The sizzling race for China’s first approved KRAS inhibitor has seen Amgen/BeiGene’s Lumakras drop out and Mirati/Zai Lab’s Krazati lag in a confirmatory Phase III trial, while domestic fast-followers are in the meantime eyeing their first approval filings by the end of this year.
The business model of in-licensing foreign drug assets has been seen as a shortcut to the launch of novel therapies in China. However, local regulatory challenges or unexpected twists in clinical development are threatening to derail some licensees’ efforts to leave behind their domestic rivals, as the case of KRAS G12C inhibitors well illustrates.
Despite its decade-old notoriety for being a hard-to-drug target, KRAS eventually became druggable in May 2021, when Amgen, Inc....
A framework to end the Iran war is in place but fractured supply chains can’t recover overnight. Data from India suggests solvent prices have generally cooled from April peaks, but API costs stay elevated or even climbed in June for some products.
Already one of the world’s largest pharmaceutical markets, China has tremendous growth potential, but significant policy and market changes are rocking the basis of competition. Multinational biopharma corporations cannot succeed in this new environment unless they fundamentally reinvent their business models to adapt to sweeping change.
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.
The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
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