[Edaily Reporter YU JIN-HEE ] Investor sentiment is recovering in the domestic pharmaceutical and biotech stock market. Unlike in the past, when sentiment relied on vague expectations, strong buying interest is now flowing primarily toward companies that have demonstrated tangible business momentum—such as benefits from new drug approvals by global regulatory agencies, a visible return to profitability, and increased prescriptions for domestically developed new drugs.

Pharm e-Daily’s pre-release analysis proves effective… SillaJen, Inc.’s “intravenous administration” draws attention following first U.S. FDA approval in 11 years

According to KG Zeroin MP Doctor (MP DOCTOR) on the 19th, the leading biotech companies that ranked among the top 40 in terms of percentage gain on the domestic stock market that day were SillaJen, Inc.(215600), BIONEER CORPORATION(064550), and #VIVOZON PHARMACEUTICAL. These three companies posted strong gains in tandem, driven by their differentiated pipeline competitiveness and news of a rebound in earnings.

SillaJen, Inc. posted a solid upward trend on the 19th, closing at 2,285 won—an 8.04% increase from the previous day. The rise in SillaJen, Inc.’s stock price was driven by PharmiDaily’s Premium content, which quickly identified major positive developments in the global anticancer virus market.

Earlier that day, at 7:30 a.m., PharmiDaily exclusively released an in-depth analysis article via its premium paid content, reporting that the U.S. Food and Drug Administration (FDA) had granted accelerated approval to Replimun’s anticancer virus therapy “Tudriqev.” This marks the first time the FDA has approved a new anticancer virus drug in 11 years, since Amgen’s “Imlygic” in 2015.

Tudriqev received marketing approval after demonstrating an objective response rate (ORR) of 24.2% in patients with unresectable, advanced cutaneous melanoma when administered in combination with Bristol Myers Squibb’s (BMS) immuno-oncology drug “Opdivo.” As the efficacy of combination therapy with immune checkpoint inhibitors was proven, investor sentiment toward the global anticancer virus development sector—which had been stagnant for several years—improved rapidly.

Market attention has focused on SillaJen, Inc., which has established the next-generation anticancer virus platform, the “SJ-600 Series.” SillaJen, Inc. has secured a distinct competitive advantage by overcoming the limitations of existing first- and second-generation therapies—which were limited to intra-tumoral (IT) injection—and independently developing an intravenous (IV) platform that allows for systemic administration.

While direct intratumoral injection offers excellent drug delivery, its application is limited to patients with deep-seated cancers or systemic metastatic cancers that are difficult to access. In contrast, SillaJen, Inc.’s SJ-600 Series is designed to evade attack by the innate immune system in the bloodstream by expressing the human complement regulatory protein (CD55) on the viral envelope. This allows for repeated intravenous administration without the virus being inactivated, even in environments where neutralizing antibodies have formed.

The technology’s efficacy has also been repeatedly validated. The candidate compounds “SJ-607” and “SJ-650” were published in the international journals *JITC* and *Molecular Therapy*, respectively, demonstrating resistance to serum neutralization and tumor-suppressing efficacy in normal immune animal models. SillaJen, Inc. is preparing to enter global clinical trials by establishing a clinical sample production system in collaboration with ReiThera, an Italian contract development and manufacturing organization (CDMO).

A SillaJen, Inc. official stated, “The FDA’s approval of an oncolytic virus—the first in 11 years—marks a turning point for the market to rebound after a period of stagnation,” adding, “SillaJen, Inc. will secure a leading position in the next-generation oncolytic virus market by combining its unparalleled clinical experience, gained from leading global Phase 3 trials, with its innovative platform technology for intravenous administration.”

'Record-High Revenue,' Return to Profitability, and Positive News from Academic Journals... 'BIONEER CORPORATION' Hits Daily Price Limit

BIONEER CORPORATION closed at 9,190 won today, up 29.99% (2,120 won)—the daily price limit—marking a record high. Explosive buying pressure drove the stock, with daily trading volume alone reaching 42.17549 billion won. BIONEER CORPORATION’s explosive stock price surge was driven by a double dose of good news: the announcement of strong financial results and the publication of a paper in a world-renowned academic journal. BIONEER CORPORATION has completely dispelled market uncertainty by simultaneously demonstrating revenue growth and improved profitability.

BIONEER CORPORATION announced that it achieved consolidated second-quarter revenue of approximately 96.1 billion won, an 8.9% increase compared to the same period last year. This marks the company’s highest quarterly revenue on record. Cumulative revenue for the first half of this year also reached approximately 177.9 billion won, continuing its robust revenue growth.

Operating profit turned positive in the second quarter after posting a loss of approximately 500 million won in the first quarter, marking a clear rebound in performance. In particular, the market highly praised this achievement because it was not merely a “recession-driven profit” resulting from simple cost-cutting, but rather a result achieved through expanded revenue scale while increasing investment in new drug research and development (R&D). In the second quarter, BIONEER CORPORATION increased its new drug R&D expenses by approximately 1.4 billion won compared to the previous quarter, focusing on accumulating Phase 1b clinical data for its core pipeline. AceBiome, its subsidiary specializing in probiotics, also contributed to growth by expanding its distribution network.

There was also good news on the R&D front. BIONEER CORPORATION announced that the results of a human clinical trial verifying the efficacy of a follow-up technology to “Cosmerna” in the scalp environment associated with stress-induced hair loss were published in “JAAD,” the official journal of the American Academy of Dermatology (AAD). JAAD is recognized as one of the most prestigious journals in the field of dermatology worldwide.

This study was conducted over 24 weeks on 72 patients with mild to moderate androgenetic alopecia. After applying a topical formulation targeting “DKK1,” a factor regulating hair follicle regression, at two-week intervals, both the low-concentration and high-concentration groups showed statistically significant improvements in hair density and thickness compared to the placebo group. Notably, the hair improvement effects were sustained even in participants with high levels of cortisol, a stress hormone. BIONEER CORPORATION plans to accelerate the commercialization of follow-up products based on its DKK1-targeting technology, “CosmeRNA ARI.”

A BIONEER CORPORATION official stated, “Our proactive investment strategy has been validated by our quarterly record revenue and return to profitability,” adding, “Now that our follow-up hair loss technology has been recognized by a prestigious academic journal, we will enhance our negotiating power in technology transfer and diversify our product portfolio to increase our corporate value.”

"VIVOZON PHARMACEUTICAL" Selected as Domestic Candidate for the "Nobel Prize of the Pharmaceutical Industry"; Prescription Sales Up 229%

VIVOZON PHARMACEUTICAL also showed a steep upward trend, closing at 3,320 won—an 18.36% surge from the previous day. The company’s stock price rose sharply as news of expanded prescriptions for “Anapra,” a non-narcotic analgesic developed as a domestically produced new drug, coincided with its selection as a nominee for a global award ceremony.

VIVOZON PHARMACEUTICAL announced that Anaprazu has been officially selected as a finalist for the Best Pharmaceutical Product Award at the first “2026 Prix Gallien Korea,” organized by the Gallien Foundation. The Prix Gallien is the most prestigious award in the life sciences field, recognizing innovative therapies and medical technologies, and is often referred to as the “Nobel Prize of the pharmaceutical industry.” A panel of expert judges, including representatives from the National New Drug Development Project, focuses on evaluating the scientific value of innovative, first-in-class drugs that address unmet medical needs, rather than simply assessing a company’s size. However, as this is the inaugural event, establishing its authority by overcoming controversies regarding commercial viability during the process of gaining a foothold in the domestic market is seen as a key challenge.

Anapraze is an injectable medication with a unique dual mechanism of action: it inhibits glycine transporter type 2 (GlyT2) and acts as a serotonin 2A (5-HT2A) receptor antagonist. It effectively manages acute pain following moderate-to-severe surgery while fundamentally eliminating the risks of addiction and misuse—the fatal side effects associated with opioid analgesics.

Prescription rates in actual clinical practice are also rising sharply. Sales of Anapraju in the second quarter of this year reached 2 billion won, a 229% surge compared to the previous quarter. This is the result of rapidly securing prescribing institutions at major domestic tertiary hospitals, such as Severance Hospital in Sinchon, Seoul, following product approval by the Ministry of Food and Drug Safety in 2024.

The company is also implementing process innovations to maximize productivity and distribution efficiency. VIVOZON PHARMACEUTICAL is collaborating with its global contract manufacturing partner, China’s Huiyou Pharmaceutical, while preparing to introduce a high-concentration injectable formulation that reduces volume to one-tenth of the previous size. VIVOZON PHARMACEUTICAL also plans to accelerate its global clinical trials and commercialization efforts.

A representative from VIVOZON PHARMACEUTICAL emphasized, “The unique mechanism of action and excellent analgesic effects of Anapra Injection are being proven through clinical data and the expansion of prescriptions at general hospitals,” adding, “We will further expand supply to tertiary hospitals while simultaneously launching a full-scale entry into the global market based on the accumulated domestic usage data.”