Core Insights - The announcement of the first patient enrollment in the Phase I clinical trial of HX111, a novel OX40-targeted antibody-drug conjugate (ADC), marks a significant milestone for the company and highlights its innovative capabilities in the ADC space [1][2] - The company has developed a dual-antibody pipeline in cell immunotherapy, showcasing its comprehensive R&D strength and high-value product matrix [1][4] ADC Development - HX111 is the first OX40-targeted ADC to enter clinical trials globally, addressing a significant technical gap in the field [2] - The drug utilizes a monoclonal antibody targeting OX40 and a potent microtubule inhibitor MMAE, specifically binding to OX40 molecules overexpressed on tumor cells, leading to effective apoptosis in resistant tumors [2] Dual-Antibody Pipeline - The company has developed two key dual-antibody candidates, HX009 and HX044, targeting CD47, which is crucial for overcoming blood toxicity issues associated with first-generation therapies [3] - HX009 employs a strategy of strong PD-1 binding and weak CD47 binding to enhance T cell activity against tumors, while HX044 is the first CTLA-4×CD47 dual antibody in clinical trials, targeting Treg cells in the tumor microenvironment [3] R&D Team and Innovation - The company's R&D strength is supported by a top-tier team with deep academic and industry experience, covering all critical aspects of the drug development process [4] - The innovative achievements stem from a thorough understanding of biological mechanisms and continuous iteration of core technologies, creating significant barriers to entry and first-mover advantages [4] Market Potential - The market for HX111, targeting relapsed/refractory tumors, presents a substantial unmet need, while the dual-antibody candidates focus on immune therapy resistance and multi-cancer treatment, representing a market potential worth hundreds of billions [4] - As clinical trials progress and commercialization expectations rise, the company's performance growth is expected to be robust [4] Future Outlook - The ongoing clinical trials for HX111, HX009, and HX044 are anticipated to further highlight the company's multi-technology synergy, leading to increased market recognition of its core value [5] - The company's commitment to innovation is setting a benchmark for Chinese biotech firms and establishing a foundation for long-term, high-quality growth [5]

Core Viewpoint - The company has initiated a Phase I clinical trial for its self-developed candidate drug HX111, an OX40-targeted antibody-drug conjugate (ADC), aimed at treating relapsed/refractory lymphoma and solid tumors, with the first patient successfully dosed recently [1] Group 1: Drug Development - HX111 is designed to bind with high affinity and specificity to the OX40 molecule on the surface of tumor cells, facilitating efficient internalization and subsequent release of a potent payload that induces tumor cell apoptosis [1] - The OX40 molecule is highly expressed in certain lymphomas and solid tumors, which currently lack effective treatment options, indicating a significant unmet clinical need [1] - HX111 is the first OX40-targeted ADC drug to enter clinical trials globally, representing a first-in-class (FIC) innovation in this therapeutic area [1] Group 2: Market Opportunity - The field of OX40-targeted therapies is still in the early exploratory stage, providing HX111 with a significant first-mover advantage [1] - The development of HX111 has the potential to address a critical gap in the treatment landscape for these types of tumors [1]

Core Viewpoint - The company has initiated a Phase I clinical trial for its self-developed candidate drug HX111, an OX40-targeted antibody-drug conjugate (ADC), aimed at treating relapsed and refractory lymphoma and solid tumors, with the first patient successfully dosed recently [1] Group 1: Drug Development - HX111 specifically binds to the OX40 molecule on the surface of tumor cells with high affinity and specificity [1] - The drug efficiently enters tumor cells through endocytosis, where it is cleaved by lysosomal proteases to release a potent payload, inducing apoptosis in tumor cells [1] - OX40 is highly expressed in certain lymphomas and solid tumors, which currently lack effective treatment options, indicating a significant unmet clinical need [1] Group 2: Market Position - HX111 is the first OX40-targeted ADC drug to enter clinical trials globally, representing a first-in-class (FIC) innovation [1] - The field of OX40-targeted therapies is still in the early exploratory stage, giving HX111 a significant first-mover advantage [1] - The drug has the potential to fill a therapeutic gap in the treatment of these types of tumors in the future [1]

Core Viewpoint - The company has initiated a Phase I clinical trial for its self-developed candidate drug HX111, an OX40-targeted antibody-drug conjugate (ADC), aimed at treating relapsed/refractory lymphoma and solid tumors, with the first patient successfully dosed recently [1] Group 1: Drug Development - HX111 specifically binds to the OX40 molecule on the surface of tumor cells with high affinity and specificity [1] - The drug efficiently enters tumor cells through endocytosis, where it is cleaved by lysosomal proteases to release a potent payload, inducing tumor cell apoptosis [1] - OX40 is highly expressed in certain lymphomas and solid tumors, which currently lack effective treatment options, indicating a significant unmet clinical need [1] Group 2: Market Position - HX111 is the first OX40-targeted ADC drug to enter clinical trials globally, marking it as a first-in-class (FIC) product [1] - The field of OX40-targeted therapies is still in the early exploratory stage, providing HX111 with a significant first-mover advantage [1] - The drug has the potential to fill a therapeutic gap in the treatment of these types of tumors [1]

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） 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，本公司已啟動自主研發的候選藥物HX111（一款OX40靶向抗體偶 聯藥物（「ADC」）候選藥物）針對復發難治性淋巴瘤及實體瘤的Ⅰ期臨床試驗，已於 近期順利完成首例患者入組給藥。 HX111可高親和、高特異性地結合腫瘤細胞表面的OX40分子，並能高效地經內吞 作用進入腫瘤細胞後，由溶酶體蛋白酶裂解連接子，釋放強效有效載荷，進而誘導 腫瘤細胞凋亡。OX40分子在部分淋巴瘤及實體瘤中呈高表達特徵，這類腫瘤目前 缺乏有效的治療手段，存在顯著的未滿足臨床需求。本公司研發的HX111，是全球 範 圍 內 ...