China's NHWD-870 Receives Breakthrough Therapy Designation for Rare NUT Carcinoma

NHWD-870 HCI, a novel oral BET inhibitor developed by Zhejiang Wenda Pharmaceutical Technology Co., Ltd., received Breakthrough Therapy Designation from China NMPA for advanced thoracic NUT carcinoma after failed chemotherapy. Phase II results showed 45.00% objective response rate in 20 patients and median overall survival of 9.33 months, compared to 6.5 months historical median. No targeted drug for NUT carcinoma has been approved globally as of May 10, 2026.

NUT carcinoma characteristics

• ▪NUT carcinoma has a median survival of approximately 6.5 months.
• ▪The median age of onset for NUT carcinoma is 23.6 years.
• ▪NUT carcinoma commonly occurs in the lungs, head, and neck regions.
• ▪NUT carcinoma is a rare, poorly differentiated carcinoma characterized by NUTM1 gene rearrangement.

NHWD-870 breakthrough designation

• ▪No effective targeted drug for NUT carcinoma has been approved globally as of May 10, 2026.
• ▪NHWD-870 HCI is a novel oral BET inhibitor independently developed by Zhejiang Wenda Pharmaceutical Technology Co., Ltd.
• ▪NHWD-870 HCI received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for advanced thoracic midline (NUT) carcinoma in patients who have failed prior chemotherapy.

Phase II clinical trial results

• ▪The objective response rate (ORR) in 20 patients with advanced thoracic NUT carcinoma treated with NHWD-870 HCI reached 45.00%.
• ▪As of December 27, 2025, 40 evaluable subjects with advanced NUT carcinoma were enrolled in the NHWD-870 HCI Phase II clinical study.
• ▪The median overall survival (mOS) for advanced thoracic NUT carcinoma patients treated with NHWD-870 HCI reached 9.33 months.
• ▪NHWD-870 HCI was generally well tolerated in preliminary safety data from the Phase II clinical study.

Treatment landscape impact

• ▪NHWD-870 HCI drives the transformation of NUT carcinoma treatment from symptomatic treatment to precision targeted therapy.
• ▪The Breakthrough Therapy Designation for NHWD-870 HCI will accelerate the regulatory review process and enable the drug to reach the market sooner.
• ▪The development and designation of NHWD-870 HCI fill the gap in targeted treatment for NUT carcinoma.

Wenda Pharma pipeline

• ▪WD-910 completed Phase I clinical trial in Australia.
• ▪WD-890 TYK2 (JH2) inhibitor indicated for moderate-to-severe plaque psoriasis has entered Phase III clinical trials.
• ▪Zhejiang Wenda Pharmaceutical Technology Co., Ltd. focuses its research in the areas of oncology, immunology, and neurodegenerative diseases.
• ▪WD-910 targeting neurodegenerative diseases is poised to enter Phase II clinical trials in China.
• ▪Zhejiang Wenda Pharmaceutical Technology Co., Ltd. was founded in 2013 and is headquartered in Shaoxing City, China.
• ▪NHWD-870 has successfully completed Phase II clinical trials.

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