Mezoo·XcellTherapeutics Surge on Earnings Improvement Expectations[K-Bio Pulse]

[Shin-Min Joon, Edaily Reporter] On May 28 the domestic pharmaceutical and biotech stock market saw notable gains in the share prices of Mezoo, XcellTherapeutics and D&D Pharmatech. Mezoo’s stock climbed on expectations that its next generation wearable patient monitoring device will be adopted by top tier general hospitals.

XcellTherapeutics shares rose as the company began making inroads into the Chinese market in earnest raising expectations for improved earnings. D&D Pharmatech extended its rally for a fifth consecutive trading session as prospects brightened for a technology export deal involving its investigational treatment for metabolic dysfunction associated steatohepatitis (MASH).

Mezoo stock trend on May 28.(Image=MP Doctor)

Mezoo Gains on Prospects for Adoption of Next-Generation Device by Major General Hospitals

According to KG Zeroin’s MP DOCTOR Mezoo shares surged 16.80% from the previous session to close at 28,500 won on the day. Investor sentiment improved after the company’s next-generation wearable patient monitoring device, HiCardi M350, recently received approval from South Korea’s Ministry of Food and Drug Safety, raising expectations for adoption by major general hospitals.

The HiCardi M350 is a wearable smart patch capable of continuously measuring and analyzing a range of vital signs for up to 48 hours, including electrocardiogram (ECG), oxygen saturation, respiration, blood pressure, and body temperature. The device wirelessly transmits patient data, allowing medical staff to monitor patients’ conditions in real time. Weighing less than 20 grams, the wireless device is designed for convenient mobility within hospitals and is equipped with dustproof and waterproof functions.

Expectations are also growing for improved annual earnings as the HiCardi M350 is anticipated to expand from Severance Hospital to other major general hospitals in Korea. The domestic patient monitoring device market is currently dominated by Philips, Mediana, and GE Healthcare, which together account for around 90% of the market. Mezoo plans to expand the number of monitoring parameters supported by HiCardi devices from the current three ECG, respiration, and body temperature to eight in the future.

The HiCardi M350 has already begun penetrating the market after being selected for Chonnam National University’s innovative product pilot procurement project. Securities analysts are also forecasting the possibility of adoption by Severance Hospital. Hana Securities stated that Mezoo’s annual sales guidance of 15.4 billion won could be exceeded when factoring in potential revenue from its central monitoring system.

A Mezoo official said “The HiCardi M350 marks a turning point in the expansion of the HiCardi product lineup from ECG-focused devices to hospital-use multi-parameter wearable patient monitoring systems.”

adding “Based on our experience operating within institutional healthcare systems through the existing HiCardi platform we will gradually respond to diverse demands in hospital mobile monitoring environments.”

XcellTherapeutics trend on May 28.(Image=MP Doctor)

XcellTherapeutics Targets 22 Trillion Won Chinese Market with CGT Media Supply

XcellTherapeutics shares jumped 16.76% from the previous session to close at 1,721 won on the day. Investor expectations for improved earnings grew after the company officially began supplying its high-performance T-cell culture medium CellCor™ T, to Shanghai Cell Therapy Group, a leading player and dominant force in China’s cell and gene therapy (CGT) market.

Market observers noted that the latest supply agreement represents more than just a simple export contract or one-off earnings boost. Founded in 2013, Shanghai Cell Therapy Group is widely recognized as one of China’s leading private CGT companies with technology capabilities considered to be on par with global standards.

Expectations that XcellTherapeutics could directly benefit from China’s planned implementation of stricter national standards for CGT ancillary materials in November also appeared to support the stock’s rally.

The new standards will require a clearly defined classification system for ancillary materials, significantly strengthened biosafety requirements, mandatory supply chain traceability, and stricter quality management systems (QMS).

As safety and consistency become increasingly important analysts believe XcellTherapeutics which possesses advanced cell culture media technology, could emerge as a major beneficiary.

An XcellTherapeutics official said “The CGT market has been showing strong momentum following news that Nature Cell applied to the U.S. Food and Drug Administration (FDA) for approval to market its stem cell therapy.”

adding “This appears to have further highlighted the strengths of XcellTherapeutics’ cell culture media business. Investors also seem to be viewing positively the fact that the company’s planned initiatives are progressing on schedule.”

D&D Pharmatech trend on May 28.(Image=MP Doctor)

D&D Pharmatech Extends Rally on Expectations for MASH Drug Licensing Deal

D&D Pharmatech shares rose 8.81% from the previous session to close at 107,500 won on the day, extending gains for a fifth consecutive trading session since May 21.

Investor optimism has continued to build after the company’s investigational treatment for metabolic dysfunction associated steatohepatitis (MASH), DD01, demonstrated improvements in liver fibrosis in a Phase 2 clinical trial, raising expectations for a large scale licensing deal.

MASH is a disease in which fat accumulates in the liver due to metabolic disorders such as obesity and diabetes, eventually leading to inflammation and fibrosis. If left untreated the condition can progress to cirrhosis or liver cancer.

The latest clinical trial was conducted across 12 clinical sites in the United States and enrolled 67 patients with metabolic dysfunction-associated steatotic liver disease (MASLD) or MASH who were overweight or obese, with a body mass index (BMI) of 25 kg/m² or higher.

Among 52 patients whose biopsies confirmed MASH and liver fibrosis stages F1 to F3, histological efficacy analysis was conducted on 35 patients who completed liver biopsies both at enrollment and at the 48-week mark while faithfully adhering to the clinical protocol.

The results showed that the DD01 treatment group (16 patients) achieved statistically significant improvements over the placebo group across all three biopsy-based endpoints resolution of steatohepatitis without worsening liver fibrosis improvement of liver fibrosis without worsening steatohepatitis and simultaneous achievement of both steatohepatitis resolution and fibrosis improvement.

In addition several key non invasive indicators important for regulatory approval of MASH treatments including reductions in liver fat measured by MRI-proton density fat fraction (MRI-PDFF) and improvements in liver stiffness assessed through magnetic resonance elastography (MRE) also demonstrated statistically significant differences compared with the placebo group.

The company noted that the therapeutic benefits observed in its previously announced 12 week clinical data in June last year were sustained through 48 weeks. From a safety perspective, DD01 demonstrated favorable tolerability throughout the 48week treatment period.

The most commonly reported adverse events were gastrointestinal symptoms, most of which were mild to moderate and resolved temporarily. To pursue global licensing agreements and strategic partnerships for DD01, D&D Pharmatech has been working with major U.S. investment banks (IBs) since mid-last year and has been engaged in discussions with multiple global pharmaceutical companies.

A D&D Pharmatech official said “Global pharmaceutical companies’ interest in MASH therapies is currently higher than ever.”

adding “Based on these clinical results, we will actively accelerate global partnering discussions and do our utmost to achieve a large scale technology licensing agreement.”