[Edaily Reporter KIM JI-WAN ] On the 22nd, investor sentiment in the domestic pharmaceutical and life sciences sector Kolon TissueGene, Inc.(950160)continued to deteriorate in the wake of the failure of TG-C’s Phase 3 clinical trial. KOLON LIFE SCIENCE Inc.(102940)hit its daily price limit for two consecutive days, while its affiliate, KOLON LIFE SCIENCE Inc., also plummeted 17%. The life sciences sector fell 3.48% that day, marking the largest decline among all sectors.

The pharmaceutical sector closed down 0.56%. Of the 160 stocks in the sector, only 44 rose. The remaining 98 stocks fell, and 18 closed unchanged. The life sciences sector performed poorly, with 36 of 91 stocks rising, 8 remaining unchanged, and 47 falling.

NanoenTek,Inc. Hits Daily Price Limit on Additional FDA Approval for Hematopoietic Stem Cell Counter

NanoenTek,Inc.(039860)’s

stock

soared to

the daily price limit

following news of additional approval

from

the U.S. Food and Drug Administration (FDA) for its hematopoietic stem

cell counter

.

According to KG Zeroin MP Doctor (MP DOCTOR) that day, NanoenTek,Inc. closed at 4,540 won, up 1,045 won (29.90%) from the previous trading day.

NanoenTek,Inc. announced that day it had obtained additional FDA approval for its hematopoietic stem cell analyzer, the “ADAM II-CD34,” to be used with frozen hematopoietic stem cell concentrates (frozen HPC-A).

The ADAM II-CD34 has expanded its testing scope to include frozen HPC-A, in addition to the previously approved peripheral blood and umbilical cord blood. As a result, the major specimens used in the hematopoietic stem cell transplantation process can now be analyzed using a single device.

With this approval, the total number of FDA 510(k)-cleared in vitro diagnostic medical devices held by NanoenTek,Inc. has expanded to 13. The company explained that it now holds the largest number of FDA-approved products among domestic immunoassay companies.

Frozen HPC-A is a specimen used in the autologous hematopoietic stem cell transplantation process for patients with blood cancer. Hematopoietic stem cells are collected from the patient in advance and stored frozen; the specimen is then used to verify cell count and viability before re-transplantation following high-dose chemotherapy.

With this approval, ADAM II-CD34 can now be used in the critical quality control stage of autologous hematopoietic stem cell transplantation to verify the quality of the cells intended for transplantation.

Hematopoietic stem cell transplantation is used to treat not only blood cancers but also congenital blood disorders such as sickle cell anemia and thalassemia. According to the World Bone Marrow Transplantation (WBMT), more than 100,000 hematopoietic stem cell transplants are performed worldwide each year, with autologous transplants accounting for more than half of these procedures.

North America and Europe are major markets where autologous hematopoietic stem cell transplants for the treatment of blood cancers are actively performed. The Middle East and North Africa region is considered a market with steady demand for hematopoietic stem cell transplants due to the relatively high incidence of hereditary blood disorders.

Since supplying its equipment, NanoenTek,Inc. has established a business model that generates recurring revenue from the sale of consumables required for testing. Last year, consumables for in vitro diagnostics (IVD) and life sciences (LS) accounted for 77.8% of total revenue. As the number of installed units increases in the global market, sales of these highly profitable consumables also rise accordingly.

In the case of the “EVE-HT” series of high-throughput cell analysis instruments—currently used by more than 30 global pharmaceutical and biotech companies—the company expects that cumulative consumables revenue will reach a level comparable to the equipment’s sales price approximately three years after installation.

NanoenTek,Inc. is expanding its business scope into the women’s health diagnostics sector by leveraging the clinic network and sales experience it has built in the U.S. men’s health diagnostics market. With the recent launch of diagnostic products for estradiol, follicle-stimulating hormone (FSH), and thyroid hormone (Free T3), the company has established a product portfolio that encompasses both men’s and women’s health diagnostics.

A company official stated, “With FDA approval, the clinical application scope of ADAM II-CD34 has expanded, and it has established itself as a key quality control device in the process of autologous hematopoietic stem cell transplantation for blood cancers.” The official added, “We will expand the ADAM series’ presence not only to blood cancer transplant centers in North America and Europe but also to the Middle East market, where there is high demand for the treatment of hereditary blood disorders.”

NGeneBio Co., Ltd. Hits Daily Price Limit on Expanded Supply of Blood Cancer Diagnostic Panels

NGeneBio Co., Ltd.(354200)has been seeing strong buying momentum for consecutive days following news that it is expanding its supply network for precision diagnostic panels for blood cancers to major hospitals.

On this day, NGeneBio Co., Ltd. closed at 2,370 won, up 545 won (29.86%) from the previous trading day. The stock surged to the intraday price limit and closed at the upper limit.

The sharp rise in the stock price is attributed to news that NGeneBio Co., Ltd. has begun supplying its “HimAcuteTest” precision diagnostic panel for blood cancers to Seoul National University Bundang Hospital, which stimulated investor sentiment. This reflects expectations that the company will accelerate its expansion into domestic and international markets based on a product portfolio that spans from blood cancer diagnosis to post-treatment recurrence monitoring.

NGeneBio Co., Ltd. currently supplies HimAcuteTest to approximately 20 major tertiary general hospitals in Korea, including Seoul St. Mary’s Hospital and the main campus of Seoul National University Hospital. With the addition of Seoul National University Bundang Hospital, the company has further expanded its supply base centered on major domestic hospitals.

In overseas markets, the company is expanding its sales reach to Singapore, Vietnam, Colombia, Germany, and Romania. This expansion of its hospital supply network is also driving revenue growth. NGeneBio Co., Ltd.’s blood cancer panel business has recorded an average annual growth rate of 36% over the past five years.

In the first quarter of this year, domestic sales from the blood cancer panel business increased by 38% year-over-year, while overseas sales rose by 102% over the same period. The company explains that its strategy of securing clinical use cases at major domestic hospitals while expanding its overseas sales channels is reflected in these results.

Since the genetic mutations associated with blood cancers vary from patient to patient, differences in treatment response and prognosis can occur even among patients diagnosed with the same disease. Consequently, the importance of precision diagnostic technologies—which analyze a patient’s genetic mutations and track the likelihood of recurrence after treatment—is growing.

NGeneBio Co., Ltd. uses HimAccuTest during the initial diagnostic stage to comprehensively analyze key genetic mutations associated with blood cancers. Following treatment, the company has established a full-cycle blood cancer diagnostic system that tracks minimal residual disease (MRD) using the “MRDaccuPanel AML FLT3.”

The MRDaccuPanel was developed to detect FLT3 mutations—a key biomarker of acute myeloid leukemia (AML)—at levels as low as 0.001%. It can be used to identify mutations associated with the minute traces of cancer cells remaining in the body after treatment, thereby enabling the early detection of potential relapse.

The company explained that this detection performance meets the ultra-high-sensitivity evaluation criteria set forth in the European Leukemia Network (ELN) guidelines.

NGeneBio Co., Ltd. is also expanding the scope of its blood cancer diagnostic panel into the field of new drug development. The company plans to utilize it as a companion diagnostic and biomarker detection platform to screen clinical trial patients, evaluate treatment responses, and confirm recurrence during the development of FLT3-targeted anticancer drugs.

Going forward, the company intends to enhance the market potential of its blood cancer diagnostic panel business by securing additional clinical evidence and pursuing new medical technology evaluation and insurance reimbursement. Its strategy is to sustain this growth by simultaneously expanding supply to leading tertiary hospitals in Korea and securing overseas references.

Song Myung-jun, Head of the Diagnostics Business Division at NGeneBio Co., Ltd., stated, “With the supply to Seoul National University Bundang Hospital as a catalyst, the clinical reliability and practical applicability of NGeneBio Co., Ltd.’s blood cancer panel will further increase,” adding, “Based on expanded supply to major domestic hospitals and the securing of global references, we will expand our presence in the precision diagnostics market for blood cancers.”

KANGSTEM BIOTECH CO., LTD. Rises for Consecutive Days on Expectations of Organoid Contract with Big Pharma

KANGSTEM BIOTECH CO., LTD.(217730)continued its upward trend

for consecutive days

following news that it had signed a Material Transfer and Evaluation Agreement (MTEA) for organoid-based technology with a top-five global pharmaceutical company. Expectations that cooperation could expand into follow-up projects—including joint research, research services, and technology transfer—starting with the evaluation of the partner’s new drug candidates are believed to have driven buying momentum.

On that day, KANGSTEM BIOTECH CO., LTD. closed at 2,250 won, up 145 won (6.89%) from the previous trading day.

KANGSTEM BIOTECH CO., LTD. announced on the 16th that it had signed an organoid-based “Material Transfer and Evaluation Agreement” (MTEA) with a top-five global pharmaceutical company.

Under this agreement, the global pharmaceutical company will evaluate the efficacy of new drug candidates it is developing by applying them to KANGSTEM BIOTECH CO., LTD.’s hair follicle organoid platform. The plan is to obtain predictive data that more closely mirrors actual clinical outcomes than animal testing by utilizing organoid data that replicates human tissue characteristics.

A company official explained, “This agreement goes beyond a simple material transfer; it marks the first step in a strategic collaboration to precisely validate the clinical efficacy of the global pharmaceutical company’s new drug candidates in advance by applying them to KANGSTEM BIOTECH CO., LTD.’s organoid platform.”

The spokesperson further emphasized that this agreement represents a process through which a global pharmaceutical company will directly validate KANGSTEM BIOTECH CO., LTD.’s organoid technology in its actual R&D process, noting that it has the potential to evolve into various forms of business collaboration, such as joint research, research service agreements, and technology licensing (license-out).

The contracting party plans to apply its new drug candidates to KANGSTEM BIOTECH CO., LTD.’s hair follicle organoids to analyze their efficacy and response. This is expected to enable an early assessment of the candidates’ clinical potential, thereby reducing development time and costs while increasing the likelihood of success in clinical trials.

KANGSTEM BIOTECH CO., LTD.’s organoid platform is based on human-derived tissue and mimics the structure and function of actual organs. According to the company, it enables the evaluation of cell-cell interactions and complex drug responses that were difficult to achieve with existing artificial skin models.

The company believes that this platform will go beyond serving as a research tool for evaluating the efficacy and toxicity of new drug candidates to eventually be utilized as a transplant material for treating hair loss and skin diseases.

The securities industry has also assessed this agreement as the first instance demonstrating the potential for KANGSTEM BIOTECH CO., LTD.’s organoid business to expand globally.

Leading Investment Securities highlighted that KANGSTEM BIOTECH CO., LTD. signed a material transfer agreement with a global pharmaceutical company based on its “Real Skin Organoid” technology. The firm analyzed that by applying new drug candidates to the hair follicle organoid platform to verify their efficacy, client companies can obtain data with higher clinical predictive power than traditional animal testing.

In particular, the firm predicted that if meaningful results are obtained during the evaluation process, this could lead not only to shorter new drug development timelines and higher clinical success rates but also to follow-up agreements such as technology transfer and joint development.

Professor Kang Kyung-sun of Seoul National University, founder of KANGSTEM BIOTECH CO., LTD., stated, “It was highly unusual that six executives—including the head of R&D and business development—from the multinational pharmaceutical company, our contractual partner, visited the KANGSTEM BIOTECH CO., LTD. research lab in the U.S. last May to conduct a due diligence-level review of not only the company’s core organoid technology but also its production capabilities.” He added, “This agreement is just the beginning, and following the evaluation, cooperation between the two companies will proceed at a very high level.”