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]

Core Viewpoint - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the clinical trial application of 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 drug development with the acceptance of the clinical trial application for GenSci143 [1] - GenSci143 is a self-developed drug by Changchun Jinsai Pharmaceutical, showcasing the company's commitment to innovative cancer therapies [1] Industry Summary - The acceptance of GenSci143's clinical trial application highlights the growing focus on dual-targeting therapies in the oncology sector, particularly those that combine chemotherapy and immunotherapy [1]

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 GenSci143, a bispecific antibody-drug conjugate targeting B7-H3 and PSMA [1] Group 1 - GenSci143 is designed to have dual therapeutic potential through 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 double positive tumor cells [1] - GenSci143 utilizes independently developed linker technology, which features strong toxin activity and high plasma stability of the linker, aiming for enhanced tumor-killing effects and improved potential safety [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock price increase, rising over 7% and currently trading at 9.59 HKD, with a trading volume of 32.19 million HKD. The company is set to hold a board meeting on August 28 to approve its mid-term performance, with expectations of a profit of no less than 20 million RMB for the first half of the year, compared to a loss of approximately 44.90 million RMB in the same period last year. The turnaround is attributed to milestone revenues from three authorized collaborations and sales from commercialized products. Additionally, the company has received acceptance for its clinical trial application for the dual-specific antibody-drug conjugate JSKN022, aimed at treating advanced malignant solid tumors, marking a significant development in the market as no similar targeted ADCs are currently available globally [1][1][1]. Financial Performance - The company anticipates a profit of at least 20 million RMB for the first half of the year, a notable recovery from a loss of around 44.90 million RMB in the previous year [1][1][1]. - The financial turnaround is primarily driven by milestone revenues from three authorized collaborations and sales from commercialized products [1][1][1]. Product Development - Corning Jereh Pharmaceutical has announced that its self-developed dual-specific antibody-drug conjugate JSKN022 has had its clinical trial application formally accepted by the National Medical Products Administration of China [1][1][1]. - The planned clinical study for JSKN022 will focus on treating advanced malignant solid tumors, with no existing targeted ADCs for integrin αvβ6 or PD-L1 currently available on the market [1][1][1].