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

Lumosa received LT5001 IND approval from TFDA for the treatment of uremic pruritus

Lumosa Therapeutics (Lumosa; code:6535.TWO) announced IND approval by the Taiwan FDA (TFDA) for the phase Ib/II study of its LT5001, a new drug under development for the treatment of uremic pruritus. The company will soon proceed with the phase Ib trial in Taiwan, which is expected to be completed within one year after initiation. Around 40% of hemodialysis patients with chronic kidney disease suffer moderate to severe uremic pruritus. These patients will benefit from LT5001 when it reaches market in the future.

Lumosa licensed LT1001 to Jemincare in China

Lumosa and Jemincare Enter into Chinese Licensing Agreement for LT1001, an Extended-Release Analgesic Injection

Lumosa announces FDA acceptance of IND application for LT1001, an extended-release analgesic injection

The harms caused by the opioid epidemic has led to an ever-increasing need for a novel agent in pain management. The US FDA has accepted the IND (investigational new drug) application for LT1001 (brand name Naldebain®), a new extended-release analgesic injection developed by Lumosa Therapeutics (“Lumosa;” 6535.TWO). Lumosa will initiate the comparative bioavailability study shortly and complete the enrollment by mid-year 2020. The study will bridge the clinical data of LT1001 and its parent drug, nalbuphine, in the US. Subsequently, a confirmatory trial according to the 505(b)(2) pathway will be conducted before the submission of a new drug application (NDA) to the US FDA for marketing authorization approval.

LT3001 China region out-Licensed to Shanghai Pharma

Lumosa Therapeutics Co., Ltd. (“Lumosa;” 6535.TWO) announced the successful licensing deal on its LT3001, a novel drug for the treatment of acute ischemic stroke (“Product”), in the China region with Shanghai Pharmaceutical Group Co., Ltd. (“Shanghai Pharma, SHP;” 601607.SS; 02607.HK), one of the top-tier publicly-traded pharmaceutical companies in China. Both companies will collaborate to enter the global market through the sharing of clinical trial data.

Naldebain to enter Switzerland

Lumosa Enters Exclusive Distribution Agreement for Its Extended-Release Analgesic Injection with Swiss’s Ideogen AG