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Provided by: LUMOSA THERAPEUTICS CO., LTD.
SEQ_NO 2 Date of announcement 2022/01/26 Time of announcement 16:59:31
Subject 
 Lumosa Announces the Termination of ��Comparative
BA Study�� for Naldebain, a New Long-Acting Analgesic
Injection, in the US Due to Additional USFDA Requirements
Date of events 2022/01/26 To which item it meets paragraph 10
Statement 
1.Date of occurrence of the event:2022/01/26
2.New drug name or code:Naldebain, LT1001
3.Indication:For pre-emptive relief of moderate to severe acute postsurgical
 pain.
4.Planned development stages:Phase 2, Phase 3, NDA
5.Current development stage:
(1) Application submission/approval/disapproval/each of clinical trials
   (include interim analysis):
    The IND application for the comparative bioavailability bridging study
    in the US population was cleared by the US FDA.
(2) Once disapproved by the competent authority or each of clinical trials
    (include interim analysis) results less than statistically significant
    sense, the risks & the associated measures the Company may occur: NA
(3) After obtaining official approval or the results of statistically
    significant sense, the future strategy: In response to more stringent
    US FDA regulations and increased investments in relevant development
    costs, the Company has decided to terminate the ��Comparative
    Bioavailability Study�� for Naldebain, a long-acting analgesic
    injection, in the US. In the meantime, the Company is also in search of
    a suitable local partner to continue with the completion of all
    successive human trials required by the FDA before marketing approval.
(4) Accumulated investment expenditure incurred:
    The accumulated development cost is related to future licensing
    negotiations. Relevant information is not disclosed at this time to
    avoid unwanted impact on the licensing deal and to protect the equity
    of the shareholders.
6.Upcoming development plan:
(1) Estimated date of completion:
    The Company will collaborate with a future licensee in the
    co-development of the ��Comparative Bioavailability Study�� and Phase 3
    study, however, the actual timeline may be adjusted based on the
    development progress.
(2) Estimated responsibilities: None
7.Market situation:Naldebain is the only analgesic injection currently on
 the market that provides analgesic effect for up to 7 days, as the
 duration of most market available analgesic medications are short-acting,
 including those for postoperative pain. According to ��Total Morphine
 Milligram Equivalent Sold�� and ��Price per Morphine Milligram Equivalent��
 in ��FDA Analysis of Long-Term Trends in Opioid Analgesic Products:
 Quantity, Sales, and Price Trends�� issued by the US FDA in 2018, the
 sales volume of prescription opioids in the US in 2015 was estimated to
 be US$7.1 billion. The company will pursue international market entrance
 through licensing, to create value quickly by the local sales team.
8.Any other matters that need to be specified:
 LT1001 related technology is exclusively licensed to Lumosa by the
 Ministry of Science and Technology (referred to as ��MOST��) and National
 Defense Medical Center (referred to as ��NDMC��). Lumosa shall pay MOST
 and NDMC sublicense fees accordingly.
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.:

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Lumosa Therapeutics Co. Ltd. published this content on 26 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 January 2022 09:15:07 UTC.