TWi Biotechnology Announces Merger with Dukang Pharmaceuticals: Unlocking Synergies, Integrating Resources, Expanding Pipeline, and Enhancing Shareholder Value

TWi Biotechnology, Inc. (TWi Biotechnology, Ticker: 6610) today announced that its Board of Directors has approved a resolution to merge with Dukang Pharmaceuticals Inc. through a share swap, with TWi Biotechnology remaining as the surviving entity. The proposed merger remains subject to approval by shareholders of both companies. TWi Biotechnology will convene its Annual General Meeting on June 6, 2025, to vote on the merger. Regulatory filings will follow shareholder approval. The effective date of the merger is tentatively set for September 30, 2025. 

Both TWi Biotechnology and Dukang Pharmaceuticals are clinical-stage pharmaceutical companies focused on the developing new drugs through the 505(b)(2) regulatory pathway. By improving existing drugs or developing new indications, both companies aim to address unmet medical needs through safer, more efficient, and accelerated drug development strategies. 

Under the terms of the merger agreement, TWi Biotechnology will issue new shares to exchange for all outstanding shares of Dukang Pharmaceuticals at a 1:1 exchange ratio. Upon completion of the merger, TWi Biotechnology’s paid-in capital will increase from NT$876 million to NT$1.836 billion.

TWi Biotechnology believes the merger will deliver multiple benefits including expanding its pipeline of innovative drug candidates, entering new therapeutic areas, enhancing R&D capabilities, consolidating clinical and regulatory resources, and creating operational synergies, ultimately strengthening competitiveness and increasing enterprise value.

TWi Biotechnology’s flagship drug asset, AC-203, is a topical formulation of 1% diacerein being developed for the treatment of Epidermolysis Bullosa Simplex (EBS). EBS is a rare genetic skin disease caused by genetic mutations, resulting in fragile epidermal cells that lead to skin blisters and superficial wounds. There are currently no approved drugs to reduce blister formation in EBS. An international, multicenter, randomized, double-blind, vehicle-controlled, phase 2/3 study with open-label extension study, referred to as the EBShield Study, is currently ongoing across multiple countries.

Dukang Pharmaceuticals specializes in developing treatments for central nervous system diseases. Its lead asset, NORA520, is an innovative oral prodrug of Brexanolone designed for the treatment of postpartum depression (PPD) and major depressive disorder (MDD), each targeting a rapidly growing patient population with unmet medical needs. NORA520 offers convenient oral administration with a pharmacokinetic profile comparable to its reference drug, Zulresso, while improving patient compliance. Phase 1 clinical trials in healthy subjects have demonstrated a strong safety profile with no severe adverse effects. A double-blind, vehicle-controlled Phase 2 trial in PPD patients is currently underway in the U.S., and a Phase 2 trial for MDD patients will kick-start in the US in the coming months.

Dr. Chih-Ming Chen, Chairman of Dukang Pharmaceuticals and the controlling shareholder of both companies, commented: “Both TWi Biotechnology and Dukang Pharmaceuticals are small biotech companies rooted in Taiwan with a global vision. This merger reflects our shared mission, strategic alignment, and commitment to resource integration. It will enable us to build a stronger platform, attract international talent, expand our market presence, and elevate our position in both the pharmaceutical landscape and capital markets.”

Jessica Wu, Chairperson of TWi Biotechnology, added: “The two companies complement each other—one focused on rare dermatological diseases and the other on neuropsychiatric disorders—both addressing areas with substantial unmet medical needs. This merger enables us to expand our pipeline, create operational synergies, and diversify risks, ultimately enhancing shareholder value.”

Following the completion of the merger, TWi Biotechnology will accelerate the development and commercialization of innovative drugs in its expanded pipeline. With the consolidation of the two companies, the benefits of the merger are expected to materialize progressively, driving the company’s future growth.

About TWi Biotechnology:

TWi Biotechnology, Inc. is a clinical-stage biopharmaceutical company based in Taipei, Taiwan, specializing in developing innovative therapies through drug repurposing strategies for dermatological and rare diseases with significant unmet medical needs. Established in 2010 by renowned scientist-turned entrepreneur Dr. Chih-Ming Chen, the company presently has two core drug development programs:

AC-203: a topical formulation of 1% diacerein being developed for EBS, a rare genetic skin disorder with no approved therapeutic treatments. Early clinical trials demonstrated significant reduction of blisters among patients with severe EBS. An international, multicenter, randomized, double-blind, vehicle-controlled, phase 2/3 study with open-label extension study, referred to as the EBShield Study, is currently underway. AC-203 has received Orphan Drug Designation in the US, EU and Taiwan, as well as Rare Pediatric Disease and Fast Track Designations from the US FDA.

AC-1101: a propriety topical gel formulation of Tofacitinib Citrate, a JAK inhibitor, for inflammatory skin diseases including Granuloma Annulare (GA), a rare, chronic skin disease with no approved treatments. A Phase 1b clinical study on GA in the US was completed in 2024, which demonstrated good safety and tolerability, minimal systemic exposure, and potential efficacy trends. An application for Orphan Drug Designation is awaiting US FDA’s decision.

TWi Biotechnology’s shares are traded on Taiwan's Emerging Stock Market with a market capitalization of approximately USD 35 million. Dr. Chih-Ming Chen owns approximately 50% of the company’s shares.

Disclaimer:

This press release contains forward-looking statements based on current expectations and assumptions. Actual results may differ due to risks and uncertainties, including market conditions and other factors beyond the company’s control. TWi Biotechnology does not undertake to update these forward-looking statements, unless legally required.

Contact:

Ruth Yang, Chief Financial Officer 

Phone: +886-2-26571788 ext. 600 

Email: ruth.yang@twibiotech.com