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Subsequently, Biosolution's stock price rose as expectations for a Phase 3 clinical trial in the U.S. were reflected following the Chinese approval of its osteoarthritis cell therapy, CartiLife. ViGenCell transitioned back to an upward trend after continuously delivering positive news regarding its autologous immune cell therapy, VT-EBV-N.
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DongWoon Anatech Surges 8%
According to KG Zeroin MP Doctor (formerly MarketPoint), DongWoon Anatech's stock closed at 51,400 won on this day, up 8.21% from the previous trading day. The rise in DongWoon Anatech's stock price this month is analyzed to be driven by news regarding the potential to prove the clinical efficacy of the saliva-based blood glucose meter, D-SaLife, which is currently under development.
On the 29th, DongWoon Anatech announced on its website that D-SaLife demonstrated high clinical efficacy in a clinical study conducted at Asan Medical Center in Seoul.
For two months from October to November of last year, DongWoon Anatech conducted a clinical trial of the D-SaLife saliva glucose measurement system on a total of 121 general individuals and diabetic patients at Asan Medical Center. Following this, the company conducted a detailed statistical analysis of the clinical trial data until late March of this year.
According to the results of this clinical trial, the clinical efficacy of D-SaLife was analyzed to be at a remarkably high level. The accuracy of quantitative blood glucose levels predicted by saliva in a fasting state showed a Mean Absolute Relative Difference (MARD) of around 8%. This is a significantly improved figure from the 12% MARD level measured in a clinical trial at Seoul St. Mary's Hospital three years ago. Furthermore, the accuracy of quantitative blood glucose levels predicted by saliva up to 2 hours after a meal was measured at a MARD in the 10% range.
MARD is a figure representing the absolute percentage difference between the measurement of the test device and the reference device. Currently, globally commercialized CGM (Continuous Glucose Monitoring) devices generally have a MARD of 8~12%, while other various non-invasive blood glucose devices have MARD values around 10~20%.
In addition, the ‘ISO 15197:2013’ regulation, which the Ministry of Food and Drug Safety (MFDS) uses as the standard for evaluating the clinical efficacy and safety of blood glucose meters, specifies that when general users measure their blood glucose, over 99% of the results must fall within zones A and B of the Consensus Error Grid (CEG). In this Asan Medical Center clinical trial, 100% of D-SaLife's blood glucose measurements fell within the A+B zones, and none of the 121 subjects who used D-SaLife experienced any adverse events.
Professor Jung Chang-hee, who led this clinical trial, evaluated in the clinical result report, "This demonstrates the high potential of the completely bloodless and non-invasive D-SaLife as an alternative for diabetic patients who avoid BGM (Blood Glucose Monitoring) or CGM due to aversion to blood drawing, risk of infection, high costs, or inconvenience, as well as for high-risk diabetic groups such as those who are overweight, obese, or in the pre-diabetic stage."
A representative from DongWoon Anatech stated, "The stock price seems to have risen as expectations for D-SaLife are reflected," adding, "Starting with the MFDS GMP review on the 11th of next month, we plan to proceed with the MFDS licensing schedule in earnest."
Biosolution: Rises 8% on U.S. Clinical Trial Expectations
Biosolution's stock closed at 11,990 won, up 8.02%. The rise in Biosolution's stock price on this day is interpreted as reflecting expectations for a U.S. clinical trial following the Chinese approval of its core product, 'CartiLife,' and the development of its next-generation pipeline, 'Spherocure.'
On the 30th, PharmEdaily analyzed the positive effects of the recent Chinese approval of Biosolution's osteoarthritis cell therapy CartiLife through the article Biosolution Accelerates U.S. Phase 3 with Chinese Approval of CartiLife… A 'Quantum Jump' Next-Generation Injection.
Biosolution believes that the entry of CartiLife into the Chinese market will serve as a 'crucial foundation of trust' for entering the global big market. Accordingly, the company plans to swiftly push forward with a Phase 3 clinical trial in the U.S. and the early commercialization of its next-generation treatment, 'Spherocure.'
In fact, the large-scale data to be accumulated in the Hainan Medical Special Zone is expected to become a powerful weapon in the future U.S. FDA approval process or in technology licensing (L/O) negotiations with global pharmaceutical companies in the Middle East and elsewhere.
In particular, regarding its entry into the U.S., Biosolution plans to hold a 'Type C' meeting with the FDA during the first half of the year to flesh out the design of the Phase 3 clinical trial. Biosolution plans to rapidly expand its market share through a strategic partner company equipped with local GMP facilities and networks in the U.S.
The next-generation pipeline, an injectable osteoarthritis treatment called 'Spherocure,' is also expected to provide strong momentum. Spherocure, an injection that maximizes patient convenience by overcoming the limitations of existing surgical methods, is expected to receive Investigational New Drug (IND) approval during the second quarter of this year.
A reevaluation of Biosolution's corporate value is highly anticipated, especially since the commercialization period can be shortened to within 2 to 3 years through the application of the Act on Advanced Regenerative Medicine and Advanced Biopharmaceuticals.
Lee Jung-sun, CEO of Biosolution, stated, "The large-scale commercialization data to be secured in China will be the strongest weapon to maximize our negotiating power for FDA Phase 3 clinical trial approval and global technology export (license out)."
He added "Starting with CartiLife, we will prove the value of our subsequent pipelines including Spherocure with concrete numbers to achieve a quantum jump."
ViGenCell: Transitions Back to an Upward Trend
On this day, ViGenCell's stock price recorded 10,890 won, up 9.89%. ViGenCell has been on a full-fledged upward trend since the 22nd. From a closing price of 5,690 won on the 21st, it hit the upper limit for two consecutive days on the 22nd and 23rd, rising to 9,600 won.
It then fell for two consecutive trading days but transitioned back to an upward trend on this day. As a result, ViGenCell's stock price has surged by approximately 91.39% compared to the closing price on the 21st.
The upward trend in ViGenCell's stock price is attributed to a series of positive news related to its main pipeline, the autologous immune cell therapy 'VT-EBV-N.'
On the 22nd, ViGenCell announced that the Phase 2 clinical study results of 'VT-EBV-N' were selected for an Oral Abstract Session at the American Society of Clinical Oncology (ASCO 2026).
Subsequently on the 24th it announced that the advanced regenerative medicine treatment plan for VT-EBV-N targeting patients with complete remission of EBV-positive extranodal NK/T-cell lymphoma, who have a high risk of relapse, received an approval of suitability from the Ministry of Health and Welfare's 'Advanced Regenerative Medicine and Advanced Biopharmaceuticals Deliberative Committee.'
In particular, ViGenCell plans to commence earnest discussions on global technology exports through the 'ChinaBio Partnering Forum' held in China.
The ChinaBio Partnering Forum is the largest bio-partnering event in China, attended by about 500 companies worldwide, where intensive discussions on technology transfer and joint development take place between global pharmaceutical companies and biotechs. At this event, ViGenCell aims to deepen consultations with existing Chinese companies and expand its partnership boundaries through new meetings with U.S. and European companies.
A ViGenCell representative said "Starting with the ASCO presentation, the interest of global pharmaceutical companies is increasing."
adding "We will translate cooperative discussions into practical results through major partnering events."
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