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翰思艾泰HX111完成首例患者给药 创新实力凸显估值洼地价值
Ge Long Hui· 2026-02-05 09:45
值得关注的是,这样一家手握全球首创药物、布局高潜力双抗管线的创新药企,其市值尚未充分反映核 心价值。HX111针对的复发难治性肿瘤市场存在巨大未满足需求,而HX009、HX044所聚焦的免疫治疗 耐药与多癌种联合治疗领域,更是坐拥数百亿美元级市场空间。随着各管线临床试验的持续推进与商业 化落地预期升温,公司业绩增长具备强劲支撑。 2026年2月4日,翰思艾泰生物医药科技(武汉)股份有限公司(股份代号:3378.HK)发布自愿性公告,宣布 其自主研发的全球首款OX40靶向抗体药物偶联物(ADC)候选药物HX111,成功完成针对复发难治性淋巴瘤 及实体瘤(R/R淋巴瘤和实体瘤)Ⅰ期临床试验的首例患者入组给药。这一里程碑事件不仅标志着中国创新药 企在全球ADC赛道的突破性进展,更与公司在细胞免疫治疗领域的双抗管线优势形成协同共振,全方位彰显 了其覆盖多技术路径、直击临床痛点的顶尖研发实力与高价值产品矩阵,而当前股价尚未兑现其核心价值,估 值洼地特征愈发显著。 未来,随着HX111临床试验的深入推进,以及HX009、HX044等双抗管线的临床数据持续释放,翰思艾 泰的多技术路径协同优势将进一步凸显,核心价值有望逐步被 ...
翰思艾泰重塑CD47赛道 引领肿瘤免疫治疗迈入黄金时代
Ge Long Hui· 2026-01-14 17:31
Core Insights - The PD-(L)1 inhibitor industry is at a pivotal development point, with Hansai Aitai (3378.HK) breaking through traditional frameworks through innovative mechanisms, particularly with its two key pipelines, HX009 and HX044, marking a new chapter in tumor immunotherapy [1] Group 1: Product Innovations - HX009 is a bispecific antibody fusion protein targeting both CD47 and PD-1, achieving historic breakthroughs by reactivating exhausted T cells and demonstrating superior anti-tumor activity compared to traditional therapies [2] - HX009 has shown excellent safety at a dosage of 10 mg/kg, with no severe hematologic toxicity, and has demonstrated clear clinical activity in refractory patients previously treated with PD-1 [2] - HX044, the world's first CTLA-4/CD47 bispecific antibody, utilizes a unique design to optimize dual-target affinity, effectively targeting Treg cells within tumors while preserving peripheral normal Treg and red blood cells [2] Group 2: Clinical Development - HX009 has successfully completed Phase I clinical trials and is advancing rapidly into Phase II studies for multiple cancers, including advanced melanoma and EBV-positive non-Hodgkin lymphoma, and has been approved for combination therapy with Enhertu for advanced triple-negative breast cancer [2] - HX044 has initiated clinical trials in Australia and China and has been approved for use in combination with PD-1 for treating advanced solid tumors, potentially reshaping the competitive landscape of solid tumor immunotherapy [2][3] Group 3: Competitive Advantage - Hansai Aitai has established an unreplicable core competitive advantage through forward-looking mechanism exploration, disruptive molecular design, and solid clinical data, effectively addressing the toxicity issues of traditional CD47 therapies [3] - The company aims to continue deepening its exploration of the new CD47 mechanism and accelerate the clinical translation of more innovative drugs, leveraging its strong pipeline value to empower industry development [3]
湖北新增一家上市公司,翰思艾泰登陆港交所
Zheng Quan Shi Bao Wang· 2025-12-23 14:46
Group 1 - Han's Biopharma (3378.HK) listed on the Hong Kong Stock Exchange on December 23, raising a total of HKD 586 million by offering 18.32 million shares at HKD 32 per share, with a market capitalization of nearly HKD 4.4 billion [1] - Following the IPO, the stock price fell significantly, closing at HKD 17.2 per share, representing a decline of 46.25% and a total market value of HKD 2.343 billion [1] - The company, founded in 2014, focuses on developing innovative drugs for precise treatment of cancer and autoimmune diseases, with a pipeline of 10 candidate drugs, including 3 in clinical stages and 7 in preclinical stages [1] Group 2 - The core product, HX009, is a self-developed dual-function antibody fusion protein that has completed Phase I clinical trials in Australia and China, and is currently undergoing Phase Ib/I/IIa clinical trials for advanced melanoma, relapsed/refractory EBV-positive non-Hodgkin lymphoma, and advanced biliary cancer in China [1] - The company also has two other main clinical-stage products: HX301, a multi-target kinase inhibitor in Phase II trials for glioblastoma, and HX044, a novel dual-function anti-CTLA-4 antibody SIRPα fusion protein in Phase I/IIa trials for advanced solid tumors [2] - The founder, Zhang Faming, is a professor and doctoral supervisor at Wuhan University, with a history of entrepreneurship in the innovative drug sector, having established multiple companies in the Wuhan East Lake High-tech Zone, which has a significant number of listed companies in the life and health sector [2]
翰思艾泰-B(03378.HK):获批准于中国境内开展注射用HX111临床试验
Ge Long Hui· 2025-12-23 13:18
Core Viewpoint - Hansa Biopharma-B (03378.HK) has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials for its innovative drug, HX111, which is a first-in-class (FIC) OX40-targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - HX111 is identified as a first-in-class OX40-targeted ADC, which shows overexpression in several malignancies, including certain lymphomas, compared to normal tissues, making it a suitable target for ADC therapies [1] - Preclinical studies indicate that OX40 is a tumor-associated antigen (TAA) and is overexpressed in regulatory T cells (Treg) within the tumor microenvironment (TME), which are known to suppress anti-tumor immunity [1] - The mechanism of action (MOA) for HX111 involves the elimination of Tregs, representing a novel approach in cancer immunotherapy with potential applications across various cancers [1] Group 2: Company Strategy - HX111 is the third first-in-class molecule to advance to clinical development following the company's previous dual-specific antibody (BsAb) therapies, HX009 and HX044 [1] - The company aims to continue its efforts in clinical development to bring more innovative FIC drugs to market [1]
翰思艾泰港股上市首日破发跌46% 2年8个月共亏2.9亿
Zhong Guo Jing Ji Wang· 2025-12-23 08:28
Core Viewpoint - Hanseata Biotechnology (Wuhan) Co., Ltd. has listed on the Hong Kong Stock Exchange, opening below the issue price and closing with a significant decline of 46.25% from the final offer price [1][6]. Group 1: Listing and Share Details - The total number of shares offered globally was 18,321,000 H-shares, with 1,832,100 shares available for public offering in Hong Kong and 16,488,900 shares for international offering [2]. - The final offer price was set at HKD 32.00 per share, resulting in total proceeds of HKD 586.3 million, with net proceeds amounting to HKD 531.3 million after deducting estimated listing expenses of HKD 55.0 million [6]. Group 2: Use of Proceeds - The net proceeds from the global offering are intended for the research and development of the company's core products (HX009, HX301, and HX044), funding for commercialization and business development activities, and general corporate purposes [6]. Group 3: Financial Performance - The company reported comprehensive losses of RMB 85.2 million for 2023, RMB 116.9 million for 2024, and RMB 48.4 million for the eight months ending August 31, 2025, primarily due to R&D costs and administrative expenses [7][8]. - The total comprehensive loss over the periods mentioned amounted to RMB 289.5 million [8]. Group 4: Cash Flow and Financial Position - The net cash used in operating activities was RMB 52.0 million for 2023 and RMB 104.9 million for 2024, with cash and cash equivalents at the end of the periods being RMB 162.0 million for 2023 and RMB 161.2 million for 2024 [10].
港股异动 | 翰思艾泰-B(03378)上市首日跌超45% 较招股价接近腰斩 总市值不足24亿港元
智通财经网· 2025-12-23 07:29
Core Viewpoint - The initial public offering (IPO) of Hansai Aitai-B (03378) experienced a significant decline, with shares dropping nearly 45.5% from the offering price of HKD 32 to HKD 17.44, resulting in a market capitalization of less than HKD 24 billion [1] Company Overview - Hansai Aitai is a biotechnology company specializing in structural biology, translational medicine, and clinical development, with a product pipeline that includes one core product and nine other candidate products [1] - The company has developed three clinical-stage candidates targeting oncology, including the core product HX009 and major products HX301 and HX044, as well as seven preclinical candidates focused on antibody-drug conjugates, bispecific antibodies, and monoclonal antibodies for autoimmune and oncology markets [1] Financial Performance - The company has not recorded any profits during the historical performance period and has incurred operating losses [1] - For the fiscal years ending August 31, 2023, 2024, and the first eight months of 2025, the company reported losses of RMB 85.16 million, RMB 117 million, and RMB 87.44 million, respectively, primarily due to research and development costs and administrative expenses [1]
武汉又冲出一个医药IPO!60岁武大学霸带队
创业邦· 2025-12-23 03:12
Core Viewpoint - Hanse Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. successfully listed on the Hong Kong Stock Exchange, marking it as the second company from Wuhan to go public under the HKEX's 18A biotech rules. The company focuses on developing innovative drugs for cancer and autoimmune diseases, addressing unmet medical needs in these areas [3][4]. Group 1: IPO Details - Hanse Aitai issued 18.321 million H-shares at an offering price of HKD 32 per share, raising a total of HKD 586 million, with a market capitalization of nearly HKD 4.4 billion at issuance [3]. - On its first trading day, the opening price was HKD 28.9, and the latest market capitalization was HKD 3 billion [3]. - The company has completed three rounds of financing prior to the IPO, totaling approximately RMB 154 million, with major investors including Betta Pharmaceuticals and Longpan Investment [4]. Group 2: Product Pipeline and R&D Focus - The core product, HX009, is the world's only PD-1/SIRPα dual-function antibody fusion protein, currently in Phase II clinical trials in China after completing Phase I trials in China and Australia [4][20]. - Another innovative product, HX044, has initiated Phase I clinical trials for advanced solid tumors in both China and Australia [4][21]. - The company plans to allocate approximately 35% of the raised funds to advance HX009, 33% to develop HX301 and HX044, and 5% for commercialization preparations [4]. Group 3: Founder's Background and Company Development - Founder Zhang Faming, who has a strong academic and professional background in biochemistry and pharmaceutical development, has previously founded and sold successful biotech companies [10][11]. - Hanse Aitai was established in 2014 and has since focused on developing next-generation immunotherapies, particularly targeting the limitations of existing PD-1 therapies [15][17]. - The company has built a robust R&D team, integrating expertise from various fields to enhance its drug development capabilities [15][20]. Group 4: Market Context and Competitive Landscape - The global PD-1/PD-L1 antibody market is projected to reach USD 53.7 billion by 2024, with expectations to grow to USD 72.5 billion by 2030, highlighting the competitive nature of the immunotherapy sector [25]. - Hanse Aitai's dual-target design for HX044 aims to address the challenges of PD-1 resistance, positioning the company in a competitive landscape with several other firms pursuing similar therapeutic strategies [26][28]. - The company is one of the few globally to have two clinical-stage products targeting the SIRPα pathway, indicating significant long-term collaboration potential [28].
翰思艾泰-B首挂上市 早盘低开9.69% 核心产品HX009正在中国进行三个临床项目
Zhi Tong Cai Jing· 2025-12-23 01:43
Core Viewpoint - Hansa Biopharma-B (03378) has made its debut on the stock market with an initial share price of HKD 32, issuing 18.321 million shares and raising approximately HKD 531 million, but has seen a decline of 9.69% to HKD 28.9 at the time of reporting [1] Company Overview - Hansa Biopharma is a biotechnology company specializing in structural biology, translational medicine, and clinical development, with a product pipeline that includes one core product and nine other candidate products [1] - The company has developed three clinical-stage candidates targeting oncology, including the core product HX009 and major products HX301 and HX044, as well as seven preclinical candidates targeting autoimmune and oncology markets [1] Product Details - The core product HX009 is a bispecific antibody fusion protein that targets both CD47 and PD-1 [1] - According to a Frost & Sullivan report, HX009's clinical trial progress is leading globally among similar CD47-targeting bispecific antibodies and bifunctional fusion protein products as of the last feasible date [1]
新股首日 | 翰思艾泰-B(03378)首挂上市 早盘低开9.69% 核心产品HX009正在中国进行三个临床项目
智通财经网· 2025-12-23 01:40
Core Viewpoint - Hantian Aitai-B (03378) has made its debut on the stock market with an initial share price of HKD 32, issuing 18.321 million shares and raising approximately HKD 531 million, but the stock has seen a decline of 9.69% to HKD 28.9 at the time of reporting [1] Company Overview - Hantian Aitai is a biotechnology company specializing in structural biology, translational medicine, and clinical development, with a product pipeline that includes one core product and nine other candidate products [1] - The company has developed three clinical-stage candidates targeting oncology, including the core product HX009 and major products HX301 and HX044, as well as seven preclinical candidates targeting autoimmune and oncology markets [1] Product Details - The core product HX009 is a bispecific antibody fusion protein that targets both CD47 and PD-1 [1] - According to a Frost & Sullivan report, HX009's clinical trial progress is leading globally among similar CD47-targeting bispecific antibody/bifunctional fusion protein products as of the last feasible date [1]
新股消息 翰思艾泰-B(03378)招股结束 孖展认购额录得1472.9亿港元 超购2511倍
Jin Rong Jie· 2025-12-18 07:54
Group 1 - The core viewpoint of the article is that Hanse Aitai-B (03378) has successfully completed its IPO with significant oversubscription, raising substantial capital for its product development [1][2]. - The company has raised HKD 1,472.9 billion in margin financing, with the public offering being oversubscribed by 2,511 times, indicating strong investor interest [1]. - Hanse Aitai plans to issue 18.32 million H-shares, with a public offering accounting for 10% of the total shares, and the share price set between HKD 28 to 32 [1]. Group 2 - The product pipeline includes one core product and nine other candidates, with three clinical-stage candidates targeting oncology, including the core product HX009 [2]. - HX009 is a bispecific antibody fusion protein targeting both CD47 and PD-1, leading in clinical trial progress among similar products globally [2]. - The company reported operating losses during the historical record period, with losses of RMB 85.16 million, RMB 117 million, and RMB 87.44 million for the fiscal years ending August 31, 2023, 2024, and 2025 respectively [2]. Group 3 - The company plans to allocate approximately 35% of the net proceeds from the global offering to the development of its core product HX009, 33% to its main products HX301 and HX044, and 17% to other important products [3]. - Additionally, about 5% of the proceeds will be used for commercialization and business development activities, while 10% will be allocated for working capital and other general corporate purposes [3].