TQB3909 / Sino Biopharm - LARVOL DELTA

A Clinical Trial to Evaluate the Efficacy and Safety of TQB3909 Tablets Versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (clinicaltrials.gov) - P3 | N=128 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P3 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Sino Biopharmaceutical…announces that a new drug application for Category 1 innovative drug TQB3909 Tablet 'BCL-2 Inhibitor'…has been submitted to and accepted by the Center for Drug Evaluation (CDE) of the China’s National Medical Products Administration, for the treatment of adult patients with…CLL/SLL who have received at least one prior systemic therapy, including a BTK inhibitor (HKEXnews) - "This marketing application is based on a single-arm, open-label, multicenter Phase II registrational clinical trial designed to evaluate the efficacy and safety of TQB3909 in patients with relapsed or refractory CLL/SLL."

China filing • Chronic Lymphocytic Leukemia • Small Lymphocytic Lymphoma

A Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Myelofibrosis (MF) (clinicaltrials.gov) - P1/2 | N=21 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=93 ➔ 21 | Trial completion date: May 2027 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2026 ➔ Dec 2025; Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Myelofibrosis

TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (clinicaltrials.gov) - P1/2 | N=19 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=39 ➔ 19 | Recruiting ➔ Terminated; Study terminated for strategic business reasons

Enrollment change • Trial termination • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • BCL2

Efficacy and safety results of TQB3909,a novel BCL-2 inhibitor, in combination with azacitidine for patients with myeloid malignancies (ASH 2025) - P1/2 | "The median time to first CRc (mTTCRc) response was 0.95 months (95% CI, 0.92 to 1.97).The median duration of CRc was not reached (95% CI, 3.91 to NR) .In the 400mg cohort (n=25), ORR andCRc were 88% and 76%, respectively; mTTCRc was 0.95 months ((95% CI, 0.92 to 1.38); the medianduration of CRc was not reached (95% CI, 2.86 to NR); median OS was not reached (95% CI, 3.19 to NR).Among 9 pts with R/R AML treated with TQB3909+AZA, ORR and CRc were 75% and 62.5%, respectively.ConclusionsThis new BCL-2 inhibitor TQB3909 combined with AZA demonstrated significant efficacy in pts withelderly/unfit TN and R/R AML. No significant new safety findings were observed."

Clinical • Combination therapy • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia

BCL-2 inhibitor TQB3909 combined with JAK inhibitors in patients with intermediate- or high-risk myelofibrosis: A two-cohort, open-label, Phase ib/II, multicenter study (ASH 2025) - P1/2 | "Previous studies of BCL-2 inhibitor plus ruxolitinib (RUX) have shown improved efficacycompared to JAKi monotherapy...Palpable splenomegaly (≥5 cm below LCM) or spleen volume ≥450 cm³ (MRI/CT) was required.Pts received either RUX or rovadicitinib (ROV) combined with TQB3909 based on investigator discretion.Dose escalation of TQB3909 (100 mg, 200 mg, 300 mg QD) was first explored in the RUX cohort, followedby a 3+3 dose-escalation design in the ROV cohort (10mg, 15 mg bid)... TQB3909 combined with JAKi demonstrated meaningful clinical activity in MF pts,particularly in combination with ROV, showing spleen reduction, symptom improvement, and potentialanemia benefit. However, TQB3909+ROV is associated with hematologic toxicities, and dose optimizationis ongoing to balance efficacy and tolerability. Acknowledgement: This research was funded by the Zhejiang Provincial Health High-level InnovativeTalent Project (2022-2026)."

Clinical • IO biomarker • P1/2 data • Infectious Disease • Myelofibrosis • Thrombocytopenia • BCL2L1 • MCL1

Prediction of CYP3A4-mediated drug-drug interactions of a novel Bcl-2 inhibitor TQB3909 using physiologically based pharmacokinetic modeling. (PubMed, Cancer Chemother Pharmacol) - No abstract available

Journal • PK/PD data • CYP3A4

Efficacy and Safety Results of TQB3909 in Patients (Pts) with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (ASH 2024) - P1/2 | "No significant new safety findings were observed. The phase II study is ongoing."

Clinical • IO biomarker • Anemia • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Respiratory Diseases • Small Lymphocytic Lymphoma • Thrombocytopenia • IGH • TP53

A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1/2 trial • Oncology

China Biopharmaceutical Class 1 New Drug BCL-2 Inhibitor Approved for Clinical Trial {Google translation] (bydrug.pharmcube.com) - P1 | N=126 | NCT04975204 | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | "On October 29, Sino Biopharmaceutical's Class 1 new drug BCL-2 inhibitor, TQB3909 tablets, was approved for clinical trials by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, and is intended to be used in combination with chemotherapy for the treatment of patients with acute lymphoblastic leukemia ( ALL)...A Phase I clinical study published by Sino Biopharmaceutical at ESMO 2024 included 69 patients for TQB3909 treatment...Research data showed that the overall response rate (ORR) of TQB3909 in patients with R/R CLL/SLL was 88.9% , and the complete remission/complete remission with incomplete hematologic recovery (CR/CRi) was 44.4%. The ORR of patients with R/R CLL/SLL who were resistant to BTK inhibitors was 83.3% , and the CR/CRi was 41.7%."

New trial • P1 data • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Non-Hodgkin’s Lymphoma

First report of BCL-2 inhibitor TQB3909 in pts with relapsed or refractory non-Hodgkin lymphoma (NHL) and acute myeloid leukemia (AML): Data from a phase I study (ESMO 2024) - P1 | "TQB3909 demonstrated significant efficacy in pts with R/R B-NHL with manageable safety profiles, providing a promising treatment option for B-NHL pts including CLL/SLL pts who were refractory to BTK inhibitors."

Clinical • P1 data • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Myelofibrosis (MF) (clinicaltrials.gov) - P1/2 | N=93 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2024 ➔ May 2024

Enrollment open • Trial initiation date • Myelofibrosis

A Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Myelofibrosis (MF) (clinicaltrials.gov) - P1/2 | N=93 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1/2 trial • Myelofibrosis

A Clinical Trial of TQB3909 Tablets Combined With TQB3702 Tablets in Patients With Hematologic Malignancy (clinicaltrials.gov) - P1 | N=208 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Hematological Disorders • Hematological Malignancies • Oncology

A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Oncology

TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (clinicaltrials.gov) - P1/2 | N=39 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

New P1/2 trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • BCL2

A Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) . (clinicaltrials.gov) - P1/2 | N=107 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • PLCG2

A Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) . (clinicaltrials.gov) - P1/2 | N=107 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1/2 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • PLCG2

A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer (clinicaltrials.gov) - P1/2 | N=65 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=126 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2021 ➔ Feb 2022

Enrollment open • IO biomarker • Trial initiation date • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • BCL2

A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1; N=126; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Initiation date: Aug 2021 ➔ Nov 2021

Clinical • IO biomarker • Trial initiation date • Oncology • BCL2

A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1; N=126; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Oncology • BCL2