After nearly three years of regulatory review, Genor Biopharma’s geptanolimab has become the first domestically-developed anti-PD-1/L1 drug to experience a major regulatory setback within the overcrowded class in China. Over the intervening years since it was submitted for approval, the country’s regulator has moved to tighten review standards.

Where once there were promising prospects for cross-strait collaboration, biopharma firms in mainland China and Taiwan may now find themselves looking elsewhere for partners following a controversial visit to Taipei by US House Speaker Nancy Pelosi.

Emerging Company Profile: Akeso's lead compound is the bispecific antibody AK104, which targets the checkpoints PD-1 and CTLA-4. It will be advanced globally with a first indication in gastric and gastroesophageal junction cancers. This is the first in a series of China-based emerging company profiles.

Celgene reworks its collaboration with Abide, dropping its buyout option. Roivant gains Chinese rights to anti-infective lemafulin and adds a fifth candidate to Dermavant's pipeline, while pSivida acquires Icon and FDA-approved Dexycu for cataract surgery inflammation.