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Samsung Bioepis Applies for First Domestic Approval of Keytruda Biosimilar Samsung Bioepis announced on August 10 that it has applied for domestic approval of its biosimilar candidate SB27 (active ingredient: pembrolizumab), which is based on the world’s top-selling immuno-oncology drug, Keytruda. This marks the first instance of a domestic pharmaceutical company seeking approval for a Keytruda biosimilar in South Korea.Keytruda, developed by Merck (MSD) in the United States, is a PD-1 inhibitor-based immuno-oncology drug. It generated approximately $31.7 billion in global sales last year. The drug works by blocking PD-1, which helps cancer cells evade the immune system, thereby restoring the cancer-fighting action of immune cells. It is used for 16 indications, including melanoma, non-small cell lung cancer, and head and neck cancer.Starting in 2024, Samsung Bioepis will conduct global Phase 1 and Phase 3 clinical trials targeting non-small cell lung cancer patients to confirm the equivalence of SB27 to the original drug.In the Phase 1 trial, conducted in four countries including South Korea with 163 participants, the pharmacokinetic evaluation metric, area under the concentration-time curve (AUC), met pre-established criteria, demonstrating equivalence to the original drug.The Phase 3 trial involved 555 participants across 14 countries, analyzing the objective response rate (ORR) at 24 weeks as the primary endpoint. The results indicated that SB27 showed equivalent efficacy to the original drug without statistically significant differences. No meaningful differences in safety and immunogenicity were observed between the two groups.Shin Dong-hoon, head of clinical medicine at Samsung Bioepis, stated, "We will thoroughly explain the research and development results of SB27 during the approval review process and ensure that related procedures are carried out smoothly to provide immuno-oncology treatment options to domestic patients as soon as possible."Meanwhile, the U.S. Food and Drug Administration (FDA) has decided to lower the application review fees for specialty drugs (PDUFA) and biosimilars starting in October. This is expected to reduce the financial burden on domestic companies like Samsung Bioepis that are developing biosimilars for the U.S. market.The application review fee for new drug applications (NDA) and biologics license applications (BLA) has been set at $4,600,753 (approximately 6.6 billion won), a 1.7% decrease from last year when clinical data is included. The biosimilar (BsUFA) fee has also been reduced by 6.3% to $1,124,936 (approximately 1.6 billion won).* This article has been translated by AI. 2026-08-10 16:56:00 -
Cooler temps bring back the royal show A royal guard-changing ceremony takes place at Gyeongbokgung Palace in Jongno District, Seoul, on Aug. 10, as the prolonged heat wave eases following Ipchu, the traditional start of autumn. The ceremony, which had been suspended due to extreme heat, resumed on Aug. 8 after Seoul lifted its highest-level heat wave alert. 2026-08-10 16:52:58 -
Minister Choi Hwi-young Meets Busan Mayor Jeon Jae-soo to Discuss Cultural Hub Support The Ministry of Culture, Sports and Tourism is strengthening comprehensive policy cooperation with Busan City in the fields of culture, sports, and tourism.On August 10, Minister Choi Hwi-young attended the opening ceremony of the '2026 Busan World Library and Information Conference (WLIC)' at BEXCO, where he met with Busan Mayor Jeon Jae-soo to discuss key issues of mutual interest.During the event, Minister Choi and Mayor Jeon celebrated the opening and toured the exhibition hall to review the conference operations and displays from participating countries. The conference, hosted by the International Federation of Library Associations and Institutions (IFLA), runs until August 13 under the theme 'Libraries Leading Change,' attracting over 3,000 attendees from more than 120 countries.In a subsequent luncheon meeting, Mayor Jeon outlined major cultural, sports, and tourism initiatives, including the construction of a multi-purpose dome stadium, and requested cooperation from the central government.In response, Minister Choi introduced several Ministry policies that can be practically utilized at the local level, such as the 'Dream Art Troupe' aimed at expanding cultural and artistic education opportunities for children and youth, and the 'Cultural Day' initiative, which increases access to cultural experiences once a week. He urged Busan's active participation in these programs.The Ministry and Busan City agreed to maintain a collaborative relationship that goes beyond individual projects, ensuring ongoing communication across all areas. The matters discussed will be further detailed at the operational level.Minister Choi stated, 'Busan possesses unique assets, from maritime and port facilities to film and video production, making it a cultural hub in the southern region. We will spare no effort in supporting its role. As this conference demonstrates, when the central and local governments work together, the results are significant. The Ministry will be a strong partner in ensuring that Busan's envisioned policies lead to tangible outcomes.'In line with Busan's cultural and tourism development, there has been a notable increase in foreign tourists. According to Busan City, 2.42 million foreign visitors came to the city from January to June this year, marking a 43.9% increase compared to the same period last year, which saw 1.68 million visitors. Notably, June recorded the highest monthly total this year, with 484,057 visitors. The largest groups of tourists came from Taiwan (477,606), China (468,876), Japan (291,141), and the United States (219,147).The influx of tourists has also contributed to the revitalization of the local economy. According to an analysis of credit card big data by the Korea Tourism Organization, foreign tourist spending in Busan reached 591.4 billion won in the first half of the year, a 63% increase from 362.1 billion won during the same period last year, surpassing the national average growth rate of 55%.* This article has been translated by AI. 2026-08-10 16:52:00
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Lee pushes to speed up chip cluster projects SEOUL, August 10 (AJP) - President Lee Jae Myung on Monday urged officials to speed up large-scale artificial intelligence (AI)-related investment initiatives to build a massive semiconductor cluster and related infrastructure in regional areas including South Jeolla Province. Lee made the remarks at a meeting to assess progress on the mega projects unveiled in June, under which Samsung Electronics and SK hynix have pledged a combined 800 trillion won (US$570 billion) in investment. Specifically, Lee called for early use of a military air base in Gwangju, selected as a main site for the planned semiconductor cluster. He instructed the Defense Ministry to temporarily relocate the base's functions to another nearby military airport by mid-2028 so the existing site can be used for the project. He said preparations can begin even before the military functions are fully relocated, adding that the relocation should not delay the project's planned schedule. He also stressed that plans to secure electricity and water supplies for the cluster should be prepared without delay, urging officials to work closely with the National Assembly to remove administrative hurdles, regulations and other bureaucratic barriers to the projects. "At this stage, what matters most is building the cluster as quickly as possible," he said, comparing it to the rapid construction of a similar semiconductor complex in Kumamoto, Japan. He said the country could not afford to waste time, pushing for "all-out efforts" on the projects. Lee also asked Samsung Electronics and SK hynix to ensure that their investment plans benefit suppliers and local economies, helping foster a broader industrial ecosystem. "Once investment is made and factories are built, it will already be too late to change course," Lee said. "We need to think from the beginning of each project about how to create growth that benefits everyone." AJP Key Takeaways: - President Lee Jae Myung on Aug. 10, 2026, urged officials to accelerate large-scale artificial intelligence (AI)-related investment projects aimed at building a semiconductor cluster and related infrastructure in regional areas, including South Jeolla Province. - Samsung Electronics and SK hynix have pledged a combined 800 trillion won (US$570 billion) in investment under mega projects unveiled in June 2026. - Lee ordered the Defense Ministry to temporarily relocate functions at a military air base in Gwangju to another nearby military airport by mid-2028, allowing the existing site to be used for the planned semiconductor cluster. - Lee called for preparations for electricity and water supplies to begin without delay and urged officials to work with the National Assembly to remove administrative, regulatory and bureaucratic barriers that could slow the projects. - Lee urged Samsung Electronics and SK hynix to ensure their investments benefit suppliers and local economies, creating a broader semiconductor industrial ecosystem rather than focusing solely on factory construction. 2026-08-10 16:50:07 -
Hanwha Increases Stake in KAI to 15.89%, Files for Merger Review Hanwha Group has increased its stake in Korea Aerospace Industries (KAI) to over 15%.According to the Financial Supervisory Service's electronic disclosure system on August 10, Hanwha Systems recently acquired 3.45% of KAI shares in the market over the past month.As a result, Hanwha Group's ownership in KAI rose from 12.44% to 15.89%.The breakdown of ownership among its affiliates includes Hanwha Aerospace at 9.90%, Hanwha Systems at 4.98%, and Hanwha Aerospace USA at 1.01%.With the stake exceeding 15%, Hanwha Group plans to apply for a merger review with the Fair Trade Commission.Currently, the largest shareholder of KAI is the Korea Export-Import Bank, which holds 26.41% of the shares, while Hanwha Group remains the second-largest shareholder. 2026-08-10 16:48:10
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Guard ceremony returns to Gyeongbokgung A royal guard-changing ceremony takes place at Gyeongbokgung Palace in Jongno District, Seoul, on Aug. 10, as the prolonged heat wave eases following Ipchu, the traditional start of autumn. The ceremony, which had been suspended due to extreme heat, resumed on Aug. 8 after Seoul lifted its highest-level heat wave alert. 2026-08-10 16:47:35 -
Tire Bank Chairman Kim Jeong-kyu Withdraws Appeal, 3-Year Prison Sentence Confirmed Kim Jeong-kyu, chairman of Tire Bank, has confirmed a three-year prison sentence after withdrawing his appeal against charges of tax evasion amounting to approximately 8 billion won through fraudulent use of dealership names.According to legal sources on August 10, Kim submitted a withdrawal of his appeal to the Supreme Court on June 22.Earlier, on June 2, he was sentenced to three years in prison and fined 14.1 billion won in a retrial. He appealed to the Supreme Court a week later, on June 9, seeking a review of the decision.However, shortly after the Supreme Court accepted the case, Kim withdrew his appeal, leading to the confirmation of the sentence from the retrial.The prosecution did not appeal the retrial's outcome.The vice chairman of Tire Bank, who was also indicted on similar charges and received a two-and-a-half-year prison sentence, also withdrew his appeal, confirming his sentence.Kim was indicted in October 2017 for allegedly evading a total of 8 billion won in comprehensive income tax by disguising some Tire Bank dealerships as being operated by their owners, thereby underreporting cash sales and transaction details.Following an administrative lawsuit, the amount of tax evasion was reduced to 3.9 billion won in the second trial. However, the Daejeon High Court sentenced Kim to three years in prison and a fine of 14.1 billion won in July of last year, leading to his immediate incarceration.In January, the Supreme Court returned the case to the Daejeon High Court, stating that the statute of limitations had expired for part of the tax evasion amount.In the retrial, the evaded amount was reduced to 3.15 billion won, but the reasons for Kim's appeal were rejected, and the sentence remained unchanged.* This article has been translated by AI. 2026-08-10 16:44:20
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Lee Jae-myung Takes Selfie with Chinese Tourists at Gyeongbokgung Lee Jae-myung, the President of South Korea, has become a topic of discussion online after taking a selfie with Chinese tourists visiting Gyeongbokgung Palace in Seoul.According to a report on August 10 by China's state-run Xinhua News Agency's social media account, the tourists encountered President Lee during their recent visit to the historic site.Xinhua noted, "Despite the heat, President Lee, dressed in long-sleeved work attire, took the initiative to hold a mobile phone and snap selfies with the Chinese tourists," adding that the atmosphere was cheerful.A Chinese netizen who met President Lee at the time shared on social media, "When taking the selfie, the president asked in English, 'China?' to which I replied, 'Yes.' He also remarked, 'People are really nice.'The released video shows President Lee taking photos with the tourists, including moments where he personally handles their mobile phones to capture the images, as well as scenes of his Chief of Staff, Kang Hoon-sik, receiving a phone to photograph the president with the tourists.The sight of a national leader spontaneously taking selfies with ordinary citizens is unusual in China, leading to significant attention on Chinese online media and social media platform Weibo. One user commented, "This is something that could not happen in China." 2026-08-10 16:44:00
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European Stock Markets Gain Attention as Alternative Investment Amid Global Tech Volatility As global technology stocks, particularly in artificial intelligence (AI) and semiconductors, experience increased volatility, European stock markets are emerging as an attractive alternative investment. With oil prices stabilizing after a surge due to the U.S.-Iran conflict and European companies reporting stronger-than-expected earnings, investment funds previously focused on tech and AI are shifting towards Europe.According to the Financial Times on September 9, financial analytics firm FactSet projects that profits for companies in the Stoxx Europe 600 index will increase by 22% in the second quarter compared to the same period last year, marking the highest growth rate since the market recovery following the COVID-19 pandemic in 2022.Marina Zavolok, a European equity strategist at Morgan Stanley, described this earnings season as "remarkable," noting that "very positive results are coming from almost all sectors." Strong earnings have also bolstered the European stock market. The Stoxx Europe 600 has recently set multiple record highs, with major indices such as Germany's DAX, the UK's FTSE 100, France's CAC 40, and Spain's IBEX also reaching new peaks.Capital inflows have resumed. Bloomberg reports that European equity exchange-traded funds (ETFs) recorded their first monthly net inflow since the onset of the U.S.-Iran conflict in late February. BlackRock's European equity products attracted $4.4 billion during the same period.Particularly, last month's sharp decline in global semiconductor stocks has highlighted the appeal of diversifying investments in the European market, which is less affected by the volatility of tech and AI stocks. Zavolok analyzed that the strong performance of European companies is further increasing the demand for diversified investments in European equities.Banking stocks are leading the rise in the European market. BNP Paribas reported a nearly 33% increase in second-quarter profits, while UBS saw a 17% rise, achieving record highs. This year, the Stoxx Europe Bank Index has risen over 21%, significantly outpacing the 11.5% increase in the Stoxx Europe 600. Semiconductor companies like ASML and Infineon have also raised their revenue forecasts for the year.The easing tensions in the Middle East are also boosting investor sentiment. Concerns about the European economy, which heavily relies on energy imports, grew as oil prices surged due to the U.S.-Iran conflict and the effective blockade of the Strait of Hormuz. However, recent efforts by both countries to seek an end to the conflict have led to a decline in oil prices to below $90 per barrel.Beata Mantey, head of European equity strategy at Citi, stated that with the reduction of tensions in the Middle East, Europe appears to have avoided the worst-case scenario of soaring energy prices, adding that "global investors are beginning to prefer Europe again." She noted that the European stock market is being highlighted as a so-called 'anti-AI investment,' attracting funds looking to diversify away from AI-centric portfolios.However, some analysts caution that it is too early to consider the capital shift towards European stocks as a clear trend. The funds flowing into European equities have not yet reached the peak levels recorded earlier this year, and investments remain concentrated in certain sectors, such as banking.Emmanuel Maconga, a European equity strategist at Barclays, assessed that until early July, the funds directed towards Europe were more reflective of capital exiting the U.S. rather than genuine interest in Europe itself. However, as earnings reports continue, he noted that "fundamentals supporting market growth are being confirmed beyond simple diversification," indicating that investors are once again turning their attention to the European market.* This article has been translated by AI. 2026-08-10 16:40:10
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Emergency Response Team Activated to Protect Vulnerable Groups Amid Ongoing Heatwave The government has established an emergency response team to address the prolonged and record-breaking heatwave, focusing on protecting vulnerable populations. Although temperatures eased somewhat over the weekend, heat advisories remain in effect, prompting officials to implement a rigorous, on-the-ground response system. The Ministry of Health and Welfare convened the first meeting of the 'Heatwave Response Emergency Headquarters' at 8:30 a.m. on August 10, led by Deputy Minister Hyun Soo-yeop. The team will closely monitor the situation and maximize protection for vulnerable groups by dividing into three specialized response teams. The first team, led by the Director of Social Welfare Policy, is focused on protecting at-risk populations, including the homeless, residents of goshiwons (small, inexpensive rooms), and those at risk of solitary deaths. They are conducting daily patrols for the homeless three times a day and checking on goshiwon residents once daily. The team is also assessing the operation of cooling centers and support for air conditioning and electricity costs. Additionally, they plan to utilize honorary social workers and maintain a constant hotline with local governments to identify households in crisis due to the heat. The second team, led by the Director of Population and Social Services Policy, is dedicated to protecting the elderly and disabled. They are checking on elderly individuals living alone through home care workers and assessing the distribution of nutritional meals and summer supplies. Notably, outdoor activities for elderly job seekers have been suspended during peak heat hours, and the team will enhance monitoring of senior centers, dementia care centers, and facilities providing services to people with disabilities. The third team, led by the Director of Essential Public Health Services, is reviewing the operation of the disease control agency's emergency room surveillance system for heat-related illnesses and the status of health management services at public health centers. Based on the analysis of emergency room data, the team will continue to implement focused protective measures for those aged 80 and older, who are most vulnerable to heat-related illnesses, while also identifying effective policy improvements through on-site visits to health centers. Deputy Minister Hyun stated, "We will not let our guard down for a moment until the heatwave situation is completely over, and we will do our utmost to ensure that vulnerable groups do not suffer. We will strengthen cooperation with local governments and relevant agencies to ensure that our heatwave response measures are effective."* This article has been translated by AI. 2026-08-10 16:40:10