European Approval Now Expected By July-August For Zaynich: Wockhardt Chairman Habil Khorakiwala
📅 Dec 31, 2025CNBC-TV1811 MIN482 VIEWS32 SEGMENTS · 2 SPEAKERS
On CNBC-TV18 | Regulatory Boost For Wockhardt
Founder & Chairman Habil Khorakiwala to CNBC-TV18
European approval now expected by July-August for Zaynich
Zaynich market size could be around $400-500 m in Europe
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Questions asked in this interview
12
1:52And do you think maybe because the US FDA had accepted your NDA or new drug application in December, the EMA took note from that and gave you an early approval?
2:37With this approval coming from the EMA or the acceleration coming from the EMA, would there be an incremental revenue potential that you're seeking and would you want to revise that $1 to $2 billion potential sales size?
4:27You indicated that you'd be looking at other markets for this drug post US and Europe as well. What's the status on that?
4:49How have sales done in India and what's the status of that one in the US?
5:38Given the shift towards GLP-1 drugs, would there be an impact on that?
7:33If you could give us a sense on the past 6 months how the company has progressed along with how the industry has progressed, do you think that 6,000 crores sales by FY28 with 15 to 20% EBITDA margins is a possibility?
8:46Okay, and would you consider any fund raise in the very near term to fund R&D because you do have about 1,700 crores of debt on your books?
9:38And what's the kind of funds you would get from this out-licensing opportunity? Have you earmarked a number?
9:54But we can hear something soon on this, right, Mr. Khorakiwala?
10:05So what's the plan to improve your balance sheet from current levels here on?
Now with that, let's move on to the first corporate on our show. Workhard. That's the stock on our radar. European Medicines Agency has granted accelerated assessment to Workhard's Zenic or WCK 5222 as we know it. To discuss this and more along with the outlook for 2026, Habil F. Khorakiwala, who's the founder and chairman at Workhard Group, joins us now. Three talking points: the EMA's accelerated assessment for Zenic, the outlook for the company's approval for Zenic and the potential market size, and alongside that the outlook for geographies and products like insulin etc. Mr. Khorakiwala, thank you so much for joining us on day one of the new year. Wish you, your team, your family a very happy and in your case a healthy 2026 as well. A disease-free one at that. Congratulations on getting the EMA's accelerated assessment for Zenic. Just wanted to understand what the next steps for this are now when it comes to approval and by when do you expect this approval from the EMA now that it's been given the accelerated status.
Good morning to you and everyone and wish you a very happy 2026. The EMA, European Medicines Agency, have informed us that they are going into accelerated approval and this would mean that we should be getting approval sometime in July, August of this year because normally they take five to six months for the approval process. This is a very big win for us because we were not expecting this early approval from the EU agency and that will put us into the complete 27 countries European market with Zenic available.
Right, that would be good. July, August next year would be good because that is when you expected the US FDA approval to come by as well, right? And do you think maybe because the US FDA had accepted your NDA or new drug application in December, the EMA took note from that and gave you an early approval?
I personally don't think so because the EU is a very independent agency and they have taken their own call based on the profile of the molecule and the unmet need in Europe, which is roughly about more than 200,000 patients who are suffering from multidrug resistance.
So now that you expect the approval to come from the US FDA and the EMA in the middle of this year, how much do you think would be the market size, the incremental market size? You said that this drug could be a $1 to $2 billion market with 40% coming from the US. With this approval coming from the EMA or the acceleration coming from the EMA, would there be an incremental revenue potential that you're seeking and would you want to revise that $1 to $2 billion potential sales size?
We believe that it would be at least $400 to $500 million potential in Europe at the peak of this molecule. What is equally important is it is meeting a very unmet need. With US and UK approval likely to be during the year, it would be a fairly fast track for us to go to other markets in the world.
It will take us time and it is like a hockey curve. Hockey stick because initially to communicate about the molecule, the product, the scientific aspect takes some time before the physicians, doctors, and hospitals start using the molecule. Once that is done in a reasonable period of 18 months or so, then one would see a very sharp increase in the revenue.
We are keeping our files ready and depending on the size and the potential of various markets, we would be making this application in the next 3 to 6 months.
McNaf would have fairly good sales in FY67 and would be about 80 to 100 crores. In the US, we are not going with it immediately. We are keeping it for the time being for India and emerging markets. We expect that we would receive approval in the MENA region, that is Saudi Arabia early, and some more countries like LATAM, Brazil, Mexico. Approval will come in the next 12 to 18 months.
16 more exchanges in this transcript
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Khorakiwala, H. (2025, December 31). European Approval Now Expected By July-August For Zaynich: Wockhardt Chairman Habil Khorakiwala [Interview transcript]. CNBC-TV18. CEOInterviews.AI. https://ceointerviews.ai/interview/611563/
MLA
Habil Khorakiwala. "European Approval Now Expected By July-August For Zaynich: Wockhardt Chairman Habil Khorakiwala." CNBC-TV18, 31 Dec. 2025. Transcript, CEOInterviews.AI, https://ceointerviews.ai/interview/611563/.
BibTeX
@misc{khorakiwala2025_611563,
author = {Habil Khorakiwala},
title = {European Approval Now Expected By July-August For Zaynich: Wockhardt Chairman Habil Khorakiwala},
howpublished = {Interview transcript, CNBC-TV18. CEOInterviews.AI},
year = {2025},
month = {dec},
url = {https://ceointerviews.ai/interview/611563/},
note = {Speaker-attributed transcript with timestamps}
}
