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Clinical trials in the emerging market of South Korea are gradually shifting from late phase trials to early phase trials since early phase provides more insight into the characteristics of the patient population the drug is targeting. [1] Also, pharma companies who focus their efforts on early phase trials have a greater chance of developing a drug compatible with the South Korean population, so collecting clinical trial data from these early phase trials is critical to increase the drug’s likelihood of approval within that market. To help improve their country’s clinical trial attractiveness in general, the South Korean government has implemented new regulatory initiatives to shorten approval timelines.  They also presently grant conditional approvals to oncology therapies to expedite entry of these drugs into the market by an estimated 2-3 years, which provides great opportunities for pharma companies. [2]

 

South Korean Market and Its Attractiveness for Clinical Trials

For Pharma companies, timeliness for assessment and approval is considered a “key” indication of a country’s attractiveness when deciding to include/exclude a country in their clinical trials. Table 1 provides review approval timelines for clinical trials in select countries, by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Based on these timelines, South Korea is a reasonably attractive market for clinical trials at 60 days when compared to Russia’s 115 days or Singapore’s 30 days. This attractiveness is demonstrated by the increased activity in South Korea; between 2011 and 2015, the country increased their global ranking in the number of clinical trial protocols from 9th to 7th. South Korea also increased their rank in industry sponsored trials by total site number from 12th to 7th in the same period. [1] Recently Pharma Intelligence’s Pink Sheet cited that the South Korean government plans to shorten the approval time even further from an average of 67 days to 55 days, which continues to increase the country’s attractiveness as a location for clinical trials. [2]

Table 1 - Comparison of Clinical Trial Review Timelines in 2013 for Select Countries [3]

Comparison of Clinical Trial Review Timetables in 2013 l Pharma Intelligence

 

Trial Development and Drug Development Pipeline for NSCLC in South Korea

South Korea’s conditional approval for oncology drugs and initiative to further reduce current drug approval timelines appears to have generated interest in immuno-oncology related deals, in particular non-small cell lung cancer (NSCLC). Earlier this year, Yuhan, one of South Korea’s leading pharma firms based in Seoul, began targeting its efforts towards immuno-oncology by establishing a majority owned joint venture with U.S. California-based Sorrento Therapeutics to develop and commercialize three of Sorrento’s immune checkpoint antibodies for both hematological malignancies and solid tumors. The purpose of this deal, according Hee Lee, president and CEO of Yuhan, “is to commit significant resources for the development of novel cancer immunotherapies in an area of significant unmet need not just in Korea but also globally.“ [4]

Yuhan has recently entered another licensing-out agreement with Luoxin Biotechnology Co. to grant exclusive rights for the development, regulatory approval filing, production and marketing of a novel epidermal growth factor receptor (EGFR) inhibitor (YH25448) for NSCLC in China, Hong Kong and Macau. [5] YH25448 is said to still be in pre-clinical stages but future Phase II trials are slated for South Korea and abroad.  Still, YH25448 will have stiff competition with AstraZeneca’s EGFR inhibitor, Tagrisso (osimertinib) which was recently launched (June 2016) in South Korea. [6]

NSCLC provides a significant challenge for healthcare providers in South Korea and China but a golden opportunity for drug manufacturers. In South Korea, lung cancer is the leading cause of death among adults and the crude incidence rate of lung cancer was 43.9 per 100,000 in 2012. One successful example of targeted cancer therapy is inhibiting the EGFR mutation. According to Datamonitor Healthcare, EGFR mutation lung cancer is steadily increasing in both men and women and this mutation occurs more frequently in the Asian population (40%) compared to the Western population (15%) for NSCLC patients. [6,7]

Table 2 shows there are few already approved drugs for treating NSCLC in South Korea that target EGFR and a handful of EGFR agonists and EGFR kinase inhibitors in clinical development. This data suggests there is still interest from additional players to make their debut in this targeted disease population in South Korea.

 

Table 2 – South Korean Landscape of NSCLC Drugs Targeting EGFR

South Korean Landscape of NSCLC Drugs Targeting EGFR l Pharma Intelligence

 

Distribution of Experienced Immuno-Oncology Investigators and Trial Sites in South Korea

Besides timely regulatory approval of clinical trials and the right patient population, another key factor that could make or break increased trial activity for this market is the availability of trial sites that can provide Phase I services to pharma companies. In a recent interview with PharmaAsia News, Min Soo Park, head of the Korea Clinical Trials Global Initiative, stated that early phase trials are “labor intensive and require scientifically advanced systems”.  He mentioned that early phase trials can be quite intricate, difficult to conduct and contain a higher amount of risk which requires more information and work from the hospitals conducting the trials. In the same breath, he also said that “In the past 10 years or so, South Korea has been fulfilling this.” [1]

These type of resources needed to conduct the early phase trials are found at large university hospitals. According to Park, there are five centers that are considered to be global centers of excellence for conducting these early phase clinical trials: Seoul National University Hospital, Yonsei University Health System, Asan Medical Center, Inje University Busan Pail Hospital and Samsung Medical Center. [1]

Table 3 below shows the number of ongoing and completed Phase I and I/II trials at these five centers for immuno-oncology (all cancer types) and NSCLC (all therapy types). When compared to the other South Korean sites who have participated in these types of trials (data not shown), all but Inje University Busan Paik Hospital possess more experience for both early phase immuno-oncology and all NSCLC trials.

 

Table 3 – Trial Experience of Five Centers of Clinical Trial Excellence

Trial Experience of Five Centers of Clinical Trial Excellence l Pharma Intelligence

 

In summary, South Korea’s shift of focus to early phase trials coupled with the government’s initiatives for shortened timelines of drug approvals, particularly in the areas of oncology and orphan drugs, and the related immuno-oncology trial experience of these five global centers makes it an attractive destination for pharma companies to conduct their next early phase oncology-related trials, particularly for NSCLC.

 

References:

[1] https://scrip.pharmamedtechbi.com/SC089592/INTERVIEW-Korea-Initiative-Aims-To-Create-Global-Clinical-Trial-Hub

[2] https://pink.pharmamedtechbi.com/PS118672/Korean-Regulatory-Overhaul-To-Cut-Drug-RnD-Approval-Time

[3] http://www.efpia.eu/uploads/Modules/Documents/efpia-position-on-clinical-trials-regulation-trialogue-27-november-2013-(1)-2.pdf

[4] https://scrip.pharmamedtechbi.com/SC089400/Yuhan-Joins-ImmunoOncology-Wave-Via-Sorrento-JV

[5] https://scrip.pharmamedtechbi.com/SC097017/Yuhan-Luoxin-Deal-Underscores-Asian-NSCLC-Therapy-Needs

[6] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4823185/

[7] Datamonitor Healthcare, November 2015



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