Yuanruida (inaticabtagene autoleucel) / CASI, Juventas Cell Therapy - LARVOL DELTA

CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=30 | Completed | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Active, not recruiting ➔ Completed | N=20 ➔ 30

Enrollment change • Trial completion • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • BCL6

CASI Pharmaceuticals Enters Into Definitive Agreement for the Divestiture of Assets in China (ACCESSWIRE) - "CASI Pharmaceuticals...announced that it has entered into a definitive Equity and Assets Transfer Agreement...with Kaixin Pharmaceuticals Inc...and CEO of the Company and two direct wholly-owned subsidiaries of the Company in China...pursuant to which the Company shall sell and transfer, and Kaixin Pharmaceuticals shall purchase and acquire, 100% equity interests in both Target Companies...and all licensing rights, distribution rights, supply arrangements and related rights related to BI-1206 (in China), CID-103 (in Asia excluding Japan) and Thiotepa (in China excluding Hong Kong, Macau and Taiwan)...for an aggregate purchase price of $20.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company....After the closing of the Transaction, the Company expects to retain the rights related to CID-103 (in Japan and non-Asian regions), EVOMELA, FOLOTYN, CNCT19 and CB-5339, and remain firmly committed to progressing CID-103 at an accelerated pace."

Commercial • Hematological Malignancies • Immunology • Solid Tumor

Real-world outcomes of inaticabtagene autoleucel in Chinese patients with B-ALL. (ASCO 2025) - P | "Clinical Trial Registration Number: NCT06450067 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

The third approval in the field of autoimmunity of Heyuan Bio! The new drug clinical trial (IND) application of Inaticabtagene autoleucel for the treatment of refractory lupus nephritis (LN) has been implicitly approved [Google translation] (Sina Corp) - "On April 24, 2025, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that the new drug clinical trial (IND) application for Inaticabtagene autoleucel (trade name: Yuanruida) independently developed by Heyuan Bio has obtained implicit approval (acceptance number: CXSL2500076) for the treatment of refractory lupus nephritis (Lupus Nephritis, LN)."

New trial • Lupus Nephritis

HY0001a: A novel antibody-drug conjugate (ADC) targeting CUB domain containing protein 1 (CDCP1) (AACR 2025) - "We identified CDCP1 as an excellent ADC TAA with great potential against multiple cancers. We discovered an antibody (HY0001) of high affinity, cancer cell-specific and efficiently internalization, and completed development of a preclinical candidate MMAE based ADC (HY0001a), which showed a great rationale for further clinical investigation to provide a novel cancer therapy."

Bladder Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Solid Tumor • CDCP1

Inati-Cel Induces High CR and MRD Negativity Rates in CD19+ R/R B-ALL (OncLive) - P2 | N=100 | NCT04684147 | Sponsor: Juventas Cell Therapy Ltd | "Findings published in Blood showed that response-evaluable patients who received inati-cel (n = 48) achieved a 3-month overall response rate (ORR) of 70.8% (95% CI, 55.9%-83.1%; P < .0001 vs historical control rate of 25%). The 3-month CR and CR with incomplete hematologic recovery (CRi) rates were 60.4% and 10.4%, respectively...The best ORR was 85.4% (95% CI, 72.2%-93.3%), which included a CR rate of 72.9% and a CRi rate of 12.5%. Notably, all 41 any-time responders achieved MRD negativity by flow cytometry; at 3 months, the MRD-negativity rate among responders was 94.1% (95% CI, 80.3%-99.3%)."

P2 data • B Acute Lymphoblastic Leukemia

Heyuan Biopharma's Nakiolunsai Injection becomes the world's first CAR-T product to receive clinical implicit approval for the treatment of autoimmune hemolytic anemia (AIHA) [Google translation] (163.com) - "The website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) shows that the new drug clinical trial application (IND) for new indications in the field of autoimmune diseases of Heyuan Biotechnology's Nakiolunsai Injection (trade name: Yuanruida) has obtained implicit approval (acceptance number: CXSL2500030), which is used to treat autoimmune hemolytic anemia (AIHA) that has failed at least 3 lines of treatment."

New trial • Autoimmune Hemolytic Anemia

A novel microbial agent reduces soil paclobutrazol residue, enhances enzyme activities and increases Ophiopogon japonicus production. (PubMed, PeerJ) - "Based on a novel microbial agent, Micrococcus yunnanensis strain HY001 (MYSH), field experiments were conducted in the main production area of O. japonicus...By reducing paclobutrazol residue and enhancing soil health and crop production, MYSH shows great potential for broader application in sustainable agricultural practices. This research highlights the efficacy of microbial agents in addressing agrochemical contamination and promoting sustainable farming, providing a valuable contribution to the development of eco-friendly agricultural solutions."

Journal

Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2024 ➔ Mar 2024

Trial primary completion date • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • BCL2 • BCL6

A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric) (clinicaltrials.gov) - P1/2 | N=47 | Recruiting | Sponsor: Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2024 ➔ Jul 2025

Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD19

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Juventas Cell Therapy Ltd.

New P1 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura

New Potent Inhibitor of Transforming Growth Factor-Beta (TGFβ) Signaling that is Efficacious against Microsatellite Stable Colorectal Cancer Metastasis in Combination with Immune Checkpoint Therapy in Mice. (PubMed, ACS Pharmacol Transl Sci) - "Here, we report the synthesis and characterization of HYL001, a potent inhibitor of TGFβ receptor 1 (ALK5), that is approximately 9 times more efficacious than the structurally related compound galunisertib, while maintaining a favorable safety profile. HYL001 in combination with immune checkpoint blockade (anti-PD1) eradicates liver metastases generated in mice by microsatellite stable, aggressive colorectal cancer tumors at doses where galunisertib is ineffective."

Journal • Preclinical • Colorectal Cancer • Oncology • Solid Tumor • TGFBR1

JUVENTAS-ALL05: Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for Newly Diagnosed B-cell ALL Patients in CR1 (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: First Affiliated Hospital of Zhejiang University

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1 (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Ruijin Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Minimal residual disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Sustained Remission and Decreased Severity of CAR T-Cell Related Adverse Events: An Updated Report on the Pivotal Study of Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment in Adult Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-Cell ALL) in China (ASH 2024) - P2 | "Inati-cel was infused 2 to 14 days after lymphodepletion with cyclophosphamide and fludarabine. The safety profile was favorable, with a low incidence of grade 3 or higher CRS and ICANS. With its distinct CAR structure containing a unique CD19 scFv (HI19a), Inati-cel provides effective treatment with potential long-term clinical benefits for adult patients with r/r B-cell ALL."

Adverse events • CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • IKZF1 • KMT2A • PBX1 • TP53

Efficacy and Safety of Inaticabtagene Autoleucel in Children with Relapsed/Refractory (R/R) B-cell Acute Lymphoblastic Leukemia in China (ASH 2024) - P1/2 | "They received a single infusion of Inati-cel at a target dose of 1×106 CAR + viable T-cells/kg (±20%) after lymphodepletion with cyclophosphamide and fludarabine. Among the 6 pts in the phase Ib stage, one patient had a DLT event observed, related to high tumor burden and severe Grade 4 CRS, and was deemed manageable by the Steering Committee.CAR T-cell expansion occurred in all pts with a median time to maximum expansion (T max ) of 15 days (range : 9-23), and a peak copy number (Cmax) of 1.24×105 copies/μg gDNA.Conclusion : This trial demonstrates that Inati-cel is safe and effective in heavily treated children with R/R B-cell ALL. A pivotal trial evaluating Inati-cel at a target dose of 1×10^6 cells/kg (±20%) in children with R/R B-ALL is underway.*On behalf of Copenhagen Hospital Biobank and International Epidemiology Lymphoma Consortium"

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Cardiovascular • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1 (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Ruijin Hospital

IO biomarker • Minimal residual disease • New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Inaticabtagene Autoleucel (CNCT19) in adult relapsed or refractory B-cell acute lymphoblastic leukemia. (PubMed, Blood Adv) - P2 | "Based on the data from this pivotal trial, Inati-cel was approved as the first CAR-T therapy for adult r/r B-ALL in China and underscores its potential therapeutic benefits for this patient population. NCT04684147."

Clinical • Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy. (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Recruiting ➔ Active, not recruiting

Enrollment closed • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology

Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Zhejiang University

CAR T-Cell Therapy • Metastases • New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor

The marketing authorization application for Yuanruida for the new indication of treating relapsed or refractory large B-cell lymphoma has been formally accepted [Google translation] (Sina Corp) - "On September 26, 2024, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration published information showing that the new indication marketing authorization application for the first CAR-T cell therapy product of Heyuan Biotechnology...Yuanruida (Nakiolunsai injection), was officially accepted, with the acceptance number of CXSS2400104, for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) after second-line or higher systemic treatment....This new drug application is based on a single-arm, open, multicenter pivotal clinical study (NCT04586478) jointly led by the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) and Ruijin Hospital Affiliated to Shanghai Jiaotong University."

China filing • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric) (clinicaltrials.gov) - P1/2 | N=47 | Recruiting | Sponsor: Juventas Cell Therapy Ltd. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD19

Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission. (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Juventas Cell Therapy Ltd. | Trial primary completion date: Jun 2024 ➔ Dec 2024

Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6