TaiMed Biologics CEO Jin-Mei Chang said on August 22 that the company is focused on three major growth drivers: rising sales of Trogarzo and expanding CDMO revenues, accelerated Phase II clinical development and licensing of its next-generation HIV therapies TMB-365/TMB-380, and advances in its antibody-drug conjugate (ADC) platform. He projected that 2026 will mark a turning point for the company’s operations.
Chang noted that Trogarzo’s commercial partner Theratechnologies (TH) is expected to complete its sale at a premium of 110% in the fourth quarter. With support from new partners, Trogarzo sales are projected to strengthen next year.
TaiMed is also advancing into new markets. In Taiwan, sales will be handled by YungShin Group, which filed a drug application last year; launch is expected in 2025. Applications have also been initiated in Sri Lanka, the Middle East, and Vietnam. Macau distribution is targeted for late 2024 or early 2025, while regulatory approval in the Middle East is expected in the second half of 2025.
On the manufacturing side, TaiMed’s CDMO business has begun to show contributions. This year, it completed production for a Taiwan-based client, and larger-scale production for a U.S. client is expected in 2025, with many of those programs already entering Phase II clinical trials.
The company’s most closely watched assets, TMB-365/380, are progressing rapidly. In the fourth quarter, TaiMed plans to apply to the U.S. FDA for Breakthrough Therapy Designation. The Phase IIb clinical trial application has already been filed, covering 20 sites across North America and Taiwan, targeting enrollment of 75 patients for 12 months of treatment. Enrollment will begin in the second half of 2024, with completion expected in the second half of 2025.
Chang emphasized that long-acting HIV therapies are becoming the dominant trend, giving TMB-365/380 strong prospects. TaiMed has engaged a consulting firm to lead licensing discussions, with the assessment that the drug has the potential to become a blockbuster therapy exceeding US$1 billion in annual sales. A licensing deal or co-development partnership with a global pharma company could be finalized within one to two years.
To further expand the applications of TMB-365, TaiMed is also advancing its ADC platform built on the antibody. The program targets two key areas: HIV treatment and autoimmune diseases. By linking the antibody with a small-molecule drug, the technology allows precise delivery into immune cells, reducing dosage and side effects while enhancing efficacy. The company will present the platform at a U.S. medical conference in October 2024, initiate animal studies in 2025, and aims to begin human clinical trials in 2027.
Resource: 中裕三大動能驅動成長 執行長：2026年營運大轉骨
