2024年度，抗体发现业务获得更多海外客户的认可，全球前10大药企中的7家成为公司抗体发现业务的 客户，对外转让的抗体分子数量快速增加，销售收入快速增长的同时，毛利率保持在较高水平。抗体发 现业务实现收入3.178亿元，较上年同期增长80.7%，占公司总收入32.4%。截至2024年12月31日，我们 累计签署约200项药物合作开发╱授权╱转让协议。其中，2024年度新增签署约100项，较去年同期增长 约70%。 百奥赛图-B(02315)发布年度业绩，股东应占盈利 3354.2万元，同比扭亏为盈 2024年度，基于初步成型的全球化网络体系，特别是配备了先进实验室以及高标準动房的美国波士顿运 营设施，模式动物业务和抗体发现业务继续保持快速增长，尤其是海外业务收入贡献比例进一步提高， 收入增长的同时毛利依然保持稳定。 智通财经APP讯，百奥赛图-B(02315)发布截至2024年12月31日止年度业绩,收益9.8亿元(人民币，下 同)，同比增长36.8%;公司权益股东应占盈利3354.2万元，同比扭亏为盈;每股盈利0.08元。 2024年度，公司战略调整成效显著，大规模研发投入阶段已经结束，研发费用为3.239 ...

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，概不就因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 百奧賽圖（北京）醫藥科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2315） 截至2024年12月31日止年度的年度業績公告 BIOCYTOGEN PHARMACEUTICALS (BEIJING) CO., LTD. 百奧賽圖（北京）醫藥科技股份有限公司（「本公司」或「百奧賽圖」）董事（「董事」） 會（「董事會」）欣然宣佈本公司及其附屬公司（統稱「本集團」）截至2024年12月31 日止年度（「報告期」）的經審核綜合年度業績連同2023年同期的經審核比較數據。 財務摘要 | | 截至 | 截至 | | | --- | --- | --- | --- | | | 2024年 | 2023年 | | | | 12月31日 | 12月31日 | | | | 止年度 | 止年度 | 同比變化 | | | 人民幣千元 | 人民幣千元 | | | 收益 | 980,454 | 716, ...

Financial Performance - Revenue increased by 25.6% to RMB 410.5 million in the first half of 2024 compared to the same period in 2023[14] - Gross profit rose by 29.8% to RMB 305.5 million in the first half of 2024[14] - Loss before taxation decreased by 75.1% to RMB 47.1 million in the first half of 2024[14] - Loss for the period attributable to equity shareholders of the company reduced by 73.3% to RMB 50.7 million in the first half of 2024[14] - Net cash generated from operating activities was RMB 29.6 million in the first half of 2024, compared to a net cash used of RMB 17.6 million in the same period in 2023[14] - Revenue in the first half of 2024 reached RMB 410.5 million, a 25.6% increase year-over-year[21] - Net loss in the first half of 2024 was RMB 50.7 million, a 73.3% decrease year-over-year[21] - Net cash inflow from operating activities in the first half of 2024 was RMB 29.6 million, turning positive for the first time[21] - Revenue for the first half of 2024 reached RMB 410.5 million, a 25.6% increase compared to RMB 326.8 million in the same period last year[39] - Gross profit for the first half of 2024 was RMB 305.5 million, up 29.8% from RMB 235.4 million in the same period last year[39] - Revenue increased by 25.6% from RMB326.8 million in H1 2023 to RMB410.5 million in H1 2024, driven by growth in animal models selling and antibody development[158][160] - Gross profit rose by 29.8% to RMB305.5 million in H1 2024, with gross profit margin improving from 72.0% to 74.4% due to higher sales volume and margins in animal models and antibody development[162][164] - Cost of sales increased by 14.8% to RMB105.0 million in H1 2024, in line with revenue growth[159][161] - Net change in fair value of biological assets surged 622.2% to RMB6.5 million in H1 2024, primarily due to a 10,000-head increase in humanized mice inventory[168][171] - Selling and marketing expenses grew 44.1% to RMB42.5 million in H1 2024, mainly due to increased salaries[169][172] - Other gains and losses, net, decreased by 54.8% to RMB9.5 million in H1 2024, primarily due to lower interest income and net foreign exchange gain[163][166] - General and administrative expenses decreased by 12.7% from RMB117.5 million in H1 2023 to RMB102.6 million in H1 2024, primarily due to reduced staff costs and cost-saving measures[173][176] - Research and development expenses decreased by 34.8% from RMB248.0 million in H1 2023 to RMB161.7 million in H1 2024, driven by reduced staff costs and completion of the 'Project Integrum' plan[174][177] - Cash and cash equivalents decreased slightly from RMB417.7 million as of December 31, 2023 to RMB411.2 million as of June 30, 2024, due to combined effects of positive operating cash flows and negative investing and financing cash flows[175][179] - Net cash generated from operating activities was RMB29.6 million in H1 2024, compared to a net cash used of RMB17.6 million in H1 2023[182] - Finance costs increased by 12.8% from RMB46.7 million in H1 2023 to RMB52.7 million in H1 2024, primarily due to increased interest on bank and other loans[183][184] - Outstanding loans increased from RMB234.8 million as of June 30, 2023 to RMB395.5 million as of June 30, 2024[185][189] - Gearing ratio increased from 2.10 as of December 31, 2023 to 2.27 as of June 30, 2024[186][190] - Net current assets increased from RMB145.4 million as of December 31, 2023 to RMB193.5 million as of June 30, 2024[187][191] - Capital expenditures decreased from RMB79.8 million as of December 31, 2023 to RMB37.1 million as of June 30, 2024, primarily for facility and office investments and scientific equipment purchases[194] - Total capital expenditure for the six months ended June 30, 2024, amounted to approximately RMB37.1 million, primarily for facility and office building investments and scientific equipment purchases[199] - The carrying net book value of machinery and equipment under sale and leaseback agreements was RMB36.0 million as of June 30, 2024[199] - The carrying net book value of mortgaged plant and buildings was RMB253.6 million as of June 30, 2024[200] - No significant contingent liabilities as of June 30, 2024[199] - No significant investments as of June 30, 2024[197] - No significant acquisitions or disposals of subsidiaries, associates, or joint ventures during the six months ended June 30, 2024[198] Business Segments and Revenue Breakdown - Antibody discovery business revenue in the first half of 2024 was RMB 118.2 million, a 33.9% increase year-over-year, accounting for 28.8% of total revenue[22] - Overseas business revenue in the first half of 2024 was RMB 293.5 million, a 70.0% increase year-over-year, accounting for 71.5% of total revenue[26] - Animal model sales revenue in the first half of 2024 was RMB 175.8 million, a 52.6% increase year-over-year[22] - The antibody discovery business achieved revenue of RMB 118.2 million in the first half of 2024, a 33.9% increase year-over-year, accounting for 28.8% of total operating revenue[40] - The animal models selling business generated revenue of RMB 175.8 million in the first half of 2024, a 52.6% increase compared to the same period last year[41] - Overseas business revenue reached RMB 293.5 million in the first half of 2024, a 70.0% increase year-over-year, accounting for 71.5% of total operating revenue[42] - Revenue breakdown for H1 2024: animal models selling (42.8%), antibody development (28.8%), pre-clinical pharmacology and efficacy evaluation (19.9%), gene editing (8.4%), and others (0.1%)[158] R&D and Innovation - The company has established a library of over 400,000 ready-to-use fully human antibody sequences targeting more than 1,000 targets[17] - The company has multiple clinical-stage antibody molecules that have been licensed to external partners[17] - The company provides thousands of gene-edited animal and cell models, including target humanized mice, under its BioMice® sub-brand[17] - R&D expenses decreased significantly by 34.8% to RMB 161.7 million in the first half of 2024 compared to the same period last year[44][46] - The company's antibody development business has a library of over 400,000 antibody sequences for more than 1,000 targets, leveraging platforms like RenMice and Project Integrum[47] - The company's pre-clinical research services include gene editing, pharmacology, efficacy evaluation, and animal models, contributing to fast-growing revenues and high gross margins[48] - The company has developed over 3,300 unique gene-edited mouse/cell line projects for antibody discovery and disease modeling[67] - Current animal models focus on tumor and autoimmune diseases, with ongoing expansion into neurological, cardiovascular, and metabolic disease areas[69][74] - The company maintains high R&D investment to develop globally competitive animal models and provide high-quality pre-clinical CRO services, driving rapid revenue growth[66][72] - The company has developed a series of immune checkpoint and other humanized mice based on the C57BL/6 genetic background, enabling effective drug validation for human antibody drugs[76][77] - The company has humanized key cytokines or cytokine receptors in mice to evaluate the efficacy and pharmacological effects of human cytokine or cytokine receptor antibody drugs[81] - The B-NDG mice, developed by the company, are severely immunodeficient and lack mature T-cells, B-cells, and NK cells, making them ideal for drug development[82] - The company has completed over 4,500 drug evaluation projects for approximately 650 global partners[90] - The company's pharmacology services include in vivo efficacy, PK/PD, biomarker assessments, toxicology, and safety evaluation[90] - The company's B-NDG B2m KO plus mice can delay the GVHD effect in PBMC reconstitution models, achieving a longer dosing window[87] - The company's B-NDG hIL15 mice promote immune reconstitution of human NK cells, and B-NDG hTHPO mice avoid radiation damage[87] - The company's pre-clinical pharmacology and efficacy evaluation services are priced based on animal types and service types, with agreements typically lasting no longer than one year[91] - The company's intellectual property for animal models generally belongs to the company, and no IP allocation discussions occurred during the reporting period[86] - The company has successfully developed and validated hundreds of syngeneic and xenogeneic tumor models to meet client scientific objectives, utilizing humanized mice and cell lines for tailored therapeutic strategies[93][95] - The company's in vivo pharmacology services include immune and autoimmune disease models, CNS diseases, ocular diseases, metabolic diseases, and kidney disease models in both wild-type and humanized mice[94][96] - The company's model-based in vivo efficacy services support high-scale screening for molecule selection, drug comparison, and evaluation, complemented by in vitro pharmacology services such as immune cell profiling and cytokine profiling[97] - The company's humanized mice enable more translatable evaluation of human antibody PK, addressing challenges in non-clinical PK and toxicity studies for biologic drug development[98][101] - The company has established a comprehensive PK/PD service platform using target humanized mice and FcRn humanized mice, supporting drug exposure characterization, dosage prediction, and safety margin establishment[99][102] - Humanized mice are recommended by the FDA for toxicology and safety evaluation, and the company has developed platforms using humanized and B-NDG mice for comprehensive safety assessments[100][103] - The company's gene editing technology supports antibody discovery and development, including the launch of Project Integrum and the development of transgenic RenMice platforms[105][106] - The company has shifted focus in gene editing customized services to overseas pharmaceutical clients, emphasizing internal R&D and innovation to enhance profitability[107] - The company has completed approximately 4,900 customized gene editing projects for clients and self-developed approximately 3,300 gene-edited animal and cell model products[110] - The company's proprietary SUPCE technology enables megabase-scale chromosomal editing, compared to other technologies limited to editing less than 30,000 bases at a time[117] - The RenMice platform consists of three types of chromosome-engineered mice: RenMab, RenLite, and RenNano, generating fully human monoclonal and bi-specific antibodies[118] - The company has established licensing and trial collaboration agreements with over ten multinational pharmaceutical companies, including Merck Healthcare KGaA, Johnson & Johnson, and BeiGene[120] - The company provides gene editing services for mouse strains including C57BL/6, BALB/c, DBA2, and NOD-scid, and rat strains including Sprague Dawley and Wistar[113] - The company has developed advanced gene editing platforms, including SUPCE, CRISPR/EGE, and ESC/HR, through over a decade of research[110] - The RenMice platform has been validated for full-length in-situ gene replacement, producing healthy mice with strong immune systems[117] - The company offers customized gene editing services for both animal models (rats/mice) and cell lines, leveraging ESC/HR and CRISPR/EGE technologies[113] - The company has launched Project Integrum and developed transgenic RenMice platforms to support antibody discovery and development[109] - The company's RenTCRm technology platform, based on RenMab, is designed for antibody drug development against intracellular targets[118] - RenMab platform uses RenMab mice for the discovery and generation of fully human monoclonal antibodies, with in-house developed transgenic mice carrying full human heavy chain and kappa light chain variable regions[121][123] - RenMab mice can produce a diverse repertoire of antibodies with subnanomolar affinity, optimized for specificity and affinity in lead antibody screening[125] - RenMab platform's key technology was granted Chinese and US patents in 2023[121][125] - RenLite platform uses RenLite mice to produce high-affinity bi-specific antibodies and ADCs, with a single fixed human common kappa light chain to resolve light chain and heavy chain mismatch issues[126][128] - RenLite platform's key technology was granted a US patent in 2024[127][130] - RenNano platform produces heavy chain antibodies with RenNano mice, featuring complete human antibody heavy chain variable region gene in situ swap, enabling high-throughput development of fully human heavy chain antibodies[132][134] - RenNano-derived antibodies have high affinity at the nM level and good biological functions in vitro and in vivo, suitable for modular assembly of innovative drug forms[134] - RenTCRm platform produces fully human antibodies targeting intracellular MAP epitopes, with higher affinity and specificity than TCR, enabling one-step generation of antibodies against intracellular antigens[133][135] - RenTCRm platform provides fully human antibody sequences for antibody-related drugs and CAR-T, offering more intracellular target options for targeting abnormal cells[136] - The company has approximately 291 R&D personnel engaged in Project Integrum and preclinical research services as of June 30, 2024[144] - R&D expenses for the six months ended June 30, 2023 and June 30, 2024 were RMB248.0 million and RMB161.7 million, respectively[144] - R&D expenses on Core Products accounted for approximately 11% of total R&D expenses, amounting to RMB17.2 million for the six months ended June 30, 2024[144] - The company's GPCR antibody discovery platform generates fully human antibodies with great diversity, increasing screening success rates[137][142] Clinical Trials and Drug Development - The Phase I/II clinical trial of YH001, sponsored by Tracon, was expected to enroll 176 patients but was halted due to Tracon's bankruptcy, leading to the reclamation of YH001 licensing[50] - The Phase I clinical trial of YH003 in Australia enrolled 26 patients, with 3 achieving partial response (PR) and 6 achieving stable disease (SD), and one patient achieving complete response (CR) after nearly 2 years of treatment[51][52] - YH003 received IND approvals from multiple regulatory bodies, including the US FDA, TGA, MedSafe, NMPA, and Taiwan FDA, for Phase II MRCT in pancreatic duct adenocarcinoma (PDAC) patients[56] - The Phase I clinical trial of YH002 reported a 46.7% incidence of adverse events, with 2 subjects experiencing Grade 3 or 4 TEAEs, and no drug-related deaths[58] - YH004, a humanized anti-4-1BB IgG1 antibody, has shown good safety and tolerability in its Phase I trial, with 17 subjects enrolled across various dose levels[59] - YH005, an anti-Claudin 18.2 antibody, has been licensed to Rongchang Biotech, with RC118 (YH005 ADC) receiving orphan drug designations from the US FDA for gastric and pancreatic cancers[60] - The company collaborated with RemeGen for the co-development of YH005, leveraging Claudin 18.2 knock-out mice and RemeGen's ADC drug development capabilities[61] - YH015, a fully human IgG1 monoclonal antibody targeting CD40, is currently at the CMC stage and has potential applications in autoimmune diseases, multiple sclerosis, and organ transplantation[63] - The company has not yet commercialized any Core Products and continues to pursue collaborations with pharmaceutical companies for product development[154] Quality Management and Compliance - The company's quality management department consists of 37 employees as of June 30, 2024, with extensive experience in quality management and successful drug submissions to the FDA and NMPA[33] - The company has established a comprehensive quality control system based on ISO9001, GMP, and GLP standards, focusing on the design, R&D, manufacturing, testing, and transportation of products and product candidates[35] - The quality management department consists of 37 employees with extensive experience in FDA and NMPA drug filings[155] Partnerships and Collaborations - The company signed approximately 150 drug development/licensing/transfer agreements by June 30, 2024, with 50 new agreements signed in the first half of 2024, a 230% increase year-over-year[22] - Approximately 150 therapeutic antibody and clinical asset co-development/out-licensing/transfer agreements were established as of June 30, 2024, with around 50 new contracts signed in the first half of 2024, a 230% increase compared to the same period last year[40] - The company has established licensing and trial collaboration agreements with over ten multinational pharmaceutical companies, including Merck Healthcare KGaA, Johnson & Johnson, and BeiGene[120] Global Expansion and Infrastructure - The company established a new R&D service facility in Boston, U.S., to enhance localized services for overseas customers[25] - The company established a new subsidiary in Heidelberg, Germany in 2022 and set up an office in San Francisco, USA in May 2023[138][149] - The company relocated to a newly leased laboratory and animal house in Boston, USA in August 2023, enhancing business capacity[138][149] - The company achieved significant sales growth by expanding its animal model categories, establishing a German subsidiary in 2022, and tripling the size of its Boston facility in 2023[62][65] Animal Models and Pre-clinical Services - The company provides thousands of gene-edited animal and cell models, including target humanized mice, under its BioMice® sub-brand[17] - The company's pre-clinical research services include gene editing, pharmacology, efficacy evaluation, and animal models, contributing to fast-growing revenues and high gross margins[48] - The company has developed over 3,300 unique gene-edited

模型以及药理药效这一部分在过去几年里面一直在稳定持续的增长第二部分是我们的抗体分子也就是我们的千树万炕业务这是基于我们白赛图基因技术开发的全能抗体属于麦思系列产生了将近上千个把柄的抗体分子也就是我们的千树万炕白赛图是一家只根据中国成为全球性的一个生物技术公司 我们在北京、江苏海门、美国的波士顿、旧金山以及德国的海德堡都有我们的生态研发中心以及商务中心可以看到这是白赛土的一个业务逻辑白赛土有一个世界一流的基因编辑技术团队大概有150人的团队 我们在过去的十年的时间里面除了对客户进行基因编辑的精确小鼠的智慧服务以外大部分的时间大部分的精力是开发自主创新的动物模型尤其是由于药物研发的八点人变化老鼠模型这些小鼠出售给我们带来大量的收入同时利用我们自主创新的动物模型进行药理药效服务也就是为客户进行药物药效临床前的药效评价 另一个优先的就是我们的全人体抗体术就是REMAPS系列这也是由我们基因编辑团队经过7个实验的时间开发出来的REMAPSREMAPS系列的REMAPS系列在2020年的时候我们完成了REMAPS系列小组以后我们在这个小组的基础上就针对上千个靶点进行抗体开发 由此我们产生了大概40万个抗体分子这些抗体分子 ...

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，概不就因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 BIOCYTOGEN PHARMACEUTICALS (BEIJING) CO., LTD. 百奧賽圖（北京）醫藥科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2315） 截至2024年6月30日止六個月的中期業績公告 百奧賽圖（北京）醫藥科技股份有限公司（「本公司」或「百奧賽圖」）董事（「董事」） 會（「董事會」）欣然宣佈本公司及其附屬公司（統稱「本集團」）截至2024年6月30日 止六個月（「報告期間」）的未經審核綜合業績，連同2023年同期的比較數字。 財務摘要 | --- | --- | --- | --- | |-------------------------------|--------------|--------------|----------| | | 截至 | 截至 | | | | 2024 年 | 2023 年 | | | | 6 月 30 日 | ...

(3) 百奥赛图 百奥賽圖 (北京)醫藥科技股份有限公司 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (A joint stock company incorporated in the People's Republic of China with limited liability) (於中華人民共和國註冊成立的股份有限公司) Stock code 股份代號：2315 Annual Report IIIII II HIII II IIII EF l Flin | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-----------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | IIIIIIII IIIIII IIIIII IIII | | | | | | | | HI HIDDI HOUDIN ...

Investment Rating - The report maintains an "Outperform" rating for Biocytogen Pharmaceuticals [3][8][16] Core Insights - In 2023, Biocytogen achieved a revenue of 717 million yuan, representing a 34% increase, with overseas revenue growing by 66% to 408 million yuan. The gross profit margin was 70.6%, an increase of 2.8 percentage points, while the net loss was reduced to 383 million yuan from 602 million yuan in the previous year [5][18] - The company has completed phased research and development for its "Thousand Mice, Ten Antibodies" project, and has successfully licensed out several clinical pipelines [6][20][21] - The preclinical CRO segment saw significant growth, with annual revenue reaching 541 million yuan, a 33% increase, and a gross margin of 67% [19][20] Financial Summary - Revenue projections for Biocytogen from 2024 to 2026 are estimated at 915 million yuan, 1.127 billion yuan, and 1.357 billion yuan, with year-on-year growth rates of 27.6%, 23.2%, and 20.4% respectively. The net profit is expected to turn positive by 2025, reaching 98 million yuan [10][22] - The company’s valuation is segmented, with the preclinical CRO business valued at 3 billion yuan, antibody development at 1.5 billion yuan, and self-developed pipelines also at 1.5 billion yuan, leading to a total valuation of 6 billion yuan [8][22]

Revenue Growth - Revenue increased by 34.3% to RMB 716.9 million in 2023 compared to RMB 533.9 million in 2022[2] - Revenue from gene editing services increased to RMB 74,325 thousand in 2023, up from RMB 61,075 thousand in 2022, representing a growth of 21.7%[13] - Revenue from preclinical pharmacology and efficacy evaluation services rose to RMB 193,396 thousand in 2023, compared to RMB 176,069 thousand in 2022, a 9.8% increase[13] - Model animal sales revenue surged to RMB 272,805 thousand in 2023, a significant 61.1% increase from RMB 169,328 thousand in 2022[13] - Antibody development revenue grew to RMB 175,870 thousand in 2023, up from RMB 126,887 thousand in 2022, marking a 38.6% increase[13] - Total revenue from customer contracts reached RMB 716,912 thousand in 2023, a 34.3% increase from RMB 533,881 thousand in 2022[13] - Revenue from the United States increased to RMB 301,169 thousand in 2023, up from RMB 178,993 thousand in 2022, a 68.3% growth[24] - Revenue from China grew to RMB 308,610 thousand in 2023, compared to RMB 287,736 thousand in 2022, a 7.3% increase[24] - Revenue from antibody development business reached RMB 175.9 million in 2023, a 38.6% increase year-over-year, while model animal sales revenue grew by 61.1% to RMB 272.8 million[43] - Overseas revenue accounted for 57.0% of total revenue in 2023, reaching RMB 408.3 million, a 65.9% increase compared to the previous year[43] - Total revenue increased by 34.3% from RMB 533.9 million in 2022 to RMB 716.9 million in 2023, driven by growth in model animal sales and antibody development[104] - Model animal sales revenue increased to RMB 272.805 million in 2023, accounting for 38.1% of total revenue[104] - Antibody development revenue grew to RMB 175.870 million in 2023, representing 24.5% of total revenue[104] Profit and Loss - Gross profit rose by 29.2% to RMB 506.0 million in 2023 from RMB 391.8 million in 2022[2] - Pre-tax loss decreased by 36.8% to RMB 380.2 million in 2023 from RMB 601.4 million in 2022[2] - Net loss for the year reduced by 36.4% to RMB 383.0 million in 2023 from RMB 602.2 million in 2022[2] - Basic and diluted loss per share decreased by 39.2% to RMB 0.96 in 2023 from RMB 1.58 in 2022[2] - Total reportable segment gross profit for 2023 was RMB 506,351 thousand, up from RMB 392,523 thousand in 2022, a 29.0% increase[23] - The company's pre-tax loss for 2023 was RMB 380,156 thousand, compared to RMB 601,353 thousand in 2022[33] - The company's net loss narrowed by approximately 36.4% in 2023, with plans to achieve near break-even by the end of 2024 through further expansion into high-margin overseas markets and cost control[44] - Gross profit increased by 29.2% from RMB 391.8 million in 2022 to RMB 506.0 million in 2023, driven by increased revenue from model animal sales and antibody development[106] - Gross margin decreased from 73.4% in 2022 to 70.6% in 2023, primarily due to the relocation to a new laboratory in Boston, USA, which reduced the gross margin of preclinical pharmacology and antibody development[106] - The company reported a net loss of RMB 383.0 million in 2023, compared to a net loss of RMB 602.2 million in 2022[117] R&D and Innovation - R&D expenses decreased by 32.2% to RMB 474.4 million in 2023 from RMB 699.2 million in 2022[3] - R&D expenses decreased by 32.2% to RMB 474.4 million in 2023 from RMB 699.2 million in 2022, as the company concluded its large-scale R&D investment phase[43] - R&D personnel totaled 366 as of December 31, 2023, with R&D expenses of RMB 474.4 million in 2023, down from RMB 699.2 million in 2022[89] - Core product R&D expenses were RMB 65.5 million in 2023, accounting for 13.8% of total R&D expenses[89] - R&D expenses decreased by 32.2% from RMB 699.2 million in 2022 to RMB 474.4 million in 2023, mainly due to reduced employee costs, outsourcing fees, and direct material costs[112] - The company's antibody development platform, RenMice, has generated a library of 400,000 to 500,000 antibody sequences for over 1,000 targets, enabling the identification of potential therapeutic antibody molecules[44] - The company's preclinical research services, including gene editing and model animal sales, have gained recognition from both domestic and international clients, contributing to rapid revenue growth and high margins[44] - The company's strategy involves advancing a small number of promising drug molecules to the preclinical stage and then partnering with biotech and pharmaceutical companies for further development and commercialization[45] - The company has completed the development of the "Thousand Mice Ten Thousand Antibodies" project and built a large antibody sequence library by the end of Q3 2023[46] - The "Thousand Mice Ten Thousand Antibodies" project has evaluated approximately 1,000 targets and developed over 800 targets, with a library of 400,000 to 500,000 fully human antibody sequences covering more than 1,000 innovative targets[48] - The company has knocked out over 680 target genes in RenMab and over 270 target genes in RenLite as part of the "Thousand Mice Ten Thousand Antibodies" project[48] - The company plans to expand the antibody library by developing bispecific antibodies and nanobodies using RenLite and RenNano technology platforms[48] - The company's business model involves commercializing antibodies through co-development, authorized transfers, and transfer development agreements, generating revenue from upfront payments, milestone payments, and sales royalties[48] - The company's revenue currently comes mainly from upfront payments, with milestone payments and sales royalties expected to grow significantly in the future[48] - The company's gene editing technology supports antibody discovery and model animal platforms, including the RenMice platform[79] - The company's gene editing services focus on overseas pharmaceutical clients to enhance profitability and value contribution[78] - The company's gene editing platforms include SUPCE, CRISPR/EGE, and ESC/HR, driving technological innovation[80] - The company provides customized gene editing services for rats/mice and cell lines, with final products including animal or cell line models with specific genotypes, genotyping reports, and project completion reports[81] - The company's proprietary SUPCE technology enables chromosome editing on a million-base scale, with high stability and repeatability, as demonstrated by the RenMice platform[82] - The RenMice platform has been licensed to several multinational pharmaceutical companies, including Merck Healthcare KGaA, Johnson & Johnson, Xencor, BeiGene, and Innovent Biologics, generating upfront payments, milestone payments, and sales royalties[83] - The RenMab platform, which uses RenMab mice to discover and generate fully human monoclonal antibodies, has obtained patents in China and the United States in 2023[84] - The RenLite platform generates high-affinity bispecific antibodies and bispecific ADCs, with the ability to produce bispecific ADCs targeting two tumor antigens, such as YH012 and YH013[85][86] - The RenNano platform produces fully human single-chain antibody fragments without the need for in vitro humanization, enabling high-throughput development of fully human heavy-chain antibodies[87] - The RenTCRm platform, based on RenMice, generates fully human antibodies targeting intracellular antigens, providing more candidate molecules for antibody-related drugs and CAR-T therapies[88] - GPCR platform developed based on RenMice, generating highly diverse fully human antibodies with high screening success rates[89] Clinical Trials and Drug Development - YH001 achieved an objective response rate (ORR) of 19.2% (95% CI: 6.6, 39.4) and a disease control rate (DCR) of 61.5% (95% CI: 40.6, 79.8) in a Phase I trial with 26 evaluable patients[50] - YH001 is being evaluated in a Phase I/II trial in the US for advanced or metastatic sarcoma, with 176 patients expected to be enrolled[51] - YH003 demonstrated a complete response (CR) in one patient with pancreatic cancer, who maintained CR status as of June 30, 2023[52] - YH003 Phase II MRCT enrolled 92 PDAC patients, with 47 in the first-line treatment group and 45 in the second-line and beyond treatment group[52] - YH003006 study in China enrolled 20 patients for the treatment of unresectable/metastatic mucosal melanoma, with results expected in the first half of 2024[53] - YH003005 study enrolled 15 patients for the treatment of advanced solid tumors in China and Australia[54] - YH002 Phase I trial showed a disease control rate (DCR) of 20% in 15 patients with advanced solid tumors[55] - YH002 was well-tolerated at doses up to 2.0mg/kg, with 46.7% of patients experiencing treatment-related adverse events (TEAEs)[55] - YH002 reported 3 serious adverse events (SAEs) at the 3.0mg/kg dose level, with no drug-related deaths[55] - YH002 demonstrated disease stabilization (SD) in 3 out of 15 patients based on RECIST v1.1 criteria[55] - YH002 has entered clinical trials in Mexico with promising initial clinical data showing anti-tumor activity[56] - YH004 Phase I clinical trial enrolled 17 patients with doses ranging from 0.01mg/kg to 3.0mg/kg, showing good safety and tolerability[57] - YH005 (RC118) received two orphan drug designations from the FDA for gastric and pancreatic cancer treatment[58] - YH008 secured a licensing deal with Microcore New Domain, including a RMB 40 million upfront payment and up to RMB 556 million in milestone payments[60] - YH012, a HER2/TROP2 bispecific ADC, entered an exclusive option and licensing agreement with Radiance in January 2024[61] - YH013, an EGFR/MET bispecific ADC, signed an exclusive option and licensing agreement with Doma Medical in 2023[62] - YH015, a CD40-targeting antibody, is currently in the CMC stage with potential applications in autoimmune diseases and organ transplantation[63] - YH016 and YH017, novel antibodies targeting myeloid cells and T/NK cells, have identified high-affinity candidate antibodies for further development[64] - YH001 is a recombinant humanized anti-CTLA-4 IgG1 monoclonal antibody[142] - YH002 is a recombinant humanized IgG1 antibody targeting the human OX40 receptor[142] - YH003 is a recombinant humanized agonistic anti-CD40 IgG2 monoclonal antibody[142] - YH004 is a humanized IgG1 anti-4-1BB agonist[142] - YH008 is an anti-PD-1/CD40 bispecific antibody for the treatment of solid tumors[142] - YH012 and YH013 are two bispecific ADCs developed using the RenLite platform, planned for the treatment of solid tumors[142] - YH015 is a fully human IgG1 anti-CD40 monoclonal antibody[142] - YH016 and YH017 are two novel molecules developed using the RenMice platform for the treatment of solid tumors and immune diseases, respectively[143] - 4-1BB is a receptor expressed on activated T cells and NK cells, providing co-stimulatory signals to promote T cell proliferation, survival, and cytotoxic effects[143] Financial Position and Expenses - Cash and bank balances decreased by 33.4% to RMB 417.7 million in 2023 from RMB 626.6 million in 2022[4] - Total equity decreased by 31.3% to RMB 790.4 million in 2023 from RMB 1,150.8 million in 2022[7] - The remaining performance obligation under existing contracts as of December 31, 2023, was RMB 182,160 thousand, expected to be recognized over the next 3 years[14] - Other income and losses net amount for 2023 was RMB 42,259 thousand, compared to RMB 86,710 thousand in 2022[25] - Net fair value change of biological assets for 2023 included realized fair value negative change of RMB 59,940 thousand and unrealized fair value positive change of RMB 64,819 thousand[26] - Financial costs for 2023 increased to RMB 99,844 thousand from RMB 56,139 thousand in 2022, mainly due to higher interest on long-term payables[27] - Employee costs for 2023 decreased to RMB 404,065 thousand from RMB 419,895 thousand in 2022, with a notable increase in equity-settled share-based payment expenses[28] - Depreciation of property, plant, and equipment for 2023 was RMB 182,299 thousand, up from RMB 171,034 thousand in 2022[31] - The company enjoyed a preferential tax rate of 15% in 2023 due to its high-tech enterprise qualification[34] - Basic loss per share for 2023 was calculated based on a net loss attributable to ordinary shareholders of RMB 382,951 thousand[35] - Trade receivables as of December 31, 2023, amounted to RMB 142,205 thousand, up from RMB 107,682 thousand in 2022[38] - The aging analysis of trade receivables showed that 88.5% were within 1 year, 10% were 1-2 years, and 1.5% were 2-3 years as of December 31, 2023[39] - Trade payables and notes payable increased to RMB 175,234 thousand in 2023 from RMB 146,190 thousand in 2022, with a significant rise in payables to third parties from RMB 104,968 thousand to RMB 115,113 thousand[40] - The company's issued and fully paid ordinary shares increased to 399,398 thousand shares by the end of 2023, following the issuance of 24,468 thousand new shares in 2022[41] - Sales costs increased by 48.4% from RMB 142.1 million in 2022 to RMB 210.9 million in 2023, in line with revenue growth[105] - Other income and losses decreased by 51.3% from RMB 86.7 million in 2022 to RMB 42.3 million in 2023, mainly due to a decrease in fair value changes of financial assets and foreign exchange gains[107] - Sales and marketing expenses increased by 25.0% from RMB 50.2 million in 2022 to RMB 62.8 million in 2023, largely due to salary increases in line with revenue growth[110] - General and administrative expenses increased by 8.7% from RMB 263.4 million in 2022 to RMB 286.3 million in 2023, primarily due to increased depreciation, amortization, and rental expenses from the new Boston facility[111] - Cash and cash equivalents decreased from RMB 626.6 million in 2022 to RMB 417.7 million in 2023, primarily due to net operating losses[114] - Financial costs increased by 77.9% from RMB 56.1 million in 2022 to RMB 99.8 million in 2023, driven by higher interest on long-term payables and bank loans[116] - The asset-liability ratio increased from 1.43 in 2022 to 2.10 in 2023, reflecting higher liabilities relative to equity[118] - Total capital expenditure for the year ended December 31, 2023, was approximately RMB 79.8 million, primarily for facility and office building investments and scientific equipment purchases[120] - The company mortgaged its factory and buildings in Baiao Situ Daxing for long-term bank loans, with a net book value of RMB 239,542,000 as of December 31, 2023[121] - Net proceeds from the global offering amounted to approximately HKD 537.0 million (equivalent to RMB 436.3 million), with 70% allocated to core product clinical R&D[125][126] - As of December 31, 2023, the company had utilized HKD 480.5 million of the net proceeds, leaving HKD 56.5 million unused, which is expected to be fully utilized by December 31, 2024[126][127] - The company allocated 35% of the net proceeds (HKD 188.0 million) to YH003 R&D and 35% (HKD 188.0 million) to YH001 clinical development[126] - 15% of the net proceeds (HKD 80.6 million) was used for facility construction and equipment procurement under the "Thousand Mice, Ten Thousand Antibodies" program[126] - The company has no significant contingent liabilities or major investments as of December 31, 2023[120][121] - The company has not conducted any significant acquisitions or disposals of subsidiaries, associates, or joint ventures during the year[122] - The company’s audit committee reviewed and confirmed compliance with accounting standards and regulations for the financial year ended December 31, 2023[128] - The board has decided not to recommend a final dividend for the year ended December 31, 2023 (2022: none)[130] - The company will suspend share transfer registration from May 23, 2024, to May 28, 2024, to determine shareholder eligibility for the annual general meeting on May 28, 2024[130] - The annual report for the year ended December 31, 2023, will be sent to shareholders and published on the Hong Kong Stock Exchange and the company

Financial Performance - Biocytogen Pharmaceuticals reported a significant increase in revenue, achieving a total of RMB 500 million for the first half of 2023, representing a 25% year-over-year growth[2]. - Revenue for the first half of 2023 reached RMB 326,836,000, a 42.6% increase compared to RMB 229,131,000 in the same period of 2022[13]. - Gross profit for the first half of 2023 was RMB 235,364,000, reflecting a 41.0% increase from RMB 166,970,000 year-on-year[13]. - Loss before taxation narrowed to RMB (189,389,000) in the first half of 2023, a 30.5% improvement from RMB (272,593,000) in the same period of 2022[13]. - Loss for the period attributable to equity shareholders decreased by 30.3%, from RMB (272,385,000) in 2022 to RMB (189,808,000) in 2023[13]. - The company maintained over 40% rapid growth in sales revenue in the first half of 2023, particularly in overseas markets[17]. - The company’s operational efficiency improvements led to a reduction in losses by approximately 30% year-on-year in the first half of 2023[18]. - The company expects to achieve profitability in 2025, with a continued narrowing of losses anticipated in 2024[127]. Market Expansion and Strategy - Biocytogen has set a future revenue guidance of RMB 1.2 billion for the full year 2023, indicating an expected growth of 30% from 2022[4]. - The company is focusing on market expansion, targeting an increase in its market share by 15% in the Asia-Pacific region by the end of 2023[6]. - The company’s board of directors has approved a new strategic initiative to enter the European market, with plans to establish a local office by Q4 2023[11]. - The company plans to enhance its digital marketing strategies, expecting a 20% increase in online engagement with potential customers[10]. - The company is actively developing new products, with 5 new drug candidates entering clinical trials in the first half of 2023[5]. Research and Development - The company is investing in advanced technologies, allocating RMB 100 million towards R&D for innovative drug development in 2023[8]. - The overall R&D strategy focuses on self-directing early discovery of drug molecules and advancing promising candidates to pre-clinical or early clinical stages[21]. - The company has established animal model production centers covering approximately 55,000 sq.m., allowing for a broad set of genetically engineered mice and disease models[110]. - The company has developed hundreds of syngeneic and xenogeneic tumor models to meet client scientific objectives[60]. - The company has developed a series of humanized mice based on the C57BL/6 genetic background to ensure effective drug validation for immune checkpoints and other targets[81]. Clinical Trials and Drug Development - The Phase I clinical trial of YH003 in combination with PD-1 in Australia is completed, with 26 patients enrolled, showing promising antitumor activity in certain cancers[25]. - Data from the Phase I clinical trial demonstrated that YH003 in combination with toripalimab was well tolerated, with three patients achieving partial response and one achieving complete response as of June 30, 2023[25]. - The ongoing Phase II MRCT study for YH003 in PDAC patients is expected to report results in 2024[27]. - YH004, a humanized anti-4-1BB IgG1 antibody, has completed the first patient dosing in Australia as part of its Phase I clinical trial, with 14 subjects enrolled as of June 30, 2023[28]. - The company has received IND approvals for YH003 from multiple regulatory bodies, including the U.S. FDA and NMPA, to conduct clinical trials in various countries[26]. Partnerships and Collaborations - The company is actively seeking strategic and synergistic partnerships with leading biopharmaceutical companies to enhance the success probability of its drug candidates and maximize their clinical and commercial value globally[21]. - The company has reached an exclusive clinical development and commercialization agreement for the YH008 bispecific antibody in Greater China, retaining global rights for YH008 outside of Greater China[23]. - The company is in cooperation with ISU ABXIS to develop a tri-specific antibody based on the YH003 sequence, entitled to receive upfront payments, milestone payments, and future sales royalties[23]. - The collaboration with RemeGen for YH005 has resulted in the development of RC118, which has received orphan drug designation from the U.S. FDA for gastric cancer treatment[48]. Financial Management and Investments - The company has submitted application materials for the proposed issuance of A-shares and received acceptance letters from the Shanghai Stock Exchange[111]. - The company has established a quality control system based on ISO9001, GMP, and GLP standards, with a quality management team of approximately 42 employees[115]. - The company has received a letter of acceptance from the Shanghai Stock Exchange for the proposed issue of A Shares[114]. - The company aims to achieve profitability by 2025, with a significant reduction in losses expected in 2024[124]. - The company has established 50 co-development/out-licensing/transfer development agreements as of June 30, 2023, including partnerships with Merck Healthcare KGaA and ADC Therapeutics, with a 45% increase in new deals signed in the first half of 2023 compared to the same period last year[51]. Employee and Operational Insights - The total number of employees as of June 30, 2023, was 1,313, a decrease from 1,348 as of December 31, 2022[162]. - The company has approximately 500 R&D personnel engaged in drug development and preclinical research services as of June 30, 2023[109]. - The management will continue to monitor foreign currency exposure and arrange hedging measures as necessary[157]. - The company has developed on-site training programs to enhance the skills of its personnel in cutting-edge scientific and technical topics[108].

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，概不就因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 BIOCYTOGEN PHARMACEUTICALS (BEIJING) CO., LTD. 百奧賽圖（北京）醫藥科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2315） 截至2023年6月30日止六個月的中期業績公告 百奧賽圖（北京）醫藥科技股份有限公司（「本公司」或「百奧賽圖」）董事（「董事」） 會（「董事會」）欣然宣佈本公司及其附屬公司（統稱「本集團」）截至2023年6月30日 止六個月（「報告期間」）的未經審核綜合業績，連同2022年同期的比較數字。 財務摘要 | --- | --- | --- | --- | |------------------------------|--------------|--------------|----------| | | 截至 | 截至 | | | | 2023 年 | 2022 年 | | | | 6 月 30 日 | 6 ...