TransThera Sciences gains NMPA nod for Phase II study of BTK inhibitor TT-01488 plus anti-CD20 antibody in mantle cell lymphoma

Bulletin Express07-01 19:25

TransThera Sciences (Stock Name: TRANSTHERA-B) announced that China’s National Medical Products Administration granted approval on 1 July 2026 for a Phase II clinical trial evaluating TT-01488 tablets in combination with an anti-CD20 monoclonal antibody for mantle cell lymphoma (MCL).

The upcoming multi-centre, open-label study will include both dose-finding and dose-expansion cohorts to assess efficacy and safety of the regimen as a potential first-line, chemotherapy-free option for MCL.

TT-01488 is a novel, non-covalent Bruton's tyrosine kinase (BTK) inhibitor with high kinase selectivity. Pre-clinical kinase profiling indicates strong target activity alongside low affinity for EGFR and Tec, a profile expected to mitigate off-target adverse events such as atrial fibrillation and bleeding.

In the completed Phase I trial, 10 efficacy-evaluable patients with non-blastoid MCL achieved a 70.00% objective response rate, comprising four complete responses and three partial responses. TransThera Sciences highlights the potential synergistic effects of combining BTK inhibition with anti-CD20-mediated immune targeting.

Pursuant to Rule 18A.08(3) of the Hong Kong Listing Rules, the company cautions that there is no assurance TT-01488 will ultimately be successfully developed or commercialised.

The voluntary announcement was authorised by Chairman and CEO Dr. Frank Wu and dated 1 July 2026.

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