Shenzhen New Industries Biomedical Engineering Co., Ltd. | Chemiluminescence Immunoassay & Clinical

Shenzhen New Industries Biomedical Engineering Co., Ltd. | Chemiluminescence Immunoassay & Clinical

3

Company Profile

Shenzhen New Industries Biomedical Engineering Co., Ltd. (brand: Snibe) is a China-based manufacturer of    fully automated chemiluminescence immunoassay (CLIA) systems and clinical laboratory analyzers, headquartered in    Pingshan District, Shenzhen, Guangdong. Founded in    1995 and led by Chairman    Rao Wei, the company was listed on the    Shenzhen Stock Exchange ChiNext Board (300832) in    2020. Snibe serves over    200,000 medical institutions across more than    180 countries and regions.

Core Products & Technologies

Chemiluminescence Immunoassay Systems

MAGLUMI X10: Flagship high-speed CLIA analyzer achieving 1,000 tests/hour; launched Q3 2025 with MPC micro-precision pipetting technology, ClearFlow dynamic sensing algorithm, and three-zero steady-state wash technology reducing carryover to near 0 ppm
   • MAGLUMI X8: High-throughput CLIA analyzer; cumulative installations reached 4,940 units by end of 2025; 276 X8/X10 units installed/sold in Q1 2026
   • MAGLUMI Series Portfolio: 12 fully automated CLIA instruments covering entry-level to high-speed platforms for laboratories of all sizes
   • Reagent Menu: 250 chemiluminescence immunoassay reagents globally, including tumor markers, thyroid, infectious disease, cardiac markers, inflammation, glycometabolism, bone metabolism, hepatic fibrosis, and autoimmune antibodies; 201 reagents registered domestically (288 total registrations)

Small-Molecule Sandwich Assay Technology

Proprietary Platform: Self-developed non-competitive sandwich immunoassay platform for small molecules, breaking through traditional competitive method limitations; launched 16 core products including 25(OH)Vitamin D, estradiol, progesterone, aldosterone, and cyclosporine A
   • Clinical Validation: Aldosterone, estradiol, and tacrolimus assays demonstrate correlation coefficients of 0.994, 0.990, and 0.993 respectively against gold-standard mass spectrometry; 25(OH)Vitamin D correlation with mass spectrometry at 0.97 (1,314-sample study)
   • Revenue Growth: Small-molecule sandwich reagent revenue reached RMB 211.18 million in 2025, up 75.36% year-over-year

Clinical Chemistry, Hematology & Other Platforms

Biochemistry Analyzers: 6 fully automated biochemistry analyzers; 80 biochemistry reagents covering renal function, hepatic function, special proteins, and lipids; 81 reagents registered domestically (116 total registrations)
   • Coagulation Diagnostics: 7 coagulation reagents including coagulation panel (PT, APTT, TT, FIB); first reagent registered June 2022
   • Molecular Diagnostics: Selected molecular diagnostic reagents with CE and domestic NMPA registrations
   • Electrolyte & Nucleic Acid Testing: 1 electrolyte analyzer and 1 fully automated nucleic acid testing analyzer

Market Position & Certifications

Snibe holds a leading position in China's domestic chemiluminescence market,    competing with Roche Diagnostics,    Abbott,    Siemens Healthineers,    Mindray, and    Autobio Diagnostics. Key strengths include:

30+ years of IVD innovation heritage
   • Domestic market penetration: Top-tier hospital coverage reaching 63.38% of domestic Class IIIA hospitals (added 98 new top-tier hospital clients in Q1 2026); 1,930 domestic tertiary hospital clients by end of 2025
   • Global expansion: Overseas revenue of RMB 2.007 billion in 2025 (up 19.16% YoY); overseas reagent revenue up 34.96%; 3,357 CLIA instruments sold overseas in 2025 with mid-to-high-end models accounting for 75.34%; established 16 overseas branches including new subsidiaries in Korea and Bangladesh
   • Regulatory compliance: NMPA Class II and III registrations; 73 products received IVDR CE certification in 2025; ISO 13485 certified manufacturing; 444 medical device registrations by end of 2025
   • Technology leadership: First domestic company to achieve small-molecule sandwich immunoassay platform at scale; proprietary AI-integrated urine sediment morphology identification

Corporate Timeline

1995 — Founded in Shenzhen, pioneering domestic chemiluminescence immunoassay technology
   2011 — Launched first-generation MAGLUMI fully automated CLIA system
   2020 — Listed on Shenzhen Stock Exchange ChiNext Board (300832)
   2022 — First coagulation diagnostic reagent received NMPA registration; breakthrough in small-molecule sandwich immunoassay platform
   2024 — MAGLUMI X8 cumulative sales exceeded 4,000 units; overseas expansion accelerated
   2025 — Annual revenue reached RMB 4.577 billion; domestic revenue RMB 2.564 billion (-9.82%), overseas revenue RMB 2.007 billion (+19.16%); MAGLUMI X10 and Biosays C10 launched; SATLARS T8 pipeline cumulative 309 installations; 73 products received IVDR CE; small-molecule reagent revenue grew 75.36% to RMB 211.18 million; R&D investment RMB 478 million (+5.33%)
   2026 — Q1 revenue of RMB 1.129 billion (+0.34% YoY) with net profit of RMB 442 million (+1.02%) and non-recurring net profit of RMB 421 million (+1.11%); domestic top-tier hospital coverage expanded to 63.38%; X8 cumulative installations reached 4,940 units; announced share buyback program

Target Markets & Applications

Clinical Laboratory Diagnostics: High-throughput chemiluminescence and biochemistry systems for hospital laboratories and reference centers
   • Oncology Screening & Monitoring: Tumor marker panels for cancer diagnosis, staging, and recurrence monitoring
   • Endocrinology & Metabolism: Thyroid function, diabetes, bone metabolism, and hypertension screening via small-molecule sandwich assays
   • Infectious Disease & Autoimmune: Pathogen serology and autoimmune antibody detection
   • Cardiac & Critical Care: Cardiac biomarkers and inflammatory markers for emergency and ICU settings
   • Global IVD Markets: Export-focused solutions across Asia, Europe, Africa, and Latin America via 16-country operational network

Contact Information

Global Headquarters

Address: 21F, Snibe Building, No. 23 Jinxiu East Road, Kengzi Street, Jinsha Community, Pingshan District, Shenzhen, Guangdong 518118, China
   Phone: +86 755 8654 0062
   Fax: +86 755 2665 4800
   Email: snibeinfo@snibe.cn
   Website: www.snibe.com

文章下方广告位

网友评论

访客信息

你已经3分钟没有访问该网站

这些可能是你需要的内容: