HOME - LATEST NEWS - Corporate - Lumosa Partner, AMed Co., Informed the Receipt of Market Authorization from Brunei (BDMCA), for Naldebain, an Extended-Release Analgesic Injection

LATEST NEWS

Corporate

Corporate

2023.09.26

Lumosa Partner, AMed Co., Informed the Receipt of Market Authorization from Brunei (BDMCA), for Naldebain, an Extended-Release Analgesic Injection

Date of occurrence of the event: 2023/09/26
Company name: Lumosa Therapeutics Co., Ltd.
Relationship to the Company (please enter ”head office” or ”subsidiaries”): head office
Reciprocal shareholding ratios: not applicable
Cause of occurrence: 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 depends on the registration approval and sales performance of the Product. Lumosa received a notification from AMed regarding the receipt of an import permit from Brunei Darussalam Medicines Control Authority (BDMCA) for Naldebain, an extend-release analgesic injection.
Countermeasures: not required
Any other matters that need to be specified: The market authorization of Naldebain, an extend-release analgesic injection, has been granted in Taiwan, Singapore, Thailand, Malaysia and Ukraine. 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.