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朗齊生醫代謝疾病新藥 LXP103拚年底前美國 FDA 提交 IND 申請

經濟日報 記者謝柏宏/即時報導

Wang Chi-hsien, Chairman of Lungkhee Biopharm (6876), recently stated that Lungkhee’s primary goal is the development of therapeutic treatments for metabolic diseases and cancer. This year, the company will go all out to accelerate LXP103 into the human clinical trial stage to seize early opportunities in the massive metabolic and fat-reduction markets. The secondary priority is to speed up the Phase I clinical trial of LXP108, aiming to realize its powerful commercial value as quickly as possible.

Lungkhee Biopharm recently held its Annual General Shareholder Meeting. During the meeting, the 2025 business report, financial statements, and the 2025 loss deficit compensation plan were acknowledged and approved, and the proposal for issuing new restricted employee shares was passed. The shareholder meeting also successfully completed the by-election of two directors and one independent director.

Wang Chi-hsien stated that the advantage of LXP103 lies in its potential to regulate adipocyte metabolism, featuring an excellent safety profile, a long half-life, and favorable drug distribution to peripheral tissues. Unlike many drugs on the market that suppress appetite through the central nervous system, LXP103 promotes lipolysis by directly regulating the metabolic pathways of fat cells. It can not only serve independently as a second-line metabolic intervention therapy but also possesses development potential for synergistic use with GLP-1 drugs to address the weight rebound phenomenon after drug discontinuation.

Results from rat trials in obesity experimental animal models showed that LXP103 demonstrated long-term weight control efficacy, and no obvious appetite suppression, inflammation, or toxicity risks were observed. These relevant data further support the development potential of LXP103 in the field of obesity and metabolic disease treatment, and it is expected to satisfy unmet medical needs in the field of weight management.

At this stage, Lungkhee is pouring all its efforts into accelerating IND-enabling regulatory toxicology studies and CMC (Chemistry, Manufacturing, and Controls) optimization. The company plans to submit an IND application to the U.S. FDA before the end of the year, with the goal of launching Phase I clinical trials at the fastest speed.

LXP108 is a highly promising, broad-spectrum novel anti-cancer drug. Its advantage lies in its ability to simultaneously inhibit multiple signaling pathways of cancer cell proliferation and reduce the generation of drug resistance, aiming to fill the limitations of existing single-target therapies in tumor escape and drug resistance control.

LXP108 is designed around multi-target kinase inhibition as its core. It can inhibit at least 15 oncogenic protein kinases at low concentrations, demonstrating significant efficacy against highly lethal cancers such as lung cancer, oral cancer, and gastric cancer. It possesses development potential for application in a variety of advanced solid tumors and is expected to provide new solutions for highly unmet clinical medical needs.

Wang Chi-hsien stated that the current Phase I clinical dose-escalation trial is progressing smoothly. The evaluation of the fourth dose cohort (0.72 mg/kg) has been completed, and enrollment for the next dose cohort is advancing according to plan, demonstrating good safety and tolerability. Lungkhee expects to aggressively launch international licensing and commercial collaborations after completing the Phase I trial in 2027.

經濟日報 記者謝柏宏/即時報導

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