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On August 3rd G1 Therapeutics and Simcere, clinical oncology companies, announced an exclusive licensing agreement for the development and commercialization of all adaptations in Chinese mainland, Hong Kong, Macau and Taiwan.
trilaciclib, discovered and developed by G1, is a first-in-class research therapy designed to improve the prognostication of cancer patients undergoing chemotherapy.
June 2020, G1 submitted to the FDA an application for the listing of a new drug (NDA) for bone marrow protection in patients with small cell lung cancer (SCLC).
terms of the agreement, G1 will receive an advance payment of $14 million and will be eligible for development and commercial milestone payments of up to $156 million.
First Sound Pharmaceuticals will also pay royalties to G1 based on Trilaciclib's annual net sales in Greater China.
First Sound Pharmaceuticals will have exclusive development and commercial rights to trilaciclib in all Greater China regions and all adaptations, and will participate in trilaciclib's global clinical trials.
G1 has the right to develop and commercialize trilaciclib in all regions except Greater China.
companies will be responsible for all development and commercialization costs in their respective areas.
is the most common cancer in the world, with small cell lung cancer accounting for about 15% of all lung cancer cases.
the International Agency for Research on Cancer (IARC), the World Health Organization's specialized cancer agency, nearly 750,000 new lung cancer cases in China in 2018.
Trilaciclib is a kinase 4/6 (CDK4/6) inhibitor that relies on cell cycle proteins and is designed to be added to standard treatments to reduce bone marrow inhibition adverse reactions.
Trilaciclib has been identified by the FDA as a breakthrough therapy based on three randomized, double-blind, placebo-controlled bone marrow protection data from small cell lung cancer (SCLC).
June 2020, G1 filed a new drug application (NDA) with the FDA regarding trilaciclib's bone marrow protection for SCLC patients.
addition, trilaciclib is conducting clinical studies to treat metastasis triple negative breast cancer and as a new complementary therapy for breast cancer.
G1 is expected to launch a registered Phase 3 trial of trilaciclib for colorectal cancer in the fourth quarter of 2020.
: s1 G1 Therapeutics and Simcere Announce Exclusive License Agreement for Trilaciclib in GreatEr China. Retrieved 2020-08-03, from.