Zai Lab Limited Price & Performance (ZLAB)

We will also refer to adjusted loss from operations. Which is a non GAAP financial measure. Please refer to our earnings release furnished with the SEC on February 27, 2025, for additional information on this non GAAP financial measure. At this time, it is my pleasure to turn the call over to Doctor. Samantha Du. Thank you, Christine. Good morning and good evening everyone. Thank you for joining us today. Sumitivore was a pivotal year for Zai Lab. Marked by strong commercial performance, growing bricky advancements in our global pipeline, in the clear path to profitability, In 2023, we outlined a bold vision revenue growth targeting a five year Zai per of 50% through the end of twenty twenty eight, we are delivering on this vision. Our total revenue for 2024 grew 50% year on year an exceptional 66% growth in the fourth quarter BGuard had an excellent first full year of launch. Generating $93,600,000 in sales in 2024. Making it one of the best immunology launches in China. We made substantial progress advancing our regional assets we recently launched several new products [indiscernible] for GMT and CIDP OXARO for ROS1 non small cell lung cancer, and ZAGGuru for bone moni infections.

We also reported a series of positive data results including PRRTT schizophrenia tumor treating fields for pancreatic cancer. Antibat for cervical cancer. Paving the way for multiple launches next year. Slickamar advancing our other innovative assets including bimetuzumab for first line gastric cancer COVID for Aizan, and CLM-eleven oh eight for Saren IADC on top of exploring additional invitations for Beefguard and Krys Tea, These successes together set the stage for strong revenue growth over the next few years. As a key part of our mission. To address unmet medical needs around the world, we took a significant step in 2024 to accelerate our global platform In October at D and A, we presented compiling earliest clinical results for DL-thirteen ten our potential first in class and best in class DL-three ADC. In small cell lung cancer Preliminary data demonstrated a seventy four percent ORR including both confirmed and unconfirmed responses. With further follow-up and additional patients, we continue to see high risk of confirmed responses and we look forward to sharing detailed updates at the major medical conference. The first half of this year. The pace of progress with 10 has been remarkably moving from Phase one initiation In January 2024, to a potential pivotal trial this year, positioning us for a possible FDA approval is small cell lung cancer in 2027.

Subject to ongoing regulatory discussions with FDA. As you know, TL3 is expressing various other tumor types, we have opened an IND to begin to explore additional indications this quarter. To maximize the potential benefits for TASIK. The MDR-three thousand and ten we're advancing a broader pipeline of globally differentiated assets. With plan to initiate global trials for an R13 or R31 bispecific antibody for atopic dermatitis and then LRRC15 ABC for solid tumors. Lastly, we have taken decisive actions to optimize our cost structure improve efficiency across the Zai while continuing to invest in key growth drivers Our loss from operations in the fourth quarter and for the full year are improved year over year by 4523% respectively. We are on track to reach profitability in the fourth quarter of twenty twenty And we have a robust cash position of $879,700,000 To support our next phase of growth, Today, satellite is at a major value inflection point the team committed to entrepreneurship innovation and execution excellence, We look forward to delivering on our goals and catalyzing on the transformative opportunities that lie ahead in 2025 and beyond. We remain confident in our ability to reach our $2,000,000,000 revenue target by 2028.

Supported by strong revenue growth in our current commercial portfolio. And the expected launches of multiple additional products or indications in the next few years. With that, I'll pass the call to Josh. Yes.

Thank you, Samantha, and thank you everyone for joining the call today. We had a good year in 2024 Zai demonstrated by our strong commercial execution, important advancements across our regional and global R and D pipeline, and multiple regulatory successes. In the fourth quarter, total revenue grew an impressive 66% year over year to $109,100,000 On a full year basis, total revenue increased 50% to $399,000,000 with growth driven by the strong adoption of VIVGART in its first year on the NRDL, along with the continued growth in ZEJULA and NUZYRA sales. We are proud of this outstanding top line growth and with three new launches underway in including VIVGART HYTRULO, ZAK DORO and Ogtyro, we expect to continue to build strong momentum this year. Let's start with ZipGart, which has had an exceptional launch year delivering full year sales of $93,600,000 and fourth quarter sales of $30,000,000 VivGuard is a testament to the outstanding execution of our commercial team. And we are excited about what this pipeline and product program will achieve in coming years. There are several factors contributing to this momentum with VIVGART. An expanding network of prescribers, greater access through hospital listings, new patient acquisition and a growing number of patients starting treatment in the maintenance phase to manage symptoms and prevent relapses.

Starting with physicians, we continue to grow the breadth and depth of our prescriber base utilizing a strong scientific and data driven approach to help educate our physicians. More than 2,000 physicians have prescribed ZivGard, including every one of our top 300 prescribers. In the fourth quarter, we saw a significant increase in the number of physicians who have highlighting the growing confidence in the treatment's long term benefits. In addition, awareness of the FCRN mechanism across the physician community is growing. This momentum will be further amplified as we launch VIVGAR HYTRULO for CIDP unlocking additional opportunities for growth. On hospitals, we successfully achieved list covering approximately 65% of gMG market potential. We are now targeting the next wave of hospital In parallel, we will focus on enhancing supplemental insurance coverage to offer additional support for the patient community. [indiscernible] We're also seeing increased utilization of VivGart as part of the maintenance treatment.

Approximately forty percent of patients who initiated treatment in the third quarter twenty twenty four returned for an additional cycle in the fourth quarter. Which aligns with clinical trial findings and reinforces our confidence in long term adherence Additionally, new formulations such as VivGuard HYTRULO and the prefilled syringe have the potential to ease the treatment burden enhancing the overall patient experience and improving DOT. We're making great progress, but there's still much to do. With over one hundred and seventy thousand gMG patients in China, our current market penetration is under 10% indicating vast potential for growth. As we look to 2025, we have well defined strategies in place to drive new patient growth and the duration of treatment for VIVGART and GMG. First, we will continue to establish infusion centers in top tier hospitals enhancing patient access and convenience for treatment. Second, the upcoming mid-twenty twenty five update to the National GMG guidelines is expected to provide tailwinds positioning VIVGART as a more prominent treatment option for gMG. We will use this opportunity to increase physician education and shift prescribing behaviors toward a more proactive usage of VivGard in the maintenance phase. Third, we are promoting the regular activities of daily living or ADL assessments reinforcing the importance of ongoing VIVGART maintenance there when ADL scores decline to ensure better long term disease management.

And lastly, we are establishing programs designed to enhance patient experience and to further optimize and extend treatment duration. As we execute on these strategies throughout the year, we anticipate driven by an expanding pool of both new and returning patients that will have a compounding effect on sales. While we do anticipate quarterly fluctuations due to seasonal factors such as holidays and hospital purchasing patterns these dynamics are expected to balance out over the course of the year. Now moving on to our other commercial products. Starting with ZEJULA. It continues to be the leading PARP inhibitor for ovarian cancer and hospital sales in China. We are seeing sales increases driven by increased penetration in first line NUZYRA, the strong sales growth this year was supported by the NRDL inclusion for both IV and oral formulations. The NRDL listing for the IV formulation was successfully renewed in January 2025, we will continue to promote ongoing access and support for patients who rely on this important treatment. In addition, we have three recent product launches that will further contribute to the total revenue growth in 2025. First, VivGuard HYTRULO, which is the subcu Efgartigimod with a shorter administration time of thirty to ninety seconds for adult patients with gMG and CIDP.

Hytrolo is not listed on NRDL this year, but is expected to be a meaningful gross Second, Ochiro and ROS1 positive non small cell lung cancer which comprises between two percent and three percent of the approximately nine hundred thousand new cases of non small cell lung cancer per year in China. Ogcairo achieved first time NRDL listing at the beginning of this year. Third, Zactoro in hospital acquired and ventilator associated pneumonia caused by Acinetobacter baumonti infections of which there are approximately three hundred thousand cases in China each year. We will leverage the industry leading commercialization infrastructure of Pfizer in the anti infective therapeutic area to help accelerate access to this important therapy for patients in need in Mainland China. With the confidence we have behind our business, driven by the expected growth of VivGuard, new product launches and the continued strong performance of our base business, we are for the first time providing total revenue guidance for the full year. We anticipate total revenues for 2025 to be in the range of $560,000,000 to $590,000,000 In parallel to strong top line growth, we're also focused on operational efficiency and financial discipline. Through our ongoing efforts on enhancing commercial efficiency, optimizing resource allocation and increasing productivity throughout the entire organization, Our loss from operations in the fourth quarter and full year 2024 declined by 4523% year over year.

We are on track to reach profitability in the fourth quarter of twenty twenty five and we have a robust cash position of $879,700,000.0 which allows us to support our next phase of growth as we drive both revenues and profitability. In summary, our strong execution in 2024 reflects XiLabs, commitment to deliver on our strategic goals. With a fast growing Greater China business, expanding global pipeline and prudent financial discipline, we expect to drive substantial value for our shareholders this year and through the remainder of the decade. And with that, I'll now pass the call over to Rafael to discuss the great progress with our pipeline.

Thank you, Josh. Let me begin by highlighting some of the key progress updates in our global pipeline since our last earnings call, along with our next steps. Starting with CL01310, a potentially highly active first in class CLL3 ADC for small cell lung cancer. We presented promising preliminary monotherapy results from the ongoing Phase one trial last year suggesting that this next generation ADC therapy has the potential to deliver antitumor responses in the majority of patients with extensive stage small cell lung cancer including Blaine lesions, with good tellurability. As Samantha said, we expect to present detailed results at an upcoming major medical conference in the first half of twenty twenty five. In January 2025, The U. S. FDA granted orphan drug designation to 10 for small cell lung cancer reflecting its potential to treat patients with this aggressive disease. Globally, small cell lung cancer affects around three hundred and seventy two thousand patients each year with a low five year survival rate of five percent to ten percent. Treatment options are limited when patients progress with the current standard of care resulting in limited clinical benefit. Despite recent advancements such as STARLASMA, there remains a critical need for readily available treatment options that offer improved efficacy and manageable safety.

We are working to address this critical gap with urgency. Enrollment in a monotherapy dose optimization study for with over thirty five patients already dosed. We're also assessing potential combinations in the first line setting and we have initiated a global Phase one dose escalation study evaluating ZL-two in combination with PD L1 and PD L1 plus chemotherapy. We expect to provide data this year. We also plan to initiate a registrational study in second line plus small cell lung cancer this year positioning us for a potential approval in 2027. Regulatory interactions with FDA related to accelerated approval for CL-thirteen ten are ongoing. CL03 is also highly expressed in other neuroendocrine tumors And after obtaining IND, clearance earlier this month, we will start a global study soon to explore ZL-thirteen ten in these indications. Beyond ZL-thirteen ten, we expect to advance at least two additional global assets into Phase one development this year including ZO-six thousand two hundred and one a novel LRRC15 ADC for solid tumors ZL-fifteen oh three an IL-thirteen, IL-thirty one bispecific antibody for atopic dermatitis. We expect to further expand our global pipeline and progress at least one global product into IND enabling or IND submissions stage this year.

Now moving to our key late stage programs. Starting with neuroscience, we achieved a major milestone with C, our M1, M4 cholinergic receptor agonist for schizophrenia. In January 2025, China's NMPA accepted our NDA for currency marking an important set towards bringing the first novel [indiscernible] Schizophrenia affects more than eight million patients in China with many patients unable to achieve adequate symptom control due to the limited effectiveness and burdensome side effects of currently available treatments, In clinical trials, CAR X T demonstrated robust efficacy achieving statistically significant reductions in all study endpoints. While maintaining a tolerable safety profile free of the side effects of classical antipsychotics. If approved, CAR T3 could redefine treatment for the millions of patients whose symptoms are inadequately managed by existing treatment options. Moving now to oncology, in December 2024, Zai Lab and Novocera announced that the pivotal Phase three PANOVA three trial is in unresectable locally advanced pancreatic cancer met its primary endpoint demonstrating a statistically significant improvement in median overall survival versus control. This is the first Phase two study to show survival benefit in this patient population and we plan to file for regulatory approval of tumor treating fields in China in the second half of twenty twenty five.

In China, approximately thirty four thousand new cases of pancreatic cancer are diagnosed each year and these patients have limited effective treatment options and a poor prognosis with a median survival of under twelve months. We hope to expand treatment options and improve outcomes for these patients in need. Turning to tisotumabezotene or TifDAC, a tissue factor ADC for recurrent or metastatic cervical cancer. In January 2025, we reported positive top line results from the China sub population of the global Phase three INNOVA TV301 study. VISTA demonstrated a clinically meaningful improvement overall survival compared to chemotherapy with a manageable safety profile as observed in the global study. Cervical cancer remains a leading cause of cancer related deaths in women in China with approximately one hundred and fifty thousand cases annually. Patients currently have limited treatment options once their cancer recurs or spreads after initial treatment. And the current treatments have a different mechanism of action and toxicities. We plan to submit a biologics license application to the NMPA for recurring metastatic cervical cancer in the first quarter of twenty twenty five. For veemarizumab, we are awaiting the results for both pivotal studies in gastric cancer, starting with forty two-one hundred and one which we expect in the first half of this year, unfortunately to one hundred and two in the second half of the year.

The marituzumab has the potential to become the first targeted therapy specifically for FGFR2b positive gastric cancer in China. Next, with our immunology franchise. SRCG mod continues to demonstrate broad potential across IgG mediated diseases. Our partner, argenx, announced in November 2024 the decision to advance cartigimab subcutaneously into the Phase twothree Alkervia study for idiopathic inflammatory myopuses, IIM or myositis, following promising Phase II results. The subtypes of myositis evaluated in this site affect with no targeted therapies currently approved. Zai Lab is actively participating in the Greater China Cohort of this global registrational trial. We will continue to explore the pipeline in our product potential of FCR TGM mod to treat other IgG mediated autoimmune indications including thyroid eye disease or TED, myositis, serenegative gMG, ocular MG and lupus nephritis. In 2025, we expect top line results from the global Phase three study of serenegative generalized mastina gravis and the Phase two study of lupus nephritis. We also recently strengthened our regional immunology franchise with two late stage assets that are highly synergistic with Efcharitimab. Powitazizab immunoglobulin a nephropathy and ZIL-eleven oh eight in thyroid eye disease. Mobitasekab is a novel dual BAAF B cell activating factor in APPRL, a proliferation inducing ligand antagonist with best in class potential in IgN F property supported by its compelling Phase two data.

In China, IgN nephropathy has an estimated prevalence of three million to five million patients, yet there are currently no approved therapies targeting the underlying cause of the disease. Despite standard of care treatments including ACE inhibitors and steroids thirty percent to forty percent of patients eventually progress to end stage renal disease. Underscoring the significant need for innovative treatment options. China has already joined the global pivotal trial for povagitase in IgA and we are leveraging our regional expertise and established footprint for renal diseases with efgartigimab to accelerate development timelines. We aim to bring this first in class therapy to patients expeditiously. ZL-eleven oh eight is an anti IgF antibody which represents another valuable addition to our regional portfolio. It significantly reduces the treatment burden for thyroid IGCs through shorter infusion times and a more concise course of therapy compared to other anti IGF-one ART therapies. In its Phase three studies, VL-eleven oh eight has consistently demonstrated reductions in pructosis diplopia, and CAS across both active and chronic thyroid eye disease. We expect to initiate a China bridging study for TETPACE Thyroid IgG is affects approximately three point three million people [indiscernible] of which one million are diagnosed with moderate to severe forms of the disease.

While estimates can vary, the active or acute phase of thyroid eye disease generally lasts between six and twenty four months. Roughly twenty percent to thirty percent of the overall disease course. Before transitioning into a chronic phase that typically Zai makes up the remaining seventy percent to eighty percent. The stratigimab is under evaluation in active phase and thus ZIL-eleven oh eight complements our debt franchise creating synergies with a cartigimab in both development and commercialization Zai. The wealth of advancements reflect our relentless focus on delivering innovative potential best in class or first in class therapies to patients with high unmet knee. We will continue to execute with speed and precision advancing our pipeline while exploring new opportunities. I look forward to sharing further updates in the coming quarters. And now, Yajin will give an overview of our financial results. Yajin?

Now I will discuss highlights from our fourth quarter and full year 2024 financial results compared to the prior year periods. We had a strong top line growth in the fourth quarter and for 2024, driven by increased sales for ViviGuard, [indiscernible] and then UZYRA. Total net product revenue grew 65% to $108,500,000 in the fourth quarter For the full year, net product revenue was $397,600,000 reflecting robust growth of 49% year over year. Our focus on financial discipline and ongoing efficiency efforts was also reflected on the expenses side.

R and D expenses for the fourth quarter declined 36% year over year and the full year R and D expenses declined 12% as late stage studies completed and as we continue to prioritize our investment, to advancing high value regional and global pipeline programs. SG and A expenses in the fourth quarter were flat year over year and a modest 6% increase for the full year was primarily due to higher general selling expenses related to the launch of Vivigart and the growing sales for NUZYRA. Partially offset by a decrease in G and A expenses and selling Our loss fund operations decreased 45% for the fourth quarter to $67,900,000 and 23% for the full year to 282,100,000.0 When you adjust our loss from operations to exclude certain non cash items, specifically depreciation, amortization and share based compensation. We had adjusted loss from operations of $47,600,000 in the fourth quarter and $199,600,000 for the full year, reflecting year over year improvement of 5328% respectively.

We are in a strong financial position ending the quarter with a cash position of 879,700,000.0 Now turning to our financial outlook for 2025. [indiscernible] We expect our 2025 total revenues to be in the range of $560,000,000 to $590,000,000 This revenue forecast reflects strong growth for the Visika franchise continued growth across our other products, [indiscernible] ZEJULA and MZYRA. And contributions from our newly launched products Aktyra and Zactorro. Lastly, based on our operating plan, our anticipated revenue growth, we expect to achieve profitability in the fourth quarter of twenty twenty five. And with that, I would now like to turn the call back over to the operator to open up the line for questions. Operator, We will now take our first question from the line of Anupam Rama from JPMorgan. Please ask your question.

Hey, guys. Thanks so much for taking the question.

And congrats on all the progress. Just when it comes to the 2025 revenue guidance, which came in ahead of consensus, Wondering if there are products beyond the Vist Guard we should be thinking about outside growth for the year? Hi, Antoine, it's Josh. No, I think you look at our revenue range, we expect the base business to grow strongly. We'd point to ZEJULA and NUZYRA as particular growth drivers. Of VIMGART, we expect to grow faster than the overall rate of growth implied in the May to May. And of course, we're launching first full year launch for Ogtyro and Exact Ouro.

So we'll we will expect some sales there. But I think there, it's just strong performance across the brand. We're excited about the year. [indiscernible] Thank you. We will now take our next question from the line of Michael Yee from Jefferies. Please ask your question, Michael.

Hey, good morning. Thank you for the question.

We had two First was on, Vidyard While there's no specific revenue guidance for 2025 for that product line, I think you made some nice comments around the shape of the curve for this year. Can you just a little more color on the growth trajectory in the first half of the year versus the second half of the year? And is that driven by the recruitment guidelines Maybe just help us out a little bit about where the trajectory of Julia could be the end of the year? And then a R and D question around DLL3, Can you just confirm your thoughts about how fast you can move into a pivotal study I think there's another Chinese ADC that was recently in licensed and put up some data around the 70% response rates. I'm just trying to think about the competitive dynamic there in speed it with you. Thank you. Thanks, Mike. It's Josh. First on Vivcard.

I think we're excited about the momentum we have coming into this year and expect to to have a really good growth year again in 2025. As you pointed out, I think what we particularly expect to see as we get through the year is the compounding effect of the new patients we're starting, particularly those in the maintenance or what we would call consolidation phase where these are patients who are going to expect to go on multiple cycles through the year and of course those build up and accumulate through the year. Big year, we do expect an official update to the myosinib Gravis treatment guidelines in China that more prominently VivGuard, so we'll get some benefits there. And of course, we're CIDP is not on the NRDL, we're in the process of launching that in and making sure patients who do have the supplemental insurance or other ways of accessing the drug that they get it as well. So I think those things when you put them together just lead to even stronger, I think second half growth and we'll see in the first half. But certainly don't mean to imply that we won't see growth throughout the year and again very strong outlook for Vipgar for this year.

Rafael will take Thank you, Michael. With regards to the regulatory pathway and SPEED, We think we have an opportunity to achieve accelerated approval. We are in discussions with regulators we plan to start that study this year. We started a number of patients already that will be presented in the first half of this year. And yes, there are other DLL3 products but they're much earlier, probably one point five years or so behind. So we're confident that we could be the first ones to be approved. And the properties observe with the first patients that we've treated. So So overall, very confident that we will start the study this year. And that accelerated approval is a viable pathway.

Very good. Thank you.

Thank you. We will now take our next question from the line of Jonathan Chang from Liberink Partners. Please ask your question, Jonathan. Hello. This is Yander Li for Jonathan Chang.

So I have a follow-up question regarding the the regulatory strategy for BL1310, the BLF program. So for the pivotal study, could you share your current view on whether you can do a single arm study or you would need a randomized control study to support the accelerated approval And how does that influence your thought on the twenty twenty three BOA submission timeline?

And I have follow-up question after that.

Yes. So it's it's a good question, but obviously we don't discuss details of regulatory discussions with FDA. There's been two products approved as single arms. But there are other products that are approved as accelerated approval in randomized trials. And the advantage of the latter is that one can confirm the approval with the the definitive endpoint of survival. So how will we proceed and will we reveal once we launch that study? Whichever way we go forward, we will move expeditiously. As I said, we will start today. There's a lot of enthusiasm from investigators to accrued to this product and we're confident that we will be able to move this and potentially get approval in 2027. So stay tuned. Got it. Yes. And can I just add a follow-up question? So can you comment on the like the the 2023 sorry, 2026 the biosimilian timeline relatively to the timeline of potential tarlatumumab for approval and the timeline of [indiscernible] Does that like kind of align with what you're thinking? Thank you. Yes. There are always [indiscernible] has accelerated approval and It's a very different agent. And obviously, there's been precedence that even with full approval in the same line of therapy accelerated approval can be granted.

There are multiple examples in the hematology field. The mechanism of action is different. It looks toxicity is different, And so far, the level of activity of thirteen ten is higher, is in the 70% range as opposed to 40%. So we're not too concerned about the potential of Tarlatamax getting full approval before our PDUFA date. So that's with regards to tarlatumumab in second line. B7H3, my sense is that they started or they plan to start start a pivotal trial, but we don't really comment on the details of competitors. And I actually do not know what their timelines are. All I can say is that our plan is to move as fast as possible with an accelerated approval pathway. Understood. Thank you so much for answering my questions.

Thank you.

Our next question comes from the line of Ygal Notromovit from Citi. Please ask your question, Egal. Hi. This is Rina on for Yigal. Thanks for taking my question. I just wanted to ask on DLL3, just wondering if you could talk about your strategy going into the first line setting and then with the update expected at upcoming medical Congress, just wondering what kind of data we should expect there? Like how many patients have efficacy claims, anything you could tell, sir?

Yes. Thank you for the question. I'll answer the second question first. We will Have data on the various dose escalation doses And we should have a fair amount of maturity in the earlier doses And definitely enough time for responses to have been confirmed. In addition to that, as we mentioned in in the prior quarter, we started the dose optimization And we've accrued really fast to that randomized cohort of the study that was 50 patients and we should have At least the opportunity to be confirmed in the vast majority of patients. So we think we'll have data in about seventy five patients or so and different levels of follow-up obviously. With regards to first line, we were pretty active in first line we started combinations with PVO-one inhibitor and then very soon we're going start with Carboplatin plus PD-one inhibitor, so a triplet. Our initial goal is to avoid topazide because it's a very mild depressive drug and that's really what tends to limit the length of therapy [indiscernible] ADCs that combine with PD-one inhibitor, checkpoint inhibitors have been able to supplant chemotherapy such as PADCEV in GU So if you think about the fact that we can get seventy percent in second line and the response rate in first line is slightly lower than that is in the 50s to 60s.

It's not very far fetched to think that ZL1310 plus PE-one inhibitor could be potentially superior to the current standard of care. So this is the way we're thinking. Nevertheless, we are going to test the combination with CARVOL and then we will have to select those ORCL1310 with that combination. We should have data this year on that dose Zai. And then we will have regulatory discussions as to how to move it into frontline.

That makes sense. Super helpful. Thanks for taking my question.

Thank you. We will now take question from the line of Ling Hai Zhou from Goldman Sachs. Please ask your question, Ling Hai.

Thanks for taking my question. I have two questions.

The first one is about FCAR. Since we have the CIDP and also the SC formula approved in the second half of twenty twenty four, I'm curious, what has been the observations of, real world patient usage and adoption We have observed so far. And in terms of sales breakdown, how what percentage of sales coming from the CIDP and subcutaneous formula? And in the longer term, what percentage would you expect would come from this CIDP and subcu forming where? That's the first question. And the second question is about CAR XT. Since we have our NDA has been accepted in January. That means that the China approval should be around roughly a year away. And most recently, BMS has also shown that they have received a very encouraging feedback and the early trend has been pretty good. So that's but we all know that in The U. S. Market. So in the China market, can you share a bit more on the potential differences in the SKU schizophrenia treatment between U. S. And how would you see the potential commercial hurdles in China Any addition, any updates on the ADP clinical development? Thank you. Thanks for the question.

Josh, I'll start and then Rafael can talk a little bit about ADT for parks.

First one, CID, your question about CIDP, in VivGART, just keep in mind that while we received approval by the time we got the product up for commercial launch, it was right at the end of twenty twenty four. We do not have NRDL listed.

For iTralo or CIDP in 2025. So I think we expect a relatively limited impact. It's only going to be available through supplemental insurance or cash paying market. So we're really looking forward to listing in later years and full benefit there. So our focus this year, while we do want patients with CIDP to have the opportunity to benefit from this product, really to vast majority of our sales and efforts will focus on gMG in 2025 and gMG and in IV. Formulation. To the question about CAR XT, I think we are very excited about the the commercial opportunity for CAR XT in schizophrenia. Of course, we're as you mentioned, we submitted at the end of last year and are looking forward to an approval and a launch. There are eight million patients with schizophrenia in China, about four million of whom are seeking care in pretty intensive settings typically using an atypical antipsychotic And I think we know from the clinical trial experience and certainly what BMS is seeing in The U. S. Is that Kobenphi or CAR XT provides a really important opportunity to help patients who are not responding well to antipsychotics or who can get more of the the positive symptom relief that you can get with Coventry versus the atypical antipsychotic.

So we're just excited get the product approved and start to launch. We'll launch with sales force in about 150 person range focused on these big treatment centers and we're looking forward to that. I think it's going to be a great product in China.

For schizophrenia. Rafael, maybe you can make some comments about Alzheimer's.

Sure.

So dementia related psychosis, there's a series of studies, they call it DEBT studies that are being executed by BMS. As you know, antihistamines have a black box warning against the use in dementia, which RXD doesn't have. And in fact, we're seeking an indication in in this setting, which is really met need We very much want to pursue this indication We're in discussions with PMS as to what the best regulatory pathway is. Whether it's participating in a debt versus doing other [indiscernible] other potential registration pathways, but that will be performed this [indiscernible] And just to reiterate that it's an indication that we will be pursuing.

Thank you. Now take our next question from the line of Li Wachek from Cantor Fitzgerald.

Please go ahead.

Hey, guys. Thanks for taking our questions. I have one on pipeline, one on commercial. I guess for ZL's thirteen ten deals, ADCs in terms of durability where would you place ADC versus the other modalities such as T cell engagers or radio? And can you talk about chemosensitivity or real sensitivity in small cell lung cancer, And then if you align on AEPAS for second line, how should we think about the confirmatory study and the enrollment timeline there? And then second for VITGARD, anything you can share in terms of breakdown of new patient adds versus maintenance for Q4? And then how should we think about the sequential contribution from each group going forward?

Rafael, do you want to start on Yes. I'll I'll start with DLL3. I think the durability of response, which I think was your first comment, It's still early to be able to know what the median durability response is going to be. And I think that is a good thing. Perhaps by ASCO, we may know, but we haven't reached it yet. Last time we looked And I think a good DOR if fifty percent of patients are at six months or greater, that would be I think something important, particularly given that there's so many patients that respond. If you look at tarlatumumab, the response rate is in the 40s with DOR of nine months. That's really what's in the label. So we hope to be thereabouts those number hopefully the longer the better. In terms of chemosensitivity, I'm not sure exactly whether you're referring to whether patients were biometrically resistant We've looked at that and there's really no difference in sensitivity to thirteen ten. Patients tend to respond With the same proportion whether or not they are refractory or resistant to platinum. And that is not the case with other agents as you may know. With regards to the confirmatory trial, it depends on how the Acellera approval is obtained.

If it's obtained in the context of a randomized trial where accelerated approval is is obtained by response, then the same study will confirm the approval using 10 to 11 endpoint, which tends to be overall survival in second line.

Otherwise, one has to do a second study, which [indiscernible] So the regulatory pathway, we will disclose it once that that study starts. So I hope that answers your questions with regards to thirteen ten. And obviously, we'll know more at the time of the presentation. Thanks, Rafael. Thanks, Lee. On 1,000 patient initiations per month. So we're really pleased with that. And increasingly, those patients are being started in the maintenance or consolidation phase of their disease. So these again are the patients maintain treatment on VIVGART for three to five cycles per year based on what we know from the clinical [indiscernible] that the majority of patients now that we're getting on a monthly basis are starting in that setting. And so to your question, the more of that we get, the we progress through the year this year, you're going to have that reservoir of existing patients coming back in for their second, third and fourth courses. And as I mentioned at the beginning of the call, we just look at patients who started on VIVGARD in the third quarter of twenty twenty three, about forty percent of those patients had already come back in, in the fourth quarter come back into their physicians to start a second course of therapy.

So we're really pleased with the progress we see here. This very much I think matches what argenx saw in about the space of their launch in The U. S. So again gives us a lot of confidence about the long term prospects here for Vivgard.

Thanks.

Our next question comes from the line of Jack Lin from Morgan Stanley. Please ask your question, Jack.

Hi. Thank you for taking question. I have two questions, one on pulpitasacep and the other on the catalyst. So pulpitasac, I'm curious if you could share more. I mean, you mentioned earlier you'd be joining the global study But in terms of timeline, what might be we looking at in terms of China launch? And following that, given that there is some product that have been approved or are in the late stage of development, how do we see the kind of relatively later launch in China with what's our strategy to kind of long term push COVID-nineteen in China and kind of what the potential might be especially with consideration of potential label expansion beyond IGA in?

So that's kind of the first question on pulvetazizat. And at the same point, just curious could you help me summarize what are the the key top major catalysts that are the most exciting company in this coming year? Thank you.

Yes.

So perhaps I will start with Praveen. In terms of participation in the China trial, you're right. We initiated an I mean, there is enrollment already in China that was initiated and actually is expected to end this year. So we will file with a global trial And we hope to actually be able to get Accelera approval this is disease where there really aren't active drugs and patients get immunosuppressive drops in the form of steroids when they develop proteinuria And so being able to have an agent account hold natural history of the disease is really important because as I mentioned in the preparatory remarks, lot of these patients end up in renal failure. There are other agents out there. This is a vast APL inhibitor.

Others target all their targets like BILES, April Zai is commonly targeted with these agents, but there are some properties of this product that I think may make it ideal. Obviously, we will have to see comparisons regards to efficacy and safety.

But it's giving every four weeks. We have data globally as opposed to local data from China only. So it's we have sort of a more diverse population with regards to activity and safety. And we will we have actually longer term data than some of the the other products. So We are confident that particularly if we get accelerated approval, this will be transformational for for patients with this disease, particularly those that have the severe form of IgA nephropathy. Thanks, Jack. This is Samantha. I'll address your key catalyst in 2025.

Since we have a very limited time left of just gave you a feel very key highlights. [indiscernible] First of all, on the pipeline side, on the global, as we talk today in lengthy about our DL3 assets ADC assets.

We will have data updates for monotherapy in small cell lung cancer had a major conference in the first half this year. We will have data updates for DL1310 Compose For first line Smartsail lung cancer this year. Of course, we also will initiate a pivotal study in small cell lung cancer. With possibility for an FDA approval in 2027. We'll initiate a global Phase one study in other [indiscernible] [indiscernible] cancers in first half is And we also, of course, as we mentioned our news release, have other preclinical data updates for at least two additional global access that are moving into Phase one development.

Recently, [indiscernible] news will be bimetusimab will see data readouts and followed by NPS submission in first half twenty twenty five. And we also have five regular submissions in China And I won't give you the detailed numbers, but is a big one. As you know, first line gastric cancer. On the PT side, we have additional global [indiscernible] and of course, if [indiscernible] would be our licensing BD deals as well.

So overall, we are very confident that we are going to achieve profitability in full quarter twenty twenty five.

Thank you. [indiscernible] Thank you.

We have now reached the end of the question and answer session. Thank you all very much for your questions. I'll now turn the conference back to Doctor. Samantha Du for her closing comments. Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support Look forward to updating you again after the first half of twenty twenty five, sorry, after first quarter of twenty twenty five.

Operator, you may now disconnect this call.