Panion and BF Biotech - Taiwan's Pioneer in New Drug Development

Panion and BF Biotech Inc. (PBF) is one of the few pharmaceutical companies in Taiwan with experience selling a new drug on the international market and a pioneer in establishing a model of international licensing, sales, and marketing for new drugs developed in Taiwan. PBF has obtained PIC/S and GMP certification for pharmaceuticals and GMP certification for cosmetics to offer top-notch manufacturing quality. In recent years, PBF has diversified its businesses as a biotech pharmaceutical company as it focuses its resources on the future development of new drugs, aesthetic medicine, and testing agents.

 
Global Alliances

Nephoxil^®, PBF's featured new drug, is a pharmaceutical grade ferric citrate coordination complex, which is an iron-based phosphate binder that doesn't contain calcium, copper, and heavy metals. Nephoxil® can reduce the absorption of phosphorus in the intestines to lower the blood phosphorus levels, thus can be used to treat hyperphosphatemia commonly seen in dialysis patients. The prevalence of terminal kidney disease in Taiwan is number 1 in the world. The approval of the new drug in Taiwan will bring a new hope for treatment of hyperphosphatemia of kidney disease patients.

The new drug has been licensed and approved for multiple markets such as the U.S. (as Auryxia™), the EU (as Fexeric^®), and Japan (as Riona^®). In the U.S. market, it is covered by Federal Medicare Part-D and is included in the coverage of 95% of the insurance policies. Global sales of the drug has exceeded 220 million U.S. dollars. Its supplemental new drug application was approved in 2017 for the treatment of iron-deficiency anemia, making it the only phosphate binder to be used for non-dialysis dependent chronic kidney disease. It can lower the blood phosphorus level of terminal kidney disease patients as well as provide relief for iron-deficiency anemia in chronic kidney disease patients. In the future, PBF will continue to expand the indication to include iron-deficiency anemia in other markets.

Currently, PBF is applying for drug permits in China and Korea. PBF and Shandong Weigao Pharmaceutical Co., one of the top-3 dialysis equipment providers in China, have jointly established a Hong Kong company to bring Nephoxil^® to the Chinese market as an import. The company has received approval for clinical testing by the CFDA, and the drug may hit the Chinese market by 2019. Meanwhile, PBF has granted exclusive rights to Kyowa-Kirin to bring the product to the Korean market. Additionally, PBF will continue to expand into the South East Asian market to complete its global market strategy.

Expansion into Aesthetics Medicine and Diagnostic Tests

PBF's aesthetics medicine unit has developed a proprietary molecule "sachitin" used as adjuvant treatment in minimally invasive surgeries to alleviate post-operative inflammation. PBF has leveraged its own microneedle release technology (a non-invasive percutaneous control method) to develop a microneedle patch for cosmetics which transports the drug to the epidermis through physical or chemical means. Pilot production of the product has been completed, while sales and marketing for the product in the China, Hong Kong, Macau, and Taiwan markets are being planned. PBF's diagnostic test business is focused on the development of In Vitro diagnostic devices for diseases of the respiratory tract and digestive tracts. These include tests for influenza, group A and group B streptococci, enterovirus and Helicobacter pylori, and personalized cancer treatment diagnosis, three of which will be approved for market this year.

(Editing by Jim Shih, Research Center for Biotechnology and Medicine Policy)

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