LT1001 (Naldebain(R)), an Extended-Release Analgesic Injection, Received Its Second Approval from Singapore's HSA

LT1001 (Naldebain(R)), an Extended-Release Analgesic Injection, Received Its Second Approval from Singapore's HSA

PR Newswire

TAIPEI, Dec. 21, 2020

TAIPEI, Dec. 21, 2020 /PRNewswire/ --Ā Lumosa Therapeutics is pleased to announce the market approval of LT1001 (NaldebainĀ®), an extended-release analgesic injection, from Singapore's Health Science Agency (HSA). HSA is regarded as one of the regulatory reference countries in the world. The approval from Singapore has significance in accelerating the introduction of LT1001 in Southeast Asia.

According to CPHI, the annual revenue growth in the Southeast Asian pharmaceutical market is predicted to exceed 11% over the next 5 years with expected sales of $40bn in 2020, while Cortelis reports that the pharmaceutical market in Singapore is estimated to grow from USD 1.22 billion in 2017 to USD 1.62 billion by 2020, for a CAGR of 5.8%. Applications for drug approval were also submitted to the health authorities of other Southeast Asian countries, including Malaysia and Thailand. Applications to other ASEAN countries will soon follow.

Lumosa CEO, Mr. Lin, stated: "We are aiming to strategically expand the regional market through approvals from pharmaceutical-advanced countries such as Singapore and Switzerland to facilitate the acceptance in the rest of the world. The company is looking forward to receiving additional approvals from Switzerland, Malaysia, and Thailand. In the meantime, development in China and the US are still under progress."

LT1001 is the world's first week-long extended-release analgesic injection. When compared to morphine, oxycodone, and other commonly used analgesic agents for similar indications, LT1001 provides an extended analgesic effect but also has a better safety profile with low abuse potential. These characteristics mark a unique market position for LT1001.

About Lumosa

Headquartered in Taipei, Taiwan, Lumosa Therapeutics is a public-traded, fully integrated, mid- to late-stage specialty biotech company (6535.TWO; with an extensive pipeline focused on developing innovative products to address unmet medical needs within the stroke and neurological markets. With its expertise, the company identifies, develops, and obtains regulatory approvals of novel and proprietary pharmaceutical products. Lumosa develops transformative medicines faster in creative ways and delivers innovative therapies worldwide.

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