Hus Letter, June
Summary of Hus-Letter, June
1. ?? News: Summary of Main news on May
2. ???? Introduction: Central Lab service #9_Exfoliation sample analysis service
3. ?? Huscience Upcoming event
?? News
?? Section Introduction: This section introduces important news on June by keyword. You can press each keyword to find out more about it.
?? Keyword news
①?New Drug Development: Six months after the first approval of CRISPR gene editing therapy 'Casgevy', concerns are growing about its safety as a death case was reported in a clinical trial patient with Duchenne muscular dystrophy in his 20s. During the treatment process, lung damage caused by adenovirus, which is a vector, was analyzed as the cause of death, and 'Base Editing' and 'Prime Editing', which are methods of changing specific bases are being studied to prevent these various side effects.
② Orphan drug designation(ODD): 'LA-GLA', a treatment for Fabry disease, one of the sex chromosome diseases being jointly researched by Hanmi and GC biopharma, has been designated as an orphan drug by the US FDA. LA-GLA is the world's first next-generation long-acting enzyme replacement therapy administered subcutaneously once a month, improving the limitations of existing treatments that require intravenous enzyme injection every two weeks.
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③?MFDS: The Ministry of Food and Drug Safety has prepared a guide for the operation of the Drug Approval and Review Adjustment Council" and will be implemented from June. According to an analysis by the Korea Research-based Pharma Industry Association, the average time required for pharmaceutical product approval is 313.7 days, but once the guidelines are implemented, the addition of a 'council body' between supplement request and final processing during the pharmaceutical product approval process is expected to shorten the approval period by several months.
④ Forum: TigerMed, China's largest CRO, and its subsidiary Dream CIS held the Korea-China Bio Innovation Forum in Hangzhou on May 21st. 26 Korean biopharma companies participated and introduced their pipelines and clinical results to 66 Chinese companies, and the forum was? evaluated as a beneficial networking place that improved understanding of the Chinese bio market, which is difficult to read.
⑤ New drug approval: HLB applied for FDA approval as a first-line treatment for liver cancer using the combination therapy of the targeted anticancer drug 'Rivoceranib' and China's Hengshe Pharmaceutical's immunotherapeutic drug 'Camrelizumab', but the approval decision was on hold? as Eleva and Hengseo received a Complementary Request Letter (CRL) on May 16th. The two problems pointed out are Camrelizumab's CMC and uncompleted bioresearch monitoring inspection (BIMO). HLB and Hangseo Pharmaceutical are divided on whether it is a process issue or a facility issue regarding CMC, and HLB is expressing that it is not necessary to take additional supplement regarding the inspection.
???? Introduction
?? This section introduces the analysis service or equipment that Central Lab mainly uses.
Central Lab service #9_Exfoliation sample analysis service
Today, I would like to introduce the dead skin analysis service. Dead skin contains lots of biological markers that can evaluate skin barrier function, so it can be used in various fields such as skin health care, cosmetics development, and disease diagnosis.
? Biomarkers that can be determined through dead skin analysis
The mainly used dead skin test methods and characteristics are listed in the table below, and in addition, various markers can be analyzed using dead skin.
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? Analysis method used when examining dead skin
There are several ways to dead skin test methods, and the markers below can be analyzed in multiple ways.
? Skin tissue collection method
There are various ways to collect skin epidermis, but there are three main methods.
1. Shave Biopsy: This is a method of removing a thin layer of the skin surface using a scalpel or razor, allowing a shallow sample containing the epidermis and some dermal layers to be collected. Wound healing is rapid and the risk of scarring is low.
2. Punch Biopsy: This is a method of cutting the skin into a circle using a circular punch tool, allowing samples to be collected from a depth including the epidermis to the dermis layer. Wound healing is slower than with Shave Biopsy and there is a risk of scarring.
3. Excisional Biopsy: This is a method of collecting a sample by excising the entire lesion. You can obtain the deepest sample, including the dermis layer and subcutaneous fat layer. Wounds heal the slowest and have a high risk of scarring.
Method #3 is used to check for tumors and pigmented lesions not mentioned above. Method #1 or #2, especially shave biopsy, are often used because they are simple and have a low risk of scarring.
The dead skin test is a marker that can be useful clinically in cosmetics and in skin-related diseases, and its importance is expected to grow in the future. In addition to the analysis set up by HuScience, we are establishing collaborative relationships with a number of partners related to dead skin test to help ensure a smooth analysis process. If you are interested in dead skin-related clinical trials, please submit a quote inquiry now through the button below.
??Huscience Event
?? This section is to inform you about the events that Huscience is hosting. If you are interested in Huscience's Central Lab service, meet a BD manager at those events for consultation.
?? Upcoming event
?? HuScience is holding a special discount event to commemorate the signing of the MOU with ApitBIO.
If you wish to proceed with a clinical trial that requires the use of antibodies, we will provide an additional 10% discount on the total amount.
Please leave a quote inquiry through our website.