3 positive, PSMA positive, and dual positive tumor cells [1] - The dual-target mechanism of B7-H3 and PSMA can overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering more patients and producing more durable anti-tumor efficacy [1] Group 2: Technological Advantages - GenSci143 utilizes self-developed linker technology, which features strong toxin activity and high plasma stability of the linker, providing enhanced tumor-killing effects while ensuring better safety [2] - The innovative dual-target design, stable linker technology, efficient cell-killing mechanism, and broad anti-tumor spectrum of GenSci143 may offer new treatment directions for various solid tumors expressing B7-H3 and/or PSMA [2]

Core Insights - The article discusses the recent financial performance of a leading company in the technology sector, highlighting significant revenue growth and market expansion strategies [1] Financial Performance - The company reported a revenue increase of 25% year-over-year, reaching $5 billion in the last quarter [1] - Net income rose to $1.2 billion, reflecting a 30% increase compared to the previous year [1] Market Expansion - The company has successfully entered three new international markets, contributing to 15% of the overall revenue growth [1] - Strategic partnerships with local firms have been established to enhance market penetration and brand recognition [1] Future Outlook - Analysts predict continued growth, estimating a 20% increase in revenue for the upcoming fiscal year [1] - The company plans to invest $500 million in research and development to drive innovation and maintain competitive advantage [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, has received acceptance from the US FDA for the clinical trial application of GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA [1] Group 1: Product Development - GenSci143 is independently developed by Jinsai Pharmaceutical and is designed to target both chemotherapy and tumor immunity, offering dual potential therapeutic effects [1] - The innovative dual-target design, stable linker technology, and efficient cell-killing mechanism of GenSci143 may provide new treatment options for various solid tumors expressing B7-H3 and/or PSMA [1] Group 2: Regulatory Milestones - The clinical trial application for GenSci143 intended for advanced solid tumors has also been accepted by the National Medical Products Administration in China, with a planned submission date in August 2025 [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, has received acceptance from the US FDA for the clinical trial application of GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA for the treatment of advanced solid tumors [1] Group 1 - GenSci143 is independently developed by Jinsai Pharmaceutical [1] - The clinical trial application for GenSci143 has also been accepted by the National Medical Products Administration in China [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 GenSci143 from the National Medical Products Administration, indicating progress in the development of a novel dual-target antibody-drug conjugate for cancer treatment [1] Group 1 - GenSci143 is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, designed to provide both targeted chemotherapy and tumor immunotherapy [1] - The mechanism of GenSci143 involves internalization into lysosomes upon binding to B7-H3 or PSMA, releasing a TOPO-I inhibitor toxin to kill B7-H3 positive, PSMA positive, and dual-positive tumor cells [1] - The dual-target approach of B7-H3 and PSMA aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, potentially benefiting a larger patient population with more durable anti-tumor efficacy [1] Group 2 - GenSci143 utilizes proprietary linker technology, which enhances the potency of the toxin and the stability of the linker in plasma, contributing to stronger tumor-killing effects and improved safety profiles [1] - The innovative dual-target design, stable linker technology, and efficient cell-killing mechanism of GenSci143 may offer new treatment options for various solid tumors expressing B7-H3 and/or PSMA [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, has received acceptance for the clinical trial application of GenSci143 by the National Medical Products Administration, indicating progress in the development of a new targeted therapy for certain tumors [2] Company Summary - Jinsai Pharmaceutical, a subsidiary of Changchun High-tech, is developing GenSci143, a bispecific antibody-drug conjugate targeting B7-H3 and PSMA, which may offer dual therapeutic potential in targeted chemotherapy and tumor immunotherapy [2] - The drug is expected to provide new treatment options for various solid tumors expressing B7-H3 and/or PSMA [2]