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 2.21 million in the same period of 2021, representing a growth of approximately 1,150%[20]. - The company reported 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 41.18 million in the same period of 2021, reflecting a rise of about 103%[20]. - The gross profit for the same period was 2.21 million in 2021, indicating a substantial improvement in profitability[197]. - The company incurred a loss before tax of 61.60 million in the previous year, reflecting an increase in losses of approximately 18%[197]. - Total administrative expenses decreased to 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 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].
和铂医药-B(02142) - 2022 - 中期财报