On January 28, 2023, COSELA® (trilaciclib), a first-in-class FDA and NMPA-approved therapy indicated to decrease the incidence of chemotherapy-induced myelosuppression, has been prescribed following its commercialization in China, which marks its official clinical application in the region.
COSELA® is an innovative drug jointly developed by Simcere Pharmaceutical Group and G1 Therapeutics (U.S.); Simcere Zaiming, a newly-launched oncology biopharmaceutical company, and a subsidiary of Simcere Pharmaceutical Group Limited, will be leading commercialization efforts in China.
Professor Cheng Ying, director of Jilin Cancer Center and Diagnosis and Treatment Center for Malignant Tumor Clinical Research of Jilin Cancer Hospital helped develop the drug as a myeloprotective treatment administered prior to chemotherapy for extensive small-stage cell lung cancer (ES-SCLC). By reducing occurrence of myelosuppression and achieving protection of the immune system, it helps improve the efficacy of chemotherapy treatment against ES-SCLC tumors.
Protect Marrow in Advance
Fill a gap in medical science
Chemotherapy is one of the main treatment protocols against most malignant tumors due to its strong effect in treating cancer cells. According to the peer-reviewed medical journal, The Lancet, more than 2 million cancer patients use chemotherapeutic drugs for their initial treatment every year.
However, chemotherapeutic drugs may also cause damage to healthy human proliferating cells. Specifically, suppression of hematopoietic stem cells induced by chemotherapy, is the most common side effect in tumor treatment. This adverse effect can increase the patients' risk of infection and bleeding, curb their immunity, and even cause sepsis and uncontrollable organ bleeding in serious cases, which will consequentially lead to reduced dosing or delayed administration and therefore reduce efficacy in cancer treatment. Patients and their loved ones may then face rapid progression of the disease, lower quality of life, increased economic burden, and a challenging prognosis.
Professor Cheng Ying:
"For a long time, there has been a lack of effective preventive methods against myelosuppression and the current treatment options only work for specific cell lineages. For example, granulocyte colony-stimulating factor (G-CSF) and thrombopoietin (TPO) are available to protect against decreases in granulocytes and platelets and G-CSF and TPO work by directing proliferation and differentiation of hematopoietic stem cells, but these treatments may lead to exhaustion of marrow and their effects may gradually weaken during long-term use. Blood component transfusion is also accompanied by risks of infection, immune responses, and allergic reactions. Overall, there is a lack of drugs simultaneously targeting multiple cell lineages. A precursor protective therapy which can effectively protect the bone marrow's blood production function and have minimal impact on the beneficial effect of chemotherapy for patients at the same time has been long hoped for. As an innovative precursor solution, COSELA® balances the effects of chemotherapy and myeloprotection thus fills this unmet therapeutic need."
New Mode of Chemotherapy
Another milestone for Zaiming in anti-tumor treatment
The essential component of COSELA® is trilaciclib, which is a highly effective, selective, and reversible CDK4/6 inhibitor. Hematopoietic stem cells (HSPCs) rely on the regulation of CDK4/6 to begin their proliferation cycles. Theoretically, the use of trilaciclib prior to chemotherapy can hold hematopoietic stem cells/ progenitor cells in their G1 phase. Thus, this treatment can protect the cells from chemotherapeutic damage by suspending cell division to improve exhaustion of hematopoietic stem cells.
COSELA® was designated as a "Breakthrough Therapy" by the U.S. Food and Drug Administration (FDA) in 2019 and debuted in the U.S. in February 2021. In August 2020, Simcere Pharmaceutical Group and G1 Therapeutics established a strategic partnership, to develop and commercialize COSELA® to China and rapidly began clinical studies in the region by coordinating trials across 35 clinical centers. The two biopharmaceutical companies also utilized the special tourism zone located in Lecheng, Boao within Hainan Province to carry out real-world studies and accelerate the approval of the drug’s first indication in ES-SCLC in China. In July 2022, the drug gained approval only 17 months after it was approved for the U.S. market and further established Simcere as an innovative global biopharmaceutical company delivering on its mission of "providing today's patients with medicines of the future” through coordinated innovation.
Now, Simcere Zaiming, a newly-launched oncology biopharmaceutical company, and a subsidiary of Simcere Pharmaceutical Group,, will lead commercialization efforts of COSELA® in China. The company has already issued the first prescription for COSELA® earlier this year and has the manufacturing capabilities to deliver this exciting new treatment to patients undergoing chemotherapy for ES-SCLC nationwide. Patients who are taking chemotherapy and who meet the requirements in indications approved by the NMPA in China can inquire about COSELA® in hospitals across the country.
In addition to the first indication of ES-SCLC, clinical studies of COSELA against triple negative breast cancer, non-small cell lung cancer, bladder cancer and other types of cancers are in progress globally. Professor Cheng Ying continued: “ We believe many patients undergoing chemotherapy can benefit from COSELA and are thrilled to provide an additional treatment option to physicians in order to aid them in the fight against cancer."
About Simcere Zaiming
Simcere Zaiming is an oncology biopharmaceutical company, and a subsidiary of Simcere Pharmaceutical Group Limited, that focuses on the R&D, production, and commercialization of innovative cancer therapeutics. The company was formed in 2023 and is committed to solving unmet clinical needs for cancer patients in China and around the world by developing breakthrough treatments. Simcere Zaiming has built an innovative R&D pipeline with differentiated clinical value, among which 15 assets are currently in clinical trials. In addition to the company’s R&D portfolio, Simcere Zaiming has three innovative drugs, COSELA®, Endostar®, and Envafolimab®. By collaborating with partners globally, Simcere Zaiming strives to bring potentially new innovative therapeutics to cancer patients worldwide.
About Simcere
Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company and owns the State Key Laboratory of Translational Medicine and Innovative Drug Development. The company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future". Driven by its in-house R&D efforts and synergistic innovation, the Company has established strategic cooperation partnerships with many innovative companies and research institutes. For more information, please visit www.simcere.com.