- 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.
- 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
- January, 2022 – new drug approval of China’s first IDH1 inhibitor TIBSOVO® (ivosidenib tablets) as a new precision therapy for patients with acute myeloid leukemia
- February, 2022 – CStone Pharmaceuticals Announces the Acceptance of New Drug Application (NDA) for Pralsetinib for the Treatment of RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC) and RET-Altered Thyroid Cancers in Taiwan, China
- February, 2022 – CStone announces the NMPA approval of GAVRETO® (pralsetinib) for the treatment of Advanced or Metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer
- March, 2022 – CStone’s partner Servier announces significant developments for TIBSOVO® (ivosidenib tablets) in the U.S. and Europe
- March, 2022 – CStone Pharmaceuticals Announces the Acceptance of New Drug Application (NDA) for Pralsetinib for the Treatment of RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC) in Hong Kong, China
- March, 2022 – CStone announced the global multi-regional registration trial of anti-PD-1 antibody nofazinlimab in combination with lenvatinib as first-line treatment for patients with advanced hepatocellular carcinoma successfully reached the prespecified enrollment target
- March, 2022 – CStone announces first patient enrollment in the U.S. in the Phase 1 clinical trial of CS5001, a potential global best-in-class ROR1-targeting ADC
- April, 2022 – CStone Announces Presentation of Preclinical data on a Multi-Specific Antibody-based Therapeutic Candidate CS2006/NM21-1480 at the American Association for Cancer Research (AACR) Annual Meeting 2022
- April, 2022 – CStone Announces Results From Phase 3 AGILE Data of TIBSOVO® (ivosidenib tablets) in Combination with Azacitidine for Patients with Previously Untreated IDH1-mutated Acute Myeloid Leukemia Published in the New England Journal of Medicine
- May, 2022 – CStone announces final PFS analysis of a registrational study of sugemalimab in patients with stage III NSCLC further demonstrates its robust efficacy and significant clinical benefits shown in interim analysis
- May, 2022 – CStone Pharmaceuticals Reports 2021 Annual Results and Recent Business Highlights
- June, 2022 – CStone’ s partner Servier announces FDA Approval of TIBSOVO® (ivosidenib tablets) in Combination with Azacitidine for Patients with Newly Diagnosed IDH1-mutated Acute Myeloid Leukemia
- June, 2022 – CStone presents clinical results of sugemalimab in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma via an oral abstract session at ASCO 2022
- June, 2022 – CStone presents updated results of anti-PD-1 antibody nofazinlimab in combination with lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma (HCC) at ASCO 2022
- June, 2022 – CStone and Pfizer announce NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer
- June, 2022 – CStone presents pre-specified overall survival data of sugemalimab for first-line treatment of stage IV non-small cell lung cancer at ASCO 2022
- July, 2022 – CStone Announces the NDA Approval of GAVRETO® (pralsetinib) for the Treatment of RET Fusion-Positive treatment-naïve (first-line) and pretreated Non-Small Cell Lung Cancer (NSCLC) in Hong Kong, China
- August, 2022 – CStone presents updated results of a registrational study of sugemalimab in patients with stage III NSCLC via oral presentation at WCLC 2022
- August, 2022 – CStone Pharmaceuticals Reports 2022 Interim Results and Business Updates
- September, 2022 – CStone announces China’s NMPA has accepted and granted priority review to the supplemental new drug application (sNDA) for sugemalimab in the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL)
- November, 2022 – CStone announces registrational study of sugemalimab for first-line treatment of locally advanced or metastatic gastric adenocarcinoma/gastroesophageal junction adenocarcinoma met primary endpoint
- December, 2022 – CStone presents updated data for GAVRETO® (pralsetinib) in Chinese patients with RET-fusion positive non-small cell lung cancer at ESMO Asia Congress 2022
- December, 2022 – CStone announces acceptance of marketing authorization application by UK MHRA for sugemalimab in metastatic non-small cell lung cancer
- December, 2022 – CStone Announces Results from the NAVIGATOR China Bridging Study of AYVAKIT® (avapritinib) Published in The Oncologist
- 2023
- January, 2023 – CStone announces the registrational clinical trial of sugemalimab as first-line treatment in patients with esophageal squamous cell carcinoma met primary endpoints and plans to submit a supplemental NDA to NMPA
- January, 2023 – CStone Announces the NDA Approval of GAVRETO® (pralsetinib) for the Treatment of Advanced RET Fusion-Positive Non-Small Cell Lung Cancer and RET-Altered Thyroid Cancer in Taiwan, China
- February,2023 – CStone announces acceptance of Marketing Authorization Application by the European Medicines Agency for Sugemalimab in metastatic squamous and non-squamous non-small cell lung cancer
- February,2023 – CStone announces China NMPA has accepted the supplementary new drug application of sugemalimab as first-line treatment for patients with locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma
- March,2023 – CStone announces publication of GEMSTONE-201 study results for Sugemalimab monotherapy in the treatment of relapsed/refractory extranodal NK/T-cell lymphoma in Journal of Clinical Oncology
- April, 2023 – CStone announces China NMPA has accepted the supplemental biologics license application for sugemalimab as a first-line treatment for esophageal squamous cell carcinoma
- June, 2023 – CStone announces GAVRETO® (pralsetinib) sNDA approval by China NMPA for first-line treatment of patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer
- October, 2023 – CStone announces NMPA approval of Sugemalimab for patients with relapsed or refractory extranodal NK/T-cell lymphoma, the first anti-PD-1/PD-L1 mAb approved for this Indication
- November,2023 – CStone announces strategic partnership and exclusive licensing agreement with 3SBio for Nofazinlimab (anti-PD-1 antibody) in Mainland China
