Will GC Pharma enter the US blood product market in 2013?

Reapplying for approval of immunoglobulin to FDA

Ochang plant GMP inspection completed

GC Pharma has challenged the US immunoglobulin blood product market worth 13 trillion won.

 

For the past 13 years since it officially entered the US market in 2010, it has experienced growing pains such as failure to obtain permits and delays, but has attempted to enter the US market again.

 

According to the industry on the 18th, GC Pharma submitted a BLA for its immunoglobulin blood product ALYGLO to the US Food and Drug Administration (FDA).

 

ALYGLO applied for approval for primary immunodeficiency indication.

 

GC Pharma satisfied all efficacy and safety evaluation parameters according to FDA guidelines in the North American phase 3 clinical trial completed in 2020.

 

In the phase 3 clinical trial, ALYGLO was administered to 48 patients with primary immunodeficiency for 12 months, and the efficacy and safety were confirmed.

 

ALYGLO is a liquid-type immunoglobulin preparation purified from plasma fractions.

 

It is used to treat primary immunodeficiency diseases such as congenital immunodeficiency syndrome and immune thrombocytopenia.

 

According to GC Pharma, the US immunoglobulin market is estimated at about 12.5 trillion won.

 

With the recent increase in autoimmune diseases, the demand for immunoglobulins is continuously increasing.

 

GC Pharma explained, “The blood product, which requires large-scale facility investment and advanced production experience, is known to frequently have a supply shortage because producers are very limited.” It is the confidence that ALYGLO will be able to secure sufficient market competitiveness if it enters the US market.

 

This is the third attempt by GC Pharma to apply for FDA approval for a blood product.

 

GC Pharma applied for approval of the IVIG-SN 5% product to the FDA at the end of 2015.

 

FDA approval was expected at the end of 2016, but in November 2016, the FDA pointed out that the manufacturing process-related data should be supplemented.

 

In September 2017, GC Pharma's approval was delayed again due to a request for additional supplementation of manufacturing process data.

 

GC Pharma planned to enter the US market first with 5% products and later with 10% products undergoing clinical trials.

 

However, as the approval of the 5% product was delayed, the company changed its strategy to release the 10% product, which has greater marketability, to the US market first.

 

GC Pharma completed phase 3 clinical trials in North America for IVIG-SN10% ALYGLO in 2020 and submitted an application for product approval to the FDA in February 2021.

 

However, in February of last year, it received a notice from the FDA to postpone the approval of the product.

 

Due to the COVID-19 situation, a non-face-to-face evaluation was conducted in the fourth quarter of 2021, but the FDA decided to postpone the approval because of the need for an on-site inspection of the production facility.

 

From April 17th to 28th, the FDA inspection team conducted an inspection of production facilities and quality systems such as fractionation, stagnation, and finished products of IVIG-SN at GC Pharma's Ochang plant.

 

After completing the GMP inspection of the Ochang plant, GC Pharma resubmitted an application for permission after consulting with the FDA.

 

The FDA's product approval process goes through a preliminary review after receiving the BLA, sets a target date for completion of the review, and starts the review process in earnest if the data is appropriate.

 

A GC Pharma official said, “We are aiming to obtain product approval early next year and launch it in the US market in the second half of the year.” He said, “We will become a global leader in blood products based on our entry into the US market in the future.” If GC Pharma receives FDA approval for ALYGLO, it will enter the US market for the first time since its foundation.

 

Yearly sales of Green Cross blood products (left) and percentage of sales (right) (unit: KRW 100 million, %, source: Financial Supervisory Service)

Blood products, including immunoglobulins, are GC Pharma's core business areas.

 

Last year, GC Pharma's blood product sales amounted to 420.4 billion won, accounting for 23.7% of the company's total sales.

 

GC Pharma's blood product sales grew only 12.4% over the past 9 years from 341.5 billion won in 2013.

 

Sales of blood products last year fell short of 429.6 billion won in 2019 and 425.4 billion won in 2018.

 

The share of blood products in GC Pharma's sales reached 43.0% in 2013, but fell to the 30% level in 2014 and fell to the 20% level from 2020.

 

Over the past nine years, the sales portion of blood products has declined by 19.4%.

 

Blood product export growth is slow.

 

Last year's GC Pharma blood product export performance was 90.9 billion won, up 48.3% from the previous year.

 

However, considering that blood product exports recorded more than 100 billion won for four consecutive years from 2017 to 2020, a breakthrough in overseas markets is urgently needed.

 

GC Pharma recorded 90.9 billion won in exports of blood products last year.

 

If ALYGLO enters the US market, the proportion of overseas sales is expected to increase.

 

In 2010, GC Pharma announced the entry of blood products into the US market.

 

GC Pharma signed a contract with ASD Healthcare in 2010 to export blood product IV Globulin SN and hemophilia treatment GreenGene F worth a total of $480 million over three years.

 

However, when the clinical trial period was delayed than originally planned, the memorandum of understanding with ASD Healthcare was also terminated in September 2015.

 

GC Pharma also faced setbacks in its hemophilia treatment plan to enter the US market.

 

In October 2016, GC Pharma decided to suspend the US clinical trial of GreenGene F, a recombinant hemophilia A treatment that is undergoing phase 3 clinical trials in the US.

 

In 2012, it announced its withdrawal after 4 years of entering phase 3 clinical trials.

 

The reason for the discontinuation of clinical trials in the United States was pointed out as “deterioration in business feasibility.” Due to the nature of rare diseases, the recruitment of new patients was slow, leading to delays in clinical trials and the emergence of competitive drugs with long duration of action.  Due to GC Pharma's delay in entering the US market, the blood product supply strategy has also changed.

 

Initially, GC Pharma sought to enter the blood product market through a local plant in North America.

 

Green Cross Holdings spent 210 million Canadian dollars (about 187 billion won) in 2017 to complete the blood product plant in Montreal, Quebec, Canada.

 

The plant, built on a land area of 63,000 square meters, has a process for producing blood products such as IV Globulin and albumin by fractionating up to 1 million liters of plasma per year.

 

However, the North American subsidiary was liquidated as the US approval of IVIG-SN, a blood product, was delayed more than expected.  In July 2020, Green Cross Holdings sold two of its North American blood products affiliates to Spain's Grifols, the world's largest blood products company, for a total of $460 million.

 

GCBT (Green Cross BioTherapeutics), a subsidiary of Green Cross North America (GCNA), was sold for 189.1 billion won, while another US subsidiary, GCAM (Green Cross America), was also handed over.

 

GCBT is a blood derivatives plant built by GC in Canada.

 

GCAM is a corporation that supplies plasma in the US.

 

It has 12 blood centers in the US.

 

Initially, a structure in which GCBT would produce blood derivatives with raw plasma made from blood secured by GCAM was conceived, but the business strategy was drastically revised in consideration of the uncertainty caused by changes in business conditions.

 

In the case of GCBT in Canada, although facility investment has been completed, it has been receiving manpower and technical support from GC Pharma's headquarters for commercial operation since 2018 due to a lack of local bio-production process experts.

 

In this situation, as Grifols actively sought out the acquisition, the sale was carried out in a flash.

 

GC Pharma is said to have recovered most of its investments in GCBT and GCAM.

 

If ALYGLO obtains FDA approval, it will be produced at GC Pharma's Ochang plant and sold through GC Biopharma USA, a US GC Pharma subsidiary.

 

A GC Pharma official said, "Immune globulin use in the United States is expected to increase further due to the increase in autoimmune diseases due to the aging population and improved awareness of the diagnosis and treatment of congenital immunodeficiency syndrome." “We expect to improve the situation of limited product supply,” he predicted.