Recently, a Phase III clinical trial (TQB2102-III-02) of TQB2102, a HER2 bispecific dual-epitope antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing, a core enterprise of Sino Biopharmaceutical (1177.HK), for HER2-positive advanced breast cancer, has completed full enrollment of all subjects. Previously, its pivotal registration study for HER2-low breast cancer had already taken the lead in completing patient enrollment, positioning it as a global leader in R&D progress. 

 

 

Breast cancer is the most common malignant tumor among women globally. In 2022, there were approximately 357,000 new cases and 75,000 deaths from breast cancer in China, posing a serious threat to women's health. Studies have found that about 20%-30% of breast cancer patients are diagnosed with HER2-positive breast cancer (IHC 3+ or FISH dual-probe positive), which is characterized by high malignancy, rapid progression, high tendency for recurrence and metastasis, and poor prognosis. 

 

This study is a pivotal registration study of TQB2102 for the treatment of HER2-positive advanced breast cancer. It aims to evaluate the efficacy and safety of TQB2102 for injection versus trastuzumab emtansine in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who have previously received anti-HER2 monoclonal antibody and taxane drug therapy. The results of the Phase Ib study of TQB2102 for HER2-positive advanced breast cancer were reported at the 2025 ESMO Congress^[1]:

 

● Efficacy: The overall objective response rate (ORR) in patients with HER2-positive breast cancer who had failed multiple prior lines of therapy was 58.8% (47/80), with the ORR in the target dose 6 mg/kg group reaching as high as 67.4%; among patients who had progressed after prior ADC therapy, 63.3% still achieved a response after treatment with TQB2102; 

 

● Safety: Grade 3 or higher treatment-related adverse events (TRAEs) in the HER2-positive population mainly included neutrophil decreased (13.75%), white blood cell decreased (6.25%), anemia (5%), and hypokalemia (10%), with a favorable overall tolerability profile. 

 

Currently, the development of TQB2102 for multiple indications, including breast cancer and digestive tract cancer, is advancing steadily. Its Phase III clinical studies for HER2-low breast cancer and HER2-positive advanced breast cancer have both successfully completed subject enrollment. Phase III registration studies for its use as first-line therapy and neoadjuvant therapy of HER2-positive breast cancer, as well as for multiple indications including colorectal cancer and bile duct cancer, are accelerating patient enrollment nationwide. 

 

In 2025, TQB2102 was successively granted Breakthrough Therapy Designation for the neoadjuvant treatment of HER2-positive breast cancer and for advanced colorectal cancer. Chia Tai Tianqing will further accelerate the product's marketing launch to bring novel treatment options to patients sooner. 

 

As a HER2 bispecific dual-epitope ADC with first-in-class (FIC) potential independently developed by Chia Tai Tianqing, TQB2102 achieves a balanced optimization of efficacy and safety mainly through three core technological breakthroughs:

 

● Dual-Epitope Targeting: The antibody component features an asymmetric structural design, simultaneously binding to the ECD II/IV domains of HER2, which significantly enhances tumor selectivity and internalization efficiency, thereby boosting anti-tumor activity; 

 

● Cleavable Linker: An enzyme-cleavable linker is used for efficient cleavage and release of the toxin, preserving the "bystander effect" and expanding the killing range against heterogeneous tumors; 

 

● Optimal DAR Value Control: The drug-to-antibody ratio (DAR) is optimized to 5.8-6.0, paired with a topoisomerase I inhibitor payload to reduce toxicity. 

 

Focusing on the field of breast cancer treatment, Sino Biopharmaceutical has established a layout covering all molecular subtypes, including HER2+, HER2-low, HR+/HER2-, and triple-negative breast cancer (TNBC). In terms of the treatment cycle, it systematically covers the entire spectrum of treatment scenarios from neoadjuvant, first-line, second-line and above, to adjuvant therapy, striving to provide new treatment options for more patients.

 

References:

 

[1] Qingyuan Zhang, et al.Preliminary efficacy and safety of TQB2102 in patients with HER2 positive recurrent/metastatic breast cancer: Results from a phase 1b study.2025 ESMO #538.

 

Declaration:

 

1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes. 

2. The company does not recommend any drugs and/or indications. 

3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific disease diagnosis and treatment information, please follow the advice or guidance of a physician or other healthcare professional. 

 

Forward-Looking Statements:

 

This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expectations of clinical benefits and advantages, commercialization outlook, the likelihood of clinical benefit for patients, and potential commercial opportunities for [TQB2102]. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances.