CTTQ’s HER2 Bispecific ADC TQB2102 Hits Phase 3 Endpoints in HER2-Low Breast Cancer, Setting Up China Filing
Chia Tai Tianqing Pharmaceutical Group (CTTQ), a core subsidiary of Sino Biopharmaceutical, has reported a major late-stage clinical win for TQB2102 (rolditamig deuderuxtecan), its internally developed HER2 bispecific antibody-drug conjugate (ADC). The drug met the prespecified primary endpoint and key secondary endpoint(s) at an interim analysis of a Phase 3 trial in patients with HER2-low relapsed or metastatic breast cancer.
The positive readout comes just days after CTTQ entered into an exclusive licensing agreement with Cipla for TQB2102 across India, South Africa and five additional emerging markets, highlighting the growing international ambitions surrounding the Chinese-developed ADC.
Phase 3 TQB2102-III-01 Trial Meets Endpoints
According to a September 2 report from Xinhua News Agency, the Phase 3 TQB2102-III-01 study completed its protocol-specified interim analysis, with an Independent Data Monitoring Committee (IDMC) determining that the study had achieved its prespecified primary endpoint as well as key secondary endpoint(s).
TQB2102-III-01 is a randomized, open-label, active-controlled, multicenter Phase 3 study evaluating TQB2102 against investigator’s choice of chemotherapy in patients with HER2-low relapsed or metastatic breast cancer.
A total of 543 patients were enrolled.
The study’s primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC).
At the interim analysis, TQB2102 significantly reduced the risk of disease progression or death compared with investigator-selected chemotherapy, producing an improvement in PFS that CTTQ described as both statistically significant and clinically meaningful.
The company has not yet disclosed the hazard ratio, median PFS, confidence intervals or detailed safety findings. Full results are expected to be presented at a future international medical conference.
The result represents an important milestone for TQB2102 and supports the potential of dual-epitope HER2 targeting in tumors with relatively low levels of HER2 expression.
China Marketing Application Could Come Soon
Perhaps even more important from a regulatory perspective, CTTQ said it has received written agreement from China’s Center for Drug Evaluation (CDE) supporting submission of a marketing application for TQB2102 in this indication.
The company plans to submit the application shortly.
If ultimately approved by China’s National Medical Products Administration (NMPA), TQB2102 could become an important new treatment option for patients with HER2-low advanced breast cancer and would mark the first commercial approval for CTTQ’s ADC pipeline.
TQB2102 is CTTQ’s first ADC candidate and has emerged as one of Sino Biopharmaceutical’s most important internally developed oncology assets.
What Is TQB2102?
TQB2102, now also known as rolditamig deuderuxtecan, is a next-generation HER2 dual-epitope bispecific ADC developed by CTTQ.
Unlike conventional HER2 antibodies that bind a single HER2 epitope, TQB2102 is designed to simultaneously target the ECD II and ECD IV extracellular domains of HER2.
The ADC incorporates a cleavable linker and a topoisomerase I inhibitor payload.
According to Sino Biopharmaceutical, the dual-epitope design is intended to increase receptor cross-linking and internalization, potentially improving delivery of the cytotoxic payload into tumor cells, including cancers expressing relatively low levels of HER2.
This could be particularly relevant in HER2-low breast cancer, where the lower density of HER2 on tumor cells presents a challenge for traditional HER2-targeted therapies.
Earlier Clinical Data Provided Encouraging Signal
The Phase 3 success follows encouraging early-stage results for TQB2102.
At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, CTTQ/Sino Biopharmaceutical presented Phase 1b data in heavily pretreated patients with HER2-low advanced breast cancer.
According to Sino Biopharmaceutical, TQB2102 produced an objective response rate (ORR) of 53.4% (39/73) in this population.
Patients had received a median of four previous systemic treatment lines for advanced disease and a median of two lines of palliative chemotherapy.
Importantly, among patients whose disease had already progressed following prior ADC treatment, 44.4% responded to TQB2102, suggesting potential activity even in some ADC-exposed tumors.
The company also reported a relatively low incidence of interstitial lung disease (ILD) in that early dataset, although the larger Phase 3 safety dataset will be important for determining the drug’s overall benefit-risk profile.
Three CDE Breakthrough Therapy Designations
TQB2102 has also accumulated regulatory recognition in China.
The candidate has received three Breakthrough Therapy Designations from China’s CDE, reflecting its development across multiple HER2-expressing tumor settings.
Beyond the newly successful Phase 3 study in HER2-low relapsed/metastatic breast cancer, CTTQ is pursuing a broad development program that includes:
- HER2-low advanced breast cancer without prior chemotherapy for recurrent/metastatic disease;
- HER2-positive advanced breast cancer following failure of anti-HER2 therapy;
- neoadjuvant treatment of HER2-positive breast cancer;
- first-line HER2-positive advanced breast cancer;
- later-line HER2-positive advanced biliary tract cancer; and
- previously treated HER2-positive advanced colorectal cancer.
CTTQ, for example, announced in April 2026 that it had enrolled the first patient in a Phase 3 study of TQB2102 in HER2-overexpressing advanced colorectal cancer, further illustrating the company’s strategy of developing the ADC across multiple HER2-driven tumors.
Cipla Deal Expands TQB2102 Beyond China
The Phase 3 result arrived almost immediately after a significant international licensing transaction.
On August 31, Cipla and Sino Biopharmaceutical announced that CTTQ had entered into an exclusive license and supply agreement with Cipla covering TQB2102.
Under the agreement announced by Cipla, Cipla receives exclusive rights to develop and commercialize TQB2102 in India, South Africa and five other emerging markets.
Cipla will be responsible for local clinical development, regulatory activities and commercialization within the licensed territories, while CTTQ will retain responsibility for manufacturing and supplying TQB2102.
Financial terms of the transaction were not disclosed in the companies’ official announcement.
The agreement gives TQB2102 access to Cipla’s established regulatory, medical, market-access and commercial infrastructure in several large emerging pharmaceutical markets while allowing CTTQ to retain manufacturing responsibility.
The timing is particularly notable: the licensing transaction was announced immediately before disclosure of the successful Phase 3 interim analysis, meaning Cipla has secured regional rights to an asset that could now be approaching its first regulatory filing.
A Potential New Competitor in the HER2 ADC Market
The success of TQB2102 adds another potentially important competitor to the rapidly expanding HER2-targeted ADC field.
HER2-low breast cancer has become a major focus of ADC development following evidence that tumors previously considered unsuitable for HER2-targeted treatment can respond to sufficiently potent antibody-drug conjugates.
TQB2102 takes the concept a step further by combining dual-epitope HER2 recognition with ADC-mediated payload delivery.
The central question will now be how its efficacy and safety compare with established HER2-directed ADC treatment options.
CTTQ has so far disclosed only the topline conclusion from the Phase 3 interim analysis. The eventual presentation of median PFS, hazard ratio, subgroup outcomes, response rates, duration of response, overall survival trends and adverse-event data will therefore be critical for evaluating TQB2102’s competitive profile.
In particular, investors and clinicians are likely to watch rates of interstitial lung disease/pneumonitis, hematologic toxicity and treatment discontinuation, all of which can influence the clinical positioning of HER2-directed ADCs.
What Comes Next
Three catalysts now stand out for TQB2102.
First, CTTQ plans to submit a Chinese marketing application shortly, following its written communication with the CDE.
Second, detailed results from TQB2102-III-01 are expected to be presented at an upcoming international medical conference, providing the first opportunity to assess the magnitude and consistency of the Phase 3 benefit.
Third, the recent Cipla partnership creates a pathway for expansion into seven emerging markets outside China.
Taken together, the Phase 3 success, imminent Chinese regulatory filing and international licensing agreement represent a significant inflection point for TQB2102 — transforming CTTQ’s first ADC candidate from a promising clinical asset into a potential near-term commercial product with an expanding international footprint.
References
- Xinhua News Agency. “Breast Cancer Precision Treatment Breakthrough: Chia Tai Tianqing HER2 Bispecific ADC Succeeds in Phase III Clinical Trial.” September 2, 2026.
https://www.news.cn/health/20260902/2986d8748588458ab172912ec2bfa495/c.html - Cipla Limited. “Cipla and SBP Group sign exclusive licensing agreement for potential best-in-class HER2 bispecific ADC Rolditamig Deuderuxtecan (TQB2102).” August 31, 2026.
https://www.cipla.com/press-releases-statements/cipla-and-sbp-group-sign-exclusive-licensing-agreement-potential-best - Sino Biopharmaceutical / SBP Group. “SBP Group Reaches Exclusive Licensing Agreement with Cipla, Bringing TQB2102 to 7 High-Growth International Markets.” August 31, 2026.
https://www.en.sbpgroup.com/news-center/dynamic/25029.html - Chia Tai Tianqing Pharmaceutical Group (CTTQ). “TQB2102 Phase III Clinical Trial Enrolls First Patient in HER2-Overexpressing Colorectal Cancer.” April 16, 2026.
https://www.cttq.com/news/579393.htm
