Naldebain Approved by Singapore HSA

Lumosa is pleased to announce the market approval of LT1001 (Naldebain®), an extended-release analgesic injection, from Singapore’s Health Science Agency (HSA). Being one of the regulatory reference countries, HSA's approval has significance in accelerating the marketing of LT1001 in the rest of ASEAN member states. Applications for drug approval were also submitted to the health authorities of other Southeast Asian countries such as Malaysia and Thailand. Applications to the rest of ASEAN countries will soon follow.

Lumosa to commence a multi-dose Phase 1 trial right after the single-dose Phase 2 to expand stroke treatment methodology

LT3001 is a novel treatment for acute ischemic stroke (AIS), currently under development by Lumosa Therapeutics (Lumosa). The company will proceed with a multi-dose and drug-drug-interaction Phase I trial right after the enrollment completion of the single-dose Phase II study for LT3001. The study will help Lumosa to obtain safety data and pharmacokinetic parameters as the administration frequency is increased, to establish foundations for the coming Phase II multiple-dose trial.

Enrollment Completed for 1st Phase 2 Trial for LT3001

Lumosa is pleased to announce that the company has completed the #enrollment of its first Phase 2 clinical trial for #LT3001, a new chemical entity for the treatment of acute ischemic stroke. The data is expected to come out in Q1 of 2021.

LT3001 Received IND Approval from China's NMPA

Lumosa Therapeutics Co., Ltd., (TPEx: 6535, hereinafter 'Lumosa') is pleased to announce that its China partner Shanghai Pharmaceutical Holding (SHP) has received the IND approval from China’s NMPA for the lead drug candidate, LT3001,  a novel treatment for acute ischemic stroke.  A phase 2 clinical study is currently on-going in the US and Taiwan. Once China studies are initiated, the clinical trials from Chinese sites will contribute additional data to accelerate LT3001 towards market approval.

Patent for Lumosa's Extended-Release Analgesic Granted by Taiwan IPO

(August 10, 2020; Taipei) Lumosa Therapeutics (Lumosa; code: 6535.TWO) announced today the granting of formulation patent for its extended-release analgesic injection, LT1001 (brand name: Naldebain®); the patent is valid until 2036.

The US FDA has granted the Orphan Drug Status to Lumosa's LT2003, an anti-tumor targeting fusion protein, for the treatment of pancreatic cancer

The US FDA Has Granted the Orphan Drug Status to Lumosa’s LT2003, an Anti-tumor Targeting Fusion Protein, for the Treatment of Pancreatic Cancer