Biologicals

Biotalys Hits Manufacturing Milestone for EVOCA NG Biofungicide

10 November 2026, Ghent: Biotalys, a Ghent-based biocontrol company listed on Euronext Brussels, said it has completed a pilot production campaign for EVOCA NG, the next generation of its protein-based biofungicide, running five consecutive production batches that delivered more than a fifteenfold improvement in production efficiency compared with its current biofungicide, EVOCA.

The campaign was carried out with manufacturing partner 21st.BIO, a precision fermentation technology provider, and generated the material and process validation data that the company says will support its ongoing product registration work and prepare it for future commercial-scale manufacturing. Carlo Boutton, Biotalys’ chief executive officer, described the result as a key milestone in moving EVOCA NG from development toward commercialization. He said the company’s next step is to scale up production through contract manufacturing organizations, which have not yet been named.

EVOCA NG is built on Biotalys’ AGROBODY platform, a protein engineering technology the company uses to design biological alternatives to synthetic crop protection chemistry. The product targets fungal diseases including Botrytis, commonly known as grey mold, and powdery mildew, in fruit and vegetable crops. Both diseases are among the more persistent problems growers face in high-value horticulture, often requiring repeated fungicide applications through a growing season to protect yield and marketable quality. EVOCA NG shares the same active biological ingredient as EVOCA, the company’s first-generation product, a link that Biotalys says should shorten the regulatory path for the newer formulation once it reaches the registration stage.

From EVOCA to EVOCA NG

EVOCA, the first-generation product, received federal approval from the US Environmental Protection Agency in December 2025, followed by state-level approvals in Florida and California during 2026. In the European Union, the regulatory review of EVOCA is still underway at the European Food Safety Authority, after Biotalys submitted additional data to the agency earlier this year. The company expects that review to conclude by the end of 2026 or in early 2027.

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Regulatory Path Ahead

For EVOCA NG, Biotalys is targeting registration in both the United States and the European Union in 2029. The company says it expects a shorter regulatory trajectory than a conventional new active ingredient would require, because the product may qualify for equivalency or amendment procedures tied to the already-reviewed EVOCA rather than a full standalone review. Biotalys pointed to a combined addressable market for the two fungal disease targets of approximately 1.1 billion dollars, citing data from Kynetec alongside its own estimates.

The pilot campaign’s five consecutive batches were intended to demonstrate the consistency and scalability of Biotalys’ manufacturing process ahead of a move to larger production volumes, addressing one of the recurring bottlenecks that has slowed protein-based biological products on their way from laboratory-scale output to volumes suitable for commercial field use. Biotalys was founded in 2013 as a spin-off from VIB, the Flanders Institute for Biotechnology, and has built its pipeline around the AGROBODY platform, which the company is also applying to other biofungicide and bioinsecticide candidates beyond the EVOCA line.

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