[Yu Jin-hee, Edaily Reporter] Investor sentiment across South Korea’s pharmaceutical and biotechnology sectors is staging a robust recovery. Moving past the speculative momentum of the past, strong institutional and retail buying is now concentrated on companies demonstrating tangible business milestones—including regulatory tailwinds from global agencies, visible operating profit turnarounds, and rapid clinical adoption of domestically developed novel drugs.

According to KG Zeroin’s MP DOCTOR on August 19, the leading biotech companies securing spots among the top 40 gainers in the domestic market were SillaJen (215600), Bioneer (064550), and Vivozon Pharmaceutical (082800). All three companies posted sharp gains, driven by their distinctive pipeline strengths and financial turnarounds.

Market participants noted that PharmEdaily’s exclusive pre-market in-depth analysis report, published earlier that morning, served as a key catalyst that sparked buying interest right from the opening bell.

Spot-On Analysis from PharmEdaily: First U.S. FDA Approval in 11 Years Puts Spotlight on SillaJen’s IV Oncolytic Platform

SillaJen surged 8.04% on August 19 to close at 2,285 KRW, maintaining a steady upward trajectory. The company’s advance was propelled by PharmEdaily’s exclusive morning report, which highlighted major regulatory progress in the global oncolytic virus sector.

Earlier at 7:30 a.m., PharmEdaily broke the news through its premium paid service that the U.S. Food and Drug Administration (FDA) had granted accelerated approval to Replimune’s oncolytic virus therapy, Tudriqev. This marks the FDA’s first approval of an oncolytic immunotherapy since Amgen’s Imlygic in 2015—an interval of 11 years.

Tudriqev received approval in combination with Bristol Myers Squibb’s (BMS) checkpoint inhibitor Opdivo for adults with unresectable, advanced melanoma who had previously received anti-PD-1 therapy, achieving an objective response rate (ORR) of 24.2%. By demonstrating that combining an oncolytic virus with immune checkpoint inhibitors can effectively overcome resistance to immunotherapy, this regulatory milestone sparked a sector-wide reassessment of oncolytic platforms.

Attention quickly turned to SillaJen, the developer of the next-generation “SJ-600 series” oncolytic platform. While conventional first- and second-generation therapies remain limited to intratumoral (IT) administration, SillaJen has engineered a proprietary systemic intravenous (IV) injection platform.

Direct intratumoral injections offer localized potency but face clear clinical hurdles in reaching deep-seated tumors or widespread metastatic lesions. In contrast, SillaJen’s SJ-600 platform expresses the human complement regulatory protein CD55 on the viral envelope, shielding the virus from innate immune complement attacks in the bloodstream. This design preserves viral viability even in the presence of neutralizing antibodies, enabling repeated intravenous administrations.

Its therapeutic viability has been confirmed in peer-reviewed literature. Research on the candidate drugs SJ-607 and SJ-650 has been published in the *Journal for ImmunoTherapy of Cancer* (JITC) and *Molecular Therapy*, respectively, confirming resistance to serum neutralization and robust tumor suppression in immunocompetent animal models. SillaJen is currently establishing clinical-grade drug manufacturing through a comprehensive partnership with the Italian CDMO ReiThera to accelerate entry into global clinical trials.

"The FDA’s first oncolytic virus approval in 11 years marks a pivotal turning point for the sector," said a SillaJen representative. "By combining our track record of leading a global Phase 3 trial with our differentiated intravenous delivery platform, we will aggressively capture market leadership in next-generation oncolytic therapies."

Record Quarterly Revenue, Profit Turnaround, and Major Journal Publication Drive Bioneer to the Daily Limit

Bioneer hit the daily upper limit on the KOSDAQ market, soaring 29.99% (up 2,120 KRW) to close at 9,190 KRW. Aggressive buying drove daily trading volume to 42.18 billion KRW. The rally was fueled by the twin drivers of record earnings and the publication of human clinical study results in a world-renowned dermatology journal.

Bioneer announced that its consolidated revenue for the second quarter reached approximately 96.1 billion KRW, up 8.9% year-over-year—marking the highest quarterly revenue in the company’s history. Cumulative revenue for the first half of the year reached roughly 177.9 billion KRW, maintaining solid top-line momentum.

Operating profit shifted from a 500 million KRW loss in the first quarter to a clear profit in the second quarter. Crucially, this turnaround was driven by operating leverage and top-line growth rather than cost-cutting measures. Bioneer increased its R&D spending by approximately 1.4 billion KRW quarter-over-quarter, directing resources toward securing Phase 1b clinical data for its core pipelines. Its healthcare subsidiary, AceBiome, also expanded its distribution channels to bolster growth.

Clinical R&D delivered equally strong news. Bioneer announced that clinical trial results validating its next-generation CosmeRNA technology in stress-related scalp environments were published in the Journal of the American Academy of Dermatology (JAAD), the official journal of the American Academy of Dermatology (AAD).

The 24-week double-blind, randomized controlled trial evaluated 72 patients with mild-to-moderate androgenetic alopecia. Biweekly topical application of a formulation targeting DKK1—a primary inhibitor of hair follicle growth—demonstrated statistically significant improvements in both hair density and hair thickness across both low- and high-dose cohorts compared to placebo. Notably, improvements in hair thickness were maintained even among subjects with elevated baseline cortisol levels. Bioneer plans to accelerate the commercialization of its DKK1-targeted pipeline following the CosmeRNA ARI.

“Our preemptive investment strategy is now translating directly into record quarterly revenues and an operating turnaround,” noted a Bioneer official. “Having validated our next-generation hair loss technology in a prestigious journal, we will leverage this momentum to strengthen our global licensing discussions and diversify our product lines.”

Named Official Prix Galien Korea Finalist as Prescription Sales Surge 229%: Vivozon Pharma Jumps 18%

Vivozon Pharmaceutical gained 18.36% to close at 3,320 KRW, driven by surging hospital prescriptions for its proprietary non-opioid analgesic “Unafra Inj.” and its nomination for a prestigious international industry award.

Vivozon Pharmaceutical announced that Unafra Inj. was selected as an official finalist for the Best Pharmaceutical Product Award at the inaugural “2026 Prix Galien Korea,” hosted by the Galien Foundation. Often referred to as the “Nobel Prize of the pharmaceutical industry,” the Prix Galien program evaluates the scientific rigor and clinical impact of first-in-class innovations addressing unmet medical needs.

Unafra Inj. operates via a dual-action mechanism targeting Glycine Transporter Type 2 (GlyT2) inhibition and Serotonin 2A (5-HT2A) receptor antagonism. It effectively manages moderate-to-severe acute postoperative pain while eliminating the severe risks of addiction and respiratory depression associated with conventional opioids.

Commercial adoption in medical institutions is rapidly gaining momentum. Second-quarter revenue for Unafra Inj. reached 2.0 billion KRW, a 229% increase from the previous quarter. This growth follows its approval by the Ministry of Food and Drug Safety (MFDS) in 2024 and its adoption across tertiary general hospitals, including Severance Hospital in Sinchon, Seoul.

Advancements in manufacturing and formulation are also underway. In collaboration with its Chinese contract manufacturing organization (CMO) partner, Huiyu Pharmaceutical, Vivozon Pharma is developing a high-concentration injectable formulation that reduces the product volume to one-tenth of the original size, substantially streamlining production and cold-chain logistics.

“The scientific novelty and clinical efficacy of Unafra Inj. are being demonstrated simultaneously through peer-reviewed clinical evidence and real-world adoption in major tertiary hospitals,” stated a Vivozon Pharmaceutical representative. “We will accelerate broader hospital adoption domestically while leveraging real-world Korean clinical data to drive our global expansion.”