Core Insights - Changchun High-tech has received multiple approvals for clinical trials of its innovative drug candidates, indicating a strong pipeline and commitment to research and development [1][2][3][4] Group 1: Drug Approvals - Changchun Jinsai Pharmaceutical has received a notice from the National Medical Products Administration (NMPA) for the clinical trial application of GenSci142 capsules, targeting Gardnerella bacteria with advantages such as rapid action and low resistance risk [1] - The company’s subsidiary, Changchun Baike Biotechnology, has also received approval for a trivalent influenza virus split vaccine (BK-01 adjuvant) aimed at individuals aged 60 and above, enhancing immune response [1] - GenSci139, a bispecific antibody-drug conjugate targeting EGFR and HER2, has been approved for clinical trials in advanced solid tumor patients, showcasing its strong tumor-killing potential and safety profile [2] - GenSci143 has received acceptance for clinical trials from the FDA, designed to treat various solid tumors with a dual-target approach and high efficacy [3] Group 2: Research and Development Focus - The company has significantly increased its R&D investments, focusing on cutting-edge innovations and accelerating international transformation [4] - Artificial intelligence (AI) is being utilized to enhance drug research efficiency, particularly in precision targeting and drug design [4] - The company is developing a diverse pipeline of innovative drugs across multiple disease areas and treatment modalities, aiming for high competitiveness and differentiation [4]

Core Viewpoint - Changchun High-tech aims to enhance its international presence and innovation capabilities by issuing H-shares for listing on the Hong Kong Stock Exchange, with funds primarily allocated for R&D, clinical trials, and international market expansion [1][3]. Fundraising Purpose - The funds raised will be used for two main directions: advancing the innovation pipeline, including clinical trials and regulatory affairs, and establishing a commercial team overseas for global collaboration and market expansion [1][3]. Financial Performance - Since 2022, Changchun High-tech's stock price has experienced significant fluctuations due to rumors surrounding the centralized procurement of growth hormones, culminating in a decline in both revenue and net profit for the first time in nearly two decades in 2024 [3]. Innovation Pipeline - The company has over 40 projects in clinical stages or IND applications, including 11 Class I innovative biological agents and 4 Class I innovative chemical drugs, focusing on endocrine and metabolic diseases, women's health, immune and respiratory systems, and oncology [3][4]. Key Products - GenSci134, a long-acting growth hormone, is currently undergoing Phase I clinical trials for adult growth hormone deficiency and has received IND approval for pediatric growth hormone deficiency and idiopathic short stature [4][5]. - GenSci074, an NK3R antagonist for treating vasomotor symptoms in menopausal women, is in Phase II clinical trials, with competition from other drugs in the same category [7][8]. Oncology Pipeline - The company is developing several innovative drugs targeting prostate, breast, and ovarian cancers, including GenSci139, GenSci140, and GenSci143, which are expected to enter Phase I clinical trials by Q4 2025 [10][11]. - GenSci139 targets low-expressing HER2 tumors and faces a competitive landscape with existing ADC therapies [11][12]. - GenSci140 aims to expand patient coverage for FRα-positive cancers and is the only FRα dual-target ADC in development in China [13][14]. - GenSci143 targets both B7-H3 and PSMA antigens, potentially offering broader patient coverage but is still in early development stages [15]. Other Therapeutic Areas - GenSci098 is a TSHR antagonist for treating thyroid-associated ophthalmopathy, indicating the company's diversification into immune and respiratory diseases [16].