Biotalys completes pilot production of Evoca NG, targeting registration in 2029

Production efficiency increased more than 15-fold compared with Evoca

According to the press release, the campaign demonstrated the consistency and scale-up capacity of the Evoca NG manufacturing process. It provides equipment and process validation data intended to support the product's registration procedures.

Chief Executive Officer Carlo Boutton sees it as “a key step in the transition of Evoca NG from development to commercialisation”. He states that the collaboration with 21st.BIO has enabled “a more than 15-fold improvement in production efficiency compared with Evoca”.

The executive outlined the next steps of the programme: “We are now ready to move on to the next phase towards commercialisation: scaling up production with contract manufacturing partners.”

Registration based on the approvals already obtained by Evoca

Developed on the Agrobody platform, Evoca NG targets two fungal diseases affecting fruit and vegetable crops: grey mould (Botrytis) and powdery mildew. The combined market targeted in the United States and Europe is estimated at approximately $1.1 billion, according to Kynetec data from 2020 and Biotalys.

The product shares the same active ingredient as Evoca, the first generation, which was authorised by the US EPA in December 2025 and then by Florida and California in 2026.

In the European Union, the review of Evoca is ongoing: the European Food Safety Authority (EFSA) is expected to finalise it by the end of the year or early next year, following the recent submission of additional data.

Biotalys anticipates a regulatory pathway for Evoca NG that is “significantly shorter” on both sides of the Atlantic, through equivalence or modification procedures.