Corporate
2019.12.02
Lumosa licensed LT1001 to Jemincare in China
Lumosa and Jemincare Enter into Chinese Licensing Agreement for LT1001, an Extended-Release Analgesic Injection
Corporate
2019.11.26
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.
Corporate
2019.11.06
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.
Corporate
2019.07.31
Naldebain to enter Switzerland
Lumosa Enters Exclusive Distribution Agreement for Its Extended-Release Analgesic Injection with Swiss’s Ideogen AG
Corporate
2019.06.13
Lumosa to launch the Phase 2 Study for its LT3001
Lumosa to Initiate Phase 2 Human Clinical Trial in the US and Taiwan for Its LT3001, A Novel Drug for the Treatment of Acute Ischemic Stroke
Corporate
2019.05.30
LT3001 patent granted in Japan and Mexico
Lumosa Therapeutics (Lumosa; code:6535.TWO), a new drug development company in Taiwan, announces that the compound patent of its LT3001, a new drug currently under development for the treatment of acute ischemic stroke (AIS), has been granted by the Japan Patent Office and Mexican Institute of Industrial Property. These are additional patents issued in major markets after the issuance of the United States and China patents. Lumosa’s LT3001 compound patent has been granted in 8 countries so far, including China, the US, Australia, Russia, Taiwan, Indonesia, Japan and Mexico. A total of ten patent applications in other jurisdictions are under examination.