Diagnostics Rally Despite Kolon TissueGene Trial Shock[K-Bio Pulse]

[Jiwan Kim, Edaily Reporter] Investor sentiment across South Korea’s pharmaceutical and life sciences sectors remained weak on July 22 following the Phase 3 setback for Kolon TissueGene’s osteoarthritis candidate TG-C.

Kolon TissueGene hit the daily lower limit for a second consecutive session, while affiliate Kolon Life Science plunged 17%. The life sciences sector fell 3.48%, the steepest decline among all industry groups.

The pharmaceutical sector closed 0.56% lower. Of its 160 listed companies, only 44 advanced, while 98 declined and 18 finished unchanged. In the life sciences sector, 36 of 91 stocks rose, 47 fell and eight ended flat.



◇NanoEnTek Hits Upper Limit on Additional FDA Clearance

NanoEnTek surged to the daily upper limit after securing additional clearance from the U.S. Food and Drug Administration for its hematopoietic stem cell counter.

According to KG Zeroin’s MP Doctor, NanoEnTek closed at 4,540 won, up 1,045 won, or 29.90%, from the previous session.

The company said its ADAM II-CD34 system received FDA clearance for use with cryopreserved hematopoietic progenitor cell-apheresis products, known as cryopreserved HPC-A.

NanoEnTek website. (Screenshot by Jiwan Kim)

The device had already been cleared for peripheral blood and cord blood testing. The additional indication allows major specimens used in hematopoietic stem cell transplantation to be analyzed with a single instrument.

The latest approval brings NanoEnTek’s total number of FDA 510(k)-cleared in-vitro diagnostic products to 13, which the company says is the highest among South Korean immunodiagnostic companies.

Cryopreserved HPC-A is used in autologous stem cell transplantation for blood cancer patients. Stem cells are collected and frozen before high-dose chemotherapy, then tested for cell count and viability before being reinfused into the patient.

The company said the expanded indication enables ADAM II-CD34 to be used in a critical quality-control stage of the autologous transplantation process.

NanoEnTek also expects its recurring consumables business to benefit from a larger installed equipment base. Consumables for its in-vitro diagnostics and life sciences businesses accounted for 77.8% of total sales last year.

Its high-throughput cell analysis platform, the EVE-HT series, is currently used by more than 30 global pharmaceutical and biotechnology companies. NanoEnTek estimates that cumulative consumables revenue can reach a level similar to the equipment sales price within about three years of installation.

A company official said, “The FDA clearance has expanded the clinical application of ADAM II-CD34 and positioned it as a core quality-control instrument in the autologous hematopoietic stem cell transplantation process for blood cancer patients.”

The official added, “We will expand the presence of the ADAM series not only at blood cancer transplant centers in North America and Europe, but also in the Middle East, where demand for treatment of hereditary blood disorders is high.”



◇NGeneBio Jumps on Expansion of Blood Cancer Diagnostic Network

NGeneBio also hit the daily upper limit as investors welcomed the expansion of its blood cancer precision diagnostic panel business.

The shares closed at 2,370 won, up 545 won, or 29.86%, from the previous session.

The rally followed news that NGeneBio had begun supplying its HEMAccuTest blood cancer panel to Seoul National University Bundang Hospital.

The company currently supplies the panel to about 20 major tertiary hospitals in South Korea, including Seoul St. Mary’s Hospital and Seoul National University Hospital. Overseas, it has expanded into Singapore, Vietnam, Colombia, Germany and Romania.

NGeneBio’s blood cancer panel business has posted a compound annual growth rate of 36% over the past five years. In the first quarter, domestic sales rose 38% from a year earlier, while overseas sales increased 102%.

NGeneBio logo. (Courtesy of NGeneBio)

HEMAccuTest analyzes major genetic mutations at the initial diagnosis stage. After treatment, the company’s MRDaccuPanel AML FLT3 is used to monitor measurable residual disease and detect possible recurrence.

The panel is designed to identify FLT3 mutations, a major biomarker in acute myeloid leukemia, at levels as low as 0.001%. The company said this sensitivity meets the ultra-high-sensitivity assessment requirements recommended by the European LeukemiaNet.

NGeneBio is also seeking to use its blood cancer panels as companion diagnostic and biomarker platforms in drug development. Potential applications include selecting patients for FLT3-targeted therapies, evaluating treatment response and monitoring recurrence.

Song Myung-jun, head of NGeneBio’s diagnostics business, said, “The supply agreement with Seoul National University Bundang Hospital will further strengthen the clinical credibility and practical applicability of NGeneBio’s blood cancer panels.”

He added, “We will expand our position in the precision blood cancer diagnostics market by increasing supplies to major domestic hospitals and securing additional global references.”



◇Kangstem, Extends Rally on Big Pharma Organoid Deal

Kangstem Biotech continued to rise after signing a material transfer and evaluation agreement, or MTEA, with a global top-five pharmaceutical company.

Kang Kyung-sun, founder of Kangstem Biotech and professor at Seoul National University. (Photo courtesy of Kangstem Biotech)

The shares gained 145 won, or 6.89%, to close at 2,250 won.

Under the agreement, the partner will apply its drug candidates to Kangstem Biotech’s hair follicle organoid platform to evaluate efficacy. The goal is to obtain data that may predict clinical outcomes more accurately than conventional animal testing.

The company described the contract as the first stage of a strategic partnership that could potentially expand into joint research, research service agreements or licensing deals.

Kangstem Biotech’s organoid platform uses human-derived tissue to mimic the structure and function of actual organs. It is designed to assess complex cellular responses that are difficult to reproduce using conventional artificial skin models.

The company also sees potential applications in transplantable products for hair loss and skin disease treatments.

Kangstem Biotech founder Kang Kyung-sun, a professor at Seoul National University. (Courtesy of Kangstem Biotech)

Leading Investment & Securities said the agreement demonstrated the global commercial potential of Kangstem Biotech’s Real Skin Organoid technology.

The brokerage noted that the pharmaceutical partner will test drug candidates using the hair follicle organoid platform, potentially generating data with stronger clinical predictability than animal studies.

It added that positive evaluation results could lead to shorter development timelines, improved clinical success rates and follow-on collaboration, including licensing or joint development.

Kang Kyung-sun, founder of Kangstem Biotech and a professor at Seoul National University, said six research and business development executives from the multinational pharmaceutical company visited Kangstem Biotech’s research facility in May.

“It was highly unusual for them to review not only our core organoid technology but also our production capabilities at a level comparable to technical due diligence,” Kang said.

“This agreement is only the beginning, and we expect cooperation between the two companies to advance to a much higher level following the evaluation.”