TQB2102 / Sino Biopharm - LARVOL DELTA

Preliminary efficacy and safety of TQB2102 in HER2-positive locally advanced unresectable or metastatic biliary tract cancer: Phase Ib study results (ESMO Asia 2025) - P1/2 | "Notably, in Cohort 1, the ORR was 28.6% (95% CI: 3.7–71.0) in pts with prior anti-HER2 therapy( Trastuzumab,Pertuzumab,DS-8201) and 50% (95% CI: 6.8–93.2) in HER2 IHC 2+ and ISH+ pts. TQB2102 demonstrated favorable tolerability and encouraging antitumor activity in HER2-positive locally advanced/metastatic BTC. The 7.5 mg/kg dose showed superior efficacy versus 6.0 mg/kg and is therefore recommended as the RP2D for BTC. The Phase 2 study is currently in preparation."

Clinical • Metastases • P1 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • CD4 • HER-2

TQB2102-Ib/II-01: A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer (clinicaltrials.gov) - P1/2 | N=103 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2029 | Trial primary completion date: May 2025 ➔ May 2027

Trial completion date • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

TQB2102-II-03: A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Trial completion date: Feb 2026 ➔ Dec 2026 | Trial primary completion date: Oct 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and Safety of Neoadjuvant TQB2102 in Locally Advanced or Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: A Randomized, Open-Label, Multicenter, Phase II Trial. (PubMed, J Clin Oncol) - P2 | "To our knowledge, this was the first study to report the efficacy and safety of the bispecific HER2-directed ADC TQB2102 in the neoadjuvant setting for HER2-positive breast cancer. TQB2102 showed robust activity and was well-tolerated."

Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

Preliminary efficacy and safety of TQB2102 in patients with HER2 positive recurrent/metastatic breast cancer: Results from a phase Ib study (ESMO 2025) - P1 | "All pts had received prior anti-HER2 therapies such as trastuzumab and the median of 3 prior lines in the metastatic setting; 50 pts had received anti-HER2 TKI (pyrotinib etc), 33 had received pertuzumab, also 28 had received anti-HER2 ADC therapy. The recommended dose of TQB2102 in HER2 positive r/m BC was 6.0 mg/kg Q3W. A phase III trial to evaluate the efficacy and safety of TQB2102 versus Trastuzumab Emtansine in HER2 positive r/m BC is currently ongoing."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CD4 • HER-2

Sino Biopharmaceutical Limited…announces that TQB2102 'HER2 bispecific antibody-drug conjugate (ADC)' for injection, being a national Class 1 new drug independently developed by the Group, has been included in the Breakthrough Therapeutic Designation (BTD) process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (HKEXnews) - "The drug is used for the treatment of HER2 IHC 3+ advanced colorectal cancer that has failed in prior attempts with oxaliplatin, irinotecan, and fluorouracil-based regimens....The Group presented the preliminary data from the Phase I clinical study for TQB2102 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting."

Breakthrough therapy • Colorectal Cancer

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer (clinicaltrials.gov) - P3 | N=544 | 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

Efficacy and Safety of TQB2102, a Biparatopic HER2-Targeting ADC, in HER-2 Aberrant NSCLC: A Phase II Study (IASLC-WCLC 2025) - "Conclusions : TQB2102 demonstrated robust efficacy, particularly in patients with HER2 mutation and concurrent HER2/EGFR aberration NSCLC. The favorable safety profile supports further investigation of TQB2102 in combination therapy trials and biomarker-driven studies to optimize its clinical application for this challenging patient population."

Clinical • P2 data • Anemia • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • EGFR • HER-2

Efficacy and Safety of TQB2102, a Biparatopic HER2-Targeting ADC, in HER-2 Aberrant NSCLC: A Phase II Study (IASLC-WCLC 2025) - "Conclusions : TQB2102 demonstrated robust efficacy, particularly in patients with HER2 mutation and concurrent HER2/EGFR aberration NSCLC. The favorable safety profile supports further investigation of TQB2102 in combination therapy trials and biomarker-driven studies to optimize its clinical application for this challenging patient population."

Clinical • P2 data • Anemia • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • EGFR • HER-2

Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer. (clinicaltrials.gov) - P2 | N=280 | Not yet recruiting | Sponsor: Henan Cancer Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer (clinicaltrials.gov) - P3 | N=544 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=792 ➔ 544

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

Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=246 | 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

TQB2102-II-01: A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer (clinicaltrials.gov) - P2 | N=104 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2026 ➔ Feb 2028 | Trial primary completion date: Jan 2025 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

TQB2102-II-04: A Clinical Trial Evaluating TQB2102 for Injection in Combination With Behmosubaisumab/Payamprolizumab With or Without Chemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

TQB2102-I-01: Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=219 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • HER-2

TQB2102-II-05: A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic Advanced (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=90 ➔ 170

Enrollment change • Gynecologic Cancers

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer (clinicaltrials.gov) - P3 | N=792 | 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

A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=642 | 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

Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=246 | 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

TQB2102-I-01: Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=226 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | N=71 ➔ 226 | Trial completion date: Oct 2024 ➔ Jul 2027 | Trial primary completion date: Apr 2024 ➔ Jul 2025

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Oncology • HER-2

Safety and efficacy of TQB2102, a novel bispecific anti-HER2 antibody–drug conjugate, in patients with advanced solid tumors: Preliminary data from the first-in-human phase 1 trial. (ASCO 2025) - P1, P3 | "The bispecific antibody component can target both extra-cellular domains II (pertuzumab binding site) and IV (trastuzumab binding site) of HER2...Most common tumor types included MBC (N = 80),Colorectal cancer(N = 37)and Gastric cancer (N = 23).Twenty-five (31%) MBC received prior anti-HER2 ADCs, including 21 pts received T-DM1, 8 pts received DS-8201.The median duration of follow-up was 8.15 months... TQB2102 is well tolerated with promising anti-tumor activity in pts with HER2-expressing cancer. These early signs of activity support a phase 3 trial in patients with HER2-low MBC that has been initiated (NCT06561607)."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Colorectal Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Preliminary efficacy and safety of TQB2102 in patients with HER2 low-expressing recurrent/metastatic breast cancer: Results from a phase 1b study. (ASCO 2025) - P1, P3 | "TQB2102 was well-tolerated and showed promising antitumor activity in heavily pretreated HER2 low-expressing recurrent/metastatic breast cancer pts. The recommended phase 3 dose of TQB2102 in HER2 low-expressing r/m BC was 7.5 mg/kg Q3W. A phase III trial to evaluate the efficacy and safety of TQB2102 versus investigator-selected chemotherapy in HER2 low-expressing r/m BC is currently ongoing (NCT06561607)."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • CD4 • HER-2

Efficacy and safety of neoadjuvant TQB2102 in women with locally advanced or early HER2-positive breast cancer: A randomized, open-label, multi-centre phase 2 trial. (ASCO 2025) - P2 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT06198751 Background: Standard neoadjuvant regimens for HER2-positive breast cancer include trastuzumab and pertuzumab combined with chemotherapy, and the efficacy and safety of third-generation HER2-direted antibody-drug conjugate (ADC) is unknown. This is the first study to report the efficacy and safety of third-generation duel-HER2-directed ADC in the neoadjuvant setting for HER2-positive breast cancer. TQB2102 is highly efficient and well tolerated. pCR in All patients and by HR status."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CD4 • HER-2

DATA FROM PHASE I STUDY OF TQB2102 (BISPECIFIC ANTI-HER2 ADC) PRESENTED AT 2025 ASCO ANNUAL MEETING (Sino Biopharm Press Release) - P1 | N=181 | NCT05735496 | "The results of the study showed that in terms of efficacy for the dose group of 6mg/kg and above, the objective remission rate (ORR) was 51.3% for HER2-positive breast cancer, 51.5% for HER2 low-expression breast cancer, 34.8% for HER2 high-expression (HER2 immunohistochemistry 3+) colorectal cancer, and 70% for HER2-positive gastric cancer or gastroesophageal junction cancer. Among them, the subgroup of HER2- positive breast cancer with brain metastasis showed an ORR of 70%, and one case of intracranial lesion was in complete remission; treatment with TQB2102 for 31% of breast cancer subjects remained effective after T-DM1/DS-8201 resistance....In terms of safety, Grade ≥3 adverse events (AEs) in the total population were mainly neutropenia (21.7%), decreased white blood cell count (10.6%), anaemia (8.9%) and decreased platelet count (6.1%)."

P1 data • Solid Tumor