HBM HOLDINGS(02142)
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和铂医药(02142) - 2024 - 年度财报
2025-04-22 14:13
Financial Performance - Revenue for 2024 was $38.1 million, a decrease of 57.5% compared to $89.5 million in 2023[11] - The company reported a net profit of $2.7 million for 2024, compared to a profit of $22.8 million in 2023[11] - Cash and cash equivalents increased to $166.8 million in 2024 from $140.3 million in 2023[11] - Total assets decreased to $215.0 million in 2024 from $228.5 million in 2023[11] - Recurring revenue increased from $5.7 million for the year ended December 31, 2023, to $16.9 million for the year ended December 31, 2024, representing a growth of 196.5%[116] - Research and development expenses were $21.0 million, down 53.3% from $45.1 million in 2023[11] - Administrative expenses fell from $19.5 million in 2023 to $13.2 million in 2024, primarily due to a reduction in employee costs[122] - Other income and gains increased from $6.6 million in 2023 to $11.2 million in 2024, a rise of 69.7%[118] - The company recorded cash and cash equivalents of $0.9 million as of December 31, 2024, an increase from $0.7 million as of December 31, 2023[135] - The total compensation cost for the year ended December 31, 2024, was $23.7 million, down from $26.3 million for the year ended December 31, 2023[143] Research and Development - The company has submitted a Biologics License Application for HBM9161 for generalized Myasthenia Gravis to the NMPA in July 2024[13] - A new drug application for HBM9378/WIN378 for Chronic Obstructive Pulmonary Disease is expected to be submitted in November 2024[14] - The company has initiated a Phase I clinical trial for HBM9027 after receiving IND approval from the FDA in January 2024[18] - The company has expanded its Harbour Therapeutics pipeline to include 8 assets from preclinical to late clinical stages, targeting a potential market exceeding $20 billion[31] - In 2024, the company submitted a Biologics License Application (BLA) for Bartolizumab to treat generalized Myasthenia Gravis (gMG) and an Investigational New Drug (IND) application for HBM9378 for treating COPD in China[31] - The company received IND approval from the FDA for HBM9027 and PD-L1xCD40 bispecific antibodies, initiating clinical studies in the U.S.[32] - Nona Bio has been advancing research and development (R&D) capabilities, focusing on delivering innovative solutions that could save lives despite global uncertainties[28] - The company has established significant partnerships with leading pharmaceutical and biotech companies to enhance R&D capabilities[31] - The company has a robust product pipeline focused on immunology and oncology, strategically selecting clinical assets with significant unmet needs[48] Collaborations and Partnerships - The company entered a global licensing agreement with AstraZeneca, receiving an upfront payment of $19 million and potential milestone payments of up to $575 million[20] - In October 2024, Nona Bio entered a strategic collaboration with OverT Bio to develop next-generation cell therapies for solid tumors using proprietary platforms[23] - In December 2024, Nona Bio partnered with Kodiak Sciences Inc. to advance multi-target novel antibody therapies for ophthalmic diseases[23] - The company has established multiple strategic collaborations, including a partnership with Boostimmune, Inc. for antibody-drug conjugates[20] - A global exclusive licensing agreement was signed with Windward Bio in January 2025 for the development and commercialization of HBM9378/WIN378, excluding Greater China and certain Southeast Asian and West Asian countries[59] - The company entered into a collaboration with Kodiak Sciences Inc. to advance multi-target antibody therapies for ophthalmic diseases using its proprietary Harbour Mice® platform[93] - A research collaboration and licensing agreement with Candid Therapeutics was signed in December 2024, allowing for up to $320 million in upfront and milestone payments[84] - HBM Alpha Therapeutics announced a strategic collaboration in February 2025, with potential payments up to $395 million for developing a new therapy targeting CRH[86] Product Development and Pipeline - HBM9161, a fully human monoclonal antibody targeting FcRn, has completed Phase III clinical trials for gMG, marking the first successful critical trial for this product globally[54] - The BLA for HBM9161 was accepted by NMPA in June 2023, representing the first BLA submission since the company's establishment[54] - HBM9378, developed in collaboration with Keren Biotechnology, received IND approval for moderate to severe asthma in February 2022 and completed Phase I trials in October 2023[58] - HBM4003 is a next-generation fully human anti-CTLA-4 antibody, progressing from candidate screening to clinical stage within three years, showing promising efficacy and safety in treating various solid tumors[61] - HBM1020, a fully human monoclonal antibody targeting B7H7, showed preliminary efficacy signals with 46.7% of 15 patients achieving stable disease and tumor reductions of 11% and 25%[64] - HBM7008, a bispecific antibody targeting B7H4 and 4-1BB, is the only clinical-stage bispecific antibody for these targets globally, with a focus on improving safety and efficacy in PD-L1 negative patients[65] - HBM7020, a BCMAxCD3 bispecific antibody, received IND approval in China for cancer treatment, with a strategic shift towards immune diseases planned for 2024[70] - HBM9027, a novel PD-L1×CD40 bispecific antibody, received IND approval from the FDA to initiate Phase I trials in the U.S. in January 2024[74] - HBM7004, a new bispecific antibody targeting B7H4xCD3, demonstrated strong anti-tumor efficacy and significant in vivo stability in preclinical studies[75] - HBM9014, a first-in-class antibody targeting leukemia inhibitory factor receptor (LIFR), showed significant anti-tumor efficacy and good safety in primate toxicology studies[78] Risks and Challenges - The company has incurred net losses over the past several years, raising concerns about future profitability[186] - The lengthy and costly clinical development process is fraught with uncertainties, which may delay or hinder the commercialization of candidate drugs[186] - Regulatory approval processes for candidate drugs are time-consuming and may evolve, posing risks to the company's business[190] - The company faces intense competition and rapid technological changes, which may adversely affect its financial condition and ability to commercialize candidate drugs[193] - The production process of biopharmaceuticals is complex and requires significant expertise and capital investment, posing risks to the business if production issues arise in the future[193] - The company lacks experience in launching and marketing candidate drugs, which may hinder its ability to effectively establish and manage its sales network[193] - Legislative changes may increase the difficulty and cost of obtaining market approval and commercialization for candidate drugs, impacting potential pricing[195] - The company may face specific risks when conducting business and operations in international markets due to licensing of commercialization rights and global collaborations[195] - The company’s patents may have limited geographic protection, potentially failing to safeguard its intellectual property globally[195] - The company may incur significant costs and time in legal disputes related to patent infringement claims, which could adversely affect its reputation and stock price[195] Corporate Governance and Management - The company has a strong leadership team with extensive experience in the pharmaceutical and biotechnology industries, including independent directors with significant backgrounds in finance and research[158][160] - The company focuses on two main business segments: Harbour Therapeutics, which specializes in clinical-stage research and development of differentiated antibody therapies for oncology and immune diseases, and Nona Bio, which collaborates on various therapeutic approaches in these disease areas[166] - The management discussion and analysis section of the annual report provides insights into the business review and future development of the group[169] - The company has maintained key relationships with employees, customers, suppliers, and other stakeholders that significantly impact its operations[166] Future Outlook - The company expects to submit at least two new product IND applications in 2025, focusing on immunology[109] - The company aims to strategically expand into the immunology field and enhance its product pipeline by leveraging its discovery engines[109] - The company plans to continue exploring drug development strategies and seek collaboration opportunities[79] - The company anticipates more global collaboration opportunities as its preclinical products mature[38] - The company is actively exploring the scalability of its proprietary technology platform to maximize its value[80] - The company plans to build an innovation center in Beijing with AstraZeneca to further advance their collaboration projects[107]
和铂医药(02142) - 翌日披露报表
2025-04-17 12:16
公司名稱: 和鉑醫藥控股有限公司 表格類別: 股票 狀態: 新提交 呈交日期: 2025年4月17日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 02142 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 事件 | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | | | | | | | 已發行股份(不包括庫存股份)數 目 | | 佔有關事件前的現有已發 行股份(不包括庫存股 份)數目百分比 (註3) | 庫存股 ...
和铂医药(02142) - 翌日披露报表
2025-04-16 12:43
FF305 表格類別: 股票 狀態: 新提交 公司名稱: 和鉑醫藥控股有限公司 呈交日期: 2025年4月16日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | | 是 | | | | 證券代號 (如上市) | 02142 | 說明 | | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | | | | | | 事件 | | 已發行股份(不包括庫存股份)數 目 | | 佔有關事件前的現有已發 行股份(不包括 ...
港股异动 | 医药股涨幅居前 再鼎医药(09688)涨近15% 和铂医药-B(02142)涨超10%
智通财经网· 2025-04-14 02:05
广发证券认为,当前资本市场的关注焦点正悄然从传统的地产和政策周期转向更具长期战略意义的中美 科技博弈。该行建议重视港股创新药的配置价值,原因在于:核心逻辑一:中国创新药出海的全球竞争 优势正在凸显;核心逻辑二:当前关税政策对创新药影响远小于其他成长性板块;核心逻辑三:政策及 监管态度逐步转向对板块有利的情形。2023年下半年以来,政策层面出现了一系列积极信号,标志着行 业监管思路的调整,包括但不限于集采规则优化、创新药支持政策加码、医疗反腐常态化与纠偏。 此外,财报层面:头部港股创新药公司受益于License-out放量,营收和利润稳步增长。估值层面:年初 以来科技股的放量大涨之后,医药板块相比于其他成长行业,估值处于相对安全的区间。该行表示,年 初以来在DeepSeek的激励下,港股市场交投情形改善显著,相比之下,港股医药板块的关注度并不算 高,对医药的基本面修复,市场定价或尚不充分。 智通财经APP获悉,医药股早盘涨幅居前,截至发稿,再鼎医药(09688)涨14.86%,报25.5港元;和铂医 药-B(02142)涨10.07%,报7.87港元;荣昌生物(09995)涨8.22%,报30.95港元;君实生 ...
和铂医药(02142) - 自愿公告 - 於市场上进行股份购回
2025-04-10 13:29
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分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 和鉑醫藥控股有限公司 HBM Holdings Limited (於開曼群島註冊成立的有限公司) 和鉑醫藥控股有限公司(「本公司」,連同其附屬公司統稱「本集團」)董事會(「董 事會」)謹此宣佈,根據本公司股東(「股東」)於本公司2024年6月6日舉行的股東 週年大會上批准的購回股份的一般授權及(如適用)未來股東於本公司不時的股東 大會上批准的購回股份的任何一般授權(「購回授權」),其擬不時於公開市場上購 回價值不超過200百萬港元的本公司股份(「股份」)。包括目前的購回計劃,本公 司於2025年至今累計撥出240百萬港元用於股份購回,彰顯了本公司持續提升股 東價值的承諾。 本公司將根據香港聯合交易所有限公司(「聯交所」)證券上市規則(「上市規則」) 進行股份購回。根據上市規則第10.06(2)(e)條,發行人在得悉內幕消息後,不得 在聯交所購回其股份,直至有關消息已公開為止。尤其是,發行人不得在以下較 ...
和铂医药(02142) - 翌日披露报表
2025-04-08 13:08
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別: 股票 狀態: 新提交 公司名稱: 和鉑醫藥控股有限公司 呈交日期: 2025年4月8日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | | 02142 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | | 庫存股份變動 | 每股發行/出售價 (註4) | 已發行股份總數 ...
和铂医药(02142) - 完成根据一般授权发行认购股份
2025-04-08 11:03
和鉑醫藥控股有限公司 HBM Holdings Limited (於開曼群島註冊成立的有限公司) (股份代號:02142) 完成根據一般授權 發行認購股份 茲提述和鉑醫藥控股有限公司(「本公司」,連同其附屬公司統稱「本集團」)日期為 二零二五年三月二十一日的公告(「該公告」),內容有關(其中包括)根據一般授權 向AstraZeneca Holdings發行認購股份及和鉑上海與AstraZeneca之間的戰略合作。 除非另有界定,否則本公告所用詞彙與該公告所界定者具有相同涵義。 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分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 (i) 約70%將用於臨床前發現以及臨床項目的研發;及 (ii) 約30%將用作營運資金及其他一般公司用途。 認購股份已根據一般授權獲發行及配發。根據一般授權,董事獲授權發行、配發 及處理最多153,775,282股股份。緊隨認購事項前,本公司根據一般授權可配發及 發行的新股份數目為153,775,282股。緊接認購事項完成後,本 ...
和铂医药(02142) - 翌日披露报表
2025-04-01 12:41
公司名稱: 和鉑醫藥控股有限公司 呈交日期: 2025年4月1日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 FF305 | 第一章節 | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 | | | | 是 | | | | 證券代號 (如上市) 02142 | 說明 | | | | | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | 事件 | | 已發行股份(不包括庫存股份)變動 | | | 庫存股份變動 | | | | | | | | | 已發行股份(不包括庫存股份)數 目 | | 佔有關事件前的 ...
和铂医药(02142) - 2024 - 年度业绩
2025-03-31 10:10
Financial Performance - Revenue for the year ended December 31, 2024, was $38.1 million, a decrease of 57.5% compared to $89.5 million in 2023[4] - Net profit for the year was $2.742 million, down from $22.763 million in the previous year, reflecting a significant decline[4] - Total revenue for 2024 was $38.1 million, a decrease of 57.5% from $89.5 million in 2023[78] - The company reported a net loss of $3.5 million in 2024, compared to a net loss of $1.4 million in 2023[140] - The company achieved a profit of $2.7 million and cash profit of $130.7 million for the year ended December 31, 2024[76] - The company reported a total comprehensive income of USD 3,068,000 for the year, down from USD 23,541,000 in 2023[117] Research and Development - Research and development expenses decreased to $20.999 million from $45.081 million, indicating a reduction in investment in this area[4] - The company invested in Enkasei Pharma, acquiring 15.8% of its registered capital, enhancing its technology platform strategy[68] - The company received government grants totaling $1.0 million in 2024 to support R&D activities[137] - Research service fees generated $6.9 million in 2024, up from $3.2 million in 2023, indicating a growth of 118.5%[131] - HBM1020, a first-in-class fully human monoclonal antibody targeting B7H7, began Phase I clinical trials in the U.S. in May 2023, addressing unmet medical needs in solid tumor treatments[38] Product Development and Pipeline - The company submitted a Biologics License Application for HBM9161 for the treatment of generalized Myasthenia Gravis, accepted by the NMPA in July 2024[5] - A new drug application for HBM9378/WIN378 for Chronic Obstructive Pulmonary Disease is expected to be submitted in November 2024, with approval anticipated in February 2025[6] - The proprietary Harbour Mice® platform generates fully human monoclonal antibodies, enhancing the development of novel therapies[22] - The product pipeline includes multiple clinical-stage assets targeting solid tumors and immune diseases, with several candidates in Phase 1 and Phase 2 trials[24] - HBM4003 (Prusab) targets CTLA-4 for melanoma, while HBM1020 targets B7H7/HHLA2 for solid tumors, both showing significant potential[25] Collaborations and Agreements - A global licensing agreement with AstraZeneca was established, with an upfront payment of $19 million and potential milestone payments up to $575 million[13] - The company entered into a research collaboration with Candid Therapeutics, with potential payments of up to $320 million[13] - The company has established partnerships for the development and commercialization of its assets, including HBM9161 for myasthenia gravis in Greater China[26] - The company signed an exclusive licensing agreement with Windward Bio, which could yield up to $970 million in total payments, including upfront and milestone payments, along with tiered royalties based on net sales[54] - A strategic collaboration with AstraZeneca was established to co-develop next-generation therapeutic antibody projects, with potential milestone payments totaling up to $4.4 billion[72] Financial Position and Assets - Total assets decreased to $215.014 million from $228.480 million, while total liabilities reduced to $90.962 million from $108.851 million[4] - Cash and cash equivalents increased to $166.821 million from $140.324 million, indicating improved liquidity[4] - The company's cash and cash equivalents increased to $166,821,000 in 2024 from $140,324,000 in 2023, representing a growth of about 18.9%[168] - Non-current liabilities decreased significantly to $21,531,000 from $44,721,000, a reduction of 51.9%[119] - Trade receivables decreased significantly from $52,323,000 in 2023 to $9,440,000 in 2024, a reduction of approximately 82%[160] Corporate Governance and Compliance - The board does not recommend a final dividend for the year ended December 31, 2024, consistent with the previous year[102] - The company has complied with all applicable corporate governance code provisions, except for the separation of the roles of chairman and CEO[107][108] - The audit committee has reviewed the audited financial statements for the year ended December 31, 2024, and discussed accounting policies and internal controls with senior management[112] - Chen Weiwei has been appointed as the chair of the audit committee effective January 1, 2025, ensuring compliance with relevant listing rules[109] Market and Revenue Insights - Major customer A contributed $19.0 million in revenue for 2024, while customer B's contribution dropped to $2.4 million from $51.3 million in 2023[130] - Revenue from Europe increased significantly to $19.5 million in 2024 from $0.278 million in 2023[128] - Recurring revenue increased from $5.7 million for the year ended December 31, 2023, to $16.9 million for the year ended December 31, 2024[76] - Other income totaled $11.2 million in 2024, an increase of 69.5% from $6.6 million in 2023[137] Future Outlook and Strategy - The company aims to address unmet medical needs in oncology and immune-related diseases through innovative antibody therapies[19] - The strategic focus includes expanding the product pipeline with next-generation therapies to meet significant unmet medical needs[21] - The company is actively pursuing collaborations with global academic institutions and biotech firms to accelerate innovation in antibody therapies[20] - The ongoing development of bispecific immune cell engagers and antibody-drug conjugates aims to improve treatment outcomes in oncology[25]
与阿斯利康签300亿大单,和铂医药在下一盘什么棋?
3 6 Ke· 2025-03-24 07:36
Core Viewpoint - The strategic collaboration between Heptares Therapeutics and AstraZeneca, valued at over 30 billion RMB, aims to develop next-generation multispecific antibody therapies for various diseases, showcasing Heptares' innovative capabilities and global strategic planning [1][2]. Group 1: Strategic Collaboration Details - The collaboration includes a licensing agreement for multiple projects based on Heptares' proprietary Harbour Mice® platform and a $105 million equity investment from AstraZeneca [1]. - Heptares will receive an upfront payment of $175 million (approximately 1.27 billion RMB), milestone payments, and up to $4.4 billion (approximately 31.9 billion RMB) in research and commercial milestone payments, along with tiered royalties based on future product sales [2]. - This partnership marks the third strategic collaboration between Heptares and AstraZeneca since 2022, with this deal being more extensive and financially significant compared to previous agreements [2]. Group 2: Future Development and Operations - Heptares plans to establish an innovation center in Beijing in collaboration with AstraZeneca to enhance local drug discovery capabilities and integrate their unique technologies into a new ecosystem [3]. - AstraZeneca will acquire 9.15% of Heptares' newly issued shares at a price of $1.38 per share, representing a 37.2% premium over the closing price on March 21 [3]. Group 3: Market Response and Financial Strategy - Following the announcement, Heptares' stock price surged over 14%, reflecting positive market sentiment, with a closing price of 8.39 HKD per share and a total market capitalization of 63.54 billion HKD [4]. - Heptares aims to focus its resources on technology and product iterations, expanding its HCAb platform into new therapies and molecular structures while prioritizing high-return clinical projects [4]. - The company is also exploring cutting-edge biopharmaceutical technologies and has initiated a weight-loss drug project, Élancé Therapeutics, which has been in development for two years [4]. Group 4: Product Development Progress - Heptares' most advanced product, HBM9161, targeting FcRn for treating generalized myasthenia gravis, has its BLA accepted by the National Medical Products Administration in July 2024 [5]. - The rights for HBM9161 in Greater China were licensed to CSPC Pharmaceutical Group, while Heptares retains the responsibility for clinical trial design and execution [5]. - The potential benefits from HBM9161 will depend on its approval status, but the current strategic collaboration with AstraZeneca may overshadow its immediate importance [5].