Okay, so first of all, I want to give you a warm welcome to this Q&A webinar with us on Coegin Pharma. My name is Jens Eriksson, and I am the CEO of the company. And with me today is also Lars Rasmussen, our CFO, and John Zibert, our CMO. So first, I want to give you a short update on the status of the company, and we will be focusing on Follicopeptide, our innovation for hair growth. Here you can see a summary of the eventful time that we have had the last half year on Coegin Pharma. And I would like to highlight a few things of these press releases. First of all, I want to highlight the agreement with the University of Bradford that allows us to commercialize a fantastic platform of groundbreaking pigmentation peptides, of which we chose to focus on the peptide for skin pigmentation.
That's really, really exciting. Then I want to highlight that we started a development agreement with the cosmetic company to develop this skin pigmentation peptide into a finished product. Last but absolutely not least, we started a development agreement with Scandinavian Biolabs with the goal to develop a finished product for hair growth. Really, really exciting times for us on Coegin. Let's talk about the launch of Follicopeptide, our groundbreaking peptide for hair growth. First of all, what is Follicopeptide? It is a peptide derived from the human protein osteopontin, which has been developed in Lund University in Sweden. It is developed to be used in a topical formulation to apply on your scalp once daily.
What we have seen in our clinical studies conducted through several years is that we see benefits on over 70% of those who are using Follicopeptide, which is quite a lot in this area. As we see it, Follicopeptide will be launched as an ingredient in several different products all over the world. The big goal for us in the company is to launch in 2025 in the U.S. and in Europe. It's really, really exciting times. Here you can see where we have ongoing business dialogues, which have been really, really detailed and advanced.
What is really, really nice to be able to inform you is that in these dialogues, it's clear that we have been validated our innovation from the potential partners, and they have confirmed the data that we have shown to them, and they believe in our innovation, and they have the commercial belief also that this is a fit to the market, that there's a big demand on the market for a product like Follicopeptide. That is really, really nice to see and to experience. Now we are in detailed discussions about all the commercial practical issues, like production, launch plans, design on the bottles, price tags, and all that connected to a launch. Here you can see a brief overview of the timeline for the launch of Follicopeptide focused on production.
We plan to initiate the production of the Follicopeptide ingredient in the beginning of Q1 2025. The next step is to deliver the peptide to us in Denmark, where we will produce the finished product. We will deliver the finished product in the end of Q3 to a potential partner in Europe or U.S. or both in the end of Q3 for the plan of a launch in Q4 2025. As today, up to date, we are in phase in that plan. We are in the right place to be able to execute that plan, which is really nice for the company. With that, I will continue and now focus on the questions that you have mailed to us regarding the launch of Follicopeptide. To be clear, we will focus on the questions regarding Follicopeptide.
I will begin with the first question that we got. When will you launch products and on which markets? Lars, maybe you can help me on this one.
Sure, it would be a pleasure. So right now we are focusing on getting ready for Europe and U.S. That's where we have a highway in, certainly also what we deem to be the biggest market potential. So those are the two focus markets. So Europe, U.S., and the aim is a launch by the end of 2025, for which we are on track as we speak.
The following question is, what is critical for us to be able to launch?
It's been extremely critical for us, first of all, to identify the right set of potential partners. No doubt that the hair market is big. It's growing. There's a huge demand for something that actually works, is safe, is accessible, and it also can be applied in a user-friendly manner, can be used day in and day out for a long period, of course. And it's been extremely important for us to find the right partners, which we believe we have identified a nice pool of now. So getting a set of partners who knows the market, who knows the region, who knows the local markets, and know how to play this game and set up the right business model. That's been absolutely crucial. Very confident in those we're discussing with now.
Then secondly, of course, is the supplier products getting to the finish line in terms of scaling up the production. That should not be taken lightly, which we don't. That's why we focus on that also on this call here. That's where we are now, focusing on primarily getting the production up at scale. We know how to produce this. We know how to go all the way. Now we just have to get to scale. That's basically why we are aiming for this quarter four, 2025, because of the lead times that we have in production when we get to the quantities that we are talking about here, in particular for Europe and U.S. to start with. Production and commercialization capabilities are key.
Thank you, Lars. And next question, maybe you, John, can help me with that one. Can you give us a status update on the collaboration with Zhejiang Sukean in China?
Sure. So we have, as you just heard, a very stringent plan to launch Follicopeptide both in Europe and the U.S., and Sukean is a company that is quite big, and we have signed a memorandum of understanding with them in order to actually be able to, at a later stage, launch Follicopeptide. The collaboration that we have with them now is meant to actually submit the dossier of Follicopeptide to the Chinese authorities that then needs to actually review this. This is a rather fast process, as this is something that Sukean and also our production partner in China is actually well aware about, so we have some next steps that is regarding how do we actually execute the plan according to our launch sequence because we need to prioritize Europe and U.S. first, but it will take some time.
So the plan is to be able to launch in late 2026 and also according to plan.
Thank you, John. And the next question that we have got is, what is the status in the U.S.? And will you launch with the Scandinavian Biolabs? Lars?
Sure. Yeah, so the U.S., of course, is a very interesting market. It is key to have a focus on that. We have a pool of potential commercial partners over there, of which Scandinavian Biolabs also have capabilities there. So we are discussing with several how to do this best. As we go through the next set of months, we will figure out exactly who to go with. There are many things to consider. We have several types of indications, several segments. There are all things from exclusivity to be discussed to indication level exclusivity and so forth. There might be many options for the U.S.
But what is absolutely key for us is to make sure we get a partner who knows the market that we can work with and is as enthusiastic about this opportunity and the market opportunity, not least in terms of hair growth as we are. And those are what we are looking for. But we have now talking about Scandinavian Biolabs, a very good dialogue with them already. As you know, we have a development agreement with them, and they are surely in the run-up for this, as we highly appreciate that working relationship already.
Thank you. And I believe the next question, John, is a question for you. Could we explain a little bit about Follicopeptide, how it works, and a treatment with Follicopeptide should look like?
Yeah, of course. So we have worked on developing Follicopeptide for quite a while, as you also alluded, together with Lund University. And also together with Lund University, we have also identified how we believe that it's working in human beings based on lab results. So we believe that Follicopeptide is stimulating the hair growth by actually supplying the hair follicle with nutrients. So you should imagine that you have just like a tree that is fainting, you can say, a tree that is almost struggling to actually live. And the reason for that is that there's no water and there's no nutrition to actually feed the growth of the tree. And this is where Follicopeptide is actually having its actions. It's binding to a specific group of proteins that is resulting in stimulation of vessels that is just like the roots supplying the tree.
In this case, it's the hair follicle supplying it with nutrition, supplying it with blood flow, and also stimulating the actual hair follicle to be active again, just like a fertilizer, so you can envision that the way that the molecule is actually working is that it's like a fertilizer that is stimulating not only the hair follicle to maintain a hair to continue to grow, but also to supply it with the blood that is needed in order for it to actually get the right nutritions from the systemic circulation, and we have tested this now in more than 350 patients, and both in men and women, it's found to be extremely safe, so we're very confident that it is a very good solution for both men and women, and we also have seen that it can actually stimulate normal hair growth in subjects.
This is very interesting, and this is the way that we believe that it works. It's a complete differentiator as compared to all existing treatments out there. This is actually not just acting on one specific target, as minoxidil, for instance, is doing, that is causing. That's of course being used for people with hypertension, where it's actually doing vasodilation. So it opens the vessels and hence gives blood flow. What Follicopeptide is doing is completely different. It actually stimulates the whole blood vascularization in the whole area and also stimulates the actual hair follicle.
I have a question following that. What if you are completely bald?
That's a good question. As with a tree, my analogy that I was using, I mean, if you have a tree that is completely gone, I mean, there's no tree, there's no seeds, there's no nothing. You can put all the fertilizers you want in an area, and the only thing you will get is weed. In this case, you will not get anything. So you need actually a hair follicle. So that's, I mean, it's not a wonder drug or wonder molecule, so to speak. It is a cosmetic ingredient that is stimulating hair follicles to actually regain its power and hence actually make hairs to grow.
Thank you. Next question, Lars. Could you update us a little bit about FDA approval?
About FDA approval, yes. So sure. So the background of this story here is, of course, that this was developed as an Rx drug development program. It's pharma-grade, tested, proven efficacy, safety. And then a long story short, turned out to be efficacious and safe. But due to the profile of the molecule, where it comes from, and what it actually demonstrated, and also the category, we were able to make a regulatory shift. So we are definitely talking about the FDA, but not in a drug sense, more as in a cosmetic ingredient manner. And in this respect, it's very different from the approval process that is probably alluded to here from an Rx side as towards more of a cosmetic ingredient side. So in the U.S., I reckon it's U.S. FDA that is referred to here. We have other FDAs around the world.
But there's a specific framework for this and how to make sure that you end up in the right category and get the marketing authorization. But all of that, it has its separate track and is being dealt with for sure. And we have gotten the advisory we need and have a highway in terms of getting that in place. There we are quite assured. Our focus is, as I said, on the production. And that's also where the focus is right now on getting the production ready and getting the last bit characterized and registered with the FDA, as you should. But all of that is in process and on plan. So that's in place.
Thank you. And the next question, I believe I can answer. And that is, how will the marketing look like for Follicopeptide? And I mean, our role in Follicopeptide will be to launch through different partners in different areas of the world. And as we see today, the marketing will be done by our licensed partners. So we will not market Follicopeptide directly to end consumer. That is not our primary plan today. It is to launch together with a partner. And the partner probably has an existing brand and probably has existing sales channels, which they market the new product with Follicopeptide through. Next question, are we on track to release Q425, John?
The simple answer to that is yes, we are on track. So we will be able to launch both in Europe and USA. So that's all on track. And we have, as you also mentioned, Jens, a clear plan for going forward, and everything is moving according to schedule. So we are very excited about the future. We are very excited about 2025 being the year where we will see Follicopeptide being distributed with our partners in key markets.
Yeah. Thank you, and that was actually the last question, so I will say thank you to everyone who watched, and I hope to see you soon again. And thank you, Lars and John.