[금일 제약업계 주요기사] Celltrion antibody treatment’approved’… Bukwang Pharmaceutical “Corona 19 treatment, clinical phase 2 IND approval by the US FDA, etc.

【Youth Daily】 A major issue in the pharmaceutical industry on the 5th is the news that the Ministry of Food and Drug Safety has approved Celltrion’s Corona 19 antibody treatment,’Recyronaju’ (CT-P59).

Bukwang Pharm obtained approval from the US Food and Drug Administration (FDA) for the phase 2 clinical trial plan (IND) of’Levovir’ (Clevudine), which is being developed as a COVID-19 treatment, and Daewoong Pharmaceutical’s’DWRX2003′ (Niclosamide) It was announced that it was finally selected as a project to support the construction of production equipment for COVID-19 treatment by the Health Industry Promotion Agency.

Prestige Biopharma was listed on KOSPI under the brand name’Pebi Pharma’, and Humedix acquired a domestic patent for the anti-aging composition’Nanoemulsion containing liposomes in which idebenone was captured’.

SK Bioscience has begun phase 1/2 clinical trials of co-administration of’GBP510′, an immune booster of multinational pharmaceutical company GSK, with’GBP510′, which is under development, and Hyundai Pharm has continued for 20 years since 1999. The’No Gifts’ Campaign will be launched this year.

Huzel held the ‘2021 Letybo Online Launching Meeting’ for the first time in China to introduce the botulinum toxin drug’Retibo’. It came to the conclusion that it should be done.

In addition, the US pharmaceutical company Johnson & Johnson has applied for emergency use of the Corona 19 vaccine to the US Food and Drug Administration (FDA).

◆ “Korea’s first COVID-19 treatment”… Ministry of Food and Drug Safety, Celltrion antibody treatment’licensed’

The Ministry of Food and Drug Safety’s Celltrion’s Corona 19 antibody treatment drug’Rekironaju’ (CT-P59) was approved. Subjects of administration are adult patients with mild to moderate symptoms in high-risk COVID-19 patients.

Subject to administration is limited to high-risk patients with mild or moderate symptoms. ‘High-risk group’ is a group that is over 60 years old or has one or more of cardiovascular disease, chronic respiratory disease, diabetes, and high blood pressure.

In the case of Corona 19 treatments and vaccines, the Ministry of Food and Drug Safety consulted with a’triple’ meeting leading to the Verification Advisory Group consisting of experts before approval, the Central Pharmacy Review Committee (Central Pharmacy Review), and the final inspection committee.

The verification advisory group recommended the approval of Rekirona for the administration of mild and moderate patients, but the following Central Pharmacopoeia limited the range of mild patients to high risk groups. On this day, the final inspection committee concluded the same.

◆ Bukwang Pharmaceuticals “Corona 19 treatment acquired IND approval for Phase 2 clinical trial by the US FDA”

Bukwang Pharm obtained approval from the US Food and Drug Administration (FDA) for the phase 2 clinical trial plan (IND) of’Levovir’ (Clevudine), which is being developed as a COVID-19 treatment.

This clinical trial is conducted with placebo-controlled, randomized, and double-blinded outpatients. The design will be conducted to evaluate the efficacy and safety of how much Revovir can reduce the Corona 19 virus in the body of Corona patients compared to placebo by administering Levovir and placebo to 40 patients with Corona 19 excluding severe cases.

Levovir has already completed patient registration in a phase 2 clinical trial conducted in Korea with moderate patients, and is about to analyze the results after the administration is complete. Since January of this year, additional clinical trials are underway to confirm the reduction of the infectious virus through the coronavirus cell culture test of Levovir.

◆ Daewoong Pharmaceutical’s “Corona 19 treatment production equipment construction government task final selection”

Daewoong Pharmaceutical’s’DWRX2003′ (Niclosamide) was finally selected by the Korea Health Industry Development Institute as a project to support the construction of COVID-19 treatment production equipment.

The selection of this government project was based on the support of the Ministry of Health and Welfare’s treatment and vaccine production equipment construction support project group (KIMCo). Daewoong Pharm plans to mass-produce’DWRX2003′ within this year with approximately 1.95 billion won in support for one year.

Niclosamide, which is being developed together by Daewoong Pharmaceutical and Daewoong Therapeutics, has been proven in various animal models such as virus removal, cytokine storm inhibition, and respiratory distress improvement, and is attracting attention as an all-in-one treatment for Corona 19. Receiving substance.

Daewoong Pharmaceutical is smoothly conducting phase 1 clinical trials for niclosamide in Australia and India, including Korea.

In the first half of 2021, the goal is to secure the results of multi-national phase 2 clinical trials for mild to moderately ill patients, and obtain conditional approval and emergency use approval sequentially at home and abroad from the second half of the year.

◆ Prestige Bio Pharma, listed under the brand name’Pebi Pharma’… “Follow the exchange recommendations”

Prestige Biopharma is listed on the stock market (KOSPI) under the trade name’PB Pharma’.

The company explained that the official mission, Prestige BioPharma, had a large number of letters, so the company decided to use’PB Pharma’, which is briefly expressed in accordance with the guidelines of the exchange recommended to be around 6 characters.

Prestige Biopharma is a Singapore-based company that is developing 8 types of biosimilars and 2 types of new antibody drugs.

◆ Humedix “Acquired a patent for anti-aging’idebenone composition’”

Humedix acquired a domestic patent for the anti-aging composition’Nanoemulsion containing liposomes in which idebenone is captured’.

This patent maximizes the use of the ubiquinone antioxidant’idebenone’, which is known to have the effect of moisturizing, suppressing aging, and improving wrinkles by enhancing collagen synthesis, while supplementing disadvantages such as stabilization by action period, potency preservation, and skin penetration rate. For one new composition.

Humedix believes that the patented idebenone composition will have high commercial value in various fields such as cosmetics, pharmaceuticals, and health functional foods, and plans to develop its own products as well as promote collaboration with various companies.

◆ SK Bioscience “Started clinical trial for co-administration of GSK immunity enhancer to Corona 19 vaccine”

It is said that SK Bioscience has begun a phase 1/2 clinical trial in which the vaccine candidate’GBP510′, which is being developed by SK Bioscience, is co-administered with’AS03′, an immune booster from GSK.

An adjuvant that enhances the effectiveness of the vaccine by administering it to some vaccine formulations. The principle of promoting the movement of vaccine antigen substances in the body that induces an immune response and increasing the antigen stimulation time.

SK Bioscience decided to cooperate with GSK after co-administration of’AS03′ in an animal test of’GBP510′ confirming that neutralizing antibodies were highly induced and T cell activity that elicited an immune response increased.

◆ Hyundai Pharm “Implemented the’No Holiday Gifts’ Campaign’ this year”

It is said that Hyundai Pharm is carrying out the’No Holiday Gifts’ campaign, which has continued for 20 years since 1999, again this year.

‘Do not give or receive’ is a campaign to prevent illegal solicitations and bribes that may occur between Hyundai Pharm’s employees and business partners and business partners. Implemented every holiday every year as a part of Hyundai Pharm’s implementation of ethical management voluntary compliance.

Accordingly, Hyundai Pharm has conducted training on the’no give and receive’ campaign for all employees, and if inevitable gifts are received, they are immediately returned to the provider, and in situations where it is difficult to return, Hyundai Pharm has established an operating policy to deliver it to the in-house corruption prevention officer. relay.

◆ Huzel, China Letivo’Online Launching’ Held… “1,000 pre-ordered medical institutions”

Huzel said that it was the first time to introduce a botulinum toxin drug’Retibo’ in China at the ‘2021 Letybo Online Launching Meeting’.

This launching session will be broadcasted to prevent the spread of Corona 19. The launching event, which was held for about an hour starting from 19:00 on the 4th in China local time, was simultaneously broadcast on 11 platforms including Wechat, Soyoung, and Yizhibo.

The company explained that 600 investors, 3,000 medical institution officials, and general consumers from 31 provinces and cities in China were connected to it, and about 5 million people were connected, and the number of pre-order medical institutions reached 1,000.

◆ Central Pharmacopoeia recommends AstraZeneca vaccine approval… Deferring judgment for vaccinations over 65

In the second expert consultation on AstraZeneca’s COVID-19 vaccine, it was concluded that administration of the elderly over the age of 65 should be discussed in the future.

They recommend that this product be approved by the age of 18 or older, but since the data are insufficient, the vaccination for the elderly should be carefully decided and discussed at the Korea Centers for Disease Control and Prevention’s vaccination expert committee (composed of experts in infectious diseases, preventive medicine, and immunology).

In fact, it passed the judgment on whether to inoculate the elderly to the final inspection committee and the Korea Centers for Disease Control and Prevention.

◆ Johnson & Johnson applied for emergency use of Corona 19 vaccine to the US FDA

US pharmaceutical company Johnson & Johnson applied for emergency use of the COVID-19 vaccine to the US Food and Drug Administration (FDA).

According to Reuters and others, Johnson & Johnson announced that its affiliate Janssen Biotech recently applied to the FDA for approval and that it will also apply to European authorities within a few weeks.

Johnson & Johnson officials stated in a statement that they are ready to start distribution as soon as emergency use is approved.

Earlier, Johnson & Johnson said on the 29th of last month that its vaccine showed 66% preventive effect in international clinical trials.

If urgent approval is granted, the Johnson & Johnson vaccine will be licensed for the third time in the United States after Pfizer-Bioentech and Modena.

【Youth Daily = Reporter Ahn Sang-jun】