Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.

In the final part of an interview with Scrip, Menarini’s Asia-Pacific CEO talks about the group’s digital capabilities, including their impact on a shortage issue in Australia, and leveraging RWE to inform healthcare practices across the region. The Italian company is also revving up its business development and alliance engine.

Plus deals involving Elix/PRISM, Rege/Syros, Kaken/KalVista, Dr. Reddy’s/Aurigene/Edity, Nissan Chemical/Sanwa, Lupin/Renascience, Shionogi/Link Medicine, Abbisko/Merck & Co., Ono/Reborna and Apollomics/LaunXp.

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

India and the US are the major manufacturers of finished dosages for the US market in terms of volume (China accounts for 9% of injectables), though the US relies heavily on India for solid oral dosage forms and specific generics, including lenalidomide and albuterol. Scrip talks to experts on some of the key implications of geographic concentration of production for the US market amid the specter of tariffs.

Menarini's Asia-Pacific CEO talks to Scrip about how the Italian group is tailoring its portfolio and pricing approach to local markets making strong strides in primary care and consumer health, while also charting a distinct path in rare diseases and oncology. The China market is also a key focus including as a potential source of innovation as is partnering, where the group has a rich history.