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
百奥赛图-B(02315) - 2024 - 中期财报