On February 9, 2023 Simcere Pharmaceutical Group Limited (2096.HK) ("Simcere"), an innovative global biopharmaceutical company, and G1 Therapeutics, Inc., (Nasdaq: GTHX) ("G1 Therapeutics"), a commercial-stage oncology company, reported a significant milestone in the fight against cancer with the issuance of the first prescription for COSELA (trilaciclib) in China (Press release, Jiangsu Simcere Pharmaceutical Company, FEB 9, 2023, View Source [SID1234627018]).
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COSELA is a first-in-class FDA and NMPA-approved therapy indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). Myelosuppression induced by chemotherapy is a common toxic side effect in the clinical treatment of SCLC. COSELA has been shown to significantly reduce chemotherapy-induced myelosuppression, a common and potentially serious side effect of chemotherapy that can result in decreased white blood cell counts, increased risk of infections, and prolonged hospitalization.
"The issuance of the first prescription for COSELA in China is an important step forward in improving outcomes for cancer patients treated with chemotherapy," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We are proud to be working with Simcere to bring this innovative treatment option to patients in China and around the world."
"As a leading pharmaceutical company in China, this approval helps address a huge unmet clinical need in China for an effective solution to decrease the incidence of myelosuppression before it takes place," said Dr. Tang Renhong, Ph.D., Executive Director of the Board, Simcere. "Furthermore, the availability of COSELA in China in under three years from licensing the drug to prescription for patients is a truly remarkable feat and marks a significant step forward in the fight against cancer and we are proud to be a part of it."
About COSELA
COSELA (trilaciclib) is a first-in-class comprehensive myeloprotection drug to mitigate chemotherapy-induced myelosuppression on all hematopoietic lineages. It has been approved for marketing in both China and the United States as a myeloprotective treatment administered prior to chemotherapy for extensive small-stage cell lung cancer (ES-SCLC). The product is recommended in the U.S. by two updated 2022 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and in China by the 2022 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of SCLC.
In August 2020, Simcere reached an exclusive license with G1 to obtain COSELA’s development and commercialization interests of all indications in Greater China. In January, April and June 2021, three phase III clinical trials in patients with SCLC, metastatic colorectal cancer and triple negative breast cancer, were carried out in China respectively. In November 2021, the NMPA accepted the New Drug Application (NDA) by COSELA for registration and marketing of overseas manufactured drugs. In December 2021, the drug was granted priority review for COSELA to be used in patients with extensive-stage small cell lung cancer prior to chemotherapy. In February 2022, the pivotal phase III clinical trials (TRACES study) reached the primary endpoint. The research results disclosed in the abstracts at 2022 World Conference on Lung Cancer (WCLC) further confirmed that administration of trilaciclib prior to chemotherapy for the treatment of patients with ES-SCLC improves the patient tolerability of chemotherapy, as demonstrated by a reduction in DSN and improved overall safety profile.