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2021.12.29

Lumosa Receives Market Approval for Its Long-Acting Analgesic Injection from Thailand

(Taipei, Taiwan; December 29th, 2021) Lumosa Therapeutics Co., Ltd. (Lumosa; code: 6535.TWO) is pleased to announce today (Dec. 29th) that the Thai Food and Drug Administration (Thai FDA) has approved the Company's LT1001, a long-acting analgesic injection. This is the third market approval for LT1001 after Taiwan and Singapore and will bring stable cash flow to the Company as the commercialization progress continues. Lumosa is striving to achieve market authorization every year for the next three years. The Company is accelerating the preparation of drug registration for Malaysia, China, Korea, Ukraine, and Jordan, while that for Malaysia may be expected in the first half of 2022.

Thailand has the third-largest population in Southeast Asia, which drives the rapid rise of related medical needs. Furthermore, the Thai government has set its eyes to develop the country as an international and ASEAN cross-border "Asian Medical Hub," by promoting the rapid development of the Thai medical market.

An international market research report stated that the Thai pharmaceutical market is expected to grow to US$6.9 billion in 2024. The market value for analgesics is US$120 million in 2021 and is expected to have an annual growth rate of more than 6% by 2025. Because of the highly addictive nature of traditional opiate analgesics, and the possible respiratory inhibition and death they may cause if abused or overdosed, a safer and more effective pain management solution is much needed. Thailand is the largest patented drug market in Southeast Asia, which is an excellent entry point for a safer and less addictive pain management product like LT1001.

LT1001 is the world's first long-acting analgesic that features extended pain relief and is safe and convenient to use. LT1001 has the advantage of being less addictive and can be used in combination with other anesthetics or analgesics over morphine. LT1001 has unique market positioning with the potential to satisfy current unmet medical needs. Besides Singapore and Thailand, Lumosa works with its partners to advance drug registration and commercialization of LT1001 in additional ASEAN countries to strengthen the layout of the ASEAN market in the future.
 
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Lumosa Therapeutics, a public traded company in Taipei Exchange (6535.TWO), is dedicated to the development of innovative new drugs for the treatment of neurological and inflammatory diseases of unmet medical needs. The company is actively engaged in scientific in-licensing and new drug development under the “reSEARCH and DEVELOPMENT” model. This model is executed by a highly capable and experienced cross-functional teams of translational research, CMC, preclinical, clinical development, project management, regulatory affairs, intellectual property and business development experts. Current products/pipeline include Naldebain®, a long long-acting analgesic injection, launched in Taiwan in 2017 and Singapore in 2021; LT3001, an NCE for the treatment of acute ischemic stroke currently under phase II clinical trial in the US and Taiwan; LT2003, tumor-targeting enzyme prodrug; and LT5001, a novel topical drug for uremic pruritus. Visit www.lumosa.com.tw for more information.