SBP GROUP (01177.HK): NDA for TQB2102 "HER2 Bispecific ADC" Accepted for Review

NewTimeSpace · 2026/09/16 07:38 · By Jiayi Sun

On 16 September 2026, SBP GROUP (01177.HK) announced that the NDA for TQB2102 injection (a HER2 biparatopic bispecific ADC), a National Class 1 innovative drug independently developed by its subsidiary Chia Tai Tianqing, has been accepted for review by the CDE, for HER2-low breast cancer in adults.

Key Highlights:

The TQB2102-III-01 study enrolled 543 patients with HER2-low breast cancer, and met the pre-specified primary endpoint and key secondary endpoints at the interim analysis as assessed by the independent data monitoring committee.
The antibody arms of TQB2102 use an asymmetric structural design that can simultaneously bind the ECD II and ECD IV domains of HER2; the drug-to-antibody ratio is optimised to approximately 5.8 to 6.0, with a topoisomerase I inhibitor payload.
TQB2102 has secured two regional licensing collaborations, bringing the Group approximately USD 30 million in upfront and milestone payments in aggregate.

NewTimeSpace (newtimespace.com) News: On 16 September 2026, Sino Biopharmaceutical Limited (stock code: 01177) announced that the new drug application for TQB2102 injection (a HER2 biparatopic bispecific ADC), a National Class 1 innovative drug independently developed by the Group's subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has been submitted to and accepted for review by the Center for Drug Evaluation (CDE) of 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 chemotherapy in the recurrent or metastatic setting. The indication had previously been granted Breakthrough Therapy Designation by the CDE.

TQB2102 is the world's first HER2 biparatopic bispecific ADC to achieve positive Phase III clinical results in HER2-low breast cancer. The TQB2102-III-01 study is a randomised, open-label, active-controlled, multicentre Phase III clinical study. Based on the assessment of the independent data monitoring committee, the study met the pre-specified primary endpoint and key secondary endpoints at the interim analysis; compared with investigator-selected chemotherapy, TQB2102 significantly reduced the risk of disease progression or death, with the primary endpoint of progression-free survival showing a statistically significant and clinically meaningful improvement.

The drug is being advanced in multiple Phase III clinical studies covering different HER2 expression levels and tumour types, including HER2-low breast cancer, neoadjuvant and advanced treatment of HER2-positive breast cancer, and later-line treatment of HER2-positive biliary tract cancer and colorectal cancer, with three indications already granted Breakthrough Therapy Designation by the CDE. In August 2026, the Group entered into an exclusive licensing and supply agreement with Cipla Limited for TQB2102, granting Cipla exclusive rights to develop and commercialise the drug in India, South Africa and five other emerging markets.

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