Protox’s botulinum toxin preparation ‘Protoxin Inj. (tentative name)’ is speeding up commercialization. It has applied for approval in Korea and was approved for phase 3 in Russia. The analysis is that Protox’s two-track commercialization strategy at home and abroad is creating synergy.

According to the industry, Protox applied for domestic product approval for Protoxin on December 28 last year.

Protox was conducted in phase 3 at Konkuk University Hospital and four other hospitals in Korea on 274 adults in need of improvement of moderate to severe wrinkles between the eyebrows. As a result, statistical analysis of the primary efficacy evaluation index confirmed the non-inferiority of Protoxin and the control group (Allergan Botox). In addition, product safety and sustainability are additionally secured through extended clinical trials.

Global expansion is also accelerating.

Protox received Phase 3 Clinical Trial (IND) approval from the Russian Ministry of Health and Welfare (Minzdrav) on December 29 last year.

In March of last year, the company signed a contract with Russian company S to proceed with local phase 3 (full burden) and supply Protoxin injection worth 100 billion won for 10 years, and later obtained phase 3 approval through collaboration between the two companies.

We plan to begin phase 3 in Russia starting this year. Based on the results of phase 3, we plan to secure Russian approval and launch the product in Russia and 12 CIS countries.

Protox has also completed preparations for commercialization at home and abroad.

The Hyangnam Pharmaceutical Industrial Complex has a GMP production line that can produce up to 5.4 million vials of botulinum toxin products per year. It is the first bio production plant in Korea that can produce and operate with high quality standards, including installing a German Bausch filling line that meets international standards.

In April 2019, a total project cost of approximately 32 billion won was invested in the Hyangnam Pharmaceutical Complex in Hwaseong City to complete the construction of a 4-story, global standard GMP factory. After securing a pharmaceutical manufacturing license in October of that year, the company received GMP certification in July 2020.

Meanwhile, Protoxin is a botulinum toxin developed by Protoxin. It was developed as a strain that is 99.99% identical to the ATCC3502 species registered in the gene bank operated by the U.S. National Center for Biological Information (NCBI).

It is a finished product that has verified quality control results that meet internationally standardized standards, including non-clinical safety and efficacy data in line with international standards and the potency of the concentrate and finished product. Recently, it was selected as an excellent biosecurity management institution by the Ministry of Trade, Industry and Energy and received the Minister’s Award.

Protox (then a subsidiary of DSK) acquired a 51% stake and management rights in Medica Korea, an unlisted pharmaceutical company, for 38 billion won in 2016. Afterwards, Protox’s largest shareholder was changed to Synergy Group.

Protox was selected as the best among institutions with excellent biological security management as a result of ‘regular (occasional) inspection of biological agents, etc.’ over the past three years and received the Minister of Trade, Industry and Energy Award at the ‘2023 Bio Industry Day’. 4 The day was revealed.

Biosecurity management is carried out in accordance with the ‘regular (occasional) inspection of biological agents, etc.’ conducted by the government in accordance with Article 18-2 of the ‘Biological and Chemical Weapons Prohibition Act’.

The Biosecurity Management Merit Award is given to excellent institutions among regular (or regular) inspections. It is selected through deliberation by a committee comprised of experts from the Korea Biotechnology Association and BWC. As a result of the Protox deliberation, the company was awarded a ministerial commendation in recognition of its contribution to efforts to strengthen biosecurity management over the past three years.

Protox is a biopharmaceutical company that manufactures botulinum toxin medicine (aka Botox). Botox preparations are being developed using the strain ‘ATCC3502’ registered with the Korea Disease Control and Prevention Agency.

We have a bio production plant in the Hyangnam Pharmaceutical Complex in Gyeonggi-do that has introduced global standard filling facilities. We focus on security every year to systematically manage botulinum toxin strains (biological agents).

Currently, based on such security and production management, the final patient observation of Phase 3 Protox Injection has been completed. In addition, an extended clinical trial plan (IND) to analyze the effectiveness and safety of a single group of developed products has been approved, and the company is aiming for product approval in 2024.

A Protox official said, “As we have been recognized for our contribution to strengthening biosecurity, we will continue to strive for systematic and reliable security management of biological agents.”Reporter Seokjun Lee (wiviwivi@dailypharm.com)

Protox, a company specializing in manufacturing botulinum toxin drugs, announced on the 17th that it has signed an exclusive supply contract between Brazil and Russia for its own botulinum toxin type A (tentative name Protoxin stock).Protox is a subsidiary of KOSDAQ-listed DSK.

According to the company, through this contract, the company plans to jointly carry out phase 3 clinical trials in individual countries and obtain local product licenses for “Protoxin stocks” that have completed phase 1 and 2 clinical trials in Korea.Local partners will pay the full cost of phase 3 clinical trials in the country.

In addition, the company explained that after successful termination of phase 3 clinical trials and obtaining product licenses in the region, it will exclusively supply protoxin stocks worth 200 billion won in Brazil and 100 billion won in Russia for at least 10 years.

In Russia, applications for phase 3 clinical trials are currently underway, and local clinical trials will begin in earnest soon.Brazil also plans to carry out preliminary work for approval of phase 3 clinical trials in the region and register with the ANVISA (National Health Monitoring Agency).In addition, the company is conducting phase 3 clinical trials on 274 subjects from five domestic institutions to obtain domestic item licenses next year.

Newsis mrkt@newsis.com Reporter Kim Kyung-taek

Protox, a DSK subsidiary, announced on the 20th that it has received IRB (Clinical Research Review Committee) approval from Pusan National University Hospital for phase 3 clinical trials of botulinum toxin type A “Protoxin”.

Protox was approved by the Ministry of Food and Drug Safety in April this year for a phase 3 clinical trial plan for Protoxin.Protox will compare and evaluate the effectiveness and safety of Protoxin and Botox in “adults who require improvement of moderate or severe wrinkles” in phase 3 clinical trials.

Protox submitted an application for deliberation to a total of five hospitals IRB, Konkuk University Hospital, Kyung Hee University Hospital, Nowon Eulji Hospital, Busan National University Hospital, and Chung-Ang University Hospital for phase 3 clinical trials.Protox received IRB approval for phase 3 clinical trials at Pusan National University Hospital on the 5th, and other hospitals are expected to complete the deliberation within August.

Protoxin is a toxin product developed by Protox based on “ATCC3502”, and Protox commissioned a genetic analysis agency to analyze the gene sequence of the strain, and it was confirmed that it matched 99.99% with ATCC3502 species registered with the National Center for Biological Information (NCBI).

Based on non-clinical safety and efficacy data that meet international standards, Protox plans to conduct phase 3 clinical trials as a finished product that verifies quality control results that meet standards and test methods such as undiluted solution and completion titer.Protox has completed verification and evaluation of the safety and effectiveness of Protoxin through phase 1 and 2 clinical trials in Korea.

A Protox official said, “We plan to conduct phase 3 clinical trials in five domestic hospitals for 280 people,” adding, “As we have been recognized for safety and efficacy through phase 1 and 2, we will focus our capabilities on clinical management with the aim of launching products through successful phase 3 clinical trials.”

Protox is equipped with manufacturing facilities that can be produced and operated with high quality standards, such as installing a filling line from Germany’s “Bausch” company that meets international standards for the first time in Korea, he added.

Meanwhile, Protox invested about 32 billion won in the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi-do in 2017 to complete a four-story Protoxin liquor production facility with a total floor area of 6,227㎡ (about 1,886 pyeong).Protox received a pharmaceutical manufacturing license for the production facility in 2019 and obtained GMP certification in July 2020.

Pharmnews Reporter Lee Kwon-koo kwon9@pharmnews.com

Protox’s botulinum toxin A formulation ‘Protoxin’ will soon enter phase 3 clinical trials.

The Ministry of Food and Drug Safety submitted a report submitted by Protox on the 1st, titled ‘Multicenter, double-blind, random allocation to comparatively evaluate the effectiveness and safety of Protoxin and Botox in adults requiring improvement of moderate or severe glabellar lines.’ A ‘parallel, active-controlled, phase 3 clinical trial’ was approved.

Phase 3 clinical trials will be conducted at Chung-Ang University Hospital.

To develop botulinum toxin, Protox invested a total project cost of approximately KRW 32 billion in the Hyangnam Pharmaceutical Complex in Hwaseong City in April 2019 and established a GMP (good manufacturing practice) facility with a total floor area of ​​6,227 m2 (approximately 1,886 pyeong) and 4 floors above ground. On October 7 of that year, a pharmaceutical manufacturing license was obtained.

Protoxin obtained clinical plan approval and GMP approval on July 31, 2020, and has been conducting phase 2 clinical trials since last year.

Protoxin, developed from the ATCC3502 strain, is undergoing clinical trials as a finished product that has verified quality control results that meet the standards and test methods, including non-clinical safety and efficacy data in line with international standards and potency of the raw solution and finished product.

The company aims to launch the product in 2023 after successfully completing phase 3 clinical trials.
Reporter Hye-kyung Lee (hgrace7@dailypharm.com)

Protox, a biopharmaceutical affiliate of Synergy Partners Group, announced on the 3rd that it will successfully end phase 1 clinical trial of its own botulinum toxin type A, “Protoxin” and begin phase 2 clinical trial.

Protox has secured stability in the phase 1 clinical trial conducted after approval of the clinical trial plan last year, and in the phase 2 clinical trial, it plans to verify and evaluate the effectiveness of improving moderate or severe wrinkles of Protoxin.

Protoxin was developed through its own research and development at Protox, and as a result of analyzing the gene sequence by commissioning its strain to a genetic analysis agency, it was 99.99% consistent with ATCC3502 species registered with the National Center for Biological Information (NCBI).

The Protoxin Bio Production Plant began construction in May 2017 in the Hyangnam Pharmaceutical Complex in Hwaseong-si, Gyeonggi-do, and was completed in more than two years.The plant, which has a total project cost of about 32 billion won, has a total floor area of 6,227㎡ (about 1,886 pyeong) and is designed to be produced and operated on a high quality basis, such as installing a filling line from Germany’s Bausch, which can produce 5.4 million vials of botulinum toxin per year.

Protox, which started exporting after obtaining permission for export of Protoxin stocks last year, plans to make full-fledged sales from this year.

Reporter Choo Min-sun cms@newsprime.co.kr

Protox received permission to export Protoxin.

According to the Ministry of Food and Drug Safety’s Integrated Drug Information System, product approval was granted for export of Protox ‘Protoxin Injection 100 Units (Clostridium Botulinum Toxin Type A)’ on the 13th.

Protoxin is a botulinum toxin (Botox) that Protoxin is developing in-house, and is being developed as an ATCC3502 strain. Protox is a subsidiary of DSK.

According to the Ministry of Food and Drug Safety, the efficacy is “temporary improvement of moderate to severe glabellar wrinkles related to the activity of the corrugator muscle and/or procerus muscle in adults aged 18 to 65 years.” “It is written as:

Previously, Protox also obtained Phase 1/2 clinical trial (IND) approval and GMP certification for Protoxin injection from the Ministry of Food and Drug Safety on the 31st of last month.

Lee Dae-ho, Money Today Broadcasting MTN reporter

Protox, a biopharmaceutical company, announced on the 3rd that it has obtained clinical plan approval and GMP approval for Protoxin, a botulinum toxin drug, from the Ministry of Food and Drug Safety, as of the 31st of last month.

Protoxin State, developed as an ATCC3502 strain, conducts clinical trials with finished products that have verified quality control results that meet “standard and test methods,” such as non-clinical safety and efficacy data that meet international standards, and reverse prices of undiluted and finished products.

A Protox official said, “We have made efforts to develop products with safety and reliability by completing monkey toxicity tests as well as rodents early, and we have transparently identified the source and source of strains used when applying for clinical trial approval by the Ministry of Food and Drug Safety.”

Protox is rapidly developing as it received approval for clinical trials eight months after completing the construction of a GMP-standard factory last year and obtaining a manufacturing license.

Meanwhile, the botulinum toxin preparation plant located in the Hyangnam Pharmaceutical Complex has increased safety and efficiency by establishing the entire production process as an automated system, and is capable of producing 2.7 million vials of protoxin liquor annually.

Reporter Choo Min-sun cms@newsprime.co.kr

Protox announced on the 27th that it has submitted an application to the Ministry of Food and Drug Safety for approval of phase 1/2 clinical trial plan (IND), GMP certification, and export license of its own botulinum toxin type A type.

The clinical trial will be conducted at Promedis, a CRO specializing in clinical trials, after approval of the clinical trial plan.

Protox analyzed the genetic sequence of its strains through an external analysis agency and found that it matched 99.99% of ATCC3502 species registered with Genbank, operated by the National Center for Biological Information (NCBI).

Protoxin (tentative name) developed with the strain is a finished product that verifies quality control results that meet internationally standardized “standards and test methods,” such as non-clinical safety and efficacy data that meet international standards.

Meanwhile, the bio-production plant that will produce protoxin began construction in May 2017 in the Hyangnam Pharmaceutical Complex in Hwaseong-si, Gyeonggi-do, and was completed in about two years.

The plant, which has a total project cost of about 32 billion won, has a total floor area of 6,227㎡ (about 1,886 pyeong) and is designed to be produced and operated on a high quality basis, such as installing a filling line from Germany’s Bausch, which can produce 5.4 million vials of botulinum toxin per year.

Reporter Choo Min-sun cms@newsprime.co.kr

Protox, a DSK subsidiary, is expected to apply for a phase 1 clinical trial this month to develop botulinum toxin (Botox).It also applies for GMP (Korea Good Manufacturing Practice) certification for export.

A DSK official said on the 8th, “The researchers have secured the results necessary to conduct the phase 1 clinical trial, and clinical applications will be made in April,” adding, “Discussions with clinical hospitals are ongoing and the goal is to take clinical doses within this year.”

Protox’s botulinum toxin A drug (tentative name Protoxin) pre-clinization has been conducted since February last year at Biotoxtech, a certified GLP institution, and the Safety Evaluation Institute.According to the company, no abnormal symptoms were observed during the animal test observation period.In particular, in terms of the efficacy of “inhibiting muscle contraction,” it was confirmed that it was more persistent than control materials at equivalent or some doses.

Protox applied for a phase 1 clinical trial plan (IND) to the Korea Food and Drug Administration (KFDA) in April this year based on the results of its predecessor, and the medication clinical trial is scheduled to begin in earnest this year.

The bio-production plant that will produce protoxin began construction in May 2017 in the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi-do, and was completed in about two years.The total project cost was about 32 billion won, and the factory was designed based on Good Manufacturing Practice (GMP) with a total floor area of 6,227㎡ (about 1,886 pyeong).

With the completion of the plant, Protox will be able to produce 2.7 million vials of Botox per year.In order to increase production to 5.4 million vials per year in the future, redesigns are underway, including installing additional freeze dryers.

Reporter Ko Jong-min, kjm@etoday.co.kr