The new drug group is expected to report good news in the fourth quarter. In the past, it was difficult to obtain a drug certificate for new drugs, and it was not easy to obtain one in a year or a few years. However, in the fourth quarter of this year, in addition to TaiMed Biologics' Trogarzo, which was marketed by the US FDA in early October, four companies, including EirGenix, Medigen, PTS and Handa, have also entered the licensing stage, setting a new record for annual drug certificates in Taiwan's biotechnology history. The new drug industry is gradually coming to fruition.

As a result of the drug license, EirGenix will have the opportunity to recognise US$27 million (over NT$830 million) in milestone payments from its exclusive licensing partner Sandoz, contributing to EPS of approximately NT$2.60; Chung Yu will also receive US$3 million in R&D milestone payments over two years as a result of the drug license, driving significant growth in operating profit.

In addition to the five companies that have made clear progress in obtaining drug licenses, including TaiMed, EirGenix, Medigen, PTS and Handa, which will fall in the fourth quarter of this year and the first quarter of next year, the Chinese drug license for Unity's new sugar foot ulcer drug has also entered a critical phase. In addition, the Chinese drug license for Bifid is expected to be filed in the fourth quarter, and the US drug license for Taifu's biosimilar will be obtained in the first half of next year.

In terms of clinical progress, Belite's new leukaemia drug, LBS-007, will commence Phase I/II trials in Australia, while Phase II/III trials of LBS-007, a new drug for dry macular degeneration (AMD), will commence and are expected to be completed within two years.

BRIM's BRM421, a new regenerative peptide therapy, will not only revolutionise the current treatment of dry eye, but will also allow Taiwan's original drug to be seen by the world.

In addition, Advagene has developed a neo-coronary aerosol vaccine, AD17002, which focuses on "prophylactic dosing for high-risk contacts of neo-coronary pneumonia" and has recently submitted an application to the CDE for consultation and is expected to apply for clinical trials of the new drug in Phase II/III this year.

OBI's first freeze-dried dosage form will be submitted to the WHO's CEPI (Consortium for Epidemic Prevention Innovation) for clinical sponsorship, and will not rule out seeking strategic partners for collaboration or licensing. 

In addition to the new drug launches, many of phamaceutical companies are expected to reach new annual highs, including Handa's new multiple sclerosis drug HND-020, a Medigen enterovirus 71 vaccine and a similar drug for breast cancer from EirGenix.

The biotechnology industry, which has been enjoying a lot of benefits, is expected to benefit from the topic of drug certification, and the medical technology exhibition will be held on December 1, which is expected to make BIO+ICT a topic of discussion.

The Medigen enterovirus 71 vaccine, which is the first in the world to cover high-risk infants aged two months to six months, will also be registered for testing in Vietnam, Thailand, Malaysia and other ASEAN countries before the end of the year. The annual market opportunity for the vaccine is over $1 billion in Taiwan and $20-30 billion in ASEAN.

HND-020, a new drug for the treatment of multiple sclerosis, is a modification of Novartis' drug Gilenya, from a capsule to an easy-to-swallow, non-bitter and better-settled orally-dissolving lozenge that can be easily taken by patients.

In addition, TaiMed, which was awarded the new Trogarzo intravenous dosage form for AIDS in early October, will receive US$3 million in research and development mileage over two years under an agreement with its licensing partner Theratechnologies (TH), but due to unfavourable marketing in Europe, TH has terminated sales in Europe with Centrum, retaining only the US and Canadian markets.

It is understood that TaiMed has been actively seeking strategic sales partners in Europe and will not rule out cooperation with major international pharmaceutical companies. In addition, the most talked about intramuscular injection (IM) dosage form is expected to be submitted to the US FDA for marketing and registration (sBLA) of new biologics in the first half of next year after the clinical phase III trial is completed this year, which will inject new growth momentum into the industry.