TAIPEI, July 08, 2026. Taiwan’s drug regulator has told TaiMed Biologics (TPEX: 4147) that the license for its HIV therapy Trogarzo (ibalizumab; Chinese name: 佐加洛注射劑) is ready for pickup.
The Taiwan Food and Drug Administration issued what is known as a Drug License Collection Notice, and Orient EuroPharma Co., Ltd. (TPEX: 4120), the partner handling the drug’s commercial rollout, will now go through the formal steps to collect it. Once that paperwork wraps up, nothing stands between Trogarzo and its debut on the Taiwan market.
What The Notice Means
The TFDA had already sent TaiMed an approval letter back in June, signing off on the drug’s English and Chinese names and confirming what it can be prescribed for. The collection notice goes a step further: it means regulators have finished their review entirely.
After Orient EuroPharma picks up the license and finishes its launch preparations, patients in Taiwan fighting multidrug-resistant HIV-1 will have a treatment option they didn’t have before.
Why Trogarzo Stands Out
No other approved HIV drug in the world works the way Trogarzo does. It is the only monoclonal antibody on the market that targets the CD4 receptor.
Doctors prescribe it together with other antiretroviral drugs for adults whose HIV-1 has stopped responding to their current medications after years of prior treatment.
In the United States, the FDA has approved it in two forms, a standard intravenous infusion and a faster IV push. TaiMed is also working on getting the drug registered in more countries.
The Deal Behind The Launch
The two companies teamed up in May 2024, when TaiMed granted Orient EuroPharma exclusive rights to register, market, and sell Trogarzo in Taiwan. TaiMed’s job is keeping the product supplied.
Orient EuroPharma knows the infectious disease and specialty drug space well and has longstanding relationships with hospitals across Taiwan, which should help get the therapy into clinics and in front of the patients who need it without delay.
A Small Market That Pays The Bills
Trogarzo serves a narrow group of patients, those who have run out of standard treatment options, so the salvage-therapy market it competes in is modest by design.
Even so, the drug’s unusual clinical profile has carved out a dependable revenue stream. That steady income helped push TaiMed into the black in the first quarter of this year, its first profitable quarter, which the company credits to how it has managed Trogarzo’s commercial strategy and overseas expansion.
What Comes Next: TMB-365/380
The bigger prize in TaiMed’s pipeline is TMB-365/380, a long-acting therapy built from two broadly neutralizing antibodies. The last patient entered its Phase 2b trial in May 2026, and interim results should land before the year ends.
The regimen only needs to be given once every two months. If it works as hoped, it would be the first long-acting HIV antibody treatment that patients could start without first being screened for viral susceptibility, opening the door to the far larger market of people on first-line maintenance therapy.
TaiMed pegs peak worldwide sales at somewhere between US$3 billion and US$4 billion a year. Depending on how the data and regulatory discussions go, the company intends to ask the U.S. FDA for Breakthrough Therapy Designation and is exploring licensing deals and commercial partnerships around the world.
From The CEO
Dr. Jimmy Chang, who leads TaiMed Biologics, called the notice further proof that the company’s years of R&D work are paying off, pointing to its three-part playbook of innovation, manufacturing, and commercialization. He said the plan from here is to push Trogarzo into more international markets, keep TMB-365/380 moving through global development, and build TaiMed into a worldwide leader in HIV innovation that delivers lasting value for shareholders.
About TaiMed Biologics
TaiMed Biologics (4147.TWO) has been developing HIV treatments since its founding in 2007. The company brought ibalizumab (Trogarzo) to market as the first and only FDA-approved monoclonal antibody for HIV and is now developing TMB-365/380 as its lead candidate for long-acting maintenance therapy. It also runs a contract development and manufacturing (CDMO) business. TaiMed shares have traded on the OTC market since November 2015, and the stock is included in the MSCI Small Cap Index.
Forward-Looking Statements
This press release contains forward-looking statements, including projections about clinical timelines, regulatory submissions, commercial potential, and partnering discussions for TMB-365/380.
Such statements carry known and unknown risks and uncertainties that could cause actual results to differ materially, among them clinical trial outcomes, regulatory decisions, competitive dynamics, and market conditions. TaiMed Biologics undertakes no obligation to update forward-looking statements except as required by applicable law.
