HONG KONG - With a corporate valuation of $1.04 billion, the South Korean biosimilar company Aprogen Inc. has become the country’s first biotech “unicorn,” according to U.S. market research firm CB Insights. Korea now ranks fifth, tied with Germany, in terms of the number of unicorns, with total of 11 unicorns, a term used to describe private ventures with $1 billion-plus valuations. The U.S has a total of 210 unicorns, followed by China with 102, the U.K. with 22 and India with 18.

The Seongnam-based bio company secured a ₩20 billion ($16.7 million) investment from Lindeman Asia Investment Co. Ltd. in May this year, raising its valuation to more than ₩1 trillion.

“We believe that Aprogen will create high value from its existing products and future products using the company’s own drug development platform technology. Also, as the patents of global key original biopharmaceuticals expire, we expect the biosimilar market will be rapidly expanded,” Soon-hak Kwon, General Manager at Lindeman Asia Investment, told BioWorld Asia.

Kwon said the company is expected to develop blockbuster biosimilars, reduce production costs by manufacturing the drugs in a cGMP (current good manufacturing practice) facility based in Osong, Korea, and increase its market share worldwide by launching new drugs in U.S. and European markets.

Founded in 2000, Aprogen develops biosimilar products for various biologics such as infliximab, trastuzumab, adalimumab, rituximab, cetuximab, etanercept and bevacizumab. The company’s lead candidate, GS-071, is an infliximab biosimilar that was launched in Korea and Japan in 2011 and 2017, respectively. Toyama, Japan-headquartered Nichi-Iko Pharmaceutical Co. Ltd., Aprogen’s investor and R&D partner, completed the biosimilar’s phase III trial in the U.S. in May. The candidate will now be submitted for FDA review.  

In 2020, Aprogen’s biosimilar trastuzumab, AP-063 (biosimilar trastuzumab), will enter phase III, while its biosimilar rituximab, AP-056, will enter a phase I, with both clinical programs being run in the U.S.

Aprogen is also developing two additional candidates, AP-185 and AP-216. AP-185 is a pro-angiogenic fusion protein, with the potential to restore damaged blood vessels in indications including myocardial infarction, diabetic foot ulcer and erectile dysfunction. AP-216 is an anti-angiogenic fusion protein, which treats cancers such as ovarian and lung cancers, by suppressing tumor angiogenesis, metastasis and vascular leakage.

The Korean company also develops four platform technologies: a technology to humanize and engineer antibodies; a recombinant proteins design and engineering technology; a manufacturing tech for high-titer cell lines; and a technology to optimize upstream and downstream processes.   

The technology to humanize and engineer antibodies, invented by Aprogen, is a specificity-determining residues (SDR) grafting technology intended to improve upon a previous technique called complementarity-determining region (CDR) grafting. The goal is to support the creation of recombinant antibody therapies that will minimize side effects or immunogenicity for long-term treatment.

The recombinant protein design and engineering technology is intended to support increased protein solubility, biological activity, and stability within the body, and to facilitate the manufacturing and refining of a specific domain. Aprogen has developed AP-185 using the technology.  

Aprogen is also developing a high-titer recombinant protein expression system and a high-efficiency cell line selection system. Both platforms are used to establish cell lines to produce pharmaceuticals in high titers. The optimized upstream and downstream processes technology supports the development and purification of a number of therapeutic antibodies and recombinant glycosylated proteins. 

Celltrion similar?

Aprogen is often compared by Korean investors with the country’s most high-profile biosimilars company, Celltrion Inc., as both companies have characteristics in common. Aprogen is the third Korean company that has succeeded in developing biosimilars, following Celltrion and Samsung Biologics Co. Ltd.   

Both companies gained their positions via foreign investment. Celltrion received investment from Singapore’s sovereign wealth fund, Temasek Holdings Private Ltd.,  with investments of ₩207.9 billion in 2010 and ₩149.5 billion in 2013. Likewise, Aprogen has secured a total investment of more than ₩40 billion from Nichi-Iko Pharmaceutical since 2010. In 2014, the Japanese company signed an agreement with Aprogen to conduct clinical trials, file for regulatory approvals and sell Aprogen’s biosimilars in Japan, which led GS-071 to win marketing approval in Japan in 2017.

Aprogen plans to launch an IPO next year. The Korean company tried listing in 2016, however, it withdrew due to an accounting issue. To secure capital since, it acquired KOSPI-listed Nara KIC in 2017, a plant construction company that is now Aprogen KIC Inc.  

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