Protox, a botulinum toxin specialist, has signed a partnership agreement with Cottman Australia, a pharmaceutical distribution company in Australia and New Zealand, for its botulinum toxin product.

Protox said on the 30th that it had signed an exclusive partnership agreement with Cottman Australia Pty Ltd for its type A botulinum toxin product “BTSA9.”

Under the agreement, Cottman Australia will hold exclusive sales rights for BTSA9 in Australia and New Zealand for the next five years, and will handle local pharmaceutical licensing procedures as well as overall sales, marketing and distribution. Protox will be responsible for product supply and technical support.

BTSA9 is a botulinum toxin product developed and manufactured by Protox in-house, and the company is pursuing global market expansion based on its high-purity manufacturing process. Protox plans to accelerate its entry into the Australian and New Zealand markets on the back of this agreement.

Cottman Australia is a pharmaceutical and healthcare distribution specialist based in Australia, founded in 1996, and carries out the registration, supply and distribution of pharmaceuticals in the Australian and New Zealand markets.

“Australia and New Zealand are advanced markets with high regulatory standards and stringent quality requirements, and this partnership serves as an occasion to once again confirm the quality competitiveness of BTSA9,” said Kim Chang-soo, CEO of Protox. “Following Europe, we will expand our global distribution network to Oceania and present a new standard for ‘K-toxin.'”

Meanwhile, Protox signed a 10-year exclusive supply agreement with Spain’s “Mesoestetic” for the European Union, the United Kingdom and Switzerland in November 2025. It has also signed exclusive supply agreements with major markets including China, Brazil, Russia, the Commonwealth of Independent States (CIS), Turkey, Thailand and Indonesia, accelerating its global expansion.#Protox#BTSA9#Ktoxin#BotulinumToxin#CottmanAustralia#KoreaBiotech#Oceania

PROTOX, a subsidiary of DSK, announced on December 1 that it has signed an exclusive 10-year supply agreement with the Spanish aesthetics company Mesoestetic. The contract covers the supply of PROTOX’s independently developed botulinum toxin product.

Mesoestetic is already well known in Korea as a supplier of various aesthetic medical products. The company recorded €82.1 million in sales last year and has built a strong global network across more than 90 countries, including Europe, the United States, and Latin America.

PROTOX currently holds 23 intellectual property rights in Korea and abroad and is in the process of filing additional patents in the United States, Europe, China, and Japan. Leveraging this technological competitiveness, the company has already entered into long-term supply agreements (LTAs) with key partners in Russia (CIS), Brazil, China, and Türkiye. It is also actively engaging with leading partners in major regions such as Europe, the U.S., Latin America, the Middle East, and Southeast Asia to further expand its global presence.

A DSK official commented, “Through this contract, PROTOX has gained a foothold to advance into the European market. The company will continue expanding its global network to enhance its market reach.”

November 17, 2025 – SEOUL, South Korea — PROTOX Inc. announced that it has officially obtained marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its botulinum toxin product, Protoxin Injection. This marks a major regulatory milestone for the company following the completion of all required clinical and quality reviews.

Protoxin was originally developed through PROTOX’s own proprietary technology, including its patented vacuum-drying manufacturing process designed to enhance product stability and purity. After submitting its New Drug Application in December 2023, the company successfully completed both the MFDS-requested Phase 3 extension study and additional comparative assessments, demonstrating consistent efficacy and safety levels comparable to global competitors.

With this approval, PROTOX becomes one of the few Korean companies to secure domestic authorization for a next-generation botulinum toxin product based on fully independent R&D and GMP manufacturing capabilities. The company stated that it will now accelerate its global expansion strategy, including regulatory submissions in major overseas markets such as the EU, Turkey, Thailand, and China.

A PROTOX representative commented,
“This approval is a key achievement for our team and a validation of our long-term development efforts. With the Korean authorization now in place, we will move rapidly toward international filings and commercial launch plans with our global partners.”

PROTOX plans to strengthen its international footprint through strategic partnerships, leveraging the approval to expedite global commercialization of Protoxin.

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)