China

Krka has provided updates for its pair of joint ventures in two key Asian markets, India and China, as the Slovenian firm reported its first-quarter financial results.

In first confirmatory randomized controlled trial of any CAR-T therapy in solid tumors, CARsgen’s Claudin 18.2-targeting satri-cel reduced risk of death or disease progression by 63% in Chinese patients with gastric/gastroesophageal junction cancer.

Pfizer is doubling down on partnerships for combination therapies involving its antibody-drug conjugates through a new alliance with China's 3SBio’s for a bispecific antibody, potentially worth up to $6bn.

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

The AstraZeneca CEO again calls for rich European countries to pay more for new drugs because "a model where the US funds innovation in our industry for the entire world doesn't work."

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.

With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.

Generics Bulletin reviews global regulatory developments across the world.

US businesses across industry sectors remain apprehensive about higher tariffs going into effect on imports from China after three-month pause allowed on other changes.

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.