Setting a record for Taiwan-Japan biotechnology cooperation! TLC-KY’s TLC599 Japanese company’s exclusive license amounted to US$203 million

TLC CEO Ye Zhihong (file photo)

[Reporter Chen Yongji/Taipei Report] TLC-KY (7924), an emerging biotech pharmaceutical company with an innovative lipid nanoparticle (LNP) platform as its core, and Japanese pharmaceutical company Nippon Organ Pharmaceuticals Co., Ltd. jointly announced today that TLC-KY, a subsidiary of TLC, has signed an exclusive licensing contract with Nippon Organ Pharmaceuticals. According to the contract agreement, Nippon Organ has obtained the exclusive rights to develop and commercialize the long-acting analgesic TLC599 developed by Taiwan Microsystems in Japan. Taiwan Microsystems can receive a total of up to US$203 million (approximately NT$6.5 billion) including signing fees, development, regulatory and sales milestone payments. 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.

TLC-KY stated that TLC599 is a long-acting intra-articular injection developed using TLC’s proprietary BioSeizer® lipid technology for the treatment of knee osteoarthritis pain. TLC599 is injected into the joint cavity, aiming to prolong the local release time of active pharmaceutical ingredients, and is expected to provide a new treatment option for knee osteoarthritis pain. The Phase II pharmacokinetic trial of TLC599 in Japanese patients with knee osteoarthritis has recently been completed; the Phase III multi-regional clinical trial in Japan and the United States is currently ongoing.

TLC-KY pointed out that Japan Organ Pharmaceutical Co., Ltd. has long been involved in pain treatment and is engaged in drug development, manufacturing and commercialization in the fields of orthopedics and pain management. Through this cooperation, TLC and Nippon Organ will further deepen their cooperative relationship and jointly promote the development of TLC599 in Japan.

Ye Zhihong, CEO of TLC, said: "This collaboration is an important commercial milestone for TLC and confirms the clinical and commercial potential of our proprietary BioSeizer® platform. Nippon Organ has a strong commercial foundation and expertise in pain management in Japan, making it an ideal partner to expand the market accessibility of TLC599. We look forward to working closely with Nippon Organ to jointly promote the development of TLC599 in Japan and bring this highly potential treatment option to patients as soon as possible."