IVD China last week: Roche, Snibe, Wondfo, BGI, Ustar

Roche Takes Key Step in Localization Strategy: First Import-to-Local Production Project Achieves Product Registration in China

Roche Diagnostics has obtained product registration in China for its “Fully Automated Immunohistochemistry Independent Temperature-Controlled Staining System,” marking a key milestone in its localization strategy. The product recently approved not only significantly enhances pathological diagnostic efficiency and ensures stable and reliable staining quality, but also optimizes laboratory space configuration, providing automated and diversified integrated testing solutions for pathological institutions in China. Its entire production process truly achieving "globally consistent quality with localized lean manufacturing."

Roche Diagnostics has successfully localized the R&D and production of multiple products, currently, Roche’s Suzhou facility has three types of Class II active medical devices that have completed the transition from imported to local production. Since approval, cumulative sales have exceeded 500 units, generating revenue of RMB 360 million.

Snibe Obtains EU IVDR CE Certification for 18 Chemiluminescence Reagents

On August 20th, SNIBE announced that 18 of its chemiluminescence reagent products had received IVDR certification from TÜV SÜD. These products are primarily used for detecting the presence or exposure to infectious substances, as well as screening, confirming, or monitoring allergies and intolerances. This achievement marks another milestone for Chinese companies in IVDR compliance, following similar successes by Mindray and Autobio, clearing the path for market access in Europe.

To date, SNIBE has obtained IVDR CE certification for a total of 211 chemiluminescence reagent products and 67 biochemical reagent products. In compliance with the EU In Vitro Diagnostic Medical Device Regulation, these products meet the necessary requirements for entering the EU market, which is expected to enhance the company’s overall competitiveness and positively impact its future operations.

Wondfo Biotech Reports H1 2025 Revenue of RMB 1.246 Billion, Establishes Subsidiaries in Russia and Philippines

In the first half of 2025, Wondfo Biotech recorded a revenue of RMB 1.246 billion and a net profit attributable to shareholders of RMB 189 million. Despite acknowledging performance pressures, the company remains committed to its IPD transformation and internationalization strategy, leveraging digital transformation to improve efficiency.

As a pioneer in the global expansion of China’s IVD industry, Wondfo has established a global service network covering over 150 countries and regions, with localized production bases in multiple countries. This year, the company continues to deepen its global strategic layout and strengthen localized operations in key markets. Its toxicology testing products ranked first in sales on Amazon US, while subsidiaries in Russia and the Philippines have been established. Additionally, Wondfo Health has set up a branch in Malaysia to accelerate the overseas expansion of home health testing products and services.

BGI’s Saudi Subsidiary BGI Almanahil Increases Capital to Advance Awarded Project

BGI Genomics announced that its wholly-owned Saudi subsidiary, BGI Almanahil, plans to increase its capital contribution to its joint venture Genalive by 22 million Saudi Riyals, in proportion to its 50% equity stake.

In March 2025, Genalive won a centralized procurement project from Saudi Arabia’s NUPCO, valued at approximately RMB 950 million, for a three-year off-site testing service contract for public hospitals. This capital increase aims to support Genalive’s business operations, meet the funding requirements for the project, ensure high-quality delivery, enhance its comprehensive business capabilities, and deepen the strategic synergy and collaboration between BGI and Genalive. This move aligns with BGI’s long-term overseas business strategy and strengthens its leading position in Saudi Arabia and the Gulf region.

Ustar Biotech and University of Indonesia Establish Joint Innovation Center for Molecular POCT

On August 15th, 2025, Ustar Biotech and the University of Indonesia officially signed a memorandum of cooperation to establish a "Joint Innovation Center for Molecular POCT Diagnostic Technology." The center will focus on the development and clinical validation of diagnostic products for tropical diseases such as dengue and malaria, technology transfer and localized production, and talent development, aiming to enhance diagnostic capabilities in Indonesia.

Key focus areas of the center include:

· Joint R&D in molecular POCT diagnostic technology

· Development and clinical validation of diagnostic products for tropical diseases such as dengue and malaria

· Technology transfer and localized production

· Talent development and capacity building

· Establishment of a national molecular diagnostic laboratory surveillance network in Indonesia