0:00
And who is Kathleen Noack, The Vice President of Business Development Tides for Jiuzhou Pharmaceutical.
0:10
Kathleen has got a very long track record in the pharma industry going back more than 30 years into our global sales and business development.
0:19
That experience with CDMOs and in the pharmaceutical industry and in more than 20 years in peptides specifically.
0:29
So Kathleen going to talk to us today about her specific business interests with Jiuzhou pharmaceutical.
0:38
The title of the talk: From Molecule to Market: Your Trusted Partner.
0:50
Hello and thank you very much.
0:51
My pleasure being here.
0:53
Thanks for the introduction.
0:56
Thank you.
0:57
So maybe Jiuzhou is not known to many of you, not yet.
1:03
Therefore, I would like to tell you more about the company.
1:07
So usually the first question I get is how do you pronounce it?
1:12
Jiuzhou
1:13
What does it mean?
1:15
9 continents, it means it's a global company.
1:18
OK, good.
1:19
So our mission is: serve life, guard health.
1:25
That means that we are not only delighted to serve blockbuster drugs, but we are also delighted to go for orphan drugs and to support rare diseases.
1:40
Just to give you a brief overview, we are more than 5000 employees, and the company is headquartered in China in Zhejiang, having seven R&D facilities, four of those in China, 3 in other parts of the world, one in the US in North Carolina, the other one in Japan.
2:07
And the latest, the newest foundation is the one in Konstanz in Germany at the Bodensee Lake.
2:15
We have 10 manufacturing facilities and are happy to serve.
2:22
customers all over the world.
2:25
We have more than we have now 24 commercial products commercialised and serve customers in more than 90 countries.
2:46
OK, so here is the overview about the sites for peptides.
2:52
There are only three sites relevant.
2:55
So I will concentrate on those 3.
2:57
But I would like to wanted to give you an overview about the company and what else are we doing.
3:05
We come from the small molecules and that's also where most of the facilities are related to.
3:12
But peptides are made in the site in Suzhou that this is the GMP site, that is a former site we acquired from Novartis, and R&D peptides are made in Hangzhou. The big facilities we have in Taizhou, there we can do liquid phase synthesis.
3:42
Jiuzhou is already more than 50 years old, and it was in so founded in 1973.
3:56
The CDMO division has been established in 2008, and we went public in 2014.
4:05
So we are in the we are listed at the Shanghai Stock Exchange.
4:11
That also means that we do not have any governmental money in the company.
4:16
So no risk and no interaction there.
4:21
We have we have acquired the Novartis site in Suzhou in 2019.
4:30
That's where the GMP peptides are currently made.
4:35
And the last year revenue I cannot report yet because figures are not public yet, but in 23 we had 815 million U.S dollar revenue.
4:52
We are a one stop shop serving biotech pharmaceutical companies from very small scale from R&D scale up to yeah through all the clinical phases to the commercial phase.
5:08
And we provide not only the manufacturing service, but also analytical service to provide customers with the development of the analytical method, process development, validation of the analytical methods, process validation.
5:27
We provide also support in registration.
5:31
So we have plenty of experience there.
5:34
And that is the goal is always we sit in the same boat as our customer.
5:40
We treat the customer as a partner and of course we do everything possible to to have the project successfully launched in the market that is that's our goal.
5:52
Our yeah.
5:53
And I started in the company, I was very impressed about the one KPI that is the KPI delivery on time and this is 98%, this is for CDMO enormously high.
6:13
We serve customers all over the world and our main customers are the big ones.
6:18
Novartis, Roche you name it.
6:22
And we have successfully undertaken more than 1000 projects and serve more than 80 million patients worldwide.
6:37
That gives an overview about the projects and the several phases projects are in.
6:43
Of course, most of the projects are in early phases, that's clear.
6:46
But we have plenty of projects successfully undertaken through all the clinical phases and that is our experience.
6:56
We need to join the customers through all the lifetime of the product.
7:07
Regarding R&D platforms. So, I'll just show you six of the main R&D sites.
7:14
Three of them are in China, in Taizhou, that is where our headquarters is based.
7:21
Peptides are made in Hangzhou.
7:23
Hangzhou is about two hours from Shanghai. And then one in Japan, the one in the US that is in North Carolina in Brevard and that is also where our head of the tides division is based, that is Mike Pennington.
7:42
Mike is very well known in the industry.
7:44
He is more than 37 years now in Peptides.
7:49
He was 20 years the CEO of Bachem and then he served as CEO for Peptides International and more than seven years he was in the CSO for AmbioPharm.
8:07
So he's heading the tides division and reports directly to the president.
8:13
And now he's based in North Carolina.
8:18
The youngest the youngest R&D site we have that is the one in Germany, that's a former Takeda side.
8:28
And there we have currently activities in small molecules.
8:32
We are building up peptide capacities as well.
8:36
And this lab is headed by Doctor Kai Rossen.
8:42
He's also well known in the industry having long track record and you have this with all the big pharma companies.
8:53
So we have really cutting-edge capabilities and it's enormous how the company invested in these R&D sites.
9:07
We spent 6% of our revenue for R&D.
9:10
We have 900 people working in R&D.
9:14
That's really enormous.
9:15
And that makes all the innovation and makes the process of the company, yes.
9:28
So regarding peptides, we can do each and every peptide that is chemically possible to synthesise.
9:34
So we can do SPPS, LPPS and hybrid synthesis approach.
9:41
We have all the different purification capabilities in place.
9:46
And no matter how complicated the peptide is, we can do it.
9:52
Backbone cycle changes, cyclisations or conjugations labelling, whatever you the customer needs can be done.
10:06
We have the experience in house and the capacities. We have also the opportunity to serve for high potent conjugates, high potent compounds up to OEB 5.
10:26
That is possible for R&D.
10:28
It's also possible for GMP.
10:31
I come to that a little bit later and go into more details.
10:35
We can also support customers with spray drying capacities.
10:39
So that is a very efficient way to do larger scale of peptides and to avoid lyophilisation.
10:58
That is an overview about the three relevant peptide sites here for R&D.
11:05
So in our Hangzhou lab, we can do peptides and synthesise it in up to 30 litre reactors.
11:14
We do the probative HPLC purification there and we have high potent capacities.
11:26
Whenever it comes to GMP, we go to our facilities in Suzhou.
11:32
That is the facility that has been bought from Novartis in 2019 and there we have currently capacities up to 200 litres.
11:46
But we are enlarging these capacities and adding three lines this year, adding 20 litre, 300 litre and 1000 litre reactors and that will be installed by end of August.
12:04
We will duplicate these capacities next year and then we will add more capacities in 26 and 2027 for up to 3000 litre reactors. That is on the other side you see the high potent lab in Taizhou that is full GMP high potent capacities that can be offered.
12:37
So that is how it looks like here.
12:39
We can at the moment we can do up to 700 gramme per batch, high potent components and planning is to expand these capacities up to 100 to 200 kilogrammes.
13:01
When I visited the sites, I asked the decided how do you treat a peptide that you do not know yet in terms of toxicity or potency.
13:15
The answer was we treated as an OEB four.
13:20
That means all the equipment is equipped with isolators.
13:26
You see it over there, here, you see it over there.
13:34
There are all isolators and that is how our production is equipped.
13:44
We offer seamless integration from R&D to production.
13:50
So just to give you some pictures, so that is designed in Suzhou, the one from Novartis.
13:57
Novartis is our neighbour.
13:59
We produce a lot of products there for them.
14:03
And the building you see, that is a building where the SPPS lines are installed for peptides.
14:13
But the site is huge.
14:15
I mean people need a bike from to go from one end to the other.
14:20
And there's even a medical centre for the employees there.
14:27
Just to give an overview about 5 big sites, the one in Taizhou that is a very large site.
14:36
That's the one where we have all the big capacities.
14:41
There are up to 20,000 litres coming from the small molecule field.
14:52
Just pictures how it looks like. Spray drying capacities.
14:57
We have the big spray driers here from GEA and another one that gives even larger capacities, 50 kilogramme per hour powder.
15:12
That is the actual overview of the capacities we have.
15:16
As mentioned SPPS is under expansion, LPPS there's no limit we have we have reactors up to 20,000 litres.
15:28
We can offer hybrid synthesis approach, and I personally believe the type hybrid synthesis or liquid phase synthesis approach is a very clean way to save solvents.
15:40
And so the total capacities are almost 10,000 cubic metres and our fields are expanded.
15:52
The beauty is with a hybrid synthesis approach that of course the empty fragments can be purified and then you have very pure fragments, very pure peptide.
16:03
Then the peptide crystallises or can be participated.
16:07
You avoid probative HPLC purification and that's a way to reduce solvents.
16:16
That gives the overview I just told you before.
16:19
Just here you see the amounts of output that is currently available and what is planned.
16:28
That's just SPPS, so LPPS.
16:30
So I mean for LPPS we can do batches several 100 kilogrammes, there's no problem.
16:40
We focus a lot on quality.
16:44
We have all the analytic equipment in house, even NMR, we can measure particle size with distribution.
16:53
We can do all the bioburden endotoxins in house.
16:58
So that has the effect that customers don’t have to wait long for analysis.
17:05
And most important here we have really a state-of-the-art quality management system in place.
17:14
And we just last year had a US FDA inspection that was the 11th US FDA inspection with 0 483s.
17:24
So no deficiencies at all.
17:26
And this year we will have another one at our Suzhou site.
17:31
And then we can we have more than 120 audits per from customers each and every year.
17:42
That is where we learn a lot from each and every audit.
17:46
And that is what makes this big success like by court here. In terms of environmental health and safety.
18:00
We are proud having been awarded for gold award for EcoVadis that came out just last week.
18:07
And we have solvent recovery systems in place, solid incineration systems and the between the wastewater, the gas that is all in place and we have several orders from big pharma companies dedicated to EHS that we have passed successfully.
18:34
thank you very much.
18:36
That is the overview about Jiuzhou and I'm happy to answer any questions.
