The updated efficacy and safety analysis from KROCUS was presented on March 27 at the 2025 European Lung Cancer Congress (ELCC), held in Paris, France (Abstract LBA1). “The combination shows the potential to provide a chemo-free treatment option for our patients,” reported Margarita Majem, MD, PhD, from the Hospital de la Santa Creu i Sant Pau in Barcelona, Spain.
Fulzerasib emerges as a game-changer for KRAS G12C-mutated NSCLC with promising preliminary efficacy and an excellent safety profile in Phase II KROCUS Study!
As per the agreement, GenFleet will carry out the open-label, single-arm, and multicentre study across ten hospitals in China. The trial aims to evaluate the safety and efficacy of the combination therapy in patients with relapsed/refractory DLBCL.
In a landmark development for lung cancer treatment, National Medical Products Administration (NMPA), has accepted the New Drug Application (NDA) for GFH925. This is the first time an NDA for a KRAS G12C inhibitor has been accepted in China. The NMPA has also granted GFH925 a priority review designation. Additionally, GFH925 holds Breakthrough Therapy Designations for advanced NSCLC (non-small cell lung cancer) and colorectal carcinoma patients.
GFH375/VS-7375 is an orally bioavailable, potent and selective small molecule KRAS G12D (ON/OFF) inhibitor. Preclinical models demonstrate strong tumor regression as a single agent and support approaches in combination with Verastem Oncology’s RAF/MEK clamp avutometinib as well as other rational combinations across KRAS G12D-driven cancers. KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancer.
GenFleet Therapeutics's GFH312 is a small molecule inhibitor of receptor-interacting serine/threonine protein-1(RIP1) kinase, a key regulator of the TNF- downstream. GenFleet is the first Chinese company that moves RIPK1 inhibitor development into clinical stage.
A Phase Ib/II trial will analyse GFH018 in combination with a PD-1 inhibitor for advanced solid tumour patients. The other study is a Phase II trial of GFH018, a PD-1 inhibitor along with immunochemotherapy and radiotherapy to treat locally advanced and unresectable non-small cell lung cancer (NSCLC) patients.
In retrospect, China’s rise in biopharma may seem inevitable: If nothing else, the sheer size of the population spells a boon for both drug research and sales. But the world didn’t always see it that way.
