另据长春高新10月20日晚公告，金赛药业收到国家药品监督管理局核准签发的《药物临床试验批准通知 书》，同意注射用GenSci139单药在晚期实体瘤患者中开展临床试验。 GenSci139是金赛药业自主研发的一款靶向EGFR和HER2的双特异性抗体偶联药物(BsADC)，采用自主 研发的接头技术，具有毒素活性强和连接子血浆稳定性高等特性，在产生更强肿瘤杀伤作用的同时，还 具备潜在的更优秀的安全性。同时，该产品独特的双靶点结合特性可显著增强对肿瘤细胞的结合与内吞 效率，有望通过产生协同效应提升抗肿瘤效果。 此外，长春高新10月18日公告，金赛药业收到美国食品药品监督管理局(简称"FDA")书面通知，金赛药 业注射用GenSci143临床试验申请获得受理。GenSci143采用自主研发的接头技术，具有毒素活性强和连 接子血浆稳定性高等特性，在产生更强肿瘤杀伤作用的同时，还具备更优的安全性。GenSci143凭借创 新的双靶点设计、稳定的连接子技术、高效的细胞杀伤机制和广泛的抗肿瘤谱，或可为多种B7-H3和/或 PSMA表达的实体瘤提供新的治疗方向。2025年8月，GenSci143拟用于晚期实体瘤的临床试验申请在中 ...

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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].

Investment Rating - The report maintains a strong confidence in the pharmaceutical sector, anticipating a reversal in the market by 2025, with innovative drugs and the recovery of left-side sectors being the main investment opportunities [5][13]. Core Views - The report highlights that major domestic pharmaceutical companies have stabilized their revenues after previous disruptions from centralized procurement, with visible results from their innovation transformations [2][12]. - It emphasizes the importance of BD (business development) collaborations, citing significant deals involving major multinational pharmaceutical companies, which could lead to sustainable income for companies like Heng Rui Medicine [2][12]. - The report suggests focusing on innovative drugs, particularly dual/multi-target antibodies and drugs addressing unmet clinical needs, as key investment opportunities [3][5][13]. Summary by Sections Pharmaceutical Sector - The innovative drug market is experiencing adjustments, but the overall policy environment remains supportive for innovation [3]. - After ten rounds of centralized procurement, the risks for leading pharmaceutical companies are gradually being alleviated, revealing competitive innovative drug pipelines [3][22]. - The report recommends paying attention to leading pharmaceutical companies' transformation results and overseas opportunities [3][5]. Biopharmaceuticals - Jin Sai Pharmaceutical's dual-target ADC GenSci143 has received IND approval, showing potential as a leading treatment option for prostate cancer and other solid tumors [3][41][46]. Medical Devices - The registration and promotion of innovative products in the domestic medical device sector are accelerating, contributing to long-term high-quality development [4][47]. - Companies like Huitai Medical have reported significant revenue growth, with innovative products rapidly expanding their market presence [4][47][48]. Traditional Chinese Medicine - Some companies are facing performance pressure during the destocking cycle, but strong brands like Dong'e Ejiao continue to achieve resilient growth [4][54][56]. Investment Recommendations - The report suggests focusing on innovative drugs, particularly in the fields of dual/multi-target antibodies and drugs for chronic diseases, as well as opportunities in ADC and small nucleic acid sectors [5][13]. - The medical device sector is expected to see a significant performance turnaround in the second half of the year, driven by favorable policies and recovering tender trends [5][13]. Key Targets - Notable companies to watch include Innovent Biologics, Kintor Pharmaceutical, and Heng Rui Medicine, among others [6].