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[Kim Jiwan, Edaily Reporter] CKD Bio Botulinum Toxin Receives Domestic Approval, Shares Surge.

CKD BIO CI.

Ngenebio Export Approval for Leukemia Diagnostic Panel, “World’s First Technology Application”.

Labgenomics World’s First Gene Scissors Liquid Biopsy Technology Highlighted by MOU.

On April 1st, according to MP Doctor (formerly MarketPoint) from KG ZeroIn, CKD Bio stock closed at 23,300 won, up 17.14% (3,410 won) from the previous day due to the domestic approval of its botulinum toxin.

Labgenomics saw a 10.82% increase (230 won) to close at 2,355 won, bolstered by a previously signed MOU with Genecker that drew attention.

Ngenebio ended the day up 10.71% (166 won) at 1,716 won following the export approval news for its leukemia diagnostic panel.

CKD Bio, Botulinum Toxin Gains Domestic Approval

CKD Bio surged due to the domestic approval of its botulinum toxin. The company received domestic product approval on March 31 from the Ministry of Food and Drug Safety (MFDS) for its self-developed botulinum toxin product, ‘Tiemburse-ju’ 100 units (Clostridium botulinum toxin type A), indicated for moderate to severe glabellar lines. CKD Bio initially filed for approval with the MFDS on May 24 last year.

CKD Bio developed ‘Tiemburse-ju’ based on a strain exclusively obtained from a European research institution. This strain is officially registered in GenBank, the genetic sequence database of the National Center for Biotechnology Information (NCBI), ensuring a clear source of the strain. CKD Bio emphasized the safety of its toxin product by using non-animal sourced raw materials and adjuvants from strain cultivation to final product manufacturing.

A representative from CKD Bio stated, “Tiemburse-ju 100 units has adopted a vegan (non-animal) process, enhancing safety by eliminating the risk of infections and allergic reactions that can occur with animal-derived materials.” They added, “By moving away from the conventional manufacturing method using human serum albumin (HSA), we minimized the potential for infection from blood-borne pathogens, making it safe for not only patients sensitive to animal components but also for vegan consumers.”

Ngenebio, Export Approval …“World’s First Technology Application”

Ngenebio demonstrated a significant uptick upon receiving export approval for its acute myeloid leukemia diagnostic panel. On March 31, Ngenebio announced that it had received manufacturing approval from the MFDS for its product ‘MRDaccuPanel™ AML FLT3’ for export purposes. This next-generation sequencing (NGS)-based product can diagnose multiple mutations in the FLT3 gene, a key molecular biomarker for acute myeloid leukemia, including ITD and TKD mutations.

Ngenebio homepage.

The product uses an AI-based analysis solution for quantitative tracking of FLT3-ITD mutations and monitoring relapses after treatment. Notably, it can detect ultra-low-level mutations in patient blood as low as 0.001%, providing vital information for evaluating treatment responses and predicting early relapses.

A spokesperson from Ngenebio stated, “There are no other products currently approved globally that can detect FLT3 gene mutations based on next-generation sequencing technology. With this export approval, we plan to aggressively expand into European and global markets as the first NGS-based acute myeloid leukemia diagnostic solution developed domestically and internationally.”

Labgenomics, World‘s First Gene Scissors Liquid Biopsy Tech

Labgenomics experienced a strong rally as its previously signed MOU with GeneCker garnered attention. A report by the media today highlighted GeneCker’s success in diagnosing cancer using gene scissors technology in liquid biopsies, significantly enhancing the ability to detect cancer cells by more than tenfold. This technology enables the detection of early-stage cancers.

Previously, in March 2022, Labgenomics signed an MOU with Genecker for the co-development of diagnostic kits, combining Labgenomics‘ molecular diagnostic technology with GeneCker’s ultra-precision gene scissors technology to improve accuracy.

Genecker homepage.

GeneCker was the first in the world to introduce gene scissors technology to liquid biopsies, successfully enhancing test accuracy and overcoming the limitations of liquid biopsies. The core technology involves finding circulating tumor DNA (ctDNA) in the blood. However, the ctDNA proportion in patients with tumors as small as 1㎤ is only about 0.022%, making detection impossible when ctDNA levels are below 0.1%.

GeneCker applied gene scissors technology to cut cell-free DNA (cfDNA) derived from normal genes while amplifying ctDNA by 100 times. As a result, GeneCker can now detect cancer with as little as 0.01% ctDNA proportion. This process significantly reduces the diagnosis cost to one-tenth of the typical 3 million won cost for standard liquid biopsies.

A representative from Labgenomics stated, “Incorporating GeneCker’s ultra-precision gene scissors technology enables accurate genetic diagnosis. Our technological collaboration ensures quick and precise diagnostics at the point of care, overcoming the limitations of existing diagnostic kits.”