Andros Pharmaceuticals is ramping up its new drug development in the Year of the Golden Snake. Chairman AE-June Wang announced that the spray-formulation drug APC101, used for alleviating post-herpetic neuralgia, is preparing for its Phase III clinical trial application, while APC201, a foam-formulation drug for treating osteoarthritis pain, will have a complete Phase II data report in the first half of this year. As clinical trials for these new drugs progress, the company is actively seeking international licensing and cooperation opportunities.
Specializing in the development of improved new drugs, Andros Pharmaceuticals focuses on pain management and skin inflammatory diseases. In addition to the approval of LALP cream and LTC Cream as Taiwan's niche generic drugs, the company also has several new drug candidates in the late clinical stages. Furthermore, Andros owns a pharmaceutical manufacturing facility compliant with PICs/GMP standards, which includes production lines for creams, gels, and solution formulations.
Wang noted that compared to developing new drugs with entirely novel ingredients, improved new drugs offer advantages such as shorter development timelines, higher success rates, and lower investment costs. More importantly, these drugs not only contain the same active ingredients as existing marketed drugs but also provide better therapeutic outcomes and lower side effects. In recent years, improved new drugs have accounted for more than half of the new drugs approved by the U.S. FDA each year, becoming a major focus in global drug development.
Andros' proprietary S4 localized high-concentration drug delivery system extends the drug release time in the skin, reduces skin irritation, and lowers systemic drug toxicity. Among the developed drugs, the LALP cream, which has already received regulatory approval, has been successfully licensed to a Hong Kong pharmaceutical company. Additionally, LTC Cream not only became the first generic drug in Taiwan but was also the first topical dermatological drug to pass review and receive a drug license under Taiwan’s new regulations.
Regarding new drugs, APC101 has completed its Phase II clinical trials and will submit its Phase III clinical trial application this year. APC201, which has completed Phase II clinical trials and patient enrollment, is expected to have a full data report in the first half of this year, after which the company will launch a global multi-center Phase III clinical trial and push for global market technology transfer and licensing.
Andros has received approval from the Ministry of Economic Affairs for its technology enterprise, and plans to submit its application for stock listing in 2025 according to the scheduled timeline.
Resource: 竟天2新藥加速臨床試驗 積極尋求國際授權與合作的機會
