-
IASO Biotherapeutics’ Fucaso Approved in Macao for Relapsed Multiple Myeloma
•
China-based IASO Biotherapeutics announced that the New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF). This approval marks the first NDA approval for Fucaso outside of mainland…
-
BMS’s Breyanzi Approved by EC for Relapsed or Refractory Follicular Lymphoma
•
US giant Bristol-Myers Squibb (BMS; NYSE: BMY) announced receiving another indication approval from the European Commission (EC) for its Breyanzi (lisocabtagene maraleucel; liso-cel). The approval allows the drug to be used in adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Clinical…
-
CARsgen’s CT041 Awarded Breakthrough Therapy Designation for Gastric Cancer
•
CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that its chimeric antigen receptor (CAR) T-cell therapy, Satricabtagene autoleucel (CT041), has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is Claudin18.2-positive advanced gastric / gastroesophageal junction cancer (G…
-
CARsgen Therapeutics Administers KJ-C2219 in SLE Patient in IIT
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that it has administered its KJ-C2219 at the starting dose specified in the clinical protocol in the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated trial (IIT). Therapy DetailsKJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, was developed via CARsgen’s THANK-u…
-
CARsgen Therapeutics and Zhuhai SB Xinchuang Invest in UCARsgen for Allogeneic CAR-T Therapies
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has entered into an agreement with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership) to jointly invest in its subsidiary UCARsgen Biotech Limited. UCARsgen focuses on developing allogeneic CAR-T cell therapies for hematologic malignancies. Deal Highlights
-
IASO Bio’s Fucaso NDA Accepted by Hong Kong DOH for Relapsed/Refractory Multiple Myeloma
•
China-based IASO Bio announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Hong Kong Department of Health (DOH). The application is for the treatment of relapsed/refractory multiple myeloma (R/R MM) in patients…
-
Bristol-Myers Squibb’s Breyanzi Hits Primary Endpoint in Lymphoma Study
•
Bristol-Myers Squibb (BMS, NYSE: BMY) reported positive results from the Phase II TRANSCEND FL study of Breyanzi (lisocabtagene maraleucel), its CD19-directed CAR T cell therapy, in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL). The trial met its primary endpoint in the marginal zone lymphoma (MZL) cohort, demonstrating…
-
CARsgen’s Allogeneic BCMA CAR-T Therapy Achieves sCR in First Patient
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the first patient treated with its allogeneic BCMA chimeric antigen receptor (CAR)-T therapy, developed on the THANK-u Plus platform, achieved a stringent complete response (sCR) and minimal residual disease (MRD) negativity at the Day-28 assessment. Patient Background and TreatmentThe patient, diagnosed…
-
IASO Bio’s CAR-T Therapy Fucaso Accepted for Review in Singapore
•
China-based IASO Biotherapeutics has announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Health Sciences Authority (HSA) of Singapore. The therapy is intended for the treatment of relapsed/refractory multiple myeloma (R/R MM)…
-
CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2320 in AML
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the first subject dosing in an investigator-initiated trial (ITT) for its KJ-C2320, a universal chimeric antigen receptor (CAR)-T cell therapy targeting recurrent/refractory acute myeloid leukemia (R/R AML). This milestone marks a significant step forward in the development of innovative treatments for…
-
JW Therapeutics’ Carteyva Granted Breakthrough Therapy Designation by CDE
•
China-based JW Therapeutics (HKG: 2126) has announced that its Carteyva (relmacabtagene autoleucel injection) has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation recognizes the potential of Carteyva as a second-line treatment for adults with relapsed or refractory…
-
Ucello Biotech’s UC101 Receives FDA IND Clearance for Anti-CD19 Therapy
•
China-based Chengdu Ucello Biotechnology Co., Ltd., a developer of allogeneic universal chimeric antigen receptor (CAR)-T cell therapies, has announced receiving Investigational New Drug (IND) clearance from the US FDA for its anti-CD19 allogeneic universal T-cell therapy UC101. This clearance is a significant milestone in the development of UC101, paving the…
-
Inceptor Bio and GRIT Biotechnology Partner to Advance CAR-T Therapy IB-T101 for Solid Tumors
•
US-based Inceptor Bio has entered into a partnership with Chinese firm GRIT Biotechnology to advance the potential best-in-class chimeric antigen receptor (CAR)-T therapy, IB-T101, for the treatment of solid tumors. This collaboration combines the expertise of two cell therapy specialists to enhance the development and commercialization of innovative cancer treatments.…
-
SCG Cell Therapy’s SCG142 Receives NMPA Approval for HPV-Related Solid Tumor Clinical Trial
•
SCG Cell Therapy Pte. Ltd, a Singapore-based company with a presence in Shanghai, has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative therapy, SCG142. This human papillomavirus (HPV) specific T cell receptor (TCR) therapy is set to be tested in a range of HPV-related…
-
Cygenta Partners with IZVARINO Pharma for Comprehensive CDMO Services
•
Cygenta, a cell and gene therapy (CGT) focused Contract Development and Manufacturing Organization (CDMO) based in Beijing, has announced a strategic partnership with Russia-based IZVARINO Pharma Limited Liability Company. The collaboration aims to enhance the development and manufacturing capabilities for both companies, with a focus on advancing therapies in the…
-
CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2219 in China
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the initiation of an investigator-initiated-trial (ITT) for its chimeric antigen receptor (CAR)-T therapy candidate product, KJ-C2219, in China. The trial is aimed at treating recurrent/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). KJ-C2219: A Universal CAR-T Therapy Targeting CD19 and CD20KJ-C2219 is a…
-
CARsgen Therapeutics’ Satricabtagene Autoleucel Shows Positive Results in Phase II Study
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced positive results from its pivotal Phase II CT041-ST-01 study for satricabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy. The study, which is randomized, controlled, and multi-center, aims to evaluate the efficacy and safety of the therapy in patients with CLDN18.2-expressing…
-
ImmunoTech Biopharm’s CAR-T-19 Earns Breakthrough Therapy Designation for B-ALL Treatment
•
China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced receiving Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its CAR-T-19 injection. This designation is awarded for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) patients aged 25 and under, marking…
-
Legend Biotech’s Carvykti Demonstrates High MRD Negativity Rates in Phase III CARTITUDE-4 Trial
•
China-based Legend Biotech Corporation (NASDAQ: LEGN) has released new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting. The trial compared Carvykti (ciltacabtagene autoleucel; cilta-cel) with the standard of care (SoC) in treating multiple…
-
Immunofoco’s IMC002 Earns FDA Fast-Track Designation for CLDN 18.2-Positive Gastric Cancer
•
Immunofoco, a leading developer in tumor immunotherapy based in Suzhou, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its IMC002. This chimeric antigen receptor (CAR)-T therapy targets CLDN 18.2 and is intended for the treatment of patients with unresectable locally…
