Chinese drug discovery company Zhejiang Wenda Pharmaceutical Technology Co Ltd announced on Friday that its novel oral BET inhibitor NHWD-870 HCI has received Breakthrough Therapy Designation from China's National Medical Products Administration (NMPA) for the proposed indication of advanced thoracic midline (NUT) carcinoma in patients who have failed prior chemotherapy.
NUT carcinoma is a disease with extremely high malignancy and a very poor prognosis.
The granting of Breakthrough Therapy Designation to NHWD-870 HCI is primarily based on the significant efficacy and survival benefits demonstrated in a Phase II clinical study. As of 27 December 2025, a total of 40 evaluable subjects with advanced NUT carcinoma were enrolled in the study and data shows that the drug exhibited positive anti-tumour activity across different lesion sites.
The objective response rate in 20 patients with advanced thoracic NUT carcinoma reached 45% and the median overall survival for advanced thoracic NUT carcinoma patients and for all subjects both reached 9.33 months, representing a significant extension compared with standard chemotherapy regimens. Currently, some patients are still receiving ongoing treatment and close follow-up. Preliminary safety data showed that the drug was generally well tolerated and held high potential for clinical application.
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