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Economy

Blue M Tech, the blue farm operator, selected as a reserve unicorn

by Alexandra Hartman Editor-in-Chief
written by Alexandra Hartman Editor-in-Chief

2023-06-29 06:35:11

Blue M Tech announced on the 29th that it was finally selected as 15 companies for the ‘preliminary unicorn special guarantee’ operated by the Ministry of SMEs and Startups in 2023.

Blue M Tech has been selected as a baby unicorn in 2021, and it is the first time that a pharmaceutical distributor has been selected as a preliminary unicorn that evaluates technological innovation. Companies selected as preliminary unicorns will receive benefits such as technology guarantee fund guarantees of up to KRW 20 billion and advisory services for technology special listing.

About 120 companies applied for this recruitment, showing a high competition rate of 8:1.

Unlike baby unicorns, which evaluate the innovativeness of a business model, preliminary unicorns must satisfy ▲attracting more than 5 billion won in investment from venture investment institutions ▲annual average sales growth rate of 20% or higher over the past 3 years ▲technology business evaluation grade of Korea Technology Finance Corporation The eligibility criteria for application are very strict.

However, it is understood that many technology companies support it because of the value of being selected by the Ministry of SMEs and Startups and the Korea Technology Finance Corporation.

Blue M Tech operates ‘Blue Farm Korea’, an online trading service for prescription medicines for hospitals and clinics, attracting a cumulative investment of 22 billion won and continuing to grow by more than 50% every year, recording sales of 77.1 billion won last year.

It provides services that provide various benefits to its customers, medical institution founders, and has secured more than 27,000 hospitals and clinics as members by establishing a logistics system optimized for pharmaceuticals. On June 9, Blue M Tech submitted a request for preliminary examination to the Korea Exchange for listing on the KOSDAQ.

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#Blue #Tech #blue #farm #operator #selected #reserve #unicorn

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Health

Promising Results of Pegozafermin in NASH Treatment: Outperforming Resmetirom in Clinical Trials

by Alexandra Hartman Editor-in-Chief
written by Alexandra Hartman Editor-in-Chief

2023-06-28 20:20:00

Pegozafermin, which is being developed by 89BIO in the development of NASH (non-alcoholic steatohepatitis), which has regarding 130 clinical pipelines in operation around the world, is closely chasing the leading Resmetirom.

Resmetirom came one step closer to commercialization by presenting the results of phase 3 clinical trials that improved fibrosis and achieved remission of NASH, but Pegozafermine gained an advantage over Resmetirom in terms of effectiveness through phase 2 clinical trials.

According to the medical community on the 28th, the results of FGF21 analog pegozapermin administration to NASH patients conducted by researchers including Rohit Loomba of the NAFLD Research Center of the University of California Medical School in the United States were published in the international journal NEJM (DOI: 10.1056/NEJ Moa2304286).

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FGF21 is an endogenous metabolic hormone that regulates energy expenditure and glucose and lipid metabolism. It has a mechanism involved in regulating glucose and lipid homeostasis by acting on FGF (Fibroblast growth factor)21.

Pegozapermine showed a strong reduction of fatty liver and a clinically meaningful response in a significant proportion of patients. In addition, results suggesting changes in major liver markers related to NASH have been observed, and it is emerging as a drug that improves liver pathology and solves fundamental metabolic problems.

In the phase 2 clinical trial, 219 patients with biopsy-confirmed NASH and stage F2-F3 (moderate or severe) liver fibrosis were randomly assigned to receive 15/30 mg weekly, 44 mg every 2 weeks, or placebo every 2 weeks for 24 weeks.

The primary study end point was improvement in fibrosis (grade 0-4, higher score, worse), and remission rate and safety of NASH without NASH or worsening of fibrosis were also evaluated.

As a result of the analysis, the proportion of patients who met the criteria for improvement in fibrosis was 7% in the placebo group, 22% in the 15 mg pegozafermin group (14%p difference compared to placebo), 26% at 30mg (19%p difference), and 27% at 44mg (difference 19%p). With a difference of 20%p), pegozapermine was effective in a dose-dependent manner.

The percentage of patients who met NASH remission criteria was also 2% in the placebo group, 37% in the 15 mg pegozapermin group (difference 35%p compared to placebo), 23% at 30mg (difference 21%p), and 26% at 44mg (difference 24%p). %p) showed a similar pattern.

The most common adverse reactions associated with pegozapermine treatment were nausea and diarrhea.

The research team concluded, “Through the phase 2b clinical trial using pegozapermin, improvement in fibrosis was confirmed,” and “these results support the need for phase 3 clinical trials.”

In order to be approved by the FDA as a NASH treatment, one of the fibrosis improvement or NASH remission rate must be satisfied, but pegozappermine satisfies both of these, and it is said that it has confirmed its competitiveness even though it is only in phase 2 clinical trials.

In particular, looking at the response rate of the treatment group compared to the response rate of the placebo group, the fact that pegozapermine is ahead of Resmetirom in the rate of improvement of stage 1 or higher fibrosis (19/20% vs. 10/12%) is also a factor that highlights its competitiveness.

An official from the Society for the Study of the Liver said, “It is encouraging to see that various candidates are effective in improving fibrosis and remission of NASH in the absence of a suitable NASH treatment yet.” Each has a different mechanism and the method of administration is divided into oral and injection, so it remains to be seen what will be effective.”

He said, “Resmetirom has more than 300 people in each dose group, but clinical trials for other ingredients are relatively small, so the key is whether or not similar effects can be reproduced in additional clinical trials involving large-scale people.” , Attempts to divert candidates from the obesity treatment mechanism into NASH treatments are also continuing, so we have to wait and see the results.”

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#Rising #latecomers #NASH #treatment #Pegozafermin #Phase #Passing #Score

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Economy

Notice of expansion of CNS sales force of Samil Pharmaceutical, which took over Sandoz products

by Alexandra Hartman Editor-in-Chief
written by Alexandra Hartman Editor-in-Chief

2023-06-26 02:46:01

As of this month, the withdrawal of permission for major items of Sandoz Korea, which decided to withdraw from the domestic business, has become a reality.

As Samil Pharmaceutical decides to take responsibility for the remaining central nervous system (CNS)-oriented items following withdrawal, its presence in the prescription market is expected to grow further.

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According to the pharmaceutical industry on the 26th, the Ministry of Food and Drug Safety disclosed the fact that Sandoz Korea had withdrawn its approval for major items such as cardiovascular drugs Tarek, Kotarek, and Genepri.

Previously, Sandoz Korea decided to withdraw from the domestic business as of June 30. This is the effect of changing the business model in the Korean market following being spun off as an independent corporation at the end of last year.

It is interpreted that the company is going through the process of withdrawing approval for major cardiovascular drugs in line with the withdrawal time.

Among them, as Sandoz Korea’s withdrawal became a reality, Samil Pharm, which received more than the remaining medicines, is attracting attention anew.

Cardiovascular drugs are withdrawn from the domestic market, but central nervous system (CNS) drugs such as antidepressants Mitrax, Sandos escitalopram, Sandosparoxetine, Sandos sertraline, schizophrenia treatment Sandos olazapine, and insomnia treatment Sandos zolpidem This is because Samil Pharmaceutical decided to take over.

Recently, in the case of Samil Pharmaceutical, it is attracting attention by developing sales and marketing of major ophthalmology drugs, and as it took over Sandoz’s items, its influence in the prescription market has grown even more.

In fact, early this year, Samil Pharmaceutical launched ‘Reba-K (Rebamipide)’, an eye drop for treating dry eye syndrome, while taking charge of the domestic sales of ‘Amelibuju (ranibizumab)’ developed by Samsung Bioepis. ‧Influence in the medical market has grown further.

In the case of Levakey eye drops, it is expected that it will replace the market occupied by hyaluronic acid eye drops amid the government’s recent promotion of reimbursement reevaluation.

In addition, it is expected to solidify its image as a professional pharmaceutical company in the ophthalmology and CNS prescription market by taking over the business of Sandoz’s CNS-type drugs.

A domestic executive who requested anonymity said, “Samil Pharmaceutical is active in the ophthalmology market to the extent that it has formed a specialized sales organization to take over the business rights of Samsung Bioepis Ameliebu.” It is expected that the image of pharmaceutical companies in the field will be further strengthened.”

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#Notice #expansion #CNS #sales #force #Samil #Pharmaceutical #Sandoz #products

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Health

Transdermal Nitroglycerin for Hot Flashes: The Truth Revealed in Latest Study

by Alexandra Hartman Editor-in-Chief
written by Alexandra Hartman Editor-in-Chief

2023-06-07 02:58:15

Studies have shown that transdermal nitroglycerin does not have a significant effect on hot flashes in postmenopausal women.

In the first 5 weeks, the frequency of occurrence decreased by regarding once a day, but when the dosing cycle was increased to 12 weeks, there was no statistically significant difference from the placebo group.

The results of a study on transdermal nitroglycerin treatment for women with postmenopausal hot flashes conducted by researchers including Allison Hwang of the University of California Medical School, USA, were published in the international journal JAMA Internal Medicine on the 5th (doi:10.1001/jamintered.2023.1977).

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About 70% of postmenopausal women experience hot flashes in the face and neck area due to changes in hormone secretion and the skin turns red.

Since the symptoms themselves are caused by estrogen deficiency, hormone replacement therapy that administers estrogen can be used, but in this case, attention is focused on non-hormonal therapies because of the increased risk of venous thrombosis, stroke, and cardiovascular disease.

As physiological studies revealed that nitric oxide is a key factor in mediating vasodilation associated with hot flushes, the researchers hypothesized that inducing nitrogen tolerance with nitroglycerin administration might have an effect on vasomotor symptoms.

The researchers divided participants who reported seven or more hot flashes per day during menopause or postmenopause into two groups: one group received a transdermal nitroglycerin 0.2-0.6 mg/h patch (n=65) and the other group received a placebo (n=69). was administered for 12 weeks to examine the degree of symptom relief.

Participants reported an average of 11 hot flashes and 8.4 severe hot flashes per day.

As a result of the analysis, in the group that applied the transdermal nitroglycerin patch for 5 weeks, the frequency of hot flushes per day decreased by 0.9 times, and severe hot flushes by 1.1 times.

On the other hand, when the duration of treatment was increased to 12 weeks, there was no significant difference in the frequency of occurrence from the placebo group.

Compared to the placebo group, the group using the transdermal nitroglycerin patch reduced hot flashes by an average of 0.1 times per day, and severe hot flashes by 0.5 times, and no significant reduction was observed.

In an analysis combining 5- and 12-week data, there was no significant change in incidence compared to the placebo group.

In addition, a negative effect was observed in the nitroglycerin group, with 47 patients (67.1%) in the nitroglycerin group and 4 patients (5.6%) in the placebo group reporting headaches in the first week of administration.

“This randomized clinical trial confirmed that transdermal nitroglycerin administration did not result in sustained improvement in the frequency or severity of hot flashes compared to placebo,” the researchers said. concluded that

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#Hot #flushes #menopause #nitroglycerin #patch #therapy #effect

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