28 July 2025
28 July 2025
Sarepta said it accepts the CHMP decision while partner Roche said it will continue working with the EMA.
The CHMP positive recommendation comes a month after the WHO backed the drug for global HIV prevention.
The free trade agreement is expected to reduce regulatory burdens on UK exports to India and boost trade in the pharmaceutical and medical device industries.
Beyond HRS-9821, the collaboration includes up to 11 additional programmes.
The EC’s decision is underpinned by outcomes from part one of the GMMG-HD7 Phase III trial.
Based on a sample of off-patent, generic, and biosimilar prices, these medicines are typically priced between 38% to 68% lower in France, on average, when compared to the other top European markets.
SSGJ-707 is a bispecific antibody that targets PD-1 and VEGF and was developed using 3SBio’s CLF2 platform.
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