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Vaxcell-Bio Therapeutics Set to Benefit Most from Revisions to the Advanced Biotechnology Act… O-Rim Rises on Expectations of a 'Big Deal' in China [Bio Spotlight]

[Edaily Reporter KIM JI-WAN ] On the 29th, the domestic pharmaceutical and life sciences sectors surged in tandem. The pharmaceutical sector index rose 9.52% compared to the previous trading day, with 143 out of 160 listed stocks posting gains. Only 10 stocks remained unchanged and 7 declined, indicating strong buying momentum across the sector.

The life sciences sector also surged by 10.18%. Of the 91 stocks in the sector, 78 rose, 7 remained unchanged, and 6 fell, showing a distinct upward trend alongside the pharmaceutical sector.

Domestic pharmaceutical sector index on the 29th. (Source: KG Zeroin MP Doctor)
Vaxcell-Bio Therapeutics: Biggest Beneficiary of Advanced Regenerative Medicine Act Reform
Vaxcell-Bio Therapeutics(323990)has emerged as a leading beneficiary, possessing the infrastructure for NK cell manufacturing and clinical experience, as advanced regenerative medicine using autologous NK cells has been reclassified as a low-risk category, allowing treatment without prior clinical trials.

#Orum Therapeutics, Inc.: As the center of global technology transactions for antibody-drug conjugates (ADCs) and antibody-degradation conjugates (DACs) shifts to China, expectations that the value of its next-generation DAC platform and core pipeline will be reevaluated have stimulated investor sentiment.

#G2GBIO, Inc. saw growing expectations for follow-up contract achievements—including technology licensing (L/O), joint development, and contract development and manufacturing (CDMO)—based on large-scale partnering meetings held with global pharmaceutical and biotech companies at Bio USA.

Vaxcell-Bio Therapeutics hit its daily price limit amid expectations of regulatory easing for advanced regenerative medicine utilizing autologous natural killer (NK) cells. According to KG Zeroin’s MP DOCTOR (formerly Marketpoint) on that day, Vaxcell-Bio Therapeutics closed at 5,140 won, having risen by the daily price limit (29.80%, 1,180 won) compared to the previous trading day. Earlier, PharmEdaily, the premium pharmaceutical and biotech content platform of Edaily, published an article titled “Advanced Regenerative Medicine Act Adjusts NK Cell Therapy to ‘Low Risk’… Vaxcell-Bio Therapeutics Expected to Be the Biggest Beneficiary.”

On the 26th, the Ministry of Health and Welfare adjusted the risk level of advanced regenerative medicine using autologous immune cells, such as autologous NK cells, from “medium risk” to “low risk.” With this revision, medical institutions can now proceed with patient treatment following a review of the treatment plan, without first having to conduct clinical research on advanced regenerative medicine that typically spans two to three years, as was previously required.

Under the Advanced Regenerative Bio Act, advanced regenerative medicine is classified into high-risk, medium-risk, and low-risk categories. Medium-risk treatments previously required safety and efficacy to be established through clinical research before undergoing treatment plan review. However, low-risk treatments are exempt from these preliminary research procedures, significantly shortening the time required to begin actual treatment.

The biotech industry anticipates that this measure will not only improve access to treatment for patients with rare and intractable diseases but also lead to an increase in the number of patients returning to Korea from abroad who were previously receiving NK cell therapy overseas. In particular, it is anticipated that Vaxcell-Bio Therapeutics will benefit directly from these regulatory changes, as the company has obtained a license for the manufacture of advanced biopharmaceuticals, established GMP production facilities, and gained clinical experience with “VCB-1102,” an autologous NK cell-based treatment for hepatocellular carcinoma.

Vaxcell-Bio Therapeutics achieved an objective response rate (ORR) of 68.75%, a disease control rate (DCR) of 100%, and a median overall survival (mOS) of 24.05 months in a Phase 2a clinical trial for advanced hepatocellular carcinoma. Based on these results, the company is also pursuing the expansion of indications to include small cell lung cancer and pancreatic cancer.

A bioindustry official stated, “This risk adjustment is significant in that it expands treatment opportunities for patients while broadening the commercialization foundation for Korea’s advanced regenerative medicine industry,” adding, “In particular, we expect cooperation between companies with cell manufacturing capabilities and medical institutions to become even more active.”

(Photo: Vaxcell-Bio Therapeutics website)

Orum Therapeutics, Inc.: DAC Value Re-evaluated Amid Expectations of a ‘Big Deal’ in China
Orum Therapeutics, Inc.’s stock surged by over 26%. This surge is interpreted as reflecting expectations that Orum Therapeutics, Inc. will also move to secure next-generation DAC candidates and technology in China, following a series of mega-scale technology export deals (L/O) recently secured by Chinese biotech firms in the global ADC and bispecific antibody sectors. The securities industry is also paying close attention to the potential for a revaluation of the company’s market value, citing the expansion of global DAC transactions and the entry of its core pipeline into clinical trials.

On that day, Orum Therapeutics, Inc. closed at 62,200 won, up 12,900 won (26.17%) from the previous trading day. Recently, the center of gravity in the global technology export market has been rapidly shifting toward China. In particular, in the field of next-generation modalities—such as ADCs, bispecific antibodies, and targeted protein degraders (TPDs)—candidate compounds developed by Chinese biotech companies are securing major technology transfer deals one after another.

Notably, Bristol-Myers Squibb (BMS) acquired the EGFR×HER3 ADC from China’s SystImmune in a deal worth up to $8.4 billion (approximately 13 trillion won). GlaxoSmithKline (GSK) secured HanSo Pharmaceutical’s B7-H4 ADC in a deal worth up to $1.7 billion (approximately 2.6 trillion won). Pfizer also signed a licensing agreement this year with China’s 3S KOREA CO., LTD worth up to $6 billion (approximately 9 trillion won), indicating that competition among global big pharma companies to secure Chinese technology is intensifying.

DAC refers to a next-generation platform that combines ADC target delivery technology with TPD. Analysts in the biotech industry suggest that, as China is establishing competitiveness in both the ADC and TPD fields, expanding local networks is likely to lead to enhanced competitiveness of the DAC platform and the introduction of new technologies in the future.

Currently, Orum Therapeutics, Inc.’s core in-house pipeline consists of ORM-1153, which is in the preclinical stage. Development of ORM-5029 has been discontinued, while BMS is continuing development of ORM-6151 following a technology transfer.

Chad May, CSO of Orum Therapeutics, Inc. (Photo: Reporter Lim Jeong-yo)

Orum Therapeutics, Inc. has secured funding by successfully licensing technologies to companies such as BMS and Vertex Pharmaceuticals, and as of the end of the first quarter of this year, it holds approximately 2750억 won in liquid assets. The industry believes that, backed by this financial strength, the company will be able to actively pursue the acquisition of new candidate compounds or strategic technology acquisitions.

The securities industry also gave a positive assessment of the growth potential of the DAC market and Orum Therapeutics, Inc.’s platform competitiveness.

IBK Investment & Securities analyzed, “Orum Therapeutics, Inc. is a differentiated new drug development company based on its DAC platform,” adding, “We expect the company to expand its blood cancer pipeline centered on ORM-1153, and recent mergers and acquisitions (M&A) by global big pharma companies are proving the value of the DAC platform.”

Korea Investment & Securities also noted, “There has been a recent trend of increasing global DAC deals,” adding, “Orum Therapeutics, Inc. is developing two DAC platforms, and its core pipeline candidate, ORM-1153, is expected to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year.”

A biotech industry official remarked, “China is now one of the most active markets for trading global innovative new drug technologies,” adding, “As competitive technologies in the ADC and TPD fields are emerging rapidly, how quickly companies can secure them will determine their future competitiveness.”
G2GBIO,
Inc
.: Expectations for a ‘Big Deal’ Grow After BioUSA
G2GBIO, Inc.’s stock surged by more than 20% on expectations of follow-up results from the large-scale partnering meetings it held at
BioUSA
. The company is reported to have discussed technology licensing (L/O), joint development, and contract development and manufacturing (CDMO) with approximately 40 global pharmaceutical and biotech companies during the event.

On that day, G2GBIO, Inc. closed at 43,700 won, up 7,700 won (21.39%) from the previous trading day. G2GBIO, Inc. recently held individual partnering meetings with approximately 40 global pharmaceutical and biotech companies at the BIO International Convention (BIO USA 2026) held in San Diego, USA.

According to the company, these meetings were not merely networking events but served as opportunities to discuss concrete business collaboration plans, including technology exports, joint development, and CDMO partnerships.

G2GBIO, Inc. is reportedly working to expand its collaboration with global big pharma companies with which it has existing joint development agreements, while also holding executive-level meetings with Global Pharmaceutical Company A, with which it is currently discussing a new compound. The company also discussed not only licensing-out opportunities but also plans for partner companies’ candidate compound development and CDMO collaboration with firms from various countries, including the U.S., Europe, Japan, China, Canada, and South America.

Seol Eun-young, Vice President of G2GBIO, Inc., is presenting a poster at the American Diabetes Association (ADA 2026) conference. (Photo: G2GBIO, Inc.)


At the center of these meetings was G2GBIO, Inc.’s long-acting drug delivery platform, InnoLAMP. InnoLAMP is a platform capable of mass production, high drug loading, and high bioavailability.

The company recently demonstrated the platform’s competitiveness by signing technology transfer agreements with Samsung Bioepis and Episnex Labs. The market is paying close attention to the potential for the numerous meetings held at Bio USA to lead to future technology export or joint development agreements.

A company official stated, “The approximately 40 partnering meetings held at this year’s Bio USA served as a crucial opportunity to showcase our technological capabilities and business expertise to global companies,” adding, “We plan to secure long-term growth momentum by expanding the scope of our discussions beyond collaboration on our own pipeline to include CDMO partnerships for promising pipelines held by global companies.”

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