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[Hong Ju-yeon, Edaily Reporter] South Korea‘s pharmaceutical and biotech sector posted strong gains on May 22 as expectations for pipeline clinical achievements combined with concerns over the global spread of infectious diseases.
NatureCell, GI Innovation and Hyundai Bioscience each surged around 30%, 20%, and 20%, respectively while △D&D Pharmatech △LigaChem Biosciences △Rznomics △G2GBIO △HanAll Biopharma also rose more than 10% extending buying momentum across biotech stocks.
 | | Nature Cell stock chart (Source=KG Zeroin MP Doctor) |
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Nature Cell Rallies on Expectations for Direct FDA BLA Filing of JointStem According to KG Zeroin MP Doctor, formerly MarketPoint, Nature Cell closed regular trading up 29.98% from the previous session at 22,500 won.
The direct catalyst behind the sharp rise was a change in the U.S. Food and Drug Administration (FDA) approval strategy for JointStem, the company’s stem cell therapy for degenerative osteoarthritis.
Through its YouTube channel on Friday Nature Cell disclosed the outcome of its FDA meeting saying the agency confirmed that the company could immediately apply for a biologics license application (BLA) using only Phase 3 clinical data completed in Korea without conducting additional clinical trials.
The company had initially considered pursuing accelerated approval, but revised its strategy following the FDA‘s recommendation to skip the accelerated approval stage and proceed directly with a standard BLA filing.
JointStem has already secured both Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy (BT) designations from the FDA, meeting the requirements to request a shortened six-month review period instead of the standard 10-month review timeline.
However the company noted that submitting the application would not immediately trigger the review process and said it plans to focus on supplementing its chemistry manufacturing and controls (CMC) package.
Lee Jang ik professor at Seoul National University’s College of Pharmacy and an advisor to Nature Cell, told Edaily, “Unlike Korea‘s Ministry of Food and Drug Safety, which evaluates therapies based on absolute standards of efficacy and safety, the FDA makes judgments based on the balance between treatment risks and benefits.”
“This discussion can be interpreted as the FDA highly recognizing Nature Cell’s technology and therapeutic potential,” he added.
Lee also noted that Nature Cell acquired a stem cell manufacturing facility of approximately 100,000 square feet in Baltimore last year and is expected to proceed with its BLA filing after establishing GMP facilities at the site and compiling relevant documentation. “If everything proceeds smoothly, the FDA review period is expected to take about six months after the submission of the application documents,” he said.
 | | GI Innovation stock chart (Source=KG Zeroin MP Doctor) |
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GI Innovation Gains Ahead of ASCO Oral Presentation as GI-101A Data Draw Attention GI Innovation rose 20.92% from the previous trading day to 13,930 won. The gain was attributed to expectations surrounding an upcoming oral presentation on immuno-oncology candidate GI-101A (efdelikofusp alfa) at the 2026 American Society of Clinical Oncology (ASCO) meeting scheduled for May 30 (local time).
According to an abstract released on May 22, monotherapy at effective doses of 0.2–0.3 mg/kg induced complete remission (CR) in bladder cancer patients who were resistant to existing immunotherapies. Progression-free survival (PFS) reached 13.9 months, more than double Padcev‘s roughly six-month result.
In combination therapy with Keytruda (pembrolizumab), the treatment achieved an objective response rate (ORR) of 40% and a disease control rate (DCR) of 70% among 10 renal cancer patients.
The market also responded positively to data showing responses lasting as long as 16.7 months or longer despite 70% of patients previously failing immunotherapy treatment.
“GI-101A has shown a clear tendency for anti-cancer activity to increase as the dose rises,” said Yoon Na-ri, vice president of GI Innovation.
“Even after submission of the abstract, encouraging data exceeding previous results in terms of ORR and durability of response continue to be confirmed,” she added.
 | | Hyundai Bioscience stock chart (Source=KG Zeroin MP Doctor) |
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Hyundai Bioscience Gains Attention for Hantavirus and Ebola Treatment Potential Hyundai Bioscience closed up 19.98% from the previous session at 13,450 won. The company has now extended gains for two consecutive sessions as newly disclosed Ebola virus inhibition data for broad-spectrum antiviral candidate XAFTY coincided with growing global concerns over hantavirus outbreaks.
According to the company, XAFTY recorded a low half maximal inhibitory concentration (IC50) of 0.125 μM against the Ebola virus. IC50 refers to the drug concentration required to inhibit viral replication by 50%, with lower values indicating stronger antiviral activity at smaller doses.
The result was less than half the inhibitory concentration observed during clinical trials in COVID-19 patients, where efficacy was demonstrated at 0.28 μM.
XAFTY also showed inhibitory efficacy below 0.125 μM against severe fever with thrombocytopenia syndrome (SFTS) virus, raising the possibility of application to hantavirus, which belongs to the same Bunyavirales viral order.
The candidate’s safety has already been confirmed through Phase 2 and 3 COVID-19 trials as well as Phase 2 and 3 dengue fever studies conducted in Vietnam.
“XAFTY is a broad-spectrum antiviral capable of simultaneously targeting various viruses,” said Bae Byung joon president of Hyundai Bioscience. “It could become a practical alternative capable of protecting humanity during deadly infectious disease crises such as Ebola or hantavirus outbreaks,” he added.
