On August 3, 2020 Simcere Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Simcere") and tumor clinical stage company G1 Therapeutics Company ( Nasdaq: GTHX ), reported the signing of an exclusive license to introduce Trilaciclib ‘s development and commercialization rights for all indications in Greater China (Mainland China, Hong Kong, Macau and Taiwan) (Press release, Jiangsu Simcere Pharmaceutical Company, AUG 3, 2020, View Source [SID1234562741]). Trilaciclib is the world’s first innovative drug discovered and developed by G1 to improve the prognosis of cancer patients after chemotherapy.
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" Trilaciclib may become the first prophylactically administered bone marrow protective therapy, which can effectively improve the prognosis of patients undergoing chemotherapy. We are very pleased to cooperate with Simcere , a Chinese company with leading innovative drug development and commercialization capabilities. , To promote this innovative therapy in China," said G1 CEO and MD Dr. Mark Velleca . "Sincere Pharmaceuticals has extensive experience in drug clinical trials and drug registration in China, and has a nationwide professional team that supports product academic promotion and market access. These advantages make them an important strategic partner of G1 to realize our The vision of bringing Trilaciclib to patients around the world."
According to the terms of the agreement, G1 will receive a down payment of US$ 14 million, and will receive development and commercialization milestone payments of up to US$ 156 million. Simultaneously, Simcere Pharmaceuticals will pay G1 low double-digit sales commission based on Trilaciclib ‘s annual net sales in Greater China . Simcere Pharmaceuticals will have the exclusive rights to develop and commercialize Trilaciclib for all indications in Greater China, and will participate in Trilaciclib ‘s global clinical trials. G1 reserves the right to develop and commercialize Trilaciclib in all regions outside the Greater China region. Both parties will be responsible for all development and commercialization costs in their respective regions.
Dr. Wang Pin, Chief Scientific Officer of Simcere Pharmaceuticals, said: "Currently, chemotherapy is the cornerstone therapy for cancer patients. A large number of patients in China are suffering from bone marrow suppression caused by chemotherapy. We are very pleased to have a deep cooperation with G1 Therapeutics in China. Developed and commercialized Trilaciclib , the world’s first product of its kind to protect bone marrow . We look forward to further expanding its clinical value based on Trilaciclib’s unique mechanism. We hope that through the joint efforts of both parties, Trilaciclib can benefit more cancer patients around the world as soon as possible."
Lung cancer is the most common cancer in the world, and small cell lung cancer accounts for about 15% of all lung cancer cases . According to statistics from the International Agency for Research on Cancer ( IARC ), a specialized cancer agency of the World Health Organization ( WHO ) , nearly 750,000 new lung cancer cases were reported in China in 2018 .
About Trilaciclib
Trilaciclib is the world’s first innovative product of its kind designed to improve the prognosis of cancer patients with chemotherapy. Trilaciclib is given before chemotherapy in patients with small cell lung cancer ( SCLC ). Based on the bone marrow protection data of three randomized, double-blind, placebo-controlled clinical trials in the United States, it has obtained FDA breakthrough therapy designation. In a randomized trial of patients with metastatic triple-negative breast cancer, compared with chemotherapy alone, trilaciclib when used in combination with chemotherapy significantly improved the overall survival of the patient. In 2020 Nian 6 Yue, G1 in the United States submitted a new drug application ( NDA ), is used to protect the bone marrow of patients with small cell lung cancer, and as I-Spy2 part of a pilot study began neoadjuvant chemotherapy. G1 expects to initiate a Phase III registered clinical trial for colorectal cancer in the United States in the fourth quarter of 2020 .