US knocks back another Chinese PD-1 entrant

The good news for Jiangsu HengRui and its ex-China partner HLB Therapeutics is that yesterday’s FDA rejection of the first US filing for the anti-PD-1 MAb camrelizumab wasn’t apparently the result of insufficient clinical data. Rather, the FDA’s complete response letter was prompted by manufacturing site defects, in addition to an inability to inspect some sites in Russia and Ukraine. The filing, for a combination of camrelizumab and the VEGFR-2 inhibitor rivoceranib/apatinib in first-line liver cancer, was backed by the phase 3 Cares-301 trial, and one concern was that neither molecule is US-approved as monotherapy, and the study had no way of showing contribution of components, with the combo simply being compared against Nexavar. Not that the more benign reason behind the CRL was much solace to HLB, whose US subsidiary Elevar Therapeutics licensed the combo from HengRui last October, and whose shares plummeted 30% on the South Korean stock exchange today. The CRL came after US knockbacks for three other China-originated anti-PD-(L)1 MAbs, though Coherus’s Loqtorzi and BeiGene’s Tevimbra have now been approved after long delays.

The US fate of China-originated anti-PD-(L)1 MAbs

Source: OncologyPipeline.