Shaoxing, ChinaMay 9, 2026 /PRNewswire/ — Recently, the novel oral BET inhibitor NHWD-870 HCl, independently developed by Zhejiang Wenda Pharmaceutical Technology Co., Ltd., has officially received Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA). The proposed indication is for the treatment of advanced thoracic NUT carcinoma in patients who have failed prior chemotherapy. This milestone progress brings new hope for targeted therapy to patients with NUT carcinoma, a highly malignant cancer with an extremely poor prognosis.
NUT carcinoma is a rare, poorly differentiated cancer characterized by NUTM1 gene rearrangement. The disease progresses rapidly, with a median overall survival of only approximately 6.5 months. It predominantly occurs in the lungs and head and neck regions, with a median age of onset of just 23.6 years. Due to the lack of specific clinical manifestations and limited public awareness, misdiagnosis and underdiagnosis rates are extremely high, and most patients are already in advanced stages at the time of diagnosis. Currently, there are no effective targeted drugs approved globally for NUT carcinoma, making the treatment landscape extremely challenging.
The Breakthrough Therapy Designation for NHWD-870 HCl is primarily based on the significant efficacy and survival benefits demonstrated in its Phase II clinical study. As of December 27, 2025, the study had enrolled 40 evaluable patients with advanced NUT carcinoma. Data showed that the drug exhibited positive anti-tumor activity across different lesion sites: among 20 patients with advanced thoracic NUT carcinoma, the objective response rate (ORR) reached 45.00%; the median overall survival (mOS) for patients with advanced thoracic NUT carcinoma and the overall study population both reached 9.33 months, representing a significant extension compared to traditional chemotherapy regimens. Currently, some patients continue to receive treatment and undergo close follow-up. Additionally, preliminary safety data indicate that the drug is generally well-tolerated, demonstrating strong potential for clinical application.
The Breakthrough Therapy Designation holds significant importance for NUT carcinoma patients, marking a transformative advancement in this field. For patients, it will accelerate the approval process of NHWD-870 HCl, enabling earlier market availability and allowing advanced NUT carcinoma patients to access targeted therapy sooner, freeing them from the predicament of “no available treatment,” thereby significantly extending survival and improving quality of life. From a clinical perspective, the development and designation of this drug fill a gap in targeted therapy for NUT carcinoma, providing clinicians with a new treatment option. This not only drives the transition of NUT carcinoma treatment from “symptom-based therapy” to “precision targeted therapy” but also offers valuable clinical experience for the development of similar drugs in the future.
Mr. Wang Nenghui, founder of Wenda Pharmaceutical, stated: “We are delighted that our product has received Breakthrough Therapy Designation. This progress highlights the enhancement of China’s capabilities in innovative drug development for rare cancers. NHWD-870 not only brings hope to NUT carcinoma patients but also provides new insights for exploring treatments for other rare cancers.”
Professor Yin Mingzhu, Director of the Midline (NUT) Carcinoma Specialist Department at Chongqing University Three Gorges Hospital, noted: “NUT carcinoma once plunged countless patients and doctors into despair. The Breakthrough Therapy Designation for NHWD-870 is a significant achievement combining medical research and clinical practice. In the future, with the accelerated market launch of this drug, the treatment landscape for NUT carcinoma is expected to be completely transformed, injecting new momentum into China’s rare disease diagnosis and treatment efforts.”