[Edaily Reporter KIM JI-WAN ] On the 2nd, more than half of the stocks in both the pharmaceutical and life sciences sectors rose, but the sector indices showed mixed results. The pharmaceutical sector index fell 1.04% compared to the previous trading day. Out of a total of 161 stocks, 96 rose, 11 remained unchanged, and 54 closed lower. The life sciences sector index closed up 0.50%. Of the 92 stocks, 55 rose, 8 remained unchanged, and 29 fell.

On this day, Vaxcell-Bio Therapeutics, Shaperon Inc., and HLB INC. stood out in the stock market. Vaxcell-Bio Therapeutics drew attention as the government moves to ease regulations on autologous immune cell therapies; the company confirmed a tumor response in 11 out of 16 liver cancer patients in a combination clinical trial involving an NK cell therapy.

Shaperon Inc. announced that it had received a decision to register a patent for its “CD47 nanobody” in the U.S. and stated that the nanobody did not bind to human red blood cells even at concentrations 1,000 times higher than those of conventional antibodies. HLB INC. saw its entire portfolio rise in anticipation of the U.S. launch of “Ripictu,” a bile duct cancer treatment approved by the U.S. Food and Drug Administration (FDA).

Vaxcell-Bio Therapeutics: Expectations for Relaxation of Advanced Regenerative Medicine Regulations

Vaxcell-Bio Therapeutics(323990)posted a significant gain on expectations that

regulations

on

advanced regenerative medicine would be relaxed

. According to KG Zeroin MP Doctor, Vaxcell-Bio Therapeutics closed at 4,025 won, up 300 won (8.05%) from the previous trading day.

As the government decided to lower the barriers to treatments using a patient’s own immune cells, attention focused on Vaxcell-Bio Therapeutics’ autologous natural killer (NK) cell therapy “VCB-1102,” which demonstrated a tumor response in 11 out of 16 liver cancer patients. Previously, on the 30th of last month, PharmDaily published a paid article titled “Vaxcell-Bio Therapeutics Sees Response in 11 of 16 Liver Cancer Patients… Knocks on the Door for ‘Advanced Regenerative Medicine Act No. 2.’”

The core of the regulatory relaxation being promoted by the government is to lower the risk level of advanced regenerative medicine—which involves culturing and administering a patient’s own immune cells—from “medium risk” to “low risk.” If the risk level is adjusted to “low risk,” medical institutions can apply for review of treatment plans based on existing clinical literature and other evidence without having to undergo a separate clinical trial for advanced regenerative medicine, a process that typically takes two to three years. The Ministry of Health and Welfare reaffirmed this direction in its plan for the rationalization of biotech regulations announced on the 23rd of last month.

Vaxcell-Bio Therapeutics is paying close attention to this change because VCB-1102 involves isolating NK cells—which attack cancer cells—from the patient’s own blood, culturing them, and then re-administering them to the patient. Previously, in April, Yeouido St. Mary’s Hospital received the first domestic approval for a treatment plan for a rare lymphoma using ViGenCell Inc.’s autologous immune cell therapy, “VT-EBV-N.” Vaxcell-Bio Therapeutics is aiming to secure the second treatment plan approval in the field of liver cancer.

Clinical results supporting the treatment plan review have also been released. According to a Phase 2a clinical trial paper published on the 16th of last month in the international journal *Cancer Research and Treatment*, the research team administered hepatic artery infusion chemotherapy (HAIC)—in which anticancer drugs are injected directly into the hepatic artery—twice to patients with locally advanced hepatocellular carcinoma. Subsequently, for patients whose cancer had not progressed further, the team continued HAIC while administering VCB-1102.

An analysis of the 16 patients out of the 17 enrolled who were evaluable for response showed that 3 patients achieved a complete response, in which the viable tumor lesions disappeared on imaging. Additionally, 8 patients achieved a partial response, in which the lesions shrank beyond a certain threshold. The combined objective response rate for these two groups was 68.75%. According to the investigators’ assessment, the median time to disease progression after the start of treatment was 16.82 months.

Vaxcell-Bio Therapeutics stated, “With the publication of this paper, we have shared the results of the VCB-1102 Phase 2a clinical trial with the international academic community,” adding, “We will continue the clinical development of VCB-1102 while working to secure approval as a treatment under the Advanced Therapy Products Act.”

Shaperon Inc. Rises 8% on U.S. Patent Grant Decision

Shaperon Inc.(378800)Shaperon Inc.’s stock rose more than 8% on the back of a decision to grant a U.S. patent for the “CD47 nanobody” used in its next-generation immuno-oncology drug and positive preclinical trial results. Shaperon Inc. announced that even at concentrations 1,000 times higher than those of conventional antibodies, the nanobody did not bind to human red blood cells, and no hemolysis—the destruction of red blood cells—was observed in monkey trials.

On that day, Shaperon Inc.’s stock price closed at 2,410 won, up 8.56% (190 won) from the previous trading day.

According to Shaperon Inc., the patent for which the U.S. Patent and Trademark Office (USPTO) granted registration is titled “CD47 Nanobodies and Uses Thereof.” By securing a patent grant in the U.S.—following registrations in South Korea, Australia, and Japan—Shaperon Inc. has expanded its intellectual property portfolio to support global technology transfer negotiations.

CD47 is a protein that cancer cells use to evade attack by immune cells. When CD47 on the surface of a cancer cell sends a signal to macrophages saying, “Don’t eat me,” the macrophages stop their attack. Blocking this signal can induce macrophages to engulf the cancer cells. The major challenge in development is that CD47 is also present on normal red blood cells. If an antibody binds to CD47 on red blood cells, it could cause the destruction of normal red blood cells, potentially leading to anemia.

Shaperon Inc. designed its treatment to avoid binding to red blood cells by utilizing “nanobodies”—ultra-small antibodies about one-tenth the size of conventional antibodies. The anticancer drug the company is developing uses these nanobodies to block CD47 while simultaneously targeting PD-L1, a protein that suppresses T-cell attacks. This strategy uses a single therapeutic agent to induce T cells to directly attack cancer cells and macrophages to engulf them. The development goal is to provide a new treatment option for patients who do not respond adequately to existing PD-L1-based immunotherapy or who have developed resistance.

Shaperon Inc. official stated, “Leveraging safety data validated through animal studies and our global patent portfolio, including in the U.S., we will accelerate discussions on technology transfer with global pharmaceutical companies.”

Buying Frenzy for HLB INC.... Expectations for U.S. Sales of New Bile Duct Cancer Drug

As HLB INC.’s new bile duct cancer drug “Ripicto” prepares for its U.S. launch, group stocks rose in tandem, with HLBbioStep(278650)hitting its daily price limit.

Specifically, HLBbioStep closed at 6,870 won, up by the daily price limit (29.87%) compared to the previous trading day. HLB PHARMACEUTICAL(047920)closed at 10,710 won, up 12.74% (1,210 won), while HLB Therapeutics(115450)closed at 2,730 won, up 9.42% (235 won). ANYGEN CO., LTD.(196300)and HLB PANAGENE(046210)closed at 4,080 won and 1,338 won, respectively, up 7.09% (270%) and 6.27% (79 won).

HLB Therapeutics, a U.S. subsidiary of HLB INC., received marketing approval for Ripicto from the U.S. Food and Drug Administration (FDA) last September. Daesang is indicated for patients with locally advanced or metastatic cholangiocarcinoma who have confirmed FGFR2 gene fusions or rearrangements. Eleva recently set up a dedicated booth at the European Society for Medical Oncology (ESMO 2026) conference in Madrid, Spain, to discuss U.S. launch strategies with healthcare professionals and pharmaceutical distributors.

The key factors for the U.S. business are pricing and the distribution network. The monthly treatment cost for a competing drug in the U.S. is approximately $30,000 (about 40 million won). Based on Ripicto’s clinical results, the group expects to set a price 15–20% higher than that of competing drugs. The basic policy is for Eleva to handle sales directly.

In Europe, the European Medicines Agency (EMA) is currently reviewing the marketing authorization application for Ripictu.

In the field of liver cancer, the company is making another push for U.S. approval as a first-line treatment with a combination therapy of riboceranib and camrelizumab. After addressing issues related to manufacturing facilities, the application has entered the FDA’s re-review process. HLB Therapeutics is set to announce key results from the U.S. Phase 3 clinical trial of “RGN-259,” a candidate drug for neurotrophic keratitis, next month.

Chairman Jin purchased shares of affiliates—including HLB Therapeutics, HLB innoVation, and HLB Genex—on the open market on 15 separate occasions, both in his personal capacity and through Epoque, a financial investment firm in which he holds a 99% stake.

An HLB INC. official emphasized, “While thoroughly preparing for the successful launch of ‘Ripictu,’ our new drug for cholangiocarcinoma, in the U.S. market, we will continue to demonstrate the clinical efficacy of our follow-up pipeline, including Riboceranib, without any setbacks,” adding, “The management’s share purchases also reflect their confidence in the future growth potential of the entire group.”