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) 公司名稱： 和鉑醫藥控股有限公司 呈交日期： 2024年10月29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 ...

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。 委任聯席公司秘書； 豁免嚴格遵守上市規則第3.28條及第8.17條； 及 豁免嚴格遵守上市規則第3.10(2)條及第3.21條 委任聯席公司秘書 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（「董 事」）會（「董事會」）謹此宣佈，於2024年10月24日，董事會已批准委任高一帆女 士（「高女士」）為本公司聯席公司秘書，自2024年10月24日開始生效。本公司的 現任公司秘書呂穎一先生（「呂先生」）將為本公司的另一名聯席公司秘書。 高女士的履歷詳情載列如下： 高女士於2018年8月加入本集團，擔任商業情報代表。自2022年11月至2023年9 月，彼一直擔任投資者關係及商業情報副總監，負責本集團的投資者關係及香港 上市相關秘書工作。自2023年10月起，高女士成為本公司的主要聯絡人，一直與 本公司現任公司秘書呂先生合作，並與呂先生就（包括但不限於）本集團企業管 治、公司秘書及行政事 ...

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： 2024年10月24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（不包括庫 ...

Financial Performance - Revenue for the six months ended June 30, 2024, was $23.7 million, a decrease of 42.2% compared to $41.0 million for the same period in 2023[3]. - The company reported a net profit of $1.4 million for the first half of 2024, compared to a profit of $2.9 million in the same period of 2023, representing a decline of 52.1%[3]. - Gross profit for the period was $22.516 million, down from $40.973 million, reflecting a significant decline in sales[86]. - The company reported a profit before tax of $1.724 million, compared to $2.903 million in the previous year, showing a decline of 40.5%[86]. - Total comprehensive income for the period was $1.708 million, a decrease of 65.8% from $4.999 million in the same period of 2023[87]. - Profit for the reporting period decreased from $2.9 million for the half-year ended June 30, 2023, to $1.4 million for the same period in 2024, a decline of 48.3%[47]. Research and Development - Research and development expenses amounted to $13.1 million, down from $28.4 million in the previous year, reflecting a reduction of 53.8%[3]. - Employee costs in R&D dropped from $8.8 million to $6.6 million, contributing to the overall reduction in R&D expenses[43]. - The company reported R&D costs of $13.1 million for the six months ended June 30, 2024, down from $28.4 million for the same period in 2023, reflecting a decrease of 53.8%[39]. - The company has over 10 candidate drugs focused on tumor and immune diseases, ranging from preclinical to late-stage clinical phases[16]. - The company aims to expand its platform applications into immunology and inflammation fields, leveraging its Harbour Mice® and HBICE® discovery engines to identify new high-quality candidate molecules[38]. Cash and Assets - Cash and cash equivalents increased to $183.0 million as of June 30, 2024, up from $140.3 million at the end of 2023, indicating a growth of 30.4%[4]. - Total assets decreased to $219.7 million from $228.5 million, a decline of 3.0%[4]. - The company’s total liabilities reduced to $96.9 million, down 11.0% from $108.9 million[4]. - Current assets amounted to $202,891,000, down from $210,176,000, indicating a decrease of about 3.9%[88]. - Total liabilities decreased to $58,736,000 from $64,130,000, a reduction of about 8.3%[88]. Licensing and Collaborations - The company entered into a global licensing agreement with Seagen Inc. for HBM9033, with an upfront payment of $19 million expected upon deal completion[10]. - Harbour Therapeutics' BLA for HBM9161 for treating gMG was accepted by NMPA in July 2024[6]. - The collaboration with AstraZeneca includes an upfront payment of $19 million and potential milestone payments totaling up to $575 million[32]. - The company is actively exploring drug development strategies and seeking collaboration opportunities for its pipeline products[26][27][28][29][30]. Shareholder Information - As of June 30, 2024, the total number of issued shares is 768,876,410[70]. - Major shareholder Yongfengli Investment Limited owns 93,561,360 shares, which is about 12.17% of the total equity[72]. - The shareholding structure indicates significant control by a few major shareholders, with concentrated ownership among investment entities[73]. - The company has granted Dr. Wang 7,200,000 options and 956,500 restricted shares under post-IPO plans[74]. Corporate Governance - The audit committee includes two independent non-executive directors and one non-executive director, with a focus on reviewing financial statements and internal controls[63]. - The company has established a compensation committee as part of its governance structure[164]. - The company is subject to regulations by the National Medical Products Administration (NMPA) in China[165]. - The company is also regulated by the U.S. Food and Drug Administration (FDA)[165]. Future Outlook - The company aims to maximize platform value through a flexible business model leveraging complementary advantages with partners[14]. - The company plans to focus on the development of products from its proprietary platform and explore the expansion of its collaboration network[38]. - The company aims to submit at least one IND application annually generated from its discovery engine[25].

Financial Performance - For the six months ended June 30, 2024, the company reported revenue of $23.701 million, a decrease from $40.996 million in the same period of 2023, representing a decline of approximately 42.2%[2] - The company recorded a net profit of $1,397,000 for the six months ended June 30, 2024, compared to $2,914,000 in the same period of 2023, representing a decline of 52.1%[60] - Gross profit for the same period was $22,516,000, down from $40,973,000, reflecting a significant decline in profitability[59] - Revenue from major clients contributing over 10% to total revenue was $19,133 thousand in 2024, down from $39,837 thousand in 2023[72] - Revenue from product licensing fees was $20,832 thousand, while research service fees contributed $2,326 thousand in the first half of 2024[73] - The company reported a pre-tax loss of $874 thousand in the first half of 2024, compared to a profit of $23 thousand in the same period of 2023[78] - The company incurred a total tax expense of $(327) thousand in the first half of 2024, compared to $11 thousand in the same period of 2023[84] - The company has not declared or paid any dividends during the reporting period[85] Assets and Liabilities - The total assets as of June 30, 2024, were $183.038 million, compared to $140.324 million as of December 31, 2023, indicating an increase of about 30.4%[2] - The total liabilities decreased to $96.899 million from $108.851 million, reflecting a reduction of approximately 11%[2] - The company’s total equity increased to $122,807,000 as of June 30, 2024, compared to $119,629,000 at the end of 2023, indicating a positive trend in shareholder equity[64] - The total bank loans amount to $65.0 million, with lease liabilities of $1.2 million as of June 30, 2024[47] - Trade receivables as of June 30, 2024, amounted to $1.471 million, a significant decrease from $52.323 million as of December 31, 2023[89] - Trade payables as of June 30, 2024, totaled $5.382 million, down from $15.363 million at the end of 2023[90] Research and Development - The company has over 10 drug candidates focused on oncology and immune-related diseases, ranging from preclinical to late-stage clinical development[9] - The company aims to address unmet medical needs in oncology and immune diseases through innovative antibody therapies[5] - HBM4003, a next-generation fully human anti-CTLA-4 antibody, has shown positive efficacy and safety data in clinical trials for various solid tumors[13] - The company initiated a Phase I clinical trial for HBM9027 in January 2024, following the approval of an Investigational New Drug (IND) application by the FDA[3] - HBM1022, targeting CCR8, has received IND approval in the U.S. and is aimed at treating solid tumors globally[10] - The company is preparing for a Phase 2 trial for HBM9378, targeting asthma and chronic obstructive pulmonary disease[10] - HBM7020, targeting BCMAxCD3, has received IND approval in China for treating hematological malignancies[10] - HBM9378, targeting TSLP, completed its Phase I clinical trial in October 2023, with plans for a Phase II trial for severe asthma and an IND application for COPD[17] - The company aims to submit at least one IND application annually from its discovery engine, focusing on differentiated antibody therapies in oncology and immunology[19] Collaborations and Agreements - A global licensing agreement was signed with AstraZeneca in May 2024, which includes an upfront payment of $19 million and potential milestone payments totaling up to $575 million[4] - The collaboration with CSPC Pharmaceutical Group for HBM9161 is expected to optimize market potential and advance clinical development[12] - The company established partnerships with over 25 industry pioneers and academic institutions to expand its global collaboration network[25] - The company is exploring additional platform-based collaborations to enhance its product pipeline and market presence[4] - In February 2023, the company entered into a licensing and collaboration agreement with Cullinan Therapeutics for HBM7008, which will be terminated in November 2024, allowing the company to regain global rights[14] Cost Management and Expenses - R&D costs significantly decreased from $28.4 million for the six months ended June 30, 2023, to $13.1 million for the same period in 2024, a reduction of 53.8%[37] - Administrative expenses decreased to $7.9 million for the six months ended June 30, 2024, from $8.6 million for the same period in 2023, reflecting improved cost management[39] - Employee costs for R&D represented 50.2% of total R&D expenses for the six months ended June 30, 2024, compared to 31.2% for the same period in 2023[38] - The total employee compensation cost for the first half of 2024 is $13.2 million, compared to $14.4 million for the same period in 2023[48] Future Outlook - The company plans to focus on the development of products from its proprietary platform and explore expansion of its collaboration network[32] - The company expressed confidence in its ability to provide innovative treatments for immune diseases and cancer patients in the near future[31] - The company is incubating several joint ventures focused on developing next-generation therapies, utilizing a "technology for equity" model to minimize investment[29]

Financial Position - As of December 31, 2023, the fair value of the investment was $5.75 million, accounting for 2.52% of the company's total assets, with an unrealized fair value loss of $0.51 million recorded during the reporting period[3]. - The company has bank loans totaling $64.4 million and lease liabilities of $1.6 million as of December 31, 2023[9]. - The total lease liabilities as of December 31, 2023, amounted to $1.605 million, compared to $2.737 million as of December 31, 2022[10]. - The company has no significant or contingent liabilities as of December 31, 2023[8]. - The company recorded a net cash outflow from operations during the reporting period[35]. - The company faces risks related to its financial condition and additional capital needs, as well as risks associated with regulatory approvals for its candidate drugs[34]. Product Development and Pipeline - The company plans to accelerate its product pipeline in 2024, with at least two new products expected to file IND applications[4]. - The company will reallocate internal resources to focus on the development of products from its proprietary platform and the expansion of its collaboration network[5]. - The company has over 10 candidate drugs focused on tumor and immune diseases, ranging from preclinical to late-stage clinical development[77]. - HBM1007 and HBM1022 were approved in the US in January and February 2023, respectively, indicating progress in the company's product pipeline[77]. - HBM9378 has entered clinical development, completing Phase I trials in October 2023 after recruiting healthy participants in March 2023[96]. - HBM9378, a fully human monoclonal antibody targeting TSLP, shows lower immunogenicity risk and better bioavailability compared to competitors[96]. - The company aims to advance multiple internal pipeline products into clinical trials in 2024, focusing on global clinical development projects[102]. - A series of products derived from T cell and NK cell connector concepts are expected to enter clinical stages in the coming years, enhancing the company's offerings in immuno-oncology[102]. Regulatory and Market Environment - Regulatory approval processes from agencies like the FDA are lengthy and may evolve over time, with failure to obtain approval severely damaging the business[71]. - The overall industry is experiencing challenges due to policy changes affecting drug pricing and procurement, impacting the pricing of less differentiated products[80]. - The Chinese government is undertaking a year-long campaign to address corruption in the pharmaceutical sector, which may impact the industry landscape[80]. - The company acknowledges potential regulatory changes in China's biotech industry that could impact drug approvals and commercialization[106]. Supplier and Purchasing - The group purchased products from its largest supplier, accounting for 12.5% of total purchases, up from 6.8% in 2022[61]. - Purchases from the top five suppliers represented 30.6% of total purchases, an increase from 19.9% in 2022[61]. Innovation and Collaboration - The company has established a proprietary antibody technology platform, Harbour Mice®, which generates fully human monoclonal antibodies[76]. - Harbour Therapeutics aims to address unmet needs in oncology and immunology with a differentiated product pipeline[75]. - The company has launched Nona Bio to enhance industry innovation and provide comprehensive solutions for partners[76]. - The company has licensed HBM7008 rights in the US to Cullinan in February 2023, expanding its market reach[77]. - The company has licensed global rights for HBM9033, a potential best-in-class MSLN-targeted ADC, to Pfizer, showcasing its platform's strength in expanding technological boundaries[99]. - The company is incubating several joint ventures focused on next-generation innovative therapies, including multivalent antibodies and cell therapies, with minimal marginal investment[100]. - The company anticipates more global collaboration opportunities as its preclinical products mature, maximizing platform value through commercial partnerships[102]. Employee and Diversity Initiatives - The company reported a total of 177 employees, with 111 females, representing 62.7% of the workforce, exceeding the diversity goal of over 50% female representation[152]. - The company has implemented continuous learning and training programs for employees to enhance their skills and knowledge, ensuring competitiveness and improved customer service[128]. - The company has not faced any significant recruitment difficulties or severe employee turnover during the reporting period[128]. - The company has maintained a balanced gender diversity within its workforce, with specific initiatives to enhance recruitment processes and promote inclusivity[152]. Compensation and Equity Incentives - The company has established a compensation committee to review its compensation policies, considering operational performance and individual contributions of directors and senior management[150]. - The company has introduced several equity incentive plans to motivate eligible employees, including pre-IPO and post-IPO stock options and restricted shares[153]. - The post-IPO option plan is designed to provide selected participants with the opportunity to purchase exclusive rights of the company[177]. - The company aims to align the interests of employees, directors, and consultants with those of shareholders through the equity incentive plan[191]. - The company has not granted any new restricted shares during the reporting period, while 3,833,344 restricted shares vested[199]. Shareholder Information - Dr. Wang Jinsong holds 60,334,400 shares, representing 7.85% of the company's equity after the global offering[158]. - The total number of shares issued as of December 31, 2023, is 768,428,910[162]. - Yongfengli Investment Limited holds 93,561,360 shares, accounting for 12.18% of the company's equity[162]. - LC Healthcare Fund I, L.P. owns 68,601,000 shares, which is 8.93% of the company's equity[162]. - The company has three share plans: pre-IPO equity plan, post-IPO share option plan, and post-IPO share award plan[166]. - The maximum number of shares available for the pre-IPO equity plan is 132,499,240 shares[171]. - As of December 31, 2023, there are 3,040,000 unvested restricted share units[176]. - The total number of new shares that can be issued under the post-IPO equity incentive plan is 40,494,000, representing approximately 5.27% of the company's weighted average issued share capital during the reporting period[188]. - As of January 1, 2023, the maximum number of shares that can be granted under the pre-IPO equity plan is 10,689,120 shares, with 342,720 shares being canceled during the reporting period[192]. - The fair value of the restricted shares is determined based on the closing price of the common stock on the grant date, calculated according to the accounting standards and policies adopted for the preparation of the company's financial statements[199].

Product Development and Clinical Trials - HBM9027 received IND approval from the FDA in January 2024, initiating Phase I trials in the US[5] - HBM7004, a novel B7H4xCD3 bispecific antibody, is designed to provide new solutions for tumor immunotherapy, enhancing both efficacy and safety[5] - HBM1047 demonstrated significant antitumor efficacy in various preclinical models, with a maximum tolerated dose of 200 mg/kg in primate studies[12] - The company completed a Phase III clinical trial for HBM9161 in March 2023, indicating progress in its product development pipeline[172] - The company announced the completion of Phase I clinical trials for HBM9378 in October 2023, targeting neuroendocrine tumors/cancers (NET/NEC)[174] - HBM1022 received IND approval from the FDA in February 2023 to initiate Phase I trials for solid tumors[176] - HBM1007 received IND approval from the FDA in January 2023 to start Phase I trials for solid tumors[182] - The company reported the completion of patient recruitment for Phase I trials in March 2023[180] - Bartolizumab (HBM9161) completed patient treatment in early 2023, with positive Phase III trial results for gMG announced in March 2023, marking a significant milestone as the company's first Phase III trial ready for commercialization[200] - The open-label extension clinical trial for Bartolizumab was initiated in 2022 and completed enrollment in March 2023, with ongoing analysis showing sustainable efficacy and safety for long-term disease management as of November 2023[200] - Bartolizumab's Biologics License Application (BLA) was accepted by NMPA in June 2023, representing the first BLA accepted since the company's establishment[200] - The company plans to voluntarily include additional long-term safety data and resubmit the BLA for Bartolizumab in December 2023[200] Financial Performance - For the fiscal year ending December 31, 2023, the company reported revenue of $89.5 million, a significant increase of $48.8 million or 119.9% compared to $40.7 million for the fiscal year ending December 31, 2022[40] - The company achieved a profit of $22.8 million for the fiscal year ending December 31, 2023, a substantial turnaround from a loss of $137.3 million in the previous year, an increase of $160.1 million[56] - The company reported a net profit of $22,797 million for 2023, recovering from a loss of $137,222 million in 2022[120] - Basic earnings per share for 2023 were $0.03, compared to a loss of $0.19 per share in 2022[120] - The gross profit for the year was $87,468 thousand, significantly up from $40,529 thousand, indicating a strong improvement in profitability[81] - The increase in revenue was primarily driven by licensing agreements with Seagen, Cullinan, and Keren Bio[41] - The company reported a total of $10,942,000 in software and technology licensing costs as of December 31, 2023, compared to $10,900,000 in 2022, showing a slight increase[135] - Other income and gains increased from $4.8 million for the fiscal year ending December 31, 2022, to $6.6 million for the fiscal year ending December 31, 2023, primarily due to increased interest income from higher cash balances[43] Research and Development - Research and development expenses decreased to $45.1 million for the fiscal year ending December 31, 2023, down from $135.1 million in the previous year, representing a reduction of $90.0 million or 66.6%[52] - The company utilized $405.4 million for the clinical trials and related R&D activities of its core product HBM9161, with no remaining unutilized funds as of December 31, 2023[79] - The company has a strategic focus on developing differentiated products with clear clinical value to meet unmet clinical needs, particularly in the Greater China market[195] - The company’s proprietary antibody technology platform, Harbour Mice®, enables the generation of fully human monoclonal antibodies, enhancing its innovation and sustainable growth[192] - The company is actively pursuing the commercialization of its core products, including HBM9161 and HBM9036, with ongoing clinical trials in the Greater China region[78] Collaborations and Licensing Agreements - In April 2022, the company entered a global licensing agreement with AstraZeneca for HBM7022, which has received IND approvals from the FDA and NMPA in 2023[13] - The company secured a $25 million upfront payment and potential milestone payments of up to $600 million from Cullinan for HBM7008[13] - A licensing agreement with Pfizer for HBM9033 was signed in December 2023, providing $53 million in upfront payments and up to $1.05 billion in milestone payments[19] - The company is expanding its collaboration network globally, partnering with industry leaders and academic researchers to maximize the value of its proprietary technology platform[18] - The company announced a strategic collaboration with INGENIA Therapeutics in October 2023 to accelerate the development of innovative therapies for immune diseases[178] - The company is advancing a partnership with Boston Children's Hospital to develop new antibody therapies using its target discovery and antibody design platform[187] Corporate Governance and Compliance - The company has established an audit committee, nomination committee, and remuneration committee to enhance corporate governance[75] - The company plans to adopt revised international financial reporting standards when they become effective[96] - The company is committed to addressing the challenges posed by new regulatory requirements in clinical trials and patient privacy protection globally[197] Market Position and Strategy - The company aims to optimize its strategies in research, development, registration, and global collaboration to enhance its market position[197] - The company anticipates regulatory approvals for multiple products in the U.S. market in early 2024, indicating a proactive approach to market entry[194] - The Chinese pharmaceutical industry is undergoing significant reforms, impacting drug pricing and market dynamics, which the company is strategically navigating[195] - The company’s focus on innovative drug development aligns with the growing demand driven by healthcare upgrades and an aging population[197]

Financial Performance - The company reported a profit attributable to shareholders of $2,922 thousand for the six months ended June 30, 2023, compared to a loss of $73,051 thousand in the same period of 2022[3]. - The basic and diluted earnings per share for the period were both $0.00, an improvement from a loss of $0.10 per share in the prior year[3]. - The company reported a total revenue of $727.36 million for the first half of 2023, representing a significant increase compared to the previous period[73]. - Revenue for the six months ended June 30, 2023, was $40.996 million, a 48.1% increase from $27.630 million in the same period of 2022[126]. - The company reported a profit of $2.914 million for the period, compared to a loss of $73.079 million in the previous year[126]. - Cash and bank balances increased to $179.339 million from $171.705 million, indicating a strong liquidity position[126]. - The total assets decreased slightly to $223.513 million from $232.123 million, while total liabilities also decreased to $123.152 million from $139.622 million[126]. Shareholder and Equity Information - The company did not repurchase any of its own ordinary shares during the reporting period, compared to the repurchase of 1,468,000 shares for a total cost of approximately $753,000 in the prior year[26]. - The number of restricted share units at the end of the reporting period was 7,671,904, an increase from 4,149,840 in the same period of 2022[25]. - The company issued 39,967,000 stock options during the six months ended June 30, 2023, resulting in a total of 35,678,050 stock options outstanding at the end of the period[34]. - The company had a weighted average number of ordinary shares issued of 732,387,673 for the period, slightly down from 732,901,025 in the previous year[3]. - The company confirmed share-based payment expenses of $775,000 for the first half of 2023 under the 2016 equity incentive plan, a decrease from $5,717,000 for the same period in 2022[69]. - Share-based payment expenses related to the post-IPO stock option plan amounted to $1,492,000 for the first half of 2023, with no expenses recorded for the same period in 2022[70]. - The share-based payment expenses significantly decreased to $848,000 from $4,248,000, representing a decline of 80%[90]. - The total management compensation for the first half of 2023 was $2,949,000, down 54.5% from $6,488,000 in the same period of 2022[90]. Trade Receivables and Credit Quality - Trade receivables aged less than three months at the end of the reporting period were $16,398 thousand, a decrease from $22,029 thousand as of December 31, 2022[10]. - Trade receivables as of June 30, 2023, amounted to $7,191,000, slightly up from $7,118,000 as of December 31, 2022, indicating a growth of 1.0%[40]. - The company reported minimal expected credit losses on trade receivables, indicating strong credit quality[7]. - The company’s trade receivables are fully impaired, with no provisions for bad debts reported[40]. - The company has an outstanding receivable from associates amounting to $2.768 million as of June 30, 2023, slightly down from $2.872 million in the previous year[89]. Research and Development - The company has a diverse product pipeline with over ten potential differentiated drug candidates, four of which are in clinical development[106]. - The company’s management highlighted ongoing research and development efforts aimed at enhancing product offerings and technological advancements[83]. - The company is focused on expanding its innovative pipeline, particularly in the field of tumor immunotherapy and autoimmune diseases[120][121]. - The company aims to maximize the value of its platforms by focusing on innovative and efficient industry partnerships[111]. - The company is exploring multiple projects in tumor immunity and autoimmune diseases, including novel monoclonal antibody projects[109]. - The company has observed significant market opportunities despite challenges in global drug development and commercialization due to policy changes[188]. Clinical Trials and Product Development - HBM4003, a next-generation fully human anti-CTLA-4 antibody, is the first fully human heavy-chain antibody to enter clinical development globally, showing improved pharmacokinetic characteristics compared to traditional anti-CTLA-4 antibodies[107]. - The company completed a Phase III clinical trial for generalized myasthenia gravis (gMG) in March 2023[114]. - The company submitted a Biologics License Application (BLA) for the treatment of gMG, which was accepted by the National Medical Products Administration (NMPA) in June 2023[149]. - HBM4003, a next-generation fully human anti-CTLA-4 antibody, is in global development for various solid tumors, with significant progress reported in ongoing trials[145]. - The company has initiated Phase I trials for HBM1020 and HBM1022, with FDA IND approvals received in January and February 2023 respectively[128][129]. - A global licensing agreement was established with AstraZeneca for HBM7022, which has also received FDA IND approval and commenced Phase I trials[132]. - The company completed the first patient dosing in a Phase I trial for HBM1020 in June 2023[152]. - HBM1007 received IND approval from the FDA in January 2023, initiating a Phase I trial for solid tumors[153]. - The company is advancing collaborations with Boston Children's Hospital to identify and develop new antibody therapies, completing seed financing for HBM Alpha Therapeutics in January 2023[160]. Strategic Collaborations and Partnerships - Strategic collaborations were formed with Mythic Therapeutics and PIRC to enhance the development of ADC therapies and proprietary antibody platforms[134][135]. - The Harbour Mice® platform enables the development of fully human monoclonal antibodies, enhancing the company's innovation and sustainable growth[110]. - The company has global rights to use and develop the Harbour antibody platform, focusing on unmet medical needs and expanding collaborations with leading academic institutions[111]. - The company is exploring the integration of AI technology with its Harbour Mice® platform through a partnership with BaiTu Bio[157]. Compliance and Regulatory Matters - The company is focused on maintaining compliance with international financial reporting standards and local regulations[82]. - The revised Drug Registration Management Measures in China, effective July 2020, aim to accelerate the approval of urgently needed drugs, benefiting more patients[143].

Financial Performance - For the six months ended June 30, 2023, the company reported revenue of $40,996 thousand, a 48% increase from $27,630 thousand in the same period of 2022[27]. - The company recorded a net profit of $2,914 thousand for the period, compared to a net loss of $73,079 thousand in the previous year[27]. - Total revenue increased significantly from $27.6 million for the six months ended June 30, 2022, to $41.0 million for the six months ended June 30, 2023, primarily due to an increase in revenue from molecular licensing fees[159]. - The company reported a profit of $2.9 million for the six months ended June 30, 2023, compared to a loss of $73.1 million for the same period in 2022[165]. Cash and Assets - Cash and cash equivalents as of June 30, 2023, totaled $179,339 thousand, up from $171,705 thousand as of June 30, 2022[27]. - Total assets amounted to $223,513 thousand, a decrease from $268,307 thousand in the previous year[27]. - The company has a bank loan of USD 80.9 million and lease liabilities of USD 2.1 million as of June 30, 2023[193]. - The current ratio improved to 3.14 as of June 30, 2023, compared to 2.79 at the end of 2022, indicating better short-term financial health[144]. Research and Development - Research and development costs for the period were $28,378 thousand, compared to $83,619 thousand in the same period of 2022[27]. - R&D expenses decreased to $28.4 million for the six months ended June 30, 2023, down from $83.6 million for the same period in 2022[159]. - The company has established a strong antibody discovery platform and is focusing on innovative therapies for tumors and immune diseases, with ongoing clinical development progress[152][156]. - The company aims to submit at least one IND application annually generated from its discovery engine[48]. Collaborations and Agreements - In February 2023, the company signed a licensing and collaboration agreement with Cullinan Oncology Inc., receiving a $25 million upfront payment and potential milestone payments of up to approximately $600 million, along with high double-digit percentage royalties[31]. - The company has established a global licensing agreement with AstraZeneca for HBM7022, a new bispecific antibody, which has received IND approvals from the FDA and NMPA and has initiated global Phase I trials[31]. - The company is collaborating with Sichuan Kelong Biotechnology Co., Ltd. on HBM9378, which has entered the clinical development stage[45]. - The company established a collaboration with Boston Children's Hospital to develop innovative antibody therapies, with the main candidate HBM9013 entering the CMC development phase[88]. Clinical Trials and Product Development - The company announced positive Phase III clinical trial results for Bartolizumab (HBM9161) in treating gMG, marking its first successful Phase III trial and BLA acceptance by NMPA[63]. - HBM4003, a next-generation fully human anti-CTLA-4 antibody, is the first of its kind to enter clinical development globally, with ongoing trials showing promising efficacy and safety data[63]. - HBM1007, a fully human monoclonal antibody targeting CD73, is designed to inhibit both membrane-bound and soluble CD73, enhancing its activity in the tumor microenvironment[50]. - The company is exploring joint ventures focused on developing next-generation cell therapies to extend the application of its technology platform[129]. Financial Management and Governance - The board does not recommend the payment of an interim dividend for the six months ended June 30, 2023[175]. - The company remains committed to high standards of corporate governance to protect shareholder interests[196]. - The company has not planned any significant investments or capital asset acquisitions in the near future[191]. - The company did not engage in any significant acquisitions or disposals of subsidiaries or joint ventures during the reporting period[169]. Market and Strategic Outlook - The market demand for differentiated innovative drugs remains strong, driven by healthcare upgrades and an aging population[62]. - Harbour Therapeutics is committed to advancing its product pipeline based on clinical value and strategic partnerships[62]. - The company plans to accelerate its product pipeline in 2023, with at least one new product expected to file for IND approval through its Harbour Mice® and HBICE® discovery engines[99]. - The company anticipates broader global collaborations in 2023 as its preclinical products mature[132].

Licensing Agreements and Collaborations - The company entered a global licensing agreement with Enbipharma for HBM9161, receiving an upfront payment of RMB 150 million and potential milestone payments up to RMB 1.01 billion, along with tiered royalties based on sales[10]. - A global licensing agreement with AstraZeneca for HBM7022 includes an upfront payment of USD 25 million and potential milestone payments up to USD 325 million, plus tiered royalties based on sales[27]. - Nona Biosciences entered a collaboration with Moderna for developing nucleic acid immunotherapies, with an upfront payment of USD 6 million and potential milestone payments up to USD 500 million[12]. - Harbour Therapeutics has licensed global rights for HBM7022 to AstraZeneca and US rights for HBM7008 to Cullinan within one year[42]. - The collaboration with Nona Biosciences aims to empower industry innovators from idea to IND, showcasing a flexible business model and successful international partnerships[33]. - The collaboration with Mythic Therapeutics focuses on developing next-generation antibody-drug conjugates for various cancers[117]. - The company has entered into collaborations for ADC projects with Nona Biosciences, which will involve upfront payments, milestone payments, and royalties based on sales[143]. Clinical Development and Pipeline - HBM1020, HBM1022, and HBM1007 received IND approval from the US FDA for clinical trials in the first quarter of 2023[30]. - The company reported positive results from the pivotal Phase III clinical trial of HBM9161 for treating generalized myasthenia gravis, achieving primary and key secondary endpoints[10]. - HBM7015 has received IND approval from NMPA to initiate Phase I trials in China, with two additional projects expected to receive approval in 2023[43]. - The ongoing Phase III trial of HBM9036 (Tanezumab) for treating dry eye syndrome was halted due to insufficient efficacy trends, following recommendations from the independent data monitoring committee[47]. - The product pipeline includes candidates for melanoma, hepatocellular carcinoma, renal cell carcinoma, and other advanced solid tumors[39]. - The company has multiple products in various stages of clinical development, including Batoclimab (Phase 3 completed) and HBM9161 (Phase 2/3) targeting severe myasthenia gravis and thyroid-associated ophthalmopathy respectively[59]. - HBM9033, an antibody-drug conjugate targeting MSLN, is expected to demonstrate best-in-class therapeutic potential in its upcoming Phase 1 clinical trials[79]. - HBM4003 showed good safety in a trial for advanced melanoma, with 87.5% of patients reporting treatment-related adverse events[94]. - The company aims to submit at least one new drug IND application annually from its discovery platform[102]. Financial Performance and Position - Cash and bank balances exceeded financial liabilities as of December 31, 2022, indicating a strong liquidity position[129]. - Revenue from materials and third-party contract costs increased from $61.9 million in 2021 to $98.8 million in 2022 due to investments in key clinical projects[125]. - As of December 31, 2022, total employee costs were $14.77 million, accounting for 54.1% of total expenses, compared to $28.05 million (70.0%) in 2021[126]. - The company recorded an unrealized gain of $1.04 million from its investment in Enkasei during the reporting period, with the fair value of the investment as of December 31, 2022, being $6.36 million, representing 2.74% of the company's total assets[147]. - The current ratio as of December 31, 2022, was 2.79, down from 5.87 as of December 31, 2021[158]. - The company reported a total lease liability of $2.737 million as of December 31, 2022, down from $7.420 million the previous year[177]. - Unsecured bank borrowings amounted to $93.060 million as of December 31, 2022, compared to $11.276 million in the previous year[177]. Research and Development Focus - The company is focusing on developing highly differentiated products with clear clinical value to meet clinical needs, optimizing strategies in research, development, registration, and patents[61]. - The company is actively pursuing new product development and technological advancements in oncology, as evidenced by Dr. Rong's previous leadership in tumor projects at Roche[170]. - The company is focusing on innovative therapies for tumors and immunity, with ongoing drug discovery and preclinical research for new candidate drugs[139]. - The company has established a flexible business model around its proprietary technology platform, aiming to maximize platform value through collaboration with business partners[142]. - The company aims to leverage its expertise in capital markets to drive growth and investment opportunities[194]. Governance and Management - The company has appointed several independent directors with extensive experience in the pharmaceutical and biotechnology sectors, enhancing its governance structure[173][171]. - The company has established a strong board of directors with diverse backgrounds, including finance and biotechnology, to guide its strategic direction[189][185]. - The company has a strong management team with extensive experience in the biotechnology and financial sectors[194]. - The company has appointed a new Chief Medical Officer to strengthen its clinical development efforts[195]. - The management emphasizes the importance of innovation and believes the company will continue to grow in a rapidly developing industry, providing sustainable value to patients, employees, and shareholders[55]. Strategic Initiatives and Market Expansion - The company is exploring potential mergers and acquisitions to enhance its product pipeline and market presence[170]. - The company is strategically reallocating financial and other resources to maximize platform value and focus on core competencies, investing in projects with growth potential for more stable revenue[146]. - The company is actively pursuing market expansion strategies to increase its footprint in the biotechnology sector[199]. - The company has a commitment to maintaining high professional standards in its operations and governance[193]. - The company believes that co-development and external collaborations will enhance pipeline efficiency, reduce costs and risks, and stabilize its development[52].