Strategic Collaborations and Partnerships - The company has advanced strategic cooperation with Hualan Gene Engineering Co., Ltd. to submit IND applications for three innovative monoclonal and bispecific antibody projects between 2022 and 2023[2]. - The collaboration with AstraZeneca for the development and commercialization of HBM7022 includes a non-refundable upfront payment of $25 million and potential milestone payments up to $325 million[13]. - The company received a $6 million upfront payment and up to $500 million in milestone payments from Moderna for the licensing and collaboration agreement on nucleic acid immunotherapy[4]. - The company has established partnerships with LegoChem Biosciences Inc. and Duality Biotherapeutics, Inc. for antibody-drug conjugate projects, with two products licensed to partners[3]. - The company signed a licensing and collaboration agreement with Cullinan Oncology Inc. in February 2023, granting Cullinan exclusive rights to develop and commercialize product HBM7008 in the U.S., with an upfront payment of $25 million and potential milestone payments up to $600 million, along with tiered royalties in the double-digit percentage range[27]. - The company advanced its collaboration with Boston Children's Hospital, utilizing its antibody design platform to identify new therapeutic antibodies, and completed seed financing for the joint venture HBM Alpha Therapeutics in January 2023[30]. - The company is collaborating with Nona Biosciences and Mythic Therapeutics to develop next-generation antibody-drug conjugates and other therapies[64][65]. Clinical Development and Trials - HBM4003 (Porustobart) has shown promising efficacy in treating advanced hepatocellular carcinoma (HCC) with clinical benefits observed in patients previously treated with TKIs and anti-PD-1 antibodies[24]. - The company completed patient recruitment for the Ib/II clinical trial of HBM4003 in March 2022 and presented data at ASCO 2022[20][19]. - HBM4003, a next-generation fully human heavy-chain anti-CTLA-4 antibody, is in global development for various solid tumor indications, with promising efficacy and safety observed in early trials[42][45]. - The Phase I trial of HBM4003 included a dose escalation phase and a dose expansion phase, showing an overall response rate (ORR) of 11.8% and a disease control rate (DCR) of 35.3% in previously treated patients[44]. - The company has made significant progress in the development of HBM7008, with the first patient dosed in Australia in May 2022 and approvals obtained from NMPA and FDA for Phase I clinical trials[6]. - The company decided to close the Phase III trial of HBM9036 (Tenacip) for dry eye disease due to insufficient efficacy trends observed in the interim analysis[18]. - HBM1020 received IND approval from the FDA in January 2023, initiating Phase I clinical trials in the United States[62]. Financial Performance and Revenue - The company reported a significant revenue increase to $40.7 million for the year ended December 31, 2022, up from $4.3 million in the previous year, representing a growth of 843.8%[72]. - Revenue for 2022 reached $40,659 thousand, a significant increase from $4,308 thousand in 2021, representing a growth of approximately 844%[144]. - The company reported a substantial increase in licensing fees, which amounted to $38,437 thousand in 2022 compared to $2,347 thousand in 2021, reflecting a growth of about 1535%[144]. - Revenue growth was primarily driven by licensing agreements with AstraZeneca, Enbiop Pharmaceuticals, and Moderna, with technology licensing fees remaining stable at $1.4 million for 2022 compared to $2.0 million in 2021[91]. Expenses and Losses - Research and development expenses rose to $135.1 million for the year ended December 31, 2022, compared to $107.1 million in the previous year, an increase of 26.1%[72]. - Total expenses for 2022 amounted to $135.1 million, with third-party contract costs constituting 64.3% of total expenses, up from 48.5% in 2021[93]. - The company recorded a loss of $137.3 million for the year ended December 31, 2022, slightly improved from a loss of $137.9 million in the previous year[76]. - The company reported a pre-tax loss of $137,020 thousand in 2022, slightly improved from a loss of $137,829 thousand in 2021[132]. - The company reported a pre-tax loss of $137,222 thousand in 2022, compared to a loss of $137,777 thousand in 2021, indicating a slight improvement[177]. Asset and Liability Management - Total non-current assets decreased from $41,494 thousand in 2021 to $23,111 thousand in 2022, a decline of approximately 44.5%[109]. - Current assets also decreased from $240,867 thousand in 2021 to $209,012 thousand in 2022, a reduction of about 13.2%[109]. - The total liabilities increased significantly from $59,447 thousand in 2021 to $139,622 thousand in 2022, an increase of about 134%[134]. - The company’s total equity decreased from $222,914 thousand in 2021 to $92,501 thousand in 2022, a decline of about 58.5%[135]. - The company had current assets of $28,482 thousand in 2022, an increase from $24,537 thousand in 2021, showing improved liquidity[180]. - The company’s trade receivables aging at the end of the reporting period indicated that amounts less than three months were negligible in expected credit losses[162]. - The company’s total assets as of December 31, 2022, were reported at $40,659 thousand, a significant increase from $4,308 thousand in the previous year[144]. 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 patenting[35]. - The company has 10 drug candidates focused on oncology and immune diseases, ranging from preclinical to late-stage clinical development[34]. - The company is actively exploring commercialization pathways for HBM9161, having licensed its rights in Greater China to CSPC Pharmaceutical Group in October 2022[66]. - The company is incubating several joint ventures focused on developing next-generation cell therapies to enhance the application of its technology platform[69]. Regulatory and Compliance - A comprehensive disease prevention plan was implemented to protect employees from COVID-19 in office and research facilities[88]. - The company’s financial statements for the year ended December 31, 2022, have been approved by its auditor, Ernst & Young[104]. - The annual general meeting is scheduled for June 8, 2023, with notifications to be issued as per listing rules[100]. Market and Investment Strategy - The company aims to maximize platform value through global partnerships and expects broader collaborations in 2023[71]. - The company has no current plans for significant investments, acquisitions, or disposals exceeding 5% of total assets[98]. - The company holds an 11.90% stake in Enkai Cell Technology after a significant investment, enhancing its technology platform strategy[86].

Product Pipeline and Development - Harbour Biomed reported a diverse product pipeline with over ten differentiated candidates, four of which are in clinical development[12]. - The company has developed HBM9161, a fully human monoclonal antibody targeting FcRn, which has potential as a breakthrough therapy for autoimmune diseases in Greater China[13]. - HBM9036, a candidate for treating moderate to severe dry eye disease, is currently in Phase III clinical trials and aims to capture a significant market share in China's rapidly growing dry eye medication market[14]. - HBM4003, a next-generation fully human anti-CTLA-4 antibody, has advanced from candidate screening to clinical development within three years, showing improved pharmacokinetics and potential for enhanced anti-tumor efficacy[15]. - HBM7008, a bispecific antibody, received approvals for Phase I clinical trials in both Australia and the U.S. in June 2022[35]. - HBM9378 received approval from the NMPA for clinical research targeting moderate to severe asthma in February 2022[37]. - The company has 12 drug candidates focused on oncology and immunology, ranging from preclinical to late-stage clinical development[44]. - HBM7008 completed Phase I clinical trials in Australia in May 2022 and received IND approval in the US and China in June 2022[44]. - HBM1020, a fully human monoclonal antibody targeting B7H7, is planned for IND submission in the second half of 2022[86]. - HBM1022, targeting CCR8, is in preclinical development with IND submission planned for the second half of 2022[88]. - HBM9378, targeting TSLP, received IND approval in February 2022 and is set to initiate the I phase clinical trial in the second half of 2022[89]. - HBM1007 is a fully human monoclonal antibody targeting CD73, currently in preclinical research, with an IND application expected in the second half of 2022[90]. - HBM9033, an antibody-drug conjugate (ADC) targeting mesothelin, is also in preclinical research, with an IND application anticipated in 2023[93]. - HBM9027, a novel PD-L1xCD40 bispecific antibody, is in preclinical research, with an IND application expected in 2023[94]. Financial Performance - Revenue for the six months ended June 30, 2022, was $27.63 million, a significant increase from $2.21 million in the same period of 2021, representing a growth of approximately 1,150%[20]. - The company reported a net loss of $73.08 million for the first half of 2022, compared to a net loss of $61.62 million in the same period of 2021, indicating a deterioration of approximately 19%[20]. - Research and development expenses increased to $83.62 million in the first half of 2022, compared to $41.18 million in the same period of 2021, reflecting a rise of about 103%[20]. - The gross profit for the same period was $27.56 million, compared to $2.21 million in 2021, indicating a substantial improvement in profitability[197]. - The company incurred a loss before tax of $72.85 million, compared to a loss of $61.60 million in the previous year, reflecting an increase in losses of approximately 18%[197]. - Total administrative expenses decreased to $15.34 million from $25.27 million year-on-year, showing a reduction of about 39%[197]. - The total loss for the half-year ended June 30, 2022, was $73.1 million, an increase of $11.5 million from the loss of $61.6 million for the half-year ended June 30, 2021[123]. Collaborations and Partnerships - In 2022, the company entered a global licensing agreement with AstraZeneca for HBM7022, a bispecific antibody developed from its HBICE® platform[11]. - The company has established over 50 collaborations with industry and academic partners to maximize the value of its antibody platforms[11]. - The company is advancing strategic collaborations for innovative monoclonal antibodies and bispecific antibody drugs, aiming to submit IND applications in 2022 and 2023[23]. - The company has established a collaboration project with LegoChem Biosciences Inc. and Ying En Biotechnology Co., focusing on antibody-drug conjugates (ADC) for monoclonal antibodies, which includes upfront payments, milestone payments, and royalties based on sales[52]. - The strategic collaboration with Hualan Gene Engineering Co. aims to submit IND applications for three innovative monoclonal antibodies and bispecific antibody drugs (HBM1029, HBM7015, HBM7020) in 2022 and 2023[55]. - The partnership with Baidu Biotechnology has been deepened to develop innovative therapies combining the Harbour Mice® platform and AI technology, enhancing the discovery and preclinical development processes[56]. - The company has received milestone payments from its collaboration with Innovent Biologics, with additional payments expected in the second half of 2022 due to multiple clinical studies initiated[57]. - The collaboration with Boston Children's Hospital has made significant progress with the core candidate drug HBM9013, planning to submit an IND application in the U.S. in 2023[58]. Research and Development Strategy - The company aims to develop highly differentiated products that meet clinical needs, leveraging its proprietary antibody technology platform[47]. - The company is focusing on expanding its HCAb platform into new application areas, including CAR-T, CAR-NK, ADC, and nucleic acid collaborations[11]. - The company is actively expanding collaborations with leading academic institutions and industry partners to maximize platform value[49]. - The company is exploring NK cell therapies through a non-exclusive licensing agreement with Enkasei Pharma[51]. - The company has established a robust antibody discovery platform, including Harbour Mice® and HBICE® platforms, to advance towards novel and challenging drug targets[97]. - The company plans to accelerate the advancement of its product pipeline, including multiple clinical trials for core products Bartolizumab and Tenalisumab[109]. - The company anticipates submitting at least two new products for IND approval in the near future[109]. Corporate Governance and Compliance - The company has adopted the new corporate governance code effective from January 1, 2022, and has established its own governance policies to comply with the updated standards[142]. - The board believes that having the same person serve as both chairman and CEO ensures consistent internal leadership and effective strategic planning[143]. - The audit committee has reviewed the unaudited interim results for the six months ended June 30, 2022, ensuring the adequacy and effectiveness of the financial reporting system[148]. - The company has established a nomination committee and a remuneration committee in addition to the audit committee[149]. Market and Industry Context - The Chinese healthcare reform continues to deepen, presenting both challenges and opportunities for the pharmaceutical industry[46]. - The company’s pipeline products are expected to have broad market prospects due to ongoing industry demand and innovation[47]. Intellectual Property - The company applied for 47 patents during the reporting period, with 9 granted and 152 pending, enhancing intellectual property protection for core products and technology platforms[96].

HARBOUR BIOMED 和 鉗 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 2021 年 度 報 告 公司資料 2 公司概況 4 財務摘要 6 業務摘要 7 主席致辭 11 管理層討論與分析 14 董事及高級管理層 33 董事會報告 39 企業管治報告 64 風險管理報告 81 獨立核數師報告 83 綜合損益表 88 綜合全面收益表 89 綜合財務狀況表 90 綜合權益變動表 92 綜合現金流量表 94 綜合財務報表附註 97 釋義 177 目錄 和鉑醫藥控股有限公司 年報2021 公司資料 | --- | --- | |-----------------------------------|----------------------------------------------------------------------------| | | | | 董事會 | 聯席公司秘書 | | 執行董事 | 傅裕先生 | | 王勁松博士 （首席執行官）（主席） | 呂穎一先生 | | 陳小祥先生 | 開曼群島註冊辦 ...

HARBOUR BIOMED 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 2021 中 報 | --- | --- | --- | --- | --- | |-------|-------|-------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------| | | | | | | | | | | | | | | | | | | | | | | | 目錄 | | | | | | | | | | | 公司資料 | 2 | | | | | 公司概況 | 3 | | | | | 財務摘要 | 5 | | | | | 業務摘要 | 6 | | | | | 管理層討論與分析 | 8 | | | | | | | | | | | 企業管治╱其他資料 | 26 | | | | | ...

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 年報 2020 目錄 公司資料 2 公司概況 3 財務摘要 5 業務摘要 6 主席致辭 8 管理層討論與分析 11 董事及高級管理層 28 董事會報告 34 企業管治報告 60 獨立核數師報告 74 綜合損益表 80 綜合全面收益表 81 綜合財務狀況表 82 綜合權益變動表 84 綜合現金流量表 86 綜合財務報表附註 88 釋義 165 和鉑醫藥控股有限公司 年報2020 公司資料 | --- | --- | |------------------------------------------------------------|--------------------------------------------------------------------------------| | | | | 董事會 | 中國主要營業地 | | 執行董事 | 中國上海市 | | 王勁松博士 廖邁菁博士 | 徐匯區楓林路 420 號 楓林國際大廈二期 A 座 12 樓 | | Atul ...