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Trilaciclib Received Priority Review from NMPA! Patient Enrolment Achieved for Three Indications in Phase III Study in China

Release time:2022-01-10

On January 7 2022,Simcere Pharmaceutical Group (2096.HK) announced that Trilaciclib for injection, an innovative anti-tumor and myeloprotection therapy jointly developed by Simcere (2096.HK) and G1 Therapeutics, has recently hit two milestones:


  • The first NDA of trilaciclib in China (myeloprotection for Small-cell lung cancer, SCLC) received Priority Review Designation from the China National Medical Products Administration (NMPA) on Dec 22 2021;

  •  The phase III trial in patients with triple-negative breast cancer (TNBC) dosed the first patient in China on January 7 2022;

Up til now,the Phase III clinical trials of Trilaciclib for all three indications developed in China (myeloprotection for SCLC, anti-tumor for TNBC and myeloprotection and anti-tumor for Colorectal cancer) have enrolled patients.


Trilaciclib (COSELATM), which received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) in 2019 based on positive data in SCLC patients from three randomized Phase II clinical trials, is the first and only myeloprotection therapy to decrease the incidence of chemotherapy-induced myelosuppression (CIM). On February 12, 2021, FDA approved Trilaciclib to decrease the incidence of CIM 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). On March 25, 2021, trilaciclib has been added to two National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology: the Treatment Guidelines for SCLC and the Supportive Care Guidelines for Hematopoietic Growth Factors.

In August 2020, Simcere has reached a cooperation agreement with G1 Therapeutics, INC. to be responsible for the development and commercialization of trilaciclib in all indications in Greater China (Mainland China, Hong Kong, Macau and Taiwan).

Forward Looking Statements

Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.