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  • 2016
    March, 2016 - CStone commences Series A-1 to A-3 rounds of financing and in aggregate raises approximately US$150 million.
    April, 2016 - CStone founded in Suzhou.
    2017
    October, 2017 - CStone Suzhou Translational Medicine Research Center established and commences operations.
    October, 2017 - China's first full-length and fully human PD-L1 monoclonal antibody (CS1001) enters Phase I clinical trial with the dosing of the first patient in China.
    2018
    May, 2018 - CStone completes Series B round of financing, raising in aggregate approximately US$262 million, the largest of Series B financing in China's biopharmaceutical sector at the time.
    June, 2018 - CStone and Blueprint Medicines Corp. (NASDAQ:BPMC) enter into an exclusive collaboration and license agreement regarding the clinical development and commercialization of avapritinib, fisogatinib, and pralsetinib, as mono-therapies or in combination with other therapies, in Greater China including Hong Kong, Macau, and Taiwan.
    June, 2018 - CStone and Agios Pharmaceuticals Inc. (NASDAQ:AGIO) enter into an exclusive partnership and license agreement regarding the clinical development and commercialization of ivosidenib (TIBSOVO®; AG-120), as a mono-therapy or in combination with other therapies, in Greater China including Hong Kong, Macau and Taiwan.
    July, 2018 - The U.S. FDA approves TIBSOVO® (ivosidenib), a product developed by CStone's partner Agios Pharmaceuticals, for the treatment of adult patients with relapsed or refractory acute myeloid leukemia.
    December, 2018 - The clinical research program for “the Category 1 new biologic drug injectable CS1001, a recombinant anti-PD-L1 fully human monoclonal antibody” receives special national support as a “13th Five-Year Plan” major new drug technology research project.
    2019
    February 26, 2019 - CStone becomes publicly listed on the Main Board of the Hong Kong Stock Exchange, stock code: 2616.
    March - May, 2019 - Four internationally renowned oncology experts appointed to CStone's Scientific Advisory Board.
    May, 2019 - CStone and Numab Therapeutics AG enter into an exclusive collaboration and license agreement regarding the clinical development and commercialization of ND021 in Mainland China, Hong Kong, Macau, Taiwan, South Korea and Singapore.
    June, 2019 - CStone submits a New Drug Application (NDA) in Taiwan for TIBSOVO® (ivosidenib), for the treatment of adult patients with relapsed or refractory acute myeloid leukemia.
    June, 2019 – CStone and Bayer reach a global collaboration deal to jointly evaluate CS1001 in combination with regorafenib in key indications.
    August, 2019 – CStone signs an agreement to build its Global R&D Headquarters and Industrialization Base in the Suzhou Industrial Park.
    December, 2019 – CStone appoints seasoned pharmaceutical executive Shirley Zhao as the General Manager for Greater China and Head of Commercial Operations, responsible for the commercialization of the Company's products.
    2020
    January, 2020 – The U.S. FDA approves AYVAKIT™ (avapritinib), a product developed by CStone's partner, Blueprint Medicines, for the treatment of adults patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
    March, 2020 – CStone submits a New Drug Application (NDA) in Taiwan for AYVAKIT™ (avapritinib), for the treatment of adults with advanced PDGFRA exon 18 mutant gastrointestinal stromal tumor (GIST).
    April, 2020- CStone announces acceptance of its first New Drug Application in mainland China by the National Medical Products Administration, for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGRA D842V mutation.
    September,2020-CStone announces the National Medical Products Administration has accepted its New Drug Application with Priority Review Designation for Pralsetinib for the treatment of patients with RET Fusion-positive NSCLC.
    September,2020-CStone and Pfizer entered into strategic collaborations, which encompass Pfizer to invest $200 million in CStone shares and license late-stage oncology asset sugemalimab in mainland China and CStone to receive up to $280 million in milestone payments for sugemalimab, and additional royalties.
    October,2020- CStone and EQRx entered global strategic partnership for two Immune Checkpoint Inhibitors: sugemalimab and CS1003.
    October,2020- CStone announced a licensing agreement with LegoChem Biosciences, Inc. , for the development and commercialization of LCB71, a potential first-in-class/best-in-class antibody drug conjugate. CStone obtains the exclusive global right to lead development and commercialization of LCB71 outside the Republic of Korea. This agreement adds the first ADC to our pipeline, and bolsters precision medicine franchise with a new modality.
    October,2020 - CStone announced FDA granted Breakthrough Therapy Designation to anti-PD-L1 antibody sugemalimab for the treatment of adult patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). Sugemalimab becomes the first Chinese anti-PD-L1 antibody to receive Breakthrough Therapy Designation from the U.S. FDA.
    October,2020 -Ivosidenib was included in the List of the Third Batch of Overseas New Drugs Urgently Needed in Clinical Settings released by CDE.
    November,2020-CStone announced that the National Medical Products Administration has accepted the New Drug Application for sugemalimab combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer patients.
    2021
    February, 2021 – Cejemly® was granted the Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE), the National Medical Products Administration (NMPA) of China
    May, 2021 –CStone and Sinopharm Group reached strategic cooperation to accelerate commercialization
    March, 2021 – GAVRETO® was approved in Mainland China as the country’s first selective RET inhibitor
    March, 2021 – Precision medicine AYVAKIT® was approved in Mainland China for the treatment of gastrointestinal stromal tumor (GIST)
    April, 2021 – GAVRETO® won the “International Innovative Drug and Device Synchronization Award”
    April, 2021 – NMPA accepted the new drug application (NDA) of GAVRETO® with priority Review Designation for the treatment of Advanced or Metastatic RET-Altered Thyroid Cancer Patients
    April, 2021 – CStone won the “13th Healthy China Forum Annual Science and Technology Innovation Brand Award”
    May, 2021 – The prescriptions of AYVAKIT® were issued in multiple regions in China, and it is available in more than 50 hospital and retail pharmacies in several provinces
    May, 2021 – GAVRETO® was included in Chengdu MEDICARE
    May, 2021 – The registrational clinical trial of Cejemly® for the treatment of stage III Non-Small Cell Lung Cancer (NSCLC) met its primary endpoint
    June, 2021 – CStone and Pfizer jointly develop lorlatinib in Greater China for the treatment of c-ros oncogene 1 (ROS1)-positive advanced NSCLC
    June, 2021 – The first batch of prescriptions for GAVRETO® were issued in multiple regions, and it is available at around 80 pharmacies in close to 70 cities across China
    June, 2021 – The China registrational study of GAVRETO® for the first-line treatment of advanced RET fusion-positive NSCLC achieved positive results
    June, 2021 – The China registrational study of GAVRETO® for the treatment of RET-mutant medullary thyroid cancer (MTC) achieved positive results
    July, 2021 – The data from the China bridging study of AYVAKIT® for the treatment of gastrointestinal stromal tumor (GIST) were presented via a short oral report at the virtual European Society for Medical Oncology World Congress on Gastrointestinal Cancer 2021 (ESMO GI 2021)
    July, 2021 – GAVRETO® and TIBSOVO® were included in Beijing MEDICARE
    August, 2021 – The China registrational study of TIBSOVO® met the pre-specified endpoints in the treatment of relapsed or refractory acute myeloid leukemia (R/R AML), and NMPA accepted the NDA of TIBSOVO® with a Priority Review Designation
    August, 2021 – CStone is selected as a constituent stock of the Hang Seng Composite Index (HSCI).
    September, 2021 – NMPA accepted the NDA of Cejemly® for the treatment of stage III NSCLC
    September, 2021 – CStone is officially included in the Hong Kong Stock Connect
    September, 2021 – The research data of GAVRETO® for the treatment of advanced RET fusion-positive NSCLC were reported in an oral presentation at the IASLC 2021 World Conference on Lung Cancer (WCLC)
    September, 2021 – The updated data from the registrational clinical study of Cejemly® for the treatment of stage IV NSCLC were presented in an oral presentation at the IASLC 2021 World Conference on Lung Cancer (IASLC 2021 WCLC)
    September, 2021 – The investigational new drug (IND) application of multi-specific antibody CS2006 was approved in China
    September, 2021 – GAVRETO® and AYVAKIT® are both listed as recommended therapies in the 2021 CSCO Clinical Practice Guidelines
    September, 2021 – Data from the registrational clinical study of Cejemly® for the treatment of stage III NSCLC were presented in an oral presentation at the 2021 European Society for Medical Oncology (ESMO) Congress 2021
    September, 2021 – The clinical data from the China registrational bridging study of TIBSOVO® for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible IDH1 mutation were presented in a proffered paper presentation at the 2021 ESMO Congress
    October, 2021 – The clinical research data of GAVRETO® for the treatment of Chinese patients with RET-mutant medullary thyroid cancer (MTC) were presented in an oral presentaiton at the 90th Annual Meeting of the American Thyroid Association (ATA) 2021
    October, 2021 – Data on the preclinical characterization of CS5001(ROR1 ADC) were accepted in a late-breaking abstract (LBA) session as a virtual poster presentation at the 33rd AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2021
    October, 2021 – GAVRETO® was included in Jiangsu MEDICARE
    October, 2021 – The investigational new drug (IND) application of lorlatinib for the treatment of c-ros oncogene 1 (ROS1)-positive advanced NSCLC was accepted by NMPA
    November, 2021 – CStone and DotBio reach a global development collaboration and option agreement to advance the next-generation innovative pipeline
    November, 2021 – CStone and Jiangsu Hengrui Pharmaceuticals reach a strategic partnership and exclusive licensing agreement on anti-CTLA-4 mAb CS1002 in the Greater China region
    November, 2021 – CStone wins multiple blockbuster awards, and GAVRETO® is named one of the “Top 10 Innovative Oncology Drugs”
    December, 2021 – Phase 3 data from the global AGILE study of TIBSOVO® were presented in an oral session during the 63rd American Society of Hematology Annual Meeting and Exposition
    December, 2021 – Cejemly® was approved in China and will potentially reshape the treatment landscape of lung cancer
    December, 2021 – CStone was named among the first tier of Top 100 China Innovative Pharma Companies 2021
    December, 2021 – the investigational new drug (IND) application of CS5001, an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1) was approved by FDA
    2022
    January, 2022 – the investigational new drug (IND) application of lorlatinib for the treatment of c-ros oncogene 1 (ROS1)-positive advanced non-small cell lung cancer (NSCLC) was approved by NMPA
    January, 2022 – phase 2 GEMSTONE-201 trial met primary endpoint of objective response rate (ORR) in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL)
    January, 2022 – the clinical data from registrational study of sugemalimab in stage III non-small cell lung cancer published in The Lancet Oncology
    January, 2022 – the registrational clinical study results of sugemalimab in stage IV non-small cell lung cancer published in The Lancet Oncology
    January, 2022 – two key phase 3 registrational clinical trials of sugemalimab completed patient enrollment
    January, 2022 – GEMSTONE-302 study of sugemalimab met the endpoint of overall survival in the first-line treatment of metastatic non-small cell lung cancer patients
    February, 2022 – new drug approval of China’s first IDH1 inhibitor TIBSOVO® (ivosidenib tablets) as a new precision therapy for patients with acute myeloid leukemia

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