Lumosa Therapeutics : Partner, AMed Co., Informed the Receipt of Market Authorization from Malaysia NPRA for Naldebain, an Extended-Release Analgesic Injection
Lumosa Partner, AMed Co., Informed the Receipt of
Market Authorization from Malaysia NPRA for Naldebain, an
Extended-Release Analgesic Injection
Date of events
2022/06/05
To which item it meets
paragraph 53
Statement
1.Date of occurrence of the event:2022/06/05
2.Company name: Lumosa Therapeutics Co., Ltd.
3.Relationship to the Company (please enter "head office" or
"subsidiaries"):head office
4.Reciprocal shareholding ratios:not applicable
5.Cause of occurrence:
(1) Lumosa Therapeutics Co., Ltd. (Lumosa) and AMed Co., Ltd. (AMed) signed
an agreement on June 8th, 2018, for the licensing rights of LT1001, an
extended-release analgesic injection (Product), in Southeast Asian
market. AMed received the exclusive rights to submit drug registration,
technological licensing, market development and sales for the Product
in Indonesia, Malaysia, Philippines, Thailand, Singapore, Brunei,
Cambodia, Laos, Myanmar, and Vietnam. The amount for milestone payments
and royalties depend on the registration approval and sales performance
of the Product.
(2) Lumosa received an notification from AMed regarding the receipt of an
import permit from National Pharmaceutical Regulatory Agency (NPRA) of
Malaysia for Naldebain, an extend-release analgesic injection.
6.Countermeasures:not required
7.Any other matters that need to be specified:
(1) The market authorization of Naldebain, an extend-release analgesic
injection, has been granted in Taiwan, Singapore and Thailand.
(2)Development of new drugs takes significant cost and time. The outcome of
such development is inherently unpredictable. Investors must take all
these risks into account and make prudent investment decisions at their
own discretions.
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Lumosa Therapeutics Co. Ltd. published this content on 05 June 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 June 2022 12:11:02 UTC.
LUMOSA THERAPEUTICS CO., LTD. is a Taiwan-based company principally engaged in the development of new drugs. The Company is engaged in the development of new drugs for unmet medical needs in the fields of central nervous system (CNS), oncology, and inflammatory diseases. The Company is engaged in scientific licensing and new drug development under the reSEARCH and DEVELOPMENT model.
Lumosa Therapeutics : Partner, AMed Co., Informed the Receipt of Market Authorization from Malaysia NPRA for Naldebain, an Extended-Release Analgesic Injection
LUMOSA THERAPEUTICS CO., LTD. 
