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翰思艾泰港股IPO:尚未盈利且药物研发存在不确定性风险
Jin Rong Jie· 2025-06-03 09:49
Group 1 - The core viewpoint of the article is that Hansai Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, with ICBC International as the exclusive sponsor [1] - The company focuses on structural biology, translational medicine, and clinical development, having developed an innovative drug pipeline since 2016, including its core product HX009 and nine other pipeline candidates [1][2] - HX009 is a self-developed PD-1/SIRPα dual-function antibody fusion protein currently undergoing multiple clinical trials in China for treating advanced melanoma, relapsed/refractory EBV-positive non-Hodgkin lymphoma, and advanced biliary cancer [1][2] Group 2 - The company has two main products, HX301 and HX044, with HX301 being a multi-target kinase inhibitor in a Phase II clinical trial for glioblastoma in China, and HX044 being a novel dual-function anti-CTLA-4 antibody SIRPα fusion protein in Phase I/IIa trials for advanced solid tumors in Australia and China [2] - According to a Frost & Sullivan report, HX009 is leading globally in clinical trial progress among similar CD47-targeting bispecific antibodies/dual-function fusion proteins, while HX044 is the only CTLA-4/SIRPα dual-specific antibody/dual-function fusion protein in clinical trials [2] - The company has developed proprietary platforms, VersatiBody and autoRx40, for creating antibody drugs with enhanced therapeutic capabilities, and has received royalties from HX008, a PD-1 monoclonal antibody approved in 2022 [2] Group 3 - As of the fiscal years ending December 31, 2023, and 2024, the company's R&D costs are projected to be RMB 46.7 million and RMB 74.7 million, accounting for 73.0% and 61.8% of total operating expenses, respectively [2] - The company has not yet achieved profitability and continues to invest heavily in R&D activities [2] - The company faces significant risks, including uncertainties in drug development, potential unmet expectations in clinical trial results, and challenges in obtaining regulatory approvals or commercializing its products [3]
翰思艾泰再次递表港交所 去年亏损约1.17亿元
Zhi Tong Cai Jing· 2025-06-02 22:56
Core Viewpoint - Hanse Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with ICBC International as the sole sponsor, despite being in a loss-making position for the fiscal years 2023 and 2024 [1][4]. Company Overview - Hanse Aitai is an innovative biotechnology company specializing in structural biology, translational medicine, and clinical development, with a pipeline that includes one core product and nine other candidate products [4][6]. - The core product, HX009, is a self-developed PD-1/SIRPα dual-function antibody fusion protein, which has completed Phase I clinical trials in Australia and China [4][5]. Product Pipeline - The company has three ongoing clinical projects for HX009 in China, targeting advanced melanoma, relapsed/refractory Epstein-Barr virus-positive non-Hodgkin lymphoma, and advanced biliary tract cancer [5]. - Two other major products, HX301 and HX044, are in clinical stages, focusing on cancer treatment. HX301 is a multi-target kinase inhibitor, while HX044 is a novel dual-function anti-CTLA-4 antibody SIRPα fusion protein [5][6]. Financial Performance - For the fiscal years 2023 and 2024, the company reported other income and revenue of approximately RMB 6.664 million and RMB 7.681 million, respectively, while incurring losses of about RMB 85.16 million and RMB 117 million [6][8]. - The company has a total of ten candidate drugs in its pipeline, with eight targeting oncology and two for autoimmune diseases [6].