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Lumosa’s LT1001 Received First European Approval from Ukraine’s SMDC
Corporate
2023.05.15
Lumosa’s LT1001 Received First European Approval from Ukraine’s SMDC
Lumosa’s LT1001 Received First European Approval from Ukraine’s SMDC
(May 15, 2023) Lumosa Therapeutics Co., Ltd. (Lumosa; code: TWO.6535) announced today (May 15) that its extended-release analgesic injection, LT1001 (branded as Esthesia® in Ukraine), received market approval from the Ukrainian competent authority SMDC (State Service of Ukraine on Medicines and Drug Control) through its Ukrainian partner, Darnitsa. This marks the fifth market authorization for LT1001, following Taiwan, Singapore, Thailand, and Malaysia, and the first European approval. The authorization process for Korea and Jordan is also underway. Lumosa Chairman, Mr. Rongjin Lin praised Darnitsa’s outstanding performance and stated that the Ukrainian approval is significant not only for the Ukrainian pharmaceutical market but also as a basis for LT1001 to enter Central Asian and Eastern European markets.
Darnitsa, founded in 1932, has been a leader in the Ukrainian pharmaceutical industry with the top sales volumes in Ukraine occupying 16% of the total pharmaceuticals sold in the country. Darnitsa has manufacturing capabilities and exports over 280 medications from Ukraine to 16 countries (Lithuania, Moldova, Georgia, Armenia, Azerbaijan, Iraq, Turkmenistan, Ghana, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan, Poland, Yemen, and Mongolia), with over 240 overseas registrations.
LT1001 is the first week-long extended-release analgesic injection that offers extended, safe, convenient, and less habit-forming benefits when compared to traditional opioids, potentially fulfilling unmet medical needs.
About Lumosa Therapeutics Co., Ltd.
Lumosa Therapeutics Co., Ltd. (Lumosa) is a drug development company that focuses on scientific licensing and co-development collaboration to build sustainable pipelines under its “reSEARCH and DEVELOPMENT” model. Lumosa selects novel drug candidates with strong scientific rationale and high feasibility of technical success for further development before out-licensing. The company’s focus is on Large- and small-molecule treatment for CNS and oncology.
Lumosa’s pipeline includes the extended-release analgesic injection Naldebain® (approved in Taiwan, Singapore, Thailand, and Malaysia), LT3001, a new chemical entity for the treatment of acute ischemic stroke currently under Phase 2 trial, and exosomes. Please visit the Lumosa website for details.
About PrJSC Pharmaceutical Company “Darnitsa”
PrJSC Pharmaceutical Company “Darnitsa” was founded in 1930. Since 1998, “Darnitsa” has been the leader in Ukraine in terms of volume of production. Strategic areas of portfolio development include cardiology, neurology, and solving pain problems.
(May 15, 2023) Lumosa Therapeutics Co., Ltd. (Lumosa; code: TWO.6535) announced today (May 15) that its extended-release analgesic injection, LT1001 (branded as Esthesia® in Ukraine), received market approval from the Ukrainian competent authority SMDC (State Service of Ukraine on Medicines and Drug Control) through its Ukrainian partner, Darnitsa. This marks the fifth market authorization for LT1001, following Taiwan, Singapore, Thailand, and Malaysia, and the first European approval. The authorization process for Korea and Jordan is also underway. Lumosa Chairman, Mr. Rongjin Lin praised Darnitsa’s outstanding performance and stated that the Ukrainian approval is significant not only for the Ukrainian pharmaceutical market but also as a basis for LT1001 to enter Central Asian and Eastern European markets.
Darnitsa, founded in 1932, has been a leader in the Ukrainian pharmaceutical industry with the top sales volumes in Ukraine occupying 16% of the total pharmaceuticals sold in the country. Darnitsa has manufacturing capabilities and exports over 280 medications from Ukraine to 16 countries (Lithuania, Moldova, Georgia, Armenia, Azerbaijan, Iraq, Turkmenistan, Ghana, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan, Poland, Yemen, and Mongolia), with over 240 overseas registrations.
LT1001 is the first week-long extended-release analgesic injection that offers extended, safe, convenient, and less habit-forming benefits when compared to traditional opioids, potentially fulfilling unmet medical needs.
About Lumosa Therapeutics Co., Ltd.
Lumosa Therapeutics Co., Ltd. (Lumosa) is a drug development company that focuses on scientific licensing and co-development collaboration to build sustainable pipelines under its “reSEARCH and DEVELOPMENT” model. Lumosa selects novel drug candidates with strong scientific rationale and high feasibility of technical success for further development before out-licensing. The company’s focus is on Large- and small-molecule treatment for CNS and oncology.
Lumosa’s pipeline includes the extended-release analgesic injection Naldebain® (approved in Taiwan, Singapore, Thailand, and Malaysia), LT3001, a new chemical entity for the treatment of acute ischemic stroke currently under Phase 2 trial, and exosomes. Please visit the Lumosa website for details.
About PrJSC Pharmaceutical Company “Darnitsa”
PrJSC Pharmaceutical Company “Darnitsa” was founded in 1930. Since 1998, “Darnitsa” has been the leader in Ukraine in terms of volume of production. Strategic areas of portfolio development include cardiology, neurology, and solving pain problems.
