TLC-KY long-acting analgesic licensed to Japanese organs, with signing bonus of nearly 500 million yuan pocketed this season

TLC-KY cooperates with Japan Organs to launch. Pictured on the left is TLC-KY CEO Ye Zhihong, and on the right is Nippon Organ Pharmaceuticals Representative Director and President Konishi Takafumi (provided by TLC-KY)

[Reporter Chen Yongji/Taipei Report] TLC-KY (7924), an emerging company with an innovative lipid nanoparticle (LNP) platform as its core, and Nippon Organ Pharmaceutical Co., Ltd. (hereinafter referred to as "Japan Organ") will hold a launch event today (29th) for its long-acting analgesic drug TLC599 At the cooperation ceremony, TLC-KY CEO Ye Zhihong said that the Phase III clinical trials of TLC599 in Japan and the United States have been launched, and the target is to submit applications for drug licenses in 2028. This quarter, the US$15 million (approximately NT$490 million) signing fee for authorized Japanese organs will be recognized, and this quarter will also be applied simultaneously for the first listing on the stock exchange.

As for TLC590, a new post-operative analgesic drug that has recently completed the third phase of blindness relief, Ye Zhihong revealed that many major international pharmaceutical companies have taken the initiative to negotiate, and the authorization decision may be faster than TLC599. Ye Zhihong emphasized that he is very confident in the company's future operations. "It is expected to be profitable next year, and I hope to make a lot of money to give back to shareholders."

TLC-KY announced at the beginning of this month that it had signed an exclusive licensing contract for TLC599 in the Japanese market with Nippon Organ Pharmaceuticals. The total contract value is up to US$203 million (approximately NT$6.5 billion). In addition, after the product is launched, it will receive a tiered sales royalty of up to a double-digit percentage based on the net sales of the product in Japan, setting a record for the highest amount in the history of Taiwan-Japan biotechnology cooperation.

TLC599 is a sustained-release dosage form developed using TLC's exclusive BioSeizer® lipid technology. It releases active ingredients locally for a long time after a single injection into the knee joint. The drug has completed the second phase pharmacokinetic trial on Japanese patients with degenerative arthritis of the knee joint and is currently undergoing the third phase multi-regional clinical trial in Japan and the United States.