US-based EQRx Inc. (Nasdaq: EQRX), a biopharma originally established with the aim of “radically” disrupting pricing in the US market using China-licensed products, has rejigged its strategy in light of recent communications with the US FDA. The firm is abandoning a low-price strategy and will apply “market-based pricing” to any future drug launches.
Revised Strategy and FDA Feedback
EQRx’s decision reflects a recalibration of its expectations regarding the application of China-sourced data to support drug filings to the US FDA. The firm had sought clarification from the FDA on whether the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab—licensed from China’s CStone Pharmaceutical in a 2020 deal worth up to USD 1.3 billion—could be filed for US approval in non-small cell lung cancer (NSCLC) using only a bridging study. The FDA recently indicated that a full Phase III trial would be required, effectively ending sugemalimab’s prospects for NSCLC in the United States.
Setbacks and Future Focus
There was also a setback in relation to aumolertinib, the world’s second novel third-generation EGFR inhibitor, in-licensed by EQRx from Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) in 2020. The FDA gave guidance that aumolertinib could only be filed for approval as a combination therapy for NSCLC in 2027 at the earliest, while interim data (including China-derived data) to support a filing as a monotherapy would not be acceptable.
EQRx states that it will now prioritize the development of aumolertinib and lerociclib, the latter a CDK4/6 inhibitor licensed from G1 Therapeutics. The US firm states these two drugs “could form the basis of future combination therapies for multiple cancer types,” while the adoption of market-based pricing will ensure sufficient rewards are available to support ongoing R&D.-Fineline Info & Tech
