The share swap merger between Evince (1799-TW) and GenAI (4130-TW) has been approved by regulatory authorities and was officially completed today (28). As a result, GenAI has been delisted and become a 100% owned subsidiary of Evince, marking a critical milestone as the 'Taiwan-U.S. Integrated Pharmaceutical Platform' transitions from planning to substantive operations.

Evince announced that Lin Han-Fei will assume the role of Chairman of GenAI, and Wu Chih-Yung, former CEO of Sinochem Group, has been appointed as the new General Manager to accelerate the integration of R&D, manufacturing, and market resources between the two companies.

Evince emphasized that the integration aims to build a comprehensive Taiwan-U.S. pharmaceutical value chain. Through its U.S. subsidiary, Tulex Pharmaceuticals, which operates a cGMP-compliant manufacturing facility in New Jersey, Evince has secured 11 U.S. FDA drug approvals, including three 505(b)(2)改良型新薬 and eight complex generic drugs, demonstrating full capabilities from R&D and regulatory affairs to manufacturing and commercialization.

GenAI, on the other hand, has deep expertise in local R&D and manufacturing in Taiwan, with experience in drug development under Asian clinical regulations, and has long provided CDMO services to international pharmaceutical companies. Evince stated that the combination enables seamless integration across R&D, manufacturing, and market access, forming a highly complementary cross-regional industrial structure.

Following the merger, the company will further integrate GenAI’s resources and capabilities in new drug development, generics, and various formulation technologies, expanding investments in new drugs, complex generics, and high-barrier-to-entry dosage forms.

In terms of R&D momentum, the jointly developed TLX-041 (a 505(b)(2) liquid oral desmopressin for treating diabetes insipidus) obtained FDA approval and launched in the U.S. market in the first quarter of this year. Currently, over 10 pipeline products are under development, covering 505(b)(2) and high-technology barrier projects such as central nervous system drugs and injectables. One new drug candidate has completed Phase 2a clinical trials with positive results.

Additionally, Evince Biomed has initiated collaborative development of high-barrier injectable products and aims to extend its portfolio into long-acting injectables (LAI) and other advanced formulation technologies, continuously deepening and differentiating its product pipeline.

Regarding recent U.S. tariff policies, Evince stated that its FDA cGMP-compliant manufacturing base in New Jersey enables it to offer international partners flexible and cost-controlled U.S.-based manufacturing solutions. This strengthens its competitive advantage in securing international CDMO and product collaboration projects and is expected to become a new growth driver over the next three to five years.

FACT BOX

  • Source: PR Times
  • Category: Partnership
  • Organizations: Tulex Pharmaceuticals