SEOUL – Green Cross Holdings aims to make deeper inroads into the US and Europe this year with its flagship businesses - plasma-derived products and vaccines - as part of its ongoing globalization drive.

"We will push ahead with what we do best, plasma-derived products and vaccines. Until now, we have advanced into overseas markets such as Southeast Asia and South America, but now we are aiming to enter the US and Europe. Going forward, we will also accelerate efforts in cell and gene therapies," president Dr. B.G. Rhee told PharmAsia News in a recent interview.

The US FDA has recently reviewed and accepted documents for Green Cross Corp.'s I.V.-Globulin SN (IVIG SN), a human immunoglobulin G for intravenous administration, submitted through a Biologics License Application, and is expected to complete the review in the fourth quarter of this year.

Intravenous immunoglobulin G (IVIG) is a plasma-derived product administered to protect the body against infection. The latest BLA to the FDA was intended for the treatment of primary immunodeficiency diseases (PID), a class of inherited genetic disorders that cause an individual to have a deficient or absent immune system.

IVIG-SN demonstrated positive results in a Phase III study in patients with PID, meeting its primary endpoint of no acute serious bacterial infections. These results, included in the submission, were well under the requirement specified by the FDA guidance of no more than one acute serious bacterial infection per patient-year.

“We will push ahead with what we do best, plasma-derived products and vaccines…now we are aiming to enter the US and Europe.” - Green Cross Holdings’ president Dr. B.G. Rhee

More broadly, IVIG-SN marks one major step towards the group's ultimate goal of expanding its biologics business to the US marketplace. Sales of IVIG SN, one of Green Cross's main plasma-derived products, reached about KRW60bn ($49.8m) at home and abroad last year. If it gets the US FDA approval this year, it expects to launch the product in the US in 2017 at the latest.

Green Cross, the largest plasma-derived products manufacturer in Asia, has so far been marketing IVIG-SN in more than 30 countries in Asia, South America and the Middle East.

The group is now building a new plant for such products with a maximum annual production capacity of one million liters in Montreal, Canada, which will serve as the group's production base to challenge the North American markets. It aims to begin commercial production from the site by 2019 at the latest.

Green Cross Biotherapeutics kicked off construction of the plant, on the Montreal Technoparc’s Saint-Laurent Campus, in June last year, and the C$315m ($227m) project represents one of the largest green field investment projects in Canada in the biopharmaceutical industry, and will be the first IVIG and albumin manufacturing plant in the country.

Vaccines/Cell Therapy Progress

Rhee also noted that Green Cross has been making good progress in its vaccine business.

It recently gained regulatory approval from South Korea's Ministry of Food and Drug Safety (MFDS) to sell the GC FLU H5N1 vaccine, which was developed as a pre-pandemic vaccine, and also received approval for GC FLU Quadrivalent vaccine, which can prevent two types of influenza A and two types of influenza B.

The company plans to double the production capacity at its vaccine plant in South Korea by 2018 to meet increasing demand for exports of various products.

To boost its nascent cell therapy business, the leading South Korean pharma group - whose affiliates include Green Cross Corp., Green Cross Cell and Green Cross Labcell - plans to build a cell therapy center near its headquarters in South Korea.

"Construction is slated to begin in April 2016 and will be fully operational in 2018. We plan to build one of the largest cell therapy centers in Asia, which will produce immune cell products such as Immuncell-LC, NK cell and stem cell products," Rhee disclosed.

The group is engaged in the development of both autologous and allogeneic cell therapies.

Green Cross Cell's Immuncell-LC is an autologous T-cell-based anticancer immunotherapy, approved by the MFDS in 2012 for the treatment of hepatocellular carcinoma (HCC). It is an activated T-lymphocyte therapy that uses the patient's own lymphocytes to boost innate immune response ([A#28150823002]).

In January, Green Cross LabCell Corp. also received approval from the MFDS to start a Phase II clinical study with its ex vivo expanded allogeneic natural killer (NK) cell therapy MG4101, again for the treatment of HCC ([A#28160113003]).

It will be the first allogeneic NK cell therapy globally to move into Phase II studies and is also expected to be the first drug of its kind to be commercialized in the next few years.

Green Cross aims to expand clinical trials of MG4101 to global markets by 2017, the president said.

Broader Industry Issues

Talking about the broader pharma industry, Rhee said the bio-healthcare sector is the future growth engine for South Korea, so the government needs to quicken its steps to support the industry. The executive is also chairman of the Korea Biotechnology Industry Organization.

"South Korea has been growing sharply in the past 50-60 years, but its growth drivers such as semiconductor, shipbuilding, steel and petrochemical sectors are all declining now,” he said.

“The [South Korean] government has been slow to revise rules such as the Bioethics Act. It also has to hike its financial support.” – Rhee

"The Korea Biotechnology Industry Organization has been discussing this with the government. The government has been slow to revise rules such as the Bioethics Act. It also has to hike its financial support. Leading pharmas such as Green Cross and Yuhan Corp. have annual revenues of about KRW1tn, so how much can they spend for R&D?," he questioned.

Given the size of R&D investment and workforce, South Korean companies can't really compete with multinational pharmas, but fortunately, the paradigm of the pharma industry is changing and the importance of the cell and gene therapy space is growing, perhaps favoring South Korean firms working in these areas.

"There isn't a big gap between global firms and South Korean companies in cell and gene therapies as well as genomics," Rhee observed.

INTERVIEW: Green Cross Thinks Global With Plasma Products, Vaccines

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