Taipei-based Taiwan Liposome President George Yeh discussed the company's unique efforts in drug delivery, clinical trials and lab work and its position as a pioneer in the 4+4 arrangement between Taiwan and China that recognizes clinical trial data from four hospitals in each country.
In an interview with FiercePharmaAsia, Yeh remarked on the company's portfolio, highlighting that Phase II liver cancer treatment Lipotecan (TLC388) fits in squarely with the regulatory green channel it enjoys into China, as well as the outlook for the Taiwan biotech sector.
“Liver cancer is among the top killers in China and in many other parts of Asia, making it one of the ground zero diseases for unmet need in the region," Yeh said.
He noted the Taipei exchange-listed company was among the first into a landmark clinical data acceptance pact between the China FDA and Taiwan FDA, joining CANbridge and TaiGen that can take studies from the four approved hospitals in each country and head directly into Phase II in China if approved without repeating earlier work.
"This has really cut the time to 2 to 2.5 years--almost half--for the process leading to approval," he said.
The four clinical settings in Taiwan are Taipei Veterans General Hospital, Tri-Service General Hospital, National Taiwan University Hospital and Chang Gung Memorial Hospital. They are matched in China by Peking University First Hospital, Beijing Union Medical College Hospital, Shanghai Jiaotong University’s Ruijin Hospital and Shanghai Fudan University’s Zhongshan Hospital.
Yeh noted a key was getting all the hospitals to adopt common clinical protocols, which he said has worked well for the inhouse oncology candidate that came originally by way of the California Pacific Medical Center.
Yeh also noted the full enrollment for a 12-week Phase I/II arthritis candidate, TLC599, using an inhouse developed microneedle to penetrate small joints that involved detailed engineering and clinical work.
"It really starts with medical need, but the discussion with partners to identify where and how the target drug can be administered is a complex process," Yeh said. "At the early stage, just screening the drug for toxicity, dose frequency and the rest in vitro and in vivo is a hurdle even before deliverability and scalability can be determined."
In the case of TLC599, the corticosteroid therapy is encapsulated in a lipid and injected using the company’s BioSeizer platform that allows a longer impact of the therapy with fewer doses, limiting pain and extending the time before replacement surgery in many cases.
"The need, of course, is an aging population in many parts of the world with countries that are increasingly prone to arthritis," he said.
To manage pain and reduce the need for post-surgical painkillers, Taiwan Liposome is developing a separate micro-delivery method with TLC198, a liposomal encapsulated bupivacaine anesthetic.
Yeh joined Taiwan Liposome in 2002 after stints in startup management at the AsiaWired Group. He also worked as CFO for Hermes Biosciences, assisting in the structuring and negotiations of technology transfers and license contracts with pharmaceutical companies.
The company had its start out of the University of California, San Francisco, in work done by Keelung Hong, founder, chairman and CEO. Hong started Taiwan Liposome in 1997 and cofounded Hermes Biosciences in the United States in 1998.
The company has also developed ProDex (dexamethasone) to treat macular edema using a super-fine delivery method for sustained release of dexamethasone to maintain edema control.
Biotechs in Taiwan are drawing lots of interest this year with a share sales scandal at OBI Pharma bringing down the head of lead academic research institute Academia Sinica and an election that replaced one industry booster with another--though with a different view on the country's relationship with China.
But Yeh said the growing reach of Taiwan is attracting new firms, both domestic and abroad, plus the potential to raise capital. He cited JHL Biotech, which listed on the Taiwan Emerging Stock Board, an avenue for firms to test the water before a main board listing.
"JHL has done well with a great valuation, and now operating a plant in China. It shows there is local funding that is ample to make Taiwan an Asian biotech hub," Yeh said.
Taiwan Liposome PhI/II trial on acupuncture-type arthritis candidate fully enrolled
China FDA approves TaiGen Biotech pneumonia-focused Taigexyn antibiotic
James Liao named as new candidate to helm Taiwan's Academia Sinica
JHL biologics plant in China up and running
China's CANbridge files Taiwan IND for PhI/II anti-TNF candidate
Taiwan's outgoing leader touts biotech growth