Drug Development Pipeline - The company has a diverse pipeline with over ten differentiated drug candidates, four of which are in clinical development stages[26] - HBM9161, a fully human monoclonal antibody, is being developed for multiple autoimmune diseases in Greater China, focusing on conditions like Myasthenia Gravis and Immune Thrombocytopenia[27] - HBM9036, currently in Phase III clinical trials, targets moderate to severe dry eye disease and aims to capture a significant market share in China's rapidly growing dry eye medication market[28] - HBM4003, a next-generation fully human anti-CTLA-4 antibody, is the first of its kind to enter clinical development and shows improved pharmacokinetic properties compared to traditional anti-CTLA-4 antibodies[29] - HBM7008 is a bispecific antibody targeting tumor-associated antigens, expected to enhance safety and efficacy in patients resistant to existing PD-1/PD-L1 therapies[31] - The company is exploring several innovative monoclonal antibody projects, including HBM1022 (CCR8) and HBM1007 (CD73), which feature novel designs and mechanisms of action[32] - The company aims to address unmet patient needs in the immunology and oncology sectors through its differentiated antibody therapies[25] Financial Performance - Total revenue for the year 2021 was $4.308 million, a decrease of 69.5% compared to $14.107 million in 2020[37] - Research and development expenses increased significantly to $107.103 million, up 93.8% from $55.244 million in 2020[37] - The company reported a net loss of $137.878 million for 2021, compared to a net loss of $296.539 million in 2020, representing a 53.5% improvement[37] - Cash and bank balance at the end of 2021 was $216.304 million, down from $356.794 million in 2020[37] - Other income and gains rose to $6.0 million for the year ended December 31, 2021, from $5.3 million for the year ended December 31, 2020, mainly due to increased interest income and government subsidies[156] - Administrative expenses decreased to $40.1 million for the year ended December 31, 2021, from $46.3 million for the year ended December 31, 2020, due to reduced listing expenses and employee costs[160] Clinical Trials and Approvals - The company received Breakthrough Therapy Designation for BatoClimab (HBM9161) for the treatment of Myasthenia Gravis in January 2021[39] - The first patient was dosed in the Phase III clinical trial of BatoClimab in September 2021[40] - The company completed patient recruitment for the Phase II clinical trial of ITP in mid-2021, showing good tolerability and safety[42] - The first patient was dosed in the Phase III clinical trial of HBM9036 in March 2021, with over half of the patients recruited by the end of the year[49] - The company received NMPA approval for clinical trials combining PD-1 with chemotherapy for NSCLC in February 2021[58] - The company received IRB approval for the HBM7008 clinical trial in Australia in February 2022[63] - HBM9378 clinical trial for moderate to severe asthma received NMPA approval in February 2022[63] - The company completed Phase II clinical trials for HBM9161 in China and plans to submit a Biologics License Application (BLA) in 2022[70] - HBM4003, a fully human anti-CTLA-4 antibody, showed promising safety and efficacy in Phase I trials, with plans for global registration studies in 2022[72] Strategic Collaborations and Partnerships - The company has established over 50 collaborations with industry and academic partners to maximize the value of its proprietary antibody platform[34] - The partnership with Icahn School of Medicine at Mount Sinai resulted in a licensing agreement for antibody assets with SARS-CoV-2 neutralizing properties, granting the company 25% of the revenue[65] - Strategic collaborations with leading academic institutions, such as Mount Sinai Health System and Dana-Farber Cancer Institute, are aimed at translating laboratory results into clinical outcomes[74] - The company has licensed the rights to three antibodies in Greater China to Hualan Gene, anticipating IND submissions for these products in 2022[74] - The company is incubating several joint ventures focused on developing next-generation cell therapies, enhancing the application scenarios of its technology platform[74] Future Outlook and Market Strategy - Future outlook includes potential market expansion and strategic partnerships to enhance research and development capabilities[32] - The company aims to submit two or more IND applications annually starting from 2021, leveraging its discovery engine[73] - The company plans to submit BLA applications for core products Bartolizumab and Tenalisib in 2022, indicating a focus on commercialization readiness[76] - The company is focusing on developing highly differentiated products that meet clinical needs, optimizing research, development, registration, and patent strategies[87] - The pharmaceutical industry in China is undergoing structural adjustments, with ongoing demand for innovative drugs driven by healthcare upgrades and an aging population[86] - The new drug registration regulations encourage clinically valuable drug innovation, which aligns with the company's product pipeline strategy[86] - The company aims to enhance market education and promotion for its pipeline products to capture broader market opportunities[87] Manufacturing and Production Capabilities - The company initiated a clinical production supply project in 2021, with plans to commence production in 2022, aiming to establish internal manufacturing capabilities[77] - The company plans to establish internal production capabilities and scale up from pilot to commercial production as preclinical products mature[151] - The company initiated a clinical supply production facility in Suzhou, covering approximately 8,500 square meters, with a designed production capacity of 4,000 liters, expected to be operational in 2022[141] Management and Governance - The company has implemented comprehensive COVID-19 prevention measures, with no suspected or confirmed cases reported among employees[148] - The company plans to continue monitoring the COVID-19 situation and take proactive measures to ensure smooth global operations in 2022[150] - The company has not made any investments, acquisitions, or disposals exceeding 5% of total assets during the reporting period[143] - The company has no major future investment or capital asset plans[174] - As of December 31, 2021, there are no significant contingent liabilities reported[176] - The company has not engaged in any hedging transactions to manage potential foreign currency fluctuations[176] - The bank loans have an interest rate ranging from 4.10% to 4.60%[179] - The company has no assets pledged as collateral as of December 31, 2021[175] - The company has 10 candidate drugs focused on tumor and immune diseases, ranging from preclinical to late-stage clinical development[83]

Product Pipeline and Development - Harbour Biomed has a diverse product pipeline with over ten differentiated candidates, four of which are in clinical development[9]. - The company’s lead product, HBM9161, is a fully human monoclonal antibody targeting FcRn, with potential applications in multiple autoimmune diseases in Greater China[10]. - HBM9036, aimed at treating moderate to severe dry eye disease, is currently in Phase III clinical trials and targets a rapidly growing market in China[11]. - HBM4003, a next-generation fully human anti-CTLA-4 antibody, has advanced from candidate screening to clinical development within three years, showing improved pharmacokinetics compared to traditional anti-CTLA-4 antibodies[12]. - The proprietary Harbour Mice® platform enables the development of monoclonal antibodies in both classic and heavy-chain formats, enhancing the company's drug discovery capabilities[16]. - The company is exploring multiple innovative monoclonal antibody projects, including HBM1022, HBM1029, and HBM1007, which feature unique mechanisms of action[15]. - Harbour Biomed is focused on addressing unmet patient needs through the discovery and commercialization of innovative antibody therapies[8]. - The company aims to leverage its proprietary technology to develop bispecific antibodies that could achieve tumor elimination effects not attainable by current combination therapies[16]. - The company has 12 candidate drugs focused on immunological and oncological diseases, ranging from preclinical to late-stage clinical phases[41]. - HBM4003, a next-generation fully human anti-CTLA-4 antibody, has made significant progress with multiple clinical trials planned for various solid tumors[64]. Financial Performance - The financial summary and performance metrics for the first half of 2021 are detailed in the report, highlighting the company's growth trajectory[5]. - Revenue for the six months ended June 30, 2021, was $2,212,000, a decrease from $6,070,000 in the same period of 2020[20]. - Research and development costs increased significantly to $(41,183,000) from $(15,198,000) year-over-year[20]. - The company reported a net loss of $(61,615,000) for the first half of 2021, compared to a net loss of $(48,382,000) in the same period of 2020[20]. - Cash and bank balances as of June 30, 2021, were $281,024,000, down from $356,794,000 at the end of 2020[20]. - The company recorded revenue of $2.2 million for the six months ended June 30, 2021, a decrease from $6.1 million for the same period in 2020[101]. - Gross profit for the same period was $2,212,000, down from $5,783,000, reflecting a significant decline in sales[183]. - Administrative expenses increased to $2,681,000 from $349,000, indicating a rise in operational costs[183]. - The net loss for the period was $61,615,000, compared to a loss of $48,382,000 in the previous year, representing a 27.3% increase in losses[183]. - The company reported a total comprehensive loss of $61.723 million, compared to a total comprehensive loss of $48.069 million for the same period in 2020, representing an increase of approximately 28.5%[194]. Research and Development - The company is optimizing strategies in research, development, registration, and patents to focus on highly differentiated products that meet clinical needs[45]. - The company plans to initiate Phase III clinical trials for MG in the second half of 2021 and submit a BLA application in 2022[51]. - The company completed patient recruitment for Phase II clinical trials of ITP in January 2021 and plans to conduct data analysis in the second half of 2021[53]. - The company received NMPA approval for a new dosing regimen clinical trial for ITP patients in February 2021[54]. - The company plans to submit a BLA application for NMOSD in 2022 after completing patient enrollment for Phase Ib/IIa trials in July 2021[56][57]. - The company aims to submit a BLA application for GO in 2023 after initiating Phase II/III registration trials in 2021[58]. - The company anticipates significant market share for Tanfanercept in the rapidly growing dry eye disease market in China, with a BLA application planned for 2022[61][62]. - HBM1007, targeting CD73, is in preclinical research with an IND application expected in 2022[71]. - HBM1020, a first-in-class fully human monoclonal antibody targeting the B7 family, is in preclinical development with an IND application planned for 2022[76]. - HBM9378 is a fully human monoclonal antibody targeting TSLP, expected to submit IND application in H2 2021[77]. - HBM1029, a monoclonal antibody with higher CLDN18.2 binding affinity, is anticipated to submit IND application in 2022[79]. - HBM7015, a dual-function fusion protein inhibiting PD-L1, is also expected to submit IND application in 2022[82]. - HBM7020, a BCMAxCD3 bispecific antibody, is projected to submit IND application in 2022[83]. Collaborations and Partnerships - The company has established over 45 partnerships with industry and academic institutions for its antibody platform, indicating strong collaboration potential[17]. - The company received breakthrough therapy designation for BatoClimab (HBM9161) for the treatment of MG in January 2021[23]. - A strategic collaboration agreement was signed with Baidu-backed Baidu Bio in May 2021 to develop new antibody products[32]. - The company has entered the full clinical development phase for Batoclimab, marking it as the first anti-FcRn therapy in development in the Greater China region[47]. - The company is actively seeking licensing and collaboration opportunities through its improved platform technology[154]. - Strategic collaboration with Baidu's co-founders focuses on research and development of new antibody products[89]. - A multi-year research collaboration with Dana-Farber Cancer Institute aims to discover and develop new cancer therapies[90]. - Exclusive licensing agreement with Mount Sinai for antibodies with SARS-CoV-2 neutralizing properties, allowing the company to earn 25% of the revenue from the license[90]. Corporate Governance and Management - The company has established an audit committee, which includes two independent non-executive directors and one non-executive director[141]. - The audit committee is responsible for reviewing financial statements and reports before submission to the board[142]. - The board believes that having the same person serve as both chairman and CEO ensures effective and efficient strategy planning[137]. - The company has complied with all provisions of the corporate governance code, except for a deviation regarding the roles of chairman and CEO[137]. Market Outlook and Strategy - Future outlook includes continued investment in R&D to expand the product pipeline and enhance market presence in the biopharmaceutical sector[8]. - The company anticipates significant market opportunities for its pipeline products due to the ongoing demand and stable growth in the industry[45]. - The Chinese healthcare reform continues to deepen, presenting ongoing challenges and opportunities for the pharmaceutical industry, particularly in drug pricing and market access[44]. - The company is committed to a product line layout oriented towards clinical value, aligning with the supportive policy direction for drug innovation[44]. Employee and Operational Insights - The company employed 318 staff as of June 30, 2021, with 204 in R&D (64.2%) and 114 in general and administrative roles (35.8%)[132]. - Total employee compensation costs amounted to $34.4 million, including $18.2 million in share-based payment expenses, compared to $8.0 million in the previous period[132]. - The company has implemented comprehensive COVID-19 prevention measures, with no suspected or confirmed cases reported among employees[96]. - The company believes that internal manufacturing capabilities are crucial for meeting clinical drug demand as its pipeline matures[93]. Cash Flow and Liquidity - The cash flow from operating activities for the six months ended June 30, 2021, was a net outflow of $70.399 million, compared to a net outflow of $18.940 million for the same period in 2020, indicating a significant increase in cash burn[196]. - The company’s cash and cash equivalents at the end of June 30, 2021, were $41.024 million, down from $68.440 million at the end of June 30, 2020, representing a decrease of approximately 40%[199]. - The company’s investment activities resulted in a net cash outflow of $144.942 million for the six months ended June 30, 2021, compared to a net outflow of $15.663 million for the same period in 2020, indicating a substantial increase in investment spending[198]. - The company recorded a foreign exchange loss of $362,000 for the six months ended June 30, 2021, compared to a gain of $509,000 for the same period in 2020, indicating a shift in currency impact[196]. Shareholder Information - Major shareholder 永豐利投資有限公司 holds 12.18% of the company's shares, equating to 93,561,360 shares[159]. - As of June 30, 2021, Dr. Wang Jinsong held 60,334,400 shares, representing 7.86% of the company's equity[156]. - The total number of shares issued as of June 30, 2021, is 767,891,600 shares[161]. - The maximum number of shares available for the pre-IPO share option plan is 132,499,240 shares[170]. - The total number of shares available for the post-IPO share option plan is 76,789,116 shares, representing approximately 10% of the issued shares at the time of the report[174]. - The share option plans aim to attract and retain key personnel and align their interests with those of the shareholders[169].

Company Overview - The company is a clinical-stage biopharmaceutical firm focused on developing differentiated antibody therapies for immune and oncology diseases, with over ten potential differentiated drug candidates in its pipeline, five of which are in clinical development[23]. - The company's main business involves investment holding, focusing on differentiated antibody therapies for immunology and oncology[196]. - The company has been involved in research and development in the field of immunology and oncology[196]. 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 pharmacokinetics and potential to overcome existing efficacy and safety bottlenecks in tumor immunotherapy[26]. - The company has developed HBM9022, a fully human neutralizing antibody for the prevention and treatment of COVID-19, in collaboration with Utrecht University and AbbVie, with global rights acquired by AbbVie in December 2020[27]. - The Harbour Mice® platform has produced multiple projects, including HBM4003 and HBM9022, and has been recognized by over 45 biopharmaceutical and academic partners, with seven projects entering clinical stages as of December 31, 2020[31]. - The company is focusing on the development of T cell-related therapies, with HBM7008 (a bispecific antibody based on 4-1BB) and HBM1022 (CCR8) among its internal projects[30]. - The company aims to capture a significant market share in the rapidly growing dry eye disease drug market in China with its candidate product HBM9036, which is currently in Phase III clinical trials[25]. - The company is developing HBM9161, a fully human monoclonal antibody targeting FcRn, with potential applications in treating various autoimmune diseases in the Greater China region[24]. - The company has established proprietary technology knowledge from its HCAb platform, which focuses on generating differentiated bispecific antibodies for potential combination therapies[31]. - The company is actively pursuing clinical development for multiple projects, with a focus on expanding its research and development capabilities and market presence[30]. - The core product, Batolisib (HBM9161), has completed Phase I clinical trials in Greater China and is set to submit a biological product license application to the National Medical Products Administration in 2022[61]. - The company is optimistic about the market potential of Batolisib as a novel FcRn inhibitor developed in Greater China[61]. - The company has initiated Phase III trials for Tenasip (HBM9036) targeting the rapidly growing dry eye medication market in China, with clinical data from Phase II trials announced in November 2020[61]. - HBM4003, a fully human IgG1 monoclonal antibody, received clinical research approvals from major global drug regulatory agencies, including the FDA and NMPA, for both monotherapy and combination therapy[90]. - The company plans to submit a Biologics License Application (BLA) for Tanfanercept to NMPA in 2022[87]. - HBM1007, a fully human monoclonal antibody targeting CD73, is in preclinical research, with an IND application expected to be submitted in 2021[96]. - HBM7008, a bispecific antibody targeting tumor-associated antigens, is also in preclinical research, with an IND application anticipated in 2022[98]. - HBM1022, targeting CCR8, is in preclinical research, with an IND application expected in 2022[100]. - HBM1029, a monoclonal antibody with high affinity for CLDN18.2, is in preclinical research, with an IND application expected by the end of 2021[102]. - HBM7015, a dual-function fusion protein inhibiting PD-L1, has shown stronger binding activity and blocking efficacy in vitro compared to competitors[103]. - HBM9378, a potential best-in-class drug for autoimmune diseases, is in preclinical research, with an IND application expected by the end of 2022[100]. - HBM7015 is in the preclinical stage, with an IND application expected to be submitted by early 2022[104]. - HBM7020, a BCMAxCD3 bispecific antibody, is also in preclinical research, with an IND application anticipated in 2022[105]. - HBM9302 targets HER2xCD3 and is expected to have an IND application submitted in the first half of 2021[109]. Financial Performance - Revenue for the year ended December 31, 2020, was $14.1 million, a significant increase from $5.4 million in 2019, representing a 160% growth[36]. - Adjusted net loss for 2020 was $45.9 million, a decrease of $8.2 million compared to the adjusted net loss of $54.1 million in 2019, primarily due to an increase in revenue[36]. - Research and development expenses rose to $55.2 million in 2020 from $49.5 million in 2019, indicating a continued investment in product development[36]. - The company reported a total cash and bank balance of $356.8 million as of December 31, 2020, up from $33.4 million in 2019[36]. - Total assets increased to $388.7 million in 2020 from $69.5 million in 2019, reflecting the company's growth and investment in its operations[36]. - The company reported a basic and diluted loss per share of $1.69 for 2020, compared to $0.57 in 2019[36]. - The company recorded revenue of $14.1 million for the year ended December 31, 2020, compared to $5.4 million for the year ended December 31, 2019, representing a significant increase[129]. - The company's R&D expenses increased from $49.5 million in 2019 to $55.2 million in 2020, primarily due to increased employee costs[136]. - Other income and gains rose from $1.6 million in 2019 to $5.3 million in 2020, mainly due to government grants increasing from $0.9 million to $2.4 million[132]. - The fair value loss on convertible redeemable preferred shares was $213.7 million for the year ended December 31, 2020, compared to $13.4 million in 2019[129]. - The company reported a full-year loss of $296.5 million for the year ended December 31, 2020, an increase of $229.0 million from a loss of $67.5 million for the year ended December 31, 2019[144]. - The fair value change loss of convertible redeemable preferred shares was $213.7 million for the year ended December 31, 2020, compared to $13.4 million for the year ended December 31, 2019[143]. - The adjusted net loss under non-IFRS measures for the year ended December 31, 2020, was $45.9 million, compared to $54.1 million for the year ended December 31, 2019[148]. - Total employee costs for the year ended December 31, 2020, amounted to $56.4 million, including stock-based compensation of $36.9 million, compared to $18.4 million in the previous year[164]. - Administrative expenses surged from $10.6 million in 2019 to $46.3 million in 2020, largely due to costs associated with the IPO[140]. - The company had a current ratio of 14.45 as of December 31, 2020, compared to 2.59 in the previous year[154]. Strategic Collaborations and Partnerships - A strategic collaboration was established with AbbVie for the co-development of an antibody effective against SARS-CoV-2, with clinical trials commencing in December 2020[52]. - Strategic collaborations with leading academic institutions and industry partners are ongoing to maximize platform value and accelerate development[65]. - The company has signed a framework agreement with TianGang Immunology for the development of innovative antibody drugs, leveraging both parties' strengths in antibody technology and clinical development[116]. Leadership and Governance - Dr. Wang Jinsong serves as the CEO and Chairman of the Board, with extensive experience in the pharmaceutical industry, including leadership roles at Wyeth and Sanofi[168]. - Dr. Liao Maijing, the Chief Business Officer, joined the company in July 2016 and previously held a senior marketing position at Janssen[170]. - Dr. Atul Mukund Deshpande, the Chief Strategy Officer, has a background in strategic roles at Sanofi and joined the company in December 2018[173]. - The company has expanded its leadership team with experienced professionals from major pharmaceutical firms, enhancing its strategic capabilities[176]. - The leadership team is committed to maintaining high standards of governance and independent oversight through its board of directors[182]. Market and Industry Outlook - The company aims to establish internal manufacturing capabilities to meet the growing demand as preclinical products mature[68]. - The overall industry demand remains strong and stable, with differentiated innovative drugs expected to have greater market opportunities[77]. - Tanfanercept is expected to capture a significant market share in China's rapidly growing dry eye disease market, driven by increasing prevalence due to aging population and screen time[85]. - The company aims to leverage its research and development capabilities to bring innovative therapies to market[176]. - The strategic direction includes a focus on enhancing operational efficiency and maximizing shareholder value through disciplined financial management[176]. COVID-19 Impact and Response - The company has implemented comprehensive disease prevention measures against COVID-19, ensuring no suspected or confirmed cases among employees[122]. - The company anticipates limited impact from the COVID-19 pandemic on its business operations in 2021[126]. Future Plans - The company aims to submit two or more IND applications annually starting in 2021, leveraging its unique discovery engine[63]. - The company plans to accelerate the advancement of its product pipeline, including multiple clinical trials for core products[126]. - At least two new products are expected to file IND applications in 2021, leveraging the Harbour Mice® drug discovery engine[126]. - The company aims to start the Phase III registration trial for GO treatment with Batoclimab in 2021 and submit a BLA application in 2023[83].