About Us

Who We Are

Gracell Biotechnologies is a global clinical-stage biopharmaceutical company dedicated to discovering and developing innovative and highly efficacious cell therapy. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost, and lack of effective CAR-T therapies for solid tumors.

Our
History

Nov. 2023

U.S. FDA cleared IND application for phase 1/2 clinical trial of FasTCAR-T GC012F for the treatment of rSLE
Sep. 2023

Gracell dosed first patient in phase 1b/2 clinical trial in U.S. evaluating GC012F for treatment of relapsed/refractory multiple myeloma
Aug. 2023

Gracell closed ＄150 million private placement financing, led by Vivo Capital and joined by leading healthcare investors including Adage Capital Partners LP, Exome Asset Management, Janus Henderson Investors, Logos Capital, OrbiMed, Pivotal Life Sciences, RA Capital Management and TCGX
May. 2023

Gracell Biotechnologies initiated investigational study evaluating GC012F for treatment of refractory Systemic Lupus Erythematosus (SLE), expanding clinical evaluation of FasTCAR-T GC012F into autoimmune disease
Feb. 2023

China NMPA cleared IND application for Phase 1/2 clinical trial of FasTCAR-T GC012F for the treatment of r/r MM
Jan. 2023

U.S. FDA cleared IND application for Phase 1b/2 clinical trial of FasTCAR-T GC012F for the treatment of r/r MM
Dec. 2022

Gracell Biotechnologies presented first-in-human data on BCMA/CD19 dual-targeting FasTCAR-T GC012F for high risk, newly diagnosed multiple myeloma patients at ASH 2022, demonstrating 100% ORR and 100% MRD- rate
Nov. 2022

Gracell Biotechnologies won 2022 Fierce Life Sciences Innovation Award
Oct. 2022

Gracell Biotechnologies dosed first patient in phase 2 portion of registrational phase 1/2 clinical trial evaluating GC007g for the treatment of B-ALL
Jun. 2022

Gracell Biotechnologies presented updated clinical data on BCMA/CD19 dual-targeting FasTCAR-T GC012F in r/r MM at EHA2022 Congress, highlighting 100% MRD- rate in all treated patients
Feb. 2022

Gracell Biotechnologies dosed first patients in First-in-Human clinical trial evaluating GC012F, a dual-targeting FasTCAR-T Therapy for the treatment of B-Cell Non-Hodgkin's Lymphoma
Dec. 2021

Gracell Biotechnologies was selected for addition to NASDAQ Biotechnology Index
Nov. 2021

Gracell Biotechnologies was granted FDA Orphan Drug Designation for FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy candidate GC012F for the treatment of multiple myeloma
Mar. 2021

Signs agreement with Lonza to manufacture Gracell's FasTCAR product candidates in the U.S.
Jan. 2021

Completes IPO and NASDAQ listing, raising $240 million in gross proceeds
Jan. 2021

Suzhou manufacturing facility receives Medical Products Manufacturing Certificate from JSMPA
Dec. 2020

NMPA approves registrational seamless Phase 1/2 clinical trial for GC007g donor-derived allogeneic CAR-T cell therapy for r/r B-ALL
Dec. 2020

Reports first-in-human data at ASH 2020 on GC012F FasTCAR-enabled dual-targeting BCMA/CD19 cell therapy in patients with r/r MM
Oct. 2020

Closes series C funding led by Wellington Management Company, OrbiMed, and Morningside Ventures, and participation from Vivo, Temasek, LAV, Kington Capital, and Chengdu Miaoji
Aug. 2020

Suzhou GMP manufacturing facility opens
Apr. 2020

NMPA approves IND application for GC007g donor-derived CAR-T cell therapy for CD19 positive r/r B-ALL
Feb. 2019

Closes series B funding from Temasek, OrbiMed, Lilly Asia Ventures, Kington Capital, and Chengdu Miaoji
Oct. 2017

Shanghai R&D facility opens
May. 2017

Gracell Biotechnologies was founded by Dr. William Wei Cao and co-founding team