Polifarma will produce domestic SMA medicines and active ingredients

In his speech at the opening of the R&D Raw Material and Pharmaceutical Production Center established by Polifarma in the Ergene district of Tekirdağ, Health Minister Kemal Memişoğlu said he was delighted to be with the participants at a ceremony where Türkiye took a historic step in the field of healthcare.

Minister Memişoğlu stated that Anatolian lands have been the cradle of not only civilizations but also science, wisdom, and healing for thousands of years.

Memişoğlu stated that today, in lands steeped in Anatolian wisdom, we are witnessing the culmination of a vision stretching from the past to the future, a labor molded with science, and an ideal woven with faith. He said, "One of the most fundamental pillars of the 'Turkey Century' vision, which has been resolutely implemented under the leadership of our President, is undoubtedly the 'Healthy Turkey Century.'"

Memişoğlu pointed out that the vision aims not only to provide more healthcare services, but also to build a healthcare system that produces, develops its own technology, and increases its competitiveness at the global level.

"Productive Health Vision"

Memişoğlu underlined that the "Protective, Developing and Producing Health Model" implemented by the Ministry of Health is the basis of the vision encompassing the strategic journey, and noted the following:

This model is based on preventive approaches that protect the health of individuals, families, and society, as well as innovative production infrastructures, scientific research, R&D-focused solution development, and growth with domestic and national technology. One of the most important pillars of this model is undoubtedly our Productive Health Vision.

With this vision, we strive to establish a healthcare ecosystem that not only treats diseases but also develops its own pharmaceuticals and medical devices, generates innovation in genetics, biotechnology, and molecular fields, combines scientific R&D capacity with technology, and shapes the future with its own human resources. To this end, from the moment we took office, we rolled up our sleeves to enhance our country's scientific capacity in healthcare. We restructured the Turkish Health Institutes Presidency (TÜSEB), which is at the heart of our R&D and innovation ecosystem, making it both the strategic brain and the driving force of this process.

"TÜSEB has gained a structure that increases its effectiveness in the healthcare market."

Memişoğlu noted that TÜSEB has now gained a structure that establishes strong ties between the public, private sector, and academia, develops domestic solutions through guided projects, supports young scientists, and increases our country's effectiveness in the global healthcare market.

Memişoğlu emphasized that they see the process not only as a policy but also as a national responsibility and future-building initiative, saying, "Full independence in healthcare is possible not only through providing services, but also through producing, developing, sharing, and exporting. With this belief, investments like the Polifarma R&D Raw Material and Pharmaceutical Production Center, which we inaugurated today, are the pillars supporting this ambitious goal."

Memişoğlu stated that the Polifarma R&D Raw Material and Pharmaceutical Production Center is not just technical support, but the embodiment of a vision that wholeheartedly believes in this nation and its potential.

"A visionary approach has been put forward"

Memişoğlu emphasized that this meaningful investment is a concrete expression of a long-standing belief, trust in science and technology, and strategic support for our country's independence in healthcare, and continued:

I wholeheartedly congratulate the Polifarma family for this visionary approach. They not only produce pharmaceuticals, they also create space for future scientists, promote a knowledge-based production culture, and invest in Türkiye's global competitiveness in healthcare. This center is a multifaceted R&D hub where young researchers will be trained, innovative molecules will be developed, and domestic solutions for rare diseases will be developed. It is the heart of a people-focused ecosystem that operates not only on production but also on learning, development, and co-construction.

Undoubtedly, one of the most important initiatives to be undertaken here is the development of Türkiye's first domestically produced SMA drug and its active ingredient. This step clearly demonstrates not only the economic but also the humanitarian and conscientious dimension of our "Productive Health" vision. Because we view healthcare as a right, treatment as a responsibility, and drug production as a matter of sovereignty. We no longer expect solutions that touch the lives of every citizen from outside sources. We are developing them with our own scientists and technological capacity.

Memişoğlu stated that the center will not only meet Türkiye's needs but will also be a gateway to international markets, bringing our domestic and national solutions together with global demand.

Thanking the Polifarma family for their investment, Memişoğlu said, "We are witnessing a moment when the Century of Healthy Turkey is crowned with production, science is established, and healing is revitalized. We have full confidence that this facility will become a knowledge and production hub that will benefit not only our country but also the region and humanity."

Memişoğlu stated that they are working to pave the way for producers.

Memişoğlu, wishing the facility success, said, "As administrators, as our President said, 'We govern to pave the way for you.' Therefore, we are the servants of Turkish industrialists, Turkish manufacturers, and every healthcare-related stakeholder serving in Türkiye, and we are working to pave the way for them. That's why exciting openings like these excite and motivate us even more. Turkey is truly a model, a leading country for the new century. No matter how much evil exists in the world, we choose the side of good. We strive to benefit people in this world through goodness."

"We are paving the way for our industrialists"

Tekirdağ Governor Recep Soytürk also wished the facility success.

Soytürk stated that there are 3,390 registered industrial companies in the city, 23 of which are pharmaceutical companies. He said, "One of them is Polifarma. It has an annual export of approximately $250 million. Therefore, we are proud of our pharmaceutical industry. We have great respect for our industrialists. We are trying to pave the way for them as much as we can. They provide employment and generate foreign currency through exports, but then you have a product like Polifarma, where you produce a product you would normally import domestically. We will use it in Türkiye and export it. In other words, we will close the current account deficit. That's why we think this is very valuable."

"We carry health to all corners of the world"

Polifarma Chairman of the Board of Directors Ufuk Süleyman Kumrulu also provided information about the company's history from its establishment to the present, its position in the sector, and its investments.

Kumrulu emphasized that they have continued their journey, which they began in the pharmaceutical industry approximately 40 years ago as a 100% domestically capitalized organization, by strengthening their presence in global markets with their modern production facilities built on an area of ​​62,000 square meters in Tekirdağ-Ergene, a strong R&D infrastructure, and innovative solutions.

Kumrulu stated that they have an annual production capacity of approximately 500 million medicines and serums in 16 different production lines, and that they hold many international certificates, 600 domestic and international licenses, and continue to carry health with their exports to more than 50 countries.

"We will contribute to the localization of pharmaceutical production"

Kumrulu reminded that Polifarma also started producing active pharmaceutical ingredients in 2023.

Kumrulu stated that they have opened a new chapter in the localization of pharmaceutical production with the new R&D Raw Material and Pharmaceutical Production Center, saying, "We will continue our efforts to facilitate access to medicines and reduce external dependency without slowing down. Therefore, we consider our R&D Center not only an investment but also a strong indicator of our confidence in Türkiye's future and our belief in science."

Kumrulu emphasized that raw material production is also needed to grow the Turkish pharmaceutical industry and reduce its dependence on foreign sources.

Kumrulu underlined that the new R&D Center will also be responsible for the synthesis of the drug and its active ingredient for the treatment of SMA, supported by the HAMLE Project of the Ministry of Industry and Technology, and continued:

"We have begun producing nusinersen, the active ingredient in the drug for SMA, which has caused us great distress. There is great export potential here. We aim to sell the finished product as a raw material worldwide before licensing it.

We will also produce active ingredients and pharmaceuticals for various rare and genetic diseases. As Türkiye's most comprehensive R&D center, capable of producing active pharmaceutical ingredients and finished products for our country's economy, we aim to take firm steps toward becoming a 'global healthcare' hub by increasing our export potential with our value-creating projects.

The manufacturing process of the drug

Kumrulu said that a very important success had been achieved.

Kumrulu, who stated that they are proud to produce the active ingredient of the domestic SMA drug and to begin producing the finished product, said, "We are the second company in the world to produce the drug's active ingredient, and we are far ahead of other companies. We are currently starting clinical trials for the product. There will also be a licensing process. I believe it will take between 1.5 and 2 years. The product will be patented until 2030, but its use will gradually begin within the framework of clinical trials."

"The way to create lasting value in the healthcare sector is through R&D"

Polifarma Vice Chairman of the Board of Directors Vildan Kumrulu highlighted the importance of sustainable growth and R&D activities.

Kumrulu stated that they have been taking firm steps towards sustainable growth by focusing on quality production and human health in the healthcare sector for nearly 40 years.

Kumrulu emphasized that their new facility will be one of Türkiye's most comprehensive R&D centers, capable of performing both raw material synthesis and finished product production under the same roof and developing solutions for rare diseases. He stated, "We have been crowning our success not only with our financial statements but also with our scientific investments since day one. Every project developed at the Polifarma R&D Center will contribute to public health, reduce Türkiye's dependence on foreign pharmaceuticals, and position our country for a stronger position in the global pharmaceutical market."

Kumrulu also underlined that the center is one of only six pharmaceutical company centers in Türkiye with the competence and approval for Active Pharmaceutical Ingredient (API) synthesis.

- "There will be a cure for SMA and genetic diseases"

Vildan Kumrulu emphasized that they are the first and only Turkish company to invest in the "antisense oligonucleotide" production platform with their new R&D center, stating that thanks to this technology, they can more easily focus on the treatment of genetic diseases by using mRNA technology and creating short RNA chains.

Kumrulu also stated that active ingredients and drugs for the treatment of SMA disease will be produced in the new R&D center, and continued:

We have begun the necessary infrastructure work to address SMA, a rare, inherited muscle disease that is a major health concern in our country and a devastating condition for hundreds of families. Synthesizing and producing our own active ingredient, particularly for use in the treatment of rare and costly diseases like SMA, is not only scientifically sound but also a reflection of our social responsibility. We have reached the final stages of this project, which we initiated after being moved by a mother's crying and despair on television.

Every mother's greatest wish is to see their child healthy and to look to the future with hope. We want mothers to stop crying; we want their tears to turn into hope. We are continuing our intensive work to make this critically important drug available to patients as soon as possible. We are delighted and excited to touch the lives of hundreds of families with the innovative solutions we will develop for the treatment of various rare and genetic diseases, especially SMA. Because we know that touching the life of a child or a patient is not only about producing medicine, but also about healing. We will continue to bring healing to every corner of the world with our innovative solutions in the future.

Following her speeches, Vildan Kumrulu presented Minister Memişoğlu with an openwork painting bearing the 35 Basmala symbols.

Afterwards, the center, where the opening ribbon was cut, was toured by Memişoğlu and his entourage.

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