BRIEF—Singapore approval for Lumosa's pain drug

Taiwan biotech Lumosa Therapeutics has received approval for its new drug application (NDA) for its extended-release injectable pain reliever Naldebain (dinalbuphine sebacate) from Singapore’s Health Science Agency (HSA).

The company expects the move will speed up the drug's launch in other ASEAN countries, with Thailand and Malaysia as soon as in 2021.

Approved in Taiwan in 2017, Naldebain (LT1001) is recruiting for Phase I studies in the USA.

Compared to morphine, oxycodone and other commonly used analgesic agents for similar indications, LT1001 is much safer and has no abuse potential; these characteristics marks a unique market position for LT1001, the company said in a press release.

Separately, Lumosa’s candidate LT3001 for acute ischemic stroke is ready to enter Phase II studies in Taiwan and the USA.