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翰思艾泰-B(03378)获批准于中华人民共和国开展注射用HX111临床试验
智通财经网· 2025-12-23 13:17
Core Viewpoint - The company 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, a first-in-class OX40-targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - HX111 is a first-in-class (FIC) OX40-targeted antibody-drug conjugate (ADC) [1] - Preclinical studies indicate that OX40 is overexpressed in several malignancies, including certain lymphomas, making it a suitable target for ADCs like HX111 [1] - OX40 is also overexpressed in regulatory T cells (Treg) within the tumor microenvironment (TME), which are known to suppress anti-tumor immunity [1] Group 2: Mechanism of Action - The elimination of Tregs represents a novel mechanism of action (MOA) for cancer immunotherapy, which can be achieved through HX111 [1] - HX111 has potential applications across various cancers due to its unique mechanism [1] Group 3: Future Development - HX111 is the third first-in-class molecule to advance to clinical development following HX009 and HX044, both of which are bispecific antibody therapies [1] - The company aims to continue its efforts in clinical development to bring more innovative FIC drugs to market [1]
翰思艾泰(03378) - 自愿公告获批准於中华人民共和国开展注射用HX111临床试验
2025-12-23 13:09
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Hanx Biopharmaceuticals (Wuhan) Co., Ltd. 翰思艾泰生物醫藥科技(武漢)股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:3378) 自願公告 獲批准於中華人民共和國開展注射用HX111臨床試驗 本公告由翰思艾泰生物醫藥科技(武漢)股份有限公司(「本公司」)董事(「董事」) 會(「董事會」)自願刊發。 董事會欣然宣佈,由本公司開發的創新藥注射用HX111(「HX111」)已獲中華人民 共和國國家藥品監督管理局批准於中華人民共和國境內開展臨床試驗。 HX111為首創(FIC)OX40靶向抗體偶聯藥物(ADC)。臨床前研究表明,OX40為腫 瘤相關抗原(TAA),於若干惡性腫瘤(包括部分淋巴瘤)中相較於正常組織呈過度 表達,因而成為如HX111等ADC方式的合適靶點。此外,OX40亦在腫瘤微環境 (TME)中的調節性T細胞(Treg)呈過度表達,而 ...
翰思艾泰在港交所上市募资总额5.86亿港元
Jing Ji Guan Cha Wang· 2025-12-23 12:39
翰思艾泰成立于2014年,总部位于武汉东湖高新(600133)区,公司专注研发用于癌症及自身免疫疾病 精准治疗的创新药。截至目前,公司拥有10款候选药物管线,其中3款处于临床阶段、7款处于临床前阶 段。此次募集资金将主要投向产品研发。 经济观察网12月23日,翰思艾泰生物医药科技(武汉)股份有限公司(以下简称"翰思艾泰")在港交所成功 上市(股票代码:3378.HK)。本次IPO,翰思艾泰全球发售1832.1万股,发行价为32港元每股,募资总额 5.86亿港元,发行市值近44亿港元。 ...
3000倍超购换来首日暴跌近50%,翰思艾泰-B何以成为打新“陷阱”?
Zhi Tong Cai Jing· 2025-12-23 11:57
Core Viewpoint - The recent IPOs of two biotech companies, Huazhang Biotechnology and Hansai Aitai, faced significant declines on their debut trading days, indicating a bearish sentiment in the market for innovative drug companies, despite their initial hype and strong subscription rates [1][3][9]. Group 1: IPO Performance - Huazhang Biotechnology's stock fell nearly 30% on its first trading day, while Hansai Aitai's stock opened at 28.9 HKD, down 9.69% from its issue price of 32 HKD, and closed at 17.20 HKD, marking a 46.25% drop [1][3]. - Hansai Aitai's stock experienced a maximum intraday decline of 46.25%, failing to recover significantly by the end of the trading day [1][3]. Group 2: Subscription and Issuance Details - Hansai Aitai's global offering consisted of 18.32 million shares, with a public offering that was oversubscribed by 3074.09 times, resulting in a final allocation of 183.21 million shares, approximately 10% of the total offering [4][5]. - The final issue price was set at the upper limit of the range at 32 HKD, raising a net amount of 531 million HKD [5][6]. Group 3: Market Sentiment and Strategy - Both companies were initially viewed as "big meat" in the market due to their innovative drug offerings, yet their first-day performances fell short of expectations, reflecting a potential shift in investor sentiment towards unprofitable biotech firms [3][9]. - The adoption of the "Mechanism B" strategy, which favors institutional and cornerstone investors, did not yield the expected price stability for either company, as evidenced by their poor debut performances [9][10]. Group 4: Financial Performance and Valuation - Hansai Aitai reported losses of 85.16 million HKD, 117 million HKD, and 87.43 million HKD for the years 2023, 2024, and the first eight months of 2025, respectively [14]. - The company's post-IPO valuation reached 43.52 billion HKD, significantly higher than its pre-IPO valuation of approximately 16.15 billion HKD, raising concerns about its market valuation relative to industry averages [14].
3000倍超购换来首日暴跌近50%,翰思艾泰-B(03378)何以成为打新“陷阱”?
智通财经网· 2025-12-23 11:57
Core Viewpoint - The recent IPOs of Huazhang Biotechnology and Hansai Aitai have faced significant market backlash, with both companies experiencing substantial stock price declines on their first trading days, indicating a potential shift in investor sentiment towards biotech firms, particularly those classified as "unprofitable 18A" [1][3][9]. Group 1: IPO Performance - Huazhang Biotechnology's stock fell nearly 30% on its debut, while Hansai Aitai's stock opened at 28.9 HKD, down 9.69% from its issue price of 32 HKD, and closed at 17.20 HKD, marking a 46.25% drop [1][3]. - Hansai Aitai's IPO was characterized by a high subscription rate of 3074.09 times for the public offering, with only 10% of shares allocated to this segment, reflecting strong initial interest despite the subsequent price drop [3][4]. Group 2: Company Background and Strategy - Hansai Aitai is a biotech company focused on innovative therapies for cancer and autoimmune diseases, utilizing its proprietary VersatiBody platform to develop dual-function or multi-functional molecules [10]. - The company has a rich pipeline, including its lead product HX009, a PD-1/SIRPα dual-function antibody fusion protein, which is currently in various clinical trials [11]. Group 3: Financial Metrics and Valuation - The IPO pricing was set at the upper limit of 32 HKD, raising approximately 5.31 billion HKD, but the post-IPO market valuation of 23.43 billion HKD corresponds to a high price-to-book ratio of 21.77, significantly above the industry average of 4.81 [4][13]. - Financial losses for Hansai Aitai were reported at 85.16 million HKD, 117 million HKD, and 87.43 million HKD for the years 2023, 2024, and the first eight months of 2025, respectively, raising concerns about its valuation amidst ongoing losses [12].
港股异动丨首日上市破发!翰思艾泰收跌46%
Xin Lang Cai Jing· 2025-12-23 08:41
来源:格隆汇APP 格隆汇12月23日|翰思艾泰-B(3378.HK)今日首日上市收跌46.25%报17.2港元,全天成交2.32亿港元,最 新市值23.43亿港元。该股此次IPO定价32港元,所得款项净额达5.313亿港元。公开资料显示,翰思艾 泰专注于结构生物学与转化医学,致力于癌症及自身免疫疾病的新一代免疫疗法研发,旨在提供可负 担、安全且高效的精准治疗方案,满足全球未被满足的医疗需求。此次上市将助力其进一步推进产品开 发与商业化进程。 ...
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]
午评:港股恒指涨0.18% 科指跌0.42% 黄金股普涨 锂电池板块走强 诺比侃首日涨超338%
Xin Lang Cai Jing· 2025-12-23 04:02
12月23日消息,港股三大指数涨跌不一。截至午间收盘,恒生指数涨0.18%,报25848.99点,恒生科技 指数跌0.42%,国企指数涨0.11%。盘面上,科网股涨跌不一,京东、联想涨近1%,快手跌超3%,小 米、腾讯跌超1%;风电股涨幅居前,东方电气涨超5%;黄金股延续涨势,山东黄金涨超5%;锂电池板 块涨幅居前,赣锋锂业涨超4%;今日翰思艾泰、轻松健康、诺比侃上市 | 代码 | 名称 | | 最新价 涨跌幅 > | | | --- | --- | --- | --- | --- | | 01072 | 东方电气 | 0 | 25.260 5.34% | | | 00658 | 中国高速传动 | | 1.500 1.35% | | | 00579 | 京能清洁能源 | | 2.360 | 1.29% | | 00916 | 龙源电力 | | 6.770 1.20% | | | 02208 | 全风科技 | | 13.910 0.72% | | 黄金股延续涨势,山东黄金涨超5%。亚洲早盘,现货黄金涨超1%,最高至4490.88美元/盎司,续创历 史新高。摩根大通指出,关税不确定性,叠加ETF与各国央行的强劲需 ...
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]