康圣环球(09960) - 2025 - 中期财报

Definitions Definitions This section provides definitions of key terms used throughout the report Company Information Board of Directors and Committees This section lists the company's Board of Directors (executive, non-executive, independent non-executive directors) and the composition of the Audit, Remuneration, and Nomination Committees - Board members include Dr. Huang Shiang (Chairman and CEO), Mr. Tu Zanbing, Ms. Chai Haijie as executive directors; Mr. Huang Ruijin, Mr. Peng Wei, Ms. Huang Lu as non-executive directors; and Dr. Yao Shanglong, Dr. Xia Xinping, Mr. Gu Huaming as independent non-executive directors[11] - The Audit Committee Chairman is Dr. Xia Xinping, the Remuneration Committee Chairman is Mr. Gu Huaming, and the Nomination Committee Chairman is Dr. Huang Shiang[11] Corporate Administrative Information This section provides key administrative and contact information, including the company secretary, authorized representatives, legal advisors, auditors, registered office, principal place of business, website, share registrar, and principal bankers - The company secretary is Ms. Chai Haijie and Ms. Li Meiyi (resigned on August 29, 2025), and authorized representatives are Ms. Chai Haijie and Mr. Tu Zanbing (appointed on August 29, 2025)[11] - The auditor is Ernst & Young, and Hong Kong legal counsel is Jingtian & Gongcheng LLP[11] - The company's website is www.kindstar.com.cn, and stock code is 9960[12] Business Review and Outlook Specialized Diagnostic Testing Business Remains Robust In H1 2025, the company optimized operations, strengthened its market position in six core specialized diagnostic testing areas like hematology, neurology, and oncology, and expanded its business through technological innovation and strategic M&A - Hematology diagnostic testing services added over 90 new hospital clients, the pediatric hematology segment added 48 new partner hospitals, and NGS Ig/TCR rearrangement technology products sales grew over 50%[14] - The neurology field added 34 new diagnostic projects, 44 new partner referral hospitals, and deepened cooperation with Southern Hospital[14] - In oncology, 15 new key partners were added, including Peking University Cancer Hospital, with solid tumor large panel testing and solid tumor MRD testing growing over 100% year-on-year[15] - The acquisition of Kindstar Medical Guangzhou was completed in January 2025, establishing a comprehensive full-disease course diagnostic system covering solid tumor early screening, early diagnosis, recurrence monitoring, and companion diagnostics[15][16] - UriFind® (urothelial carcinoma auxiliary diagnostic reagent kit) sales volume increased by approximately 82% year-on-year in H1 2025[21] - The maternal and child specialty team was established to promote growth in pediatric endocrinology referral business[17] - In cardiovascular diagnostic testing, mass spectrometry platform R&D and testing capabilities improved, with 1 new Class I reagent filing for mass spectrometry testing and 1 new Class II in vitro diagnostic kit approved, and 3 clinical mass spectrometry laboratories co-built[17] Scientific Research and Innovation Drive Industry Development In H1 2025, the company significantly increased R&D investment, achieving notable innovations including academic publications, numerous patent applications, and new diagnostic projects, particularly in CAR-T monitoring, leukemia MRD monitoring, and AI-integrated pathology diagnostics - In H1 2025, the Group's R&D department published 33 articles, filed 67 patent applications (29 of which were authorized), and obtained 24 copyrights[18] - 56 new R&D diagnostic projects were added, covering molecular biology, flow cytometry, cytogenetics, and pathology diagnostic technologies[18] - Key developments include CAR-T monitoring and evaluation projects, acute myeloid leukemia MRD monitoring (detection limit improved to 0.1%), fusion gene quantitative detection (NGS technology for 144 genes), and plans to integrate remote scanning and AI analysis to enhance comprehensive diagnostic capabilities[18] Immunome Profiling Products Show Significant Potential The company's core immunome profiling product, 'LymphoTrack,' continues to expand in hematological malignancy MRD detection, showing significant revenue growth and international quality certification, while health monitoring and immune reconstitution products have deepened market collaborations - The core product LymphoTrack (used for hematological malignancy minimal residual disease detection) has covered over 160 institutions in 26 provinces, with revenue growing nearly 30% compared to H1 2024[19] - Kindstar Biotech's Ig/TCR project achieved a perfect score in the EuroClonality EQA program, becoming the only laboratory in China to participate and pass with a perfect score[19] - Health monitoring product Kangbeice and immune reconstitution and monitoring product Fantech continue to deepen cooperation with renowned enterprises, institutions, and pharmaceutical companies[19] Specialized Diagnostic Reagents The company's specialized diagnostic reagent product line continues to expand, covering NGS capture, multiplex amplification, universal library preparation, single gene mutation, fusion gene, and transplantation series, with significant growth in proprietary product sales and progress in acquired IVD businesses, such as a substantial increase in UriFind® sales - Haixi Bio's product line has developed and transferred over 180 products, covering NGS capture-based, NGS multiplex amplification series, NGS universal library preparation series, single gene mutation detection series, fusion gene detection series, and transplantation series products[20] - The NGS reagent kits produced by Haixi Bio are compatible with an increasing number of sequencing platforms, and its 74 fusion gene screening projects are at a leading domestic level[20] - In H1 2025, the Group's proprietary specialized diagnostic reagent business sales increased by over 20% compared to H1 2024[20] - UriFind® (the first domestically approved reagent kit for auxiliary diagnosis of urothelial carcinoma) completed procurement processes with 11 hospitals and 8 third-party clients, with reagent sales volume increasing by approximately 82% year-on-year in H1 2024[21] - The blood-based non-invasive gastric cancer early detection product Gastromia® (Wei Yijian) has completed in vitro diagnostic reagent registration clinical research and entered the product registration application phase, with a negative accuracy rate of over 99%[21] Research Services and Contract Research Organization (CRO) Leveraging its R&D innovation and bioinformatics expertise, the company has become a multi-omics research service provider for leading domestic and international biological research institutions and pharmaceutical companies, achieving significant growth in research service revenue and actively expanding into overseas markets and new product lines - Since 2023, the company has been a multi-omics research service provider for domestic and international biological research institutions and pharmaceutical companies, operating 3 PacBio Revio platforms, with 2 serving the domestic market and 1 serving the overseas market[22] - Fully upgraded to the latest PacBio SPRQ reagents, single-cell output increased by up to 49%, positioning its total delivery capacity and throughput among the top PacBio service providers nationwide[22] - The research services segment added nearly 100 new partner hospitals and enterprises in H1, achieving total revenue of nearly RMB 20 million[22] - Preliminary completion of overseas laboratory construction in New Zealand, and domestically, independently developed and