Protox has completed non-clinical testing for the development of botulinum toxin (Botox) and is preparing for full-scale phase 1 clinical trials.

DSK subsidiary Protox (CEO Lee Dong-beom) announced on the 21st that it had recently completed non-clinical testing for a botulinum toxin preparation (tentative name Protoxin).

Protox said, “We have secured the results necessary to conduct a phase 1 clinical trial through non-clinical trials,” and “we plan to proceed with a phase 1 clinical trial next year as planned.”

Non-clinical trials of Protox have been conducted at BiotoxTech, a certified GLP institute, and the Safety Evaluation Research Institute since February. No abnormal symptoms were observed during the animal experiment observation period. In particular, in terms of ‘muscle contraction inhibition’ efficacy, it was confirmed that the results were more durable than the control substance at the same or partial dose.

A Protox official explained, “In order to enter phase 1 smoothly, we secured primate safety compared to other companies early by completing monkey toxicity tests,” and added, “We are focusing on producing products that reduce the number of administrations by improving quality and sustainability.”

He added, “Currently, Protox is preparing for GMP inspection to produce clinical samples,” and “We are accelerating preparations for submission of Phase 1 IND in the first half of next year.”

Previously, Protox signed a contract for domestic clinical trials with Promedis Co., Ltd. (CEO Eun-jeong Jeon), a clinical trial trust agency.

Lee Dae-ho, Money Today Broadcasting MTN reporter

Protox, a pharmaceutical manufacturer that is developing botulinum toxin (Botox), announced on the 16th that it held a shareholder meeting at a bio-production plant located in Hyangnam Pharmaceutical Industrial Complex in Hwaseong, Gyeonggi-do.

The meeting was held with Protox CEO Lee Dong-beom, new plant manager Lee Seung-jin, executives and employees, and Protox shareholders attending.At the meeting, a question-and-answer session on business strategies and management was also held, along with sharing the R&D status, future plans, factory status, vision and strategy of Botulinum toxin A drug developed by Protox.

A company official said, “As a result of non-clinical trials, we have confirmed significant results equal to or more than that of existing products, and we believe that it will have a positive impact on entering domestic and foreign markets.”

Reporter Yoo Hyun-suk, guspower@asiae.co.kr

The number of domestic companies producing botulinum preparations used for cosmetic purposes such as wrinkle improvement is increasing. This agent, famous as Allergan’s ‘Botox’, is currently being competed with by domestic companies such as Medytox, Daewoong Pharmaceutical, and Hugel by launching products into the market.

According to the Ministry of Food and Drug Safety on the 11th, Protox (CEO Lee Dong-beom), which is developing botulinum toxin preparations, obtained a pharmaceutical manufacturing license on the 7th.

Protox completed the construction of a botulinum toxin plant last April, investing 32 billion won. The factory is located in Hyangnam Pharmaceutical Complex, Hwaseong-si, Gyeonggi-do.

This factory has a total floor area of ​​6,227㎡ (about 1,886 pyeong), 4 floors above ground, and is equipped with GMP (good manufacturing practice) facilities.

The company said that it can produce 2.7 million vials of botulinum toxin preparations per year, and that it is conducting a redesign to install additional freeze dryers to increase production to 5.4 million vials per year in the future.

It is known that ‘Protoxin’, a botulinum toxin A preparation currently being developed by Protox, has completed non-clinical trials and is preparing for clinical trials. The company explained, “We are developing a high-purity, next-generation botulinum toxin preparation with improved formulation and performance compared to existing botulinum toxin preparations,” and added, “We are aiming to launch the product in 2023, starting with clinical trials next year.”

Protox is a subsidiary of DSK, a factory automation control system developer. Protox is also the largest shareholder of pharmaceutical company Medica Korea with a 49.47% stake.

As domestic botulinum toxin preparations become success stories, such as Medytox and Hugel’s high domestic market share and Daewoong Pharmaceutical’s overseas expansion, the number of next-tier players such as Protox continues to increase. Companies currently developing botulinum toxin preparations include Eubiologics, Protox, BMI Korea, Zetema, Kanzen, and Osstem Implant.

Huons Global also received approval for ‘Riztox Injection’ in 2016, and Pharma Research Bio also received approval for ‘Reentox Injection’ in February, and is preparing to launch it on the market. Now there are five licensed companies. Latecomers dream of becoming the next Medytox, Daewoong Pharmaceutical.
Reporter Tak-soon Lee (hooggasi2@dailypharm.com)

DSK subsidiary Protox (CEO Lee Dong-beom) announced that it held a completion ceremony for a bio production plant at the Hyangnam Pharmaceutical Complex in Hwaseong-si, Gyeonggi-do on the 25th with approximately 200 Protox executives and employees and outsiders in attendance to develop botulinum toxin preparations.

The bio production plant began construction in May 2017 and was completed in about two years. A total project cost of approximately 32 billion won was invested to build a GMP (good manufacturing practice) facility with a total floor area of ​​6,227 m2 (approximately 1,886 pyeong) on ​​the 4th floor above ground.

With the completion of this factory, Protox will be able to produce 2.7 million vials of botulinum toxin preparations per year, and is undergoing redesign by installing additional freeze dryers to increase production to 5.4 million vials per year.

The company explained that it invested more than 10 billion won this year to install a German Bausch filling line that meets international standards for the first time in Korea in the GMP production line that produces botulinum toxin preparations, and that it has improved safety and efficiency by establishing an automated system for the entire production process. did.

Protox plans to complete GLP (good laboratory practice, animal testing norms) non-clinical testing of its self-developed botulinum toxin A preparation (tentative name Protoxin) at the end of this year and apply for clinical trial approval (IND).

A company official said, “With continued research and development and patent applications, we plan to export it to Southeast Asia and other countries next year and launch it domestically in 2022.”

Reporter Tak-soon Lee (hooggasi2@dailypharm.com)

Anchor>
DSK subsidiary Protox has completed its Botox production plant. Bio plants and even botox are now not uncommon materials. However, it is meaningful because it is the result of the company overcoming adversity. Reporter Dae-ho Lee covered the story.

Reporter>
Protox bio production plant located in Hyangnam Pharmaceutical Complex, Hwaseong-si, Gyeonggi-do.

Two years after construction began, the tape announcing the completion was cut.

Total floor area of ​​6,227m² (approximately 1,886 pyeong), 4 floors above ground. We have a GMP facility capable of producing approximately 2.7 million vials of Botox (Protoxin) per year.

Although Protox is a latecomer to Botox (Protoxin), we are confident that it will have sufficient differentiation.

[Lee Dong-beom / Protox CEO: The effect usually lasts for about 6 months, but ours is our own record, but we are somewhat confident that it will last for more than a year. That’s the beauty of the product. Wouldn’t that be preferred by patients because the pain is a bit milder? .]

This completion ceremony has a special meaning.

This is because the parent company, DSK, almost lost its management rights to corporate hunters in 2017, and even suffered from delisting due to their embezzlement.

In the end, founder Vice Chairman Kim Tae-gu won the legal battle, and Synergy Partners emerged as an ally and was able to settle the dispute.

[Kim Jong-won / CEO of DSK Bio Division: As we entered the conflict, we had to do our best, and it matched our concept, so we started managing and it seemed like a natural progression.] In the past, we met the wrong corporate hunter and were on the verge of bankruptcy

. DSK and its subsidiary Protox.

After two years of hardship, we are now on track for new growth.

[Money Today Broadcasting MTN = Reporter Lee Dae-ho ( robin@mtn.co.kr )]

Protox received approval to use a new factory for the development of botulinum toxin (Botox). Through this, the process of preparing for toxin approval began in earnest.

Protox, a bio venture company, announced on the 8th that it received construction permission for a botulinum toxin manufacturing plant located in Hyangnam Pharmaceutical Complex, Hwaseong-si, Gyeonggi-do as of the 4th. The completion ceremony is scheduled to be held around the end of April. Protox is a subsidiary of DSK.

The new factory has a single-scale production capacity of 2.7 million vials. It was designed according to the latest GMP standards and met the Ministry of Food and Drug Safety approval conditions. In addition, it is explained that every effort has been made to improve safety and efficiency by establishing the entire production process as an automated system.

Protox said, “We plan to export botulinum toxin products produced at this factory starting in 2020, and are currently applying for patents and conducting research and development with the goal of domestic approval and launch at the end of 2022.”

He added, “We are continuously conducting research and development with the goal of developing high-purity, next-generation products with improved toxin formulation and performance.”

[Money Today Broadcasting MTN = Reporter Lee Dae-ho (robin@mtn.co.kr)]

Protox has taken the first step to commercialize its self-developed Botox (botulinum toxin).

Protox announced on the 25th that it will start GLP non-clinical trials of its new botulinum toxin A preparation (tentatively named Protoxin).

The production of non-clinical trial products was completed and delivered to Biotoxtech, a GLP (non-clinical practice practice) organization. The goal is to end the non-clinical trial in the second half of this year and apply for approval of the investigational plan (IND).

An official from Protox said, “The GMP plant under construction in the Hyangnam Pharmaceutical Complex is scheduled to be completed next month,” adding, “We are continuously adding manpower to improve the perfection of Protoxin and commercialize it in earnest.”

Protox is a subsidiary of KOSDAQ-listed DSK (68.76% stake).

[Money Today Broadcasting MTN = Reporter Lee Dae-ho (robin@mtn.co.kr)]