双特异性抗体融合蛋白
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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]
翰思艾泰-B招股结束 孖展认购额录得1472.9亿港元 超购2511倍
Zhi Tong Cai Jing· 2025-12-18 07:38
Group 1 - The core viewpoint of the news is that Han's Biotech Company has successfully completed its IPO process, raising significant interest from investors with a substantial oversubscription rate of 2511 times [1] - Han's Biotech plans to issue 18.32 million H-shares, with a public offering accounting for 10% of the total shares, and the share price is set between HKD 28 to 32 [1] - The company has secured cornerstone investments totaling HKD 93.37 million from seven investors, representing 15.93% of the global offering [1] Group 2 - Since 2016, Han's Biotech has developed a product pipeline that includes one core product and nine other candidates, focusing on oncology and autoimmune markets [2] - The core product, HX009, is a bispecific antibody fusion protein targeting CD47 and PD-1, which is reported to be leading in clinical trial progress among similar products [2] - Financially, Han's Biotech has recorded operating losses with no profits during the reporting 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 research and development of its core product HX009, 33% to its major 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]
信达生物:IBI363后线CRC和免疫耐药非小数据超预期-20250607
Tai Ping Yang Zheng Quan· 2025-06-07 00:25
Investment Rating - The investment rating for the company is "Buy" with a target price of 95.42 HKD, compared to the last closing price of 74.25 HKD [1][10]. Core Views - The report highlights that the clinical data for IBI363, a dual-specific antibody fusion protein, has exceeded expectations in treating advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma [3][4][5][6]. - The company is expected to see significant revenue growth, with projected revenues of 94.22 billion HKD in 2024, increasing to 207.91 billion HKD by 2027, reflecting a growth rate of 51.82% in 2024 and 31.60% in 2027 [11][15]. Summary by Sections Company Overview - The total share capital is 1.65 billion shares, with a total market capitalization of 1,225 billion HKD [2]. - The company has a strong pipeline with multiple important developments expected in 2025, including approvals for various treatments [9]. Clinical Data - IBI363 showed a median progression-free survival (mPFS) of 9.3 months and a 12-month overall survival (OS) rate of 70.9% in patients with immune-resistant lung squamous cell carcinoma [4]. - In CRC patients, IBI363 demonstrated a median overall survival (mOS) of 16.1 months, indicating a significant improvement over existing treatment options [5]. - For melanoma, IBI363 achieved an mPFS of 5.7 months, with ongoing trials comparing it to pembrolizumab in treatment-naive patients [6]. Financial Projections - The company is projected to achieve a net profit of 6.23 billion HKD in 2025, with a significant increase to 30.77 billion HKD by 2027, reflecting a net profit growth rate of 132.26% in 2027 [11][15]. - The earnings per share (EPS) is expected to rise from -0.06 HKD in 2024 to 1.87 HKD in 2027 [11][15]. Valuation - The valuation methods used include DCF and NPV, resulting in a target market value of 1,574 billion HKD, which corresponds to the target stock price of 95.42 HKD [10].
信达生物(01801)全球首创PD-1/IL-2α双特异性抗体融合蛋白拟纳入突破性疗法
智通财经网· 2025-05-23 07:03
Core Insights - The National Medical Products Administration (NMPA) has proposed to include Innovent Biologics' IBI363, a PD-1/IL-2 bispecific antibody fusion protein, in its breakthrough therapy designation for treating locally advanced or metastatic squamous non-small cell lung cancer that has failed platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy [1][2] Group 1: Product Development - IBI363 is a globally innovative PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics, designed to block the PD-1/PD-L1 pathway while activating the IL-2 pathway [1] - The IL-2 arm of IBI363 has been engineered to retain affinity for IL-2 Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby lowering toxicity [1] - IBI363 has demonstrated good anti-tumor activity in various tumor-bearing pharmacology models and has shown significant tumor suppression efficacy in PD-1 resistant and metastatic models [1] Group 2: Clinical Research and Regulatory Status - IBI363 has previously been included in the breakthrough therapy drug (BTD) list by CDE, targeting unresectable locally advanced or metastatic acral and mucosal melanoma that has not undergone systemic treatment [2] - Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 against various malignancies [2] - IBI363 has received two Fast Track designations from the U.S. FDA for the treatment of advanced squamous non-small cell lung cancer and melanoma [2]