TWi Biotechnology announced on the 17th that it has completed patient enrollment for the U.S. Phase II clinical trial of its oral drug candidate NORA520, developed for the treatment of Postpartum Depression (PPD). A total of 93 participants were enrolled in the study, and full efficacy data analysis will begin once the treatment period concludes. The company expects to release the top-line results in the fourth quarter of 2025.

According to TWi Biotechnology, NORA520 is a new drug asset obtained through its merger with DuKang Pharmaceuticals. The drug is designed as a prodrug-based oral formulation, developed to treat two major indications — Postpartum Depression and Major Depressive Disorder (MDD).

The merger between TWi Biotechnology and DuKang Pharmaceuticals is scheduled to be completed by September 30, 2025. TWi Biotechnology will issue 96 million new shares to DuKang Pharmaceuticals, increasing its paid-in capital from NT$1.076 billion to NT$2.036 billion. Through this merger, TWi Biotechnology’s R&D portfolio will expand from its current focus on rare diseases and inflammatory skin disorders to include Central Nervous System (CNS) therapeutics, enhancing the company’s research diversity and overall product value.

With the ongoing progress in clinical development and the expansion of its therapeutic areas, TWi Biotechnology stated that it plans to accelerate global licensing and international collaboration efforts, expressing strong optimism about the company’s future business outlook.

Resource: 安成生技產後憂鬱症新藥完成美國二期臨床收案 Q4公布解盲數據