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 325 million[13]. - The company received a 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 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 4.3 million in the previous year, representing a growth of 843.8%[72]. - Revenue for 2022 reached 4,308 thousand in 2021, representing a growth of approximately 844%[144]. - The company reported a substantial increase in licensing fees, which amounted 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 2.0 million in 2021[91]. Expenses and Losses - Research and development expenses rose to 107.1 million in the previous year, an increase of 26.1%[72]. - Total expenses for 2022 amounted to 137.3 million for the year ended December 31, 2022, slightly improved from a loss of 137,020 thousand in 2022, slightly improved from a loss of 137,222 thousand in 2022, compared to a loss of 41,494 thousand in 2021 to 240,867 thousand in 2021 to 59,447 thousand in 2021 to 222,914 thousand in 2021 to 28,482 thousand in 2022, an increase from 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].
和铂医药-B(02142) - 2022 - 年度业绩