After Winning Approval for Its Painkiller in Thailand, Taiwan’s Lumosa Aims for Korea Nod

by Judy Ya-Hsuan Lin
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Securing a foot in the U.S. as an IND and in Korea in collaboration with Dongwha Pharmaceutical, LT1001’s (Naldebain) developer Lumosa Therapeutics continues to expand its market worldwide. LT1001 is a week-long extended-release analgesic injection with long effects and a good safety profile for the management of moderate to severe postoperative pain.

On December 29, 2021, Lumosa Therapeutics announced that LT1001 received its third approval from Thailand’s FDA after getting the nod from Taiwan’s FDA (TFDA) and Singapore’s Health Sciences Authority (HSA). Lumosa Therapeutics is aiming to obtain approvals in China, Ukraine, Jordan, and Malaysia, with regulatory progress in those regions expected by the first half of 2022.

“LT1001 is the first new drug developed by Lumosa that has successfully reached the market. With its extensive global patent strategy and the maximization of LT1001’s value through regional expansion, the product is well suited for any regional licensing and will contribute stable revenue for the company,” stated Lumosa’s CEO Rongjin Lin.


Lumosa Therapeutics


Lumosa Therapeutics is an innovative therapeutic pharmaceutical company based in Taiwan. It has been dedicated to researching central neurons’ diseases and cancer treatments with novel molecules. Its currently approved products in Taiwan are: LT3001 for ischemic stroke, LT5001 for uremic pruritus, and LT2003 as fusion protein therapy for cancer patients.


Market Opportunities in Thailand 


The analgesic therapeutic market was valued at $1.2 billion in 2021, with demand expected to increase annually by 6% by 2025. According to market analyses, the drug market in Thailand will grow up to $6.9 billion by 2024. Currently in Thailand, opioid products are the main painkillers to alleviate pain after surgeries. However, opioids are highly addictive and are known to inhibit breathing. In comparison, LT1001 is relatively safe as it holds a longer and more consistent effect and is much less likely to lead to addiction.


Market Expansions in Korea and the U.S.


Like Thailand, Korea has also experienced a growing demand for analgesics. In 2021, revenue in the analgesics was $188.21 million USD and the market is expected to increase annually by 7.04%. In mid-2021, Lumosa Therapeutics granted an exclusive distributorship agreement with Dongwha Pharmaceutical in Korea for LT1001. 

In the agreement, Lumosa Therapeutics is responsible for drug supply and authorization of LT001 in Korea while Dongwha conducts commercialization, marketing and sales of LT1001. Lumosa will receive an upfront payment and additional payments if LT1001 is approved by the Korean health authority. 

“We are pleased to partner with Dongwha. Their mature and diverse marketing channels and sales experiences are the keys to LT1001’s visibility and competitiveness in Korea. We are looking forward to seeing the day when Korean patients start to benefit from this drug,” Lin said.

Given the similarities in medical settings and in the treatment of postoperative pain between Taiwan and Korea, where opioid products are widely used, LT1001 is anticipated to be approved by mid-2022 at the earliest.

Similarly, in the U.S., the prescription opioid sales volume in 2015 was approximately $7.1 billion USD. Lumosa Therapeutics received the USFDA acceptance of the IND application for LT1001 in November 2019. In order to facilitate the licensing process and the time to market in the U.S., Lumosa obtained consent to allow the development of LT1001 in a pharmacokinetic bridging study with a reduced number of human clinical trials required for the drug approval.

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