G1 Therapeutics and Genor Biopharma have announced an exclusive license agreement for the development and commercialisation of lerociclib in the Asia-Pacific region (excluding Japan).

Discovered and developed by G1, lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies. Genor is currently developing eight novel, clinical-stage oncology compounds and recently completed a $160 million Series B financing led by Hillhouse Capital and Temasek Holdings.

“CDK4/6 inhibitors have emerged as an important therapeutic option for women with ER+, HER2- breast cancer, the most common form of the disease. We designed lerociclib to improve upon the clinical profiles of currently available CDK4/6 inhibitors, and preliminary data from our Phase 1b/2 clinical trial have shown a differentiated safety and tolerability profile along with efficacy consistent with marketed CDK4/6 inhibitors,” said Mark Velleca, CEO, GI Therapeutics.

“This agreement is an important component of our corporate strategy to form partnerships that enable global access to our promising oncology therapies. We are excited to collaborate with Genor, a leading innovator in oncology with the development and commercialisation expertise to advance this therapy on behalf of patients in China and other Asia-Pacific countries.”

Under the terms of the agreement, G1 will receive an upfront cash payment of $6 million and be eligible to receive up to an additional $40 million in development and commercial milestone payments. In addition, Genor will pay G1 tiered royalties ranging from high single to low double-digits based on annual net sales of lerociclib. Genor will have exclusive development and commercialisation rights for lerociclib in the Asia-Pacific region (excluding Japan).

“We see a significant unmet medical need in Asian patients with HR+, HER2- breast cancer in both adjuvant and metastatic settings, especially among intermediate and high-risk patients whose longer treatment duration requires therapeutics with better tolerability. Lerociclib is a potentially best-in-class CDK4/6 inhibitor, with robust efficacy and a differentiated safety profile when compared with marketed products. With lerociclib as a strategic fit in our portfolio, we look forward to working with G1 to maximise the potential of this compound in the APAC region,” commented Guo Feng, CEO of Genor.