The board of directors of the Simcere Pharmaceutical Group Limited announced that, on January 18, 2021, trilaciclib for injection, the innovative pharmaceutical being developed by the Company in collaboration with G1 Therapeutics, INC., has obtained the Clinical Trial Approval approved and issued by the Center for Drug Evaluation of National Medical Products Administration, PRC, which is designed for chemotherapy-induced myelosuppression of patients with small-cell lung cancer. Trilaciclib is a first-in-class investigational therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes. In August 2020, the U.S. Food and Drug Administration (the FDA) has accepted the new drug application (the NDA) filed by G1 Therapeutics, INC., the partner of the Company, for trilaciclib for small-cell lung cancer patients being treated with chemotherapy and granted Priority Review with a Prescription Drug User Fee Act action date of February 15, 2021, by which the FDA is expected to declare its decision on the NDA.

Based on the clinical trial data, trilaciclib has been granted Breakthrough Therapy Designationby the FDA.