Positive Phase II Trial Results for Zhejiang Wenda Pharma's NHWD-870 HCl in NUT Carcinoma

SHAOXING, China, Oct. 25, 2026 /CourierPR/ -- At the 2026 European Society for Medical Oncology (ESMO) Annual Meeting, Zhejiang Wenda Pharmaceutical Technology Co., Ltd. announced positive results from a phase II clinical trial of its oral BET inhibitor, NHWD-870 HCl, in patients with advanced NUT carcinoma (NC). The trial involved 40 patients, all of whom received the drug in a 5-days-on/2-days-off schedule in 28-day cycles until disease progression or intolerable adverse events.

The primary endpoint of the study was the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. As of 27 December 2025, the mean age of the enrolled patients was 42.2 years, with 62.5% being male. According to an independent radiologic review committee, the ORR was 30.0% (12 out of 40 patients), and the disease control rate (DCR) was 47.5% (19 out of 40 patients). The median PFS and OS were 2.76 and 9.33 months, respectively.

In the subgroup of 20 patients with primary thoracic tumors, the ORR was 45.0% (9 out of 20 patients). The most common treatment-related adverse events (TRAEs) included decreased platelet count (55.0%), hypertriglyceridemia (55.0%), increased blood bilirubin (47.5%), and anemia (47.5%). Notably, no treatment-related deaths occurred.

These findings support further clinical investigation of NHWD-870 HCl in advanced NC, a rare, highly aggressive malignancy defined by NUTM1 rearrangements. NUT carcinoma progresses rapidly, with a median survival of only about 6.7 months, and predominantly occurs in the lungs or head & neck regions, with a median age of onset as low as 23.6 years. Due to its nonspecific clinical manifestations and limited public awareness, misdiagnoses are common, and most patients are diagnosed at an advanced stage.

NHWD-870 HCl is a novel oral BET inhibitor developed by Wenda Pharma. Its mechanism of action involves competitively binding to the bromodomains (BD1, BD2) of BRD4 or BRD3, causing the dissociation of BRD4/3 from the MYC enhancer, thereby down-regulating the expression of the MYC gene, inhibiting related tumor-promoting transcription factors, and subsequently suppressing cancer cell proliferation. Based on these positive phase II results, the China National Medical Products Administration (NMPA) had officially granted breakthrough therapy designation (BTD) to NHWD-870 HCl on May 9, 2026, for advanced thoracic NUT carcinoma that has failed previous chemotherapy. This landmark progress has brought new hope for targeted therapy to patients with NUT carcinoma, a tumor characterized by extremely high malignancy and poor prognosis.

Founded in 2013 and headquartered in Shaoxing City, China, Wenda Pharma focuses on innovative drug discovery in oncology, immunology, and neurodegenerative diseases. The company's pipeline includes multiple candidates in Phase I-III trials, with NHWD-870 HCl holding potential to become a "first-in-class" oral BET inhibitor for NUT carcinoma. WD-910 (neurodegenerative diseases) is poised for Phase II trials, while WD-890 TYK2/JAK1 inhibitor for plaque psoriasis has completed Phase III enrollment, and SLE Phase II initiated.