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     135  0 Kommentare G1 Therapeutics and Simcere Announce Exclusive License Agreement for Trilaciclib in Greater China - Seite 2

    Pin Wang, Ph.D., Chief Scientific Officer of Simcere, said: “Chemotherapy is the cornerstone therapy for cancer patients. China, as a major user of this treatment modality, has a considerable patient population who are suffering from myelosuppression caused by chemotherapy. We are delighted to form this alliance with G1 Therapeutics to develop and commercialize world’s first-in-class investigational myelopreservation therapy, trilaciclib, in China. We look forward to further expanding its clinical value based on the unique mechanism of trilaciclib. It is hoped that through the joint efforts of both parties trilaciclib will soon address a key unmet medical need in the treatment of cancer patients globally.”

    Lung cancer is the most common cancer worldwide, with small cell lung cancer accounting for approximately 15% of all lung cancer cases. According to the World Health Organization’s (WHO) specialized cancer agency, the International Agency for Research on Cancer (IARC), there were almost 750,000 new lung cancer cases in China in 2018.

    About Trilaciclib
    Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Trilaciclib has received Breakthrough Therapy Designation based on myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patient with small cell lung cancer (SCLC). In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. In June 2020, G1 submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trilaciclib for myelopreservation in SCLC and began a study in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL. The company expects to initiate a registrational Phase 3 trial in colorectal cancer in the fourth quarter of 2020.

    About Simcere Pharmaceutical Group
    Simcere Pharmaceutical Group is rapidly transitioning to an innovation and R&D-driven pharmaceutical company, with a mission of “providing today’s patients with medicines of the future.” Continuously recognized as one of the “Top 10 Innovative Pharmaceutical Enterprises in China” and “Top 100 Pharmaceutical Manufacturing Enterprises of China,” it has established three R&D centers in Nanjing, Shanghai and Boston (the United States), respectively; with the approval of the Ministry of Science and Technology, Simcere has also established a national key laboratory of translational medicine and innovative pharmaceuticals. Simcere focuses on oncology, central nervous system disease and autoimmune disease therapeutic areas, with a diversified product portfolio and industry-leading capabilities. Simcere has established a unique open innovation model, building up collaborative relationships with leading domestic and international pharmaceutical companies and biotechnology companies. Simcere aims to bring more global life science breakthroughs to China, in an effort to benefit more patients and boost the country’s healthcare industry growth and development.

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    G1 Therapeutics and Simcere Announce Exclusive License Agreement for Trilaciclib in Greater China - Seite 2 Simcere to lead clinical development, regulatory submissions and commercialization of trilaciclib across all indications in Greater China G1 to receive $14 million upfront payment, sales royalties and up to $156 million in future milestone payments …

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