Wenda Pharma Secures Breakthrough Therapy Recognition for NHWD-870 HCI

China’s National Medical Products Administration has granted Zhejiang Wenda Pharmaceutical Technology Co., Ltd. Breakthrough Therapy Designation for NHWD-870 HCI.

An investigational oral BET inhibitor developed for advanced thoracic NUT carcinoma patients who have previously undergone chemotherapy treatment.

NUT carcinoma is an uncommon and rapidly progressing cancer linked to alterations in the NUTM1 gene.

Due to its aggressive nature and lack of distinct early symptoms, the disease is frequently identified at later stages, leaving patients with limited therapeutic options. No targeted treatment has yet received global approval specifically for this indication.

The designation follows encouraging Phase II clinical results involving 40 patients with advanced NUT carcinoma.

Among individuals with thoracic disease, the therapy reported a 45% objective response rate and a median overall survival of 9.33 months, suggesting meaningful clinical benefit compared with existing chemotherapy-based care.

Researchers also observed an acceptable tolerability profile during the study.

The regulatory recognition may help accelerate the therapy’s development and review process, supporting faster access to innovative treatment approaches for patients with rare and difficult-to-treat c