Suzhou, China, 11th, August 2021 -CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced that the clinical data from the China registrational bridging study CS3010-101 of its first-in-class drug ivosidenib (TIBSOVO®, the brand name in the U.S.) will be presented at the 2021 European Society for Medical Oncology (ESMO) Congress.
CS3010-101 is an ongoing phase I, multi-center, single-arm study in China, which aims to evaluate the pharmacokinetic (PK), pharmacodynamics (PD), safety, and clinical efficacy of orally administrated TIBSOVO® (ivosidenib tablets) in Chinese adults with R/R AML with a susceptible IDH1 mutation. And as the bridging study of the global pivotal AG120-C-001 study, it provides data on R/R AML patients in China. In July 2021, the China registrational study CS3010-101 of TIBSOVO® (ivosidenib tablets) has met the pre-specified endpoints in Chinese patients with R/R AML who have a susceptible IDH1 mutation. The results demonstrated efficacy and manageable safety profile of TIBSOVO® (ivosidenib tablets), which were consistent with previously reported data from the global study population.
Meanwhile, the National Medical Products Administration of China has accepted the new drug application of TIBSOVO® (ivosidenib tablets) with priority review designation for the treatment of adult patients with R/R AML who have a susceptible IDH1 mutation.
About TIBSOVO® (ivosidenib tablets)
Servier is a global independent pharmaceutical Group governed by a Foundation. In the field of oncology, Servier is conducting activities in research, development, and commercialization of therapeutic solutions in different diseases including AML. Servier has an exclusive collaboration and license agreement with CStone for the development and commercialization of TIBSOVO in Mainland China, Taiwan, Hong Kong, Macau and Singapore.
In 2020, TIBSOVO® (ivosidenib tablets) was selected in the list of the third batch of Overseas New Drugs Urgently Needed in Clinical Settings by the Center for Drug Evaluation, NMPA, and granted for fast-track designation. As a potent and highly selective first-in-class oral IDH1 inhibitor, TIBSOVO® (ivosidenib tablets) was also recommended by the 2020 edition of the CSCO Guidelines for Diagnosis and Treatment of Hematological Malignancies due to its proven clinical advantages.
TIBSOVO® (ivosidenib tablets) is currently approved in the U.S. since 2018 as monotherapy for the treatment of adults with susceptible IDH1-mutant relapsed or refractory acute myeloid leukemia (AML). In 2019, the indication was extended by the U.S. FDA to include the treatment of newly diagnosed susceptible IDH1-mutant AML adult patients who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.
The U.S. FDA has granted Breakthrough Therapy Designation for TIBSOVO® (ivosidenib tablets) in combination with azacytidine for this supplemental indication and Breakthrough Therapy Designation for TIBSOVO® (ivosidenib tablets) for the treatment of adult patients with relapsed and refractory myelodysplastic syndrome (MDS) with a susceptible IDH1 mutation.
About CStone
CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received three drug approvals in Greater China, including two in Mainland China and one in Taiwan. CStone's vision is to become globally recognized as a world-renowned biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.
For more information about CStone, please visit: www.cstonepharma.com.
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