TQB2930 / Sino Biopharm - LARVOL DELTA

TQB2930-III-01: TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=416 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=416 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Efficacy and safety results of TQB2930, a HER2-targeted bispecific antibody combined with chemotherapy in patients with HER2-positive breast cancer (BC) previously treated with ≥2 line treatments: Results from a phase 1b/2 study. (ASCO 2025) - P1/2 | "All enrolled patients received TQB2930 intravenously at a dose of 30 mg/kg every three weeks (Q3W), administered in combination with one of four investigator-selected chemotherapies (capecitabine, eribulin, gemcitabine, or vinorelbine)...Among patients who had progressed on prior T-DM1 therapy, the ORR was 36.8% (7/19), whereas patients who had failed other HER2-ADC therapies exhibited an ORR of 50% (8/16), including RC48, DS-8201, and so on... The combination of TQB2930 with chemotherapy demonstrates encouraging antitumor efficacy and an acceptable safety profile in patients with HER2-positive BC who have undergone at least two prior lines of treatment. These results support the potential of TQB2930 as a novel therapeutic strategy for HER2-positive BC and underscore the need for further clinical exploration. This study was funded by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd."

Clinical • P1/2 data • Breast Cancer • Cardiovascular • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CD4 • HER-2

TQB2930 is Well Tolerated, Elicits Antitumor Activity in HER2+ Advanced Breast Cancer (OncLive) - P1b/2 | N=154 | NCT06202261 | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | "Treatment with the HER2-targeted bispecific antibody TQB2930 was well tolerated and led to preliminary antitumor activity in patients with HER2-positive advanced breast cancer who received prior standard therapy, according to data from a phase 1b trial (NCT06202261) presented at the 2024 ASCO Annual Meeting....Efficacy-evaluable patients (n = 31) achieved an overall response rate (ORR) of 25.8%, which was comprised of 8 patients who all experienced a partial response (PR). Five patients had a confirmed PR, and 3 patients had an unconfirmed PR. The stable disease (SD) rate was 54.8%, and the progressive disease (PD) rate was 12.9%."

P1 data • Breast Cancer • Oncology • Solid Tumor

Preliminary safety and efficacy of TQB2930, a HER2-targeted bispecific antibody in patients with advanced breast cancer: Results from a phase 1b study. (ASCO 2024) - P1/2 | "Moreover, 5 pts achieved PR at 30mg/kg (ORR 41.7%), including one with prior exposure to trastuzumab, pyrotinib, tucatinib, ARX788, and the other one prior to trastuzumab, pertuzumab, lapatinib, MRG002. TQB2930 is well tolerated and has demonstrated promising single-agent anti-tumor activity in HER2-positive breast cancer who have failed standard anti-HER2 therapies, including multiple lines of prior HER2 targeted agents. These early signs of activity support the further exploration of combination therapy of TQB2930 and the study is ongoing."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • CD4 • HER-2

52 RESEARCH RESULTS WILL BE PRESENTED AT 2024 ASCO ANNUAL MEETING (HKEXnews) - "The board of directors...of the Sino Biopharmaceutical Limited...announced that the Group’s category 1 innovative drugs...'TQB3617 (BET inhibitor)', 'TQB3728 (IAP antagonist)', 'TQB2930 (HER2 bispecific antibody)' and others will present 52 latest research results at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, covering clinical research and basic research on multiple types of cancers..."

Clinical data • Breast Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Solid Tumor

A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=154 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=89 ➔ 154 | Trial completion date: Oct 2025 ➔ Oct 2027 | Trial primary completion date: Mar 2025 ➔ Dec 2026

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of TQB2930 for Injection Monotherapy or Combination Chemotherapy in Patients With Recurrent/Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=89 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Clinical Trial of the TQB2930 Injection in Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor • HER-2