rolditamig deuderuxtecan (TQB2102) / Sino Biopharm, Cipla - LARVOL DELTA

RECLAIM: Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Fudan University | Trial completion date: Apr 2027 ➔ Jun 2028 | Initiation date: Jan 2026 ➔ Jan 2027 | Trial primary completion date: Jan 2027 ➔ Dec 2027

Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

APEX-Breast01: TQB2102 versus chemotherapy in HER2-low recurrent or metastatic breast cancer (r/m BC) : Results from a randomized phase 3 study (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

TQB2102, a Novel HER2 Bispecific Antibody-Drug Conjugate, Combined with Bemotrizumab with or without Capecitabine as First-Line Therapy for HER2-Positive Advanced Gastric/Gastroesophageal Junction Cancer: A Phase II Study (ESMO 2026) - No abstract available

ADC • Bispecific • Clinical • Metastases • P2 data • Oncology • Solid Tumor

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

TQB2102-III-01: A Clinical Trial of TQB2102 for Injection in the Treatment of HER2 Low-Expressing Recurrent/Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=542 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Cipla and SBP Group sign exclusive licensing agreement for potential best-in-class HER2 bispecific ADC Rolditamig Deuderuxtecan (TQB2102) (Cipla Press Release) - "Under this agreement, Cipla will receive exclusive rights to develop and commercialise TQB2102 in India, South Africa and 5 other emerging markets. Cipla will be responsible for local clinical development, regulatory activities, and commercialisation in the licensed territories, while CTTQ will continue to manufacture and supply TQB2102."

Licensing / partnership • HER2 Breast Cancer • HER2 Positive Breast Cancer

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

Sino Biopharmaceutical Limited…announces that a new drug application for national Category 1 innovative drug TQB2102 Injection…has been submitted to and accepted by…China’s National Medical Products Administration for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have not received prior chemotherapy in the relapsed or metastatic setting (HKEXnews) - "The TQB2102-III-01 study was a randomized, open-label, active-controlled, multicenter Phase III clinical study that enrolled a total of 543 patients with HER2-low breast cancer. As assessed by the Independent Data Monitoring Committee (IDMC), the study met its pre-specified primary endpoint and key secondary endpoints at the interim analysis....Detailed data from this study will be presented at upcoming international academic conferences."

China filing • P3 data • HER2 Breast Cancer

Preclinical characterization and phase 1 results of TQB2102, a first-in-class HER2 biparatopic antibody-drug conjugate, in patients with advanced solid tumors. (PubMed, Ann Oncol) - "TQB2102 demonstrates a manageable safety profile and preliminary antitumor activity in advanced solid tumors. A phase 3 trial in patients with HER2-low MBC has been initiated."

First-in-human • Journal • P1 data • Preclinical • Breast Cancer • Colorectal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • CD4 • HER-2

Sino Biopharmaceutical…announces that TQB2102 HER2 bispecific ADC'…has been granted Breakthrough Therapy Designation by the…CDE of the China’s National Medical Products Administration, for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have not received any chemotherapy at the relapsed or metastatic stage (HKEXnews)

Breakthrough therapy • HER2 Breast 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 2028 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2027

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 Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

TQB2102-Ib-01: Evaluation of a Phase Ib clinical trial of injectable TQB2102 in recurrent/metastatic breast cancer (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | -> Recruiting | Phase classification: PN/A ➔ P1

Enrollment open • Phase classification • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

TQB2102-III-03: A phase III clinical trial evaluating injectable TQB2102 against investigator-selective treatment regimens for HER2 IHC3+ advanced colorectal cancer that has failed oxaliplatin, irinotecan, or fluorouracil-based therapies. (clinicaltrials.gov) - P3 | N=142 | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Trial initiation date • Colorectal Cancer • Oncology • Solid Tumor • HER-2

Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=178 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • HER-2

Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=178 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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

A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs (clinicaltrials.gov) - P3 | N=142 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

New P3 trial • Colorectal Cancer • Oncology • Solid Tumor • HER-2

Completion of Subject Enrollment in Phase III Clinical Trial of TQB2102 'HER2 Bispecific ADC' for HER2-low Breast Cancer (HKEXnews) - "...TQB2102...is currently undergoing a 'Randomised, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Investigator-selected Chemotherapy in HER2-Low Recurrent/Metastatic Breast Cancer' (TQB2102-III-01)."

Trial status • HER2 Breast Cancer

RECLAIM: Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

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

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