Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's second quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Billy Cho, Chief Financial Officer of Zai Lab, who will make introductory comments. Thank you, operator. Good morning. Welcome, everyone. After the market closed yesterday, Zai Lab issued a press release providing the details of the company's financial results for the second quarter ended June 30th, 2021, as well as product highlights and corporate updates. The press release is available in the investor relations section of the company's corporate website at ir.zailaboratory.com. Today's call will be led by Dr. Samantha Du, Zai Lab's Founder, Chairperson, and Chief Executive Officer. She'll be joined by Tao Fu, Chief Strategy Officer, who will provide more details on the product portfolio along with the pipeline and commercial progress. I will conclude with comments on our financial results in the quarter. Dr. Alan Sandler, President, Head of Global Development, Oncology; Dr. Harald Reinhart, Chief Medical Officer for Autoimmune and Infectious Diseases; and Jonathan Wang, Head of Business Development, will also be available to answer questions during the Q&A portions of the call. As a reminder, during today's call, Zai Lab will be making certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our business plans and objectives and timing and success of our clinical trials, regulatory applications, and commercial launches. These forward-looking statements are not guarantees of future performance and therefore you should not put undue reliance upon them. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. I refer you to our SEC filings for a discussion of risk factors that could cause our actual results to differ materially from those discussed today. At this time, it is my pleasure to turn the call over to Zai Lab's founder, Chairperson, and Chief Executive Officer, Dr. Samantha Du. Thank you, Billy. Hello, everyone. Thank you all for joining us. On this call, I'll discuss highlights from our second quarter and provide the latest updates on what we expect to accomplish for the remainder of 2021. Consistent with our past track record, Zai Lab continues to execute with speed and quality across our organization during the second quarter. We successfully launched QINLOCK in China in record time. QINLOCK is our third commercial product in oncology to launch over the last 16 months, and the first product in what we expect to become a world-class gastric cancer franchise. We continue to generate strong revenue growth from our first two products, ZEJULA and Optune. We entered into three strategic collaborations with Mirati, MacroGenics, and Schrödinger respectively to further deepen and strengthen our disease area strongholds and our global pipeline. Tao a nd Billy will discuss these achievements in more detail. We now have 25 globally innovative assets in our pipeline, and the quality, depth, and breadth of our pipeline will continue to grow. Notably, 12 products are in late-phase development, of which five have already been approved in the U.S. and three have received FDA Breakthrough Therapy Designation. In addition, our growing pipeline now includes 11 early-stage programs with worldwide rights, including three in global clinical trials. We are viewed a broad, innovative, validated portfolio whose success will allow us to achieve significant sales within just a few years. We will continue to leverage our scale and operating excellence to expand our pipeline with globally innovative products through strategic partnerships and internal R&D. We expect to achieve many exciting milestones across our product pipeline throughout the remainder of 2021. We expect approval of our fourth commercial product in NUZYRA for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections by the NMPA. We also continue to make progress on additional regulatory filings and activities. We expect to have a discussion with NMPA on the filing strategy for margetuximab in the near future. We anticipate numerous data readouts during the rest of this year for QINLOCK in second-line GIST, for margetuximab in gastric cancer, for CLN-081 in non-small cell lung cancer, for TPX-0022 in non-small cell and gastric cancer, and for other product candidates in our global pipeline. We continue to invest in our worldwide organization and facilities. During September, we will expand our presence in the U.S. by formally opening a clinical development and business facility in Cambridge, Massachusetts to tap into the Boston area bio-pharma ecosystem. In the meantime, our existing R&D and business centers in the San Francisco Bay Area and in China will continue to grow. Zai Lab has grown substantially since our inception seven years ago. With the abundance of growth opportunities we see, we strongly believe that we are still in the early stage of our growth trajectory. Given the current breadth and depth of our portfolio, we have decided to hold an R&D day on September 22nd to take a deep dive into our pipeline and disease strongholds and to highlight the fundamental growth potential of Zai. We hope you come away from it with a more comprehensive understanding of what we are doing and what we expect to accomplish in the future. We believe we have a once-in-a-generation opportunity to build a leading global biopharmaceutical company with a strong foundation in both China and in the U.S. Zai is in a great position to capture growth opportunities with our global infrastructure and ever-growing first and/or best-in-class portfolio. We remain as committed as ever to our mission to develop innovative medicines addressing the unmet medical needs of patients around the world. We believe by doing this, we'll benefit our shareholders as well. With that, I'll now ask Tao to discuss our performance and prospects in more detail. Tao? Thank you, Samantha. I will comment on the launch performance of our three commercial products and on progress we have made in the quarter in our main disease franchises: lung cancer, gastric cancer, hematology, autoimmune disorders, and infectious diseases. ZEJULA continued to perform very well in the second quarter and it achieved significant sequential revenue growth. As a reminder, ZEJULA is approved in China for first and second-line ovarian cancer and is the only PARP inhibitor monotherapy approved for all comers in the first-line. This provides significant differentiation from other PARP inhibitors. The inclusion of ZEJULA in NRDL starting from March of this year, provided a major momentum for the ZEJULA launch. One key leading indicator for the successful launch and NRDL implementation is hospital listing. Our team has been laser-focused on increasing hospital listings, and as of June 30th, 2021, ZEJULA has been listed in more than 800 hospitals in China, which represent a more than seven-fold increase from just prior to the NRDL implementation in March 2021. Combined with the differentiated label, our successful market access strategy lays the foundation for strong volume growth in the second half of the year and beyond. We remain confident that over time, ZEJULA will become the market-leading PARP inhibitor in ovarian cancer in China. Similarly, the launch of Optune is going well. As a reminder, Optune is the first innovative medical device supported by commercial health insurance in China, and also has been covered in 14 supplemental insurance plans since its launch in June 2020. During the second quarter, we held extensive multi-discipline physician education campaigns to increase brand adoption. We were pleased with the feedback we received from treatment specialists. Importantly, on the development side, we're working with our partner, Novocure, to extend indications of Tumor Treating Fields in areas of large unmet medical need globally and in China. We look forward to additional clinical data readouts in lung, pancreatic, liver, and ovarian cancers, in brain metastases, and in glioblastoma with high intensity array over the next few years. We continue to target a filing of Tumor Treating Fields for malignant pleural mesothelioma later this year. As Samantha mentioned, we achieved another important commercial milestone in successfully launching QINLOCK in fourth-line GIST in China in May, our third oncology launch in the last 16 months. QINLOCK is another great example of our track record of accelerating regulatory filing and approval of innovative oncology products. We were able to file the NDA for QINLOCK in China only two months after FDA approval, and we received NMPA approval eight months after NDA acceptance. In July, QINLOCK was included in the Chinese Society of Clinical Oncology guidelines for diagnosis and treatment of Gastrointestinal Stromal Tumors 2021 as an option for second-line treatment for advanced GIST patients. We are encouraged by our initial launch performance and look forward to updating you with our progress through the remainder of the year. Let's move on to progress in our product pipeline, starting in lung cancer, where we continue to build a disease stronghold with six products currently in clinical development. In June, we entered into an important strategic collaboration with Mirati and obtained the right to research, develop, manufacture, and exclusively commercialize adagrasib, a potential best-in-class small molecule KRAS G12C inhibitor in Greater China. Adagrasib received FDA breakthrough therapy designation in June for the potential treatment of non-small cell lung cancer patients who harbor the KRAS G12C mutation following prior systemic therapy. Zai will support accelerated enrollment in key global registration-enabling clinical trials of adagrasib in KRAS G12C cancer patients, including non-small cell lung cancer and colorectal cancer. Mirati has announced their intention to file adagrasib for second-line non-small cell lung cancer in the U.S. in the second half of 2021. We believe adagrasib has best-in-class potential, we will also aim to make it first-in-class in China, where there are currently no ongoing clinical trials in this product category. Adagrasib is a great addition to our lung cancer franchise and complements other promising Zai products being developed for lung cancer, including Tumor Treating Fields, repotrectinib, CLN-081, and TPX-0022. For Tumor Treating Fields, Zai initiated the China portion of the phase III pivotal LUNAR trial and the phase III pivotal METIS trial in brain metastases for non-small cell lung cancer. You will recall that in May, Novocure announced that the FDA approved their IDE supplement for LUNAR, reducing enrollment requirements by about a half and shortening the required patient follow-up from 18 months to 12 months, potentially accelerating the completion of the trial by more than a year. For CLN-081, in June, Zai's partner Cullinan Oncology announced phase I/II-A interim data in non-small cell lung cancer EGFR exon 20 patients. CLN-081 continues to demonstrate its best-in-class potential with good activity and encouraging safety and tolerability. Let's move on to gastric cancer, a Zai Lab disease stronghold with seven products currently in clinical development, including QINLOCK and bemarituzumab. As I mentioned earlier, we're actively launching QINLOCK in fourth-line GIST, supported by the compelling data generated from the INVICTUS phase III study. In the second half of this year, our partner, Deciphera, expects to receive data from the INTRIGUE trial of QINLOCK versus sunitinib in second-line GIST. Other gastric cancer products also made significant progress in the quarter, including bemarituzumab, the monoclonal antibody against FGFR2b. In April 2021, Zai Lab's partner Amgen was granted breakthrough therapy designation by the FDA for bemarituzumab as a first-line treatment for patients with FGFR2b overexpressing, HER2-negative, metastatic and locally advanced gastric and gastroesophageal junction adenocarcinoma in combination with modified FOLFOX. In June, Zai's partner Turning Point was granted orphan drug designation by the FDA for TPX-0022 in gastric cancer, including gastroesophageal junction adenocarcinoma. In our hematology franchise, in May 2021, Zai's partner Regeneron resumed enrollment in the phase II potentially pivotal clinical trial of odronextamab in patients with follicular lymphoma and diffuse large B-cell lymphoma. We look forward to initiating this important clinical trial in China. Since our last earnings call, we also entered into two other strategic research and development collaborations to bolster our global oncology pipeline. In June, Zai and MacroGenics announced that the two companies have entered into an exclusive collaboration and license agreement involving up to four immuno-oncology molecules. The first collaboration program covers a lead research molecule that incorporates MacroGenics' DART platform and binds CD3 and an undisclosed target that is expressed in multiple solid tumors. The second program covers a target to be designated by MacroGenics. For both molecules, Zai receives commercial rights in Greater China, Japan, and Korea, and obtains an option to convert the lead research program into a global 50/50 profit-sharing arrangement upon achieving a predefined clinical milestone. For two additional early-stage molecules, Zai Lab has exclusive global development and commercial rights. Earlier this month, Zai and Schrödinger announced a global discovery, development, and commercialization collaboration focused on a novel target in the DNA damage response pathway, a key research interest for Zai Lab in oncology. Schrödinger is an industry leader in providing computational platforms used in drug discovery. The research program will be conducted jointly by the two companies' scientific teams, and Zai Lab will have exclusive development and commercial rights globally. This initiative will complement our existing discovery efforts in DNA damage response pathway, in addition to potential combinatorial approaches within our pipeline with such products as the PARP inhibitor ZEJULA and ZL-2309. In our autoimmune franchise, in July, Zai Lab's partner, argenx, announced myelofibrosis and bullous pemphigoid as two new indications for efgartigimod at its R&D day. To date, five clinical trial applications for FR filed by Zai have been approved. With all of this progress, as you can see, that Zai's development and commercialization operations are hitting on all cylinders. We have an abundance of growth opportunities, we very much look forward to sharing our further progress with you throughout the year. Now, Billy will discuss our financial results in the quarter. Thank you, Tao. We continue to remain in high growth mode, and our financial results reflect strong progress across our business. Today, I'll briefly summarize our financial results for the second quarter as well as year-to-date 2021, which are both in line with our internal expectations. Revenues for the second quarter and year-to-date 2021 were $36.9 million and $57 million respectively. Over the same period last year, revenues were $11 million and $19.2 million respectively. We're still early in the revenue ramp cycle, but we are very pleased with the successful launches and sales trajectory of our first 3 oncology products. ZEJULA sales for the second quarter and year-to-date 2021 were $23.4 million and $36 million respectively. Over the same period last year, ZEJULA sales were $7.5 million and $13.8 million respectively. Optune sales for the second quarter and year to date 2021 were $9.5 million and $16.6 million respectively. Over the same period last year, Optune sales were $3.5 million and $5.4 million respectively. As for our third product update, we successfully launched QINLOCK on May 20th and achieved $4 million of revenue for the quarter. Research and development expenses were $142.2 million for the three months ended June 30th, 2021, compared to $68.3 million for the same period in 2020. The increase in R&D expenses was primarily attributable to additional strategic partnerships, including a $65 million upfront payment to Mirati and a $25 million upfront payment to MacroGenics, expenses related to ongoing and newly initiated late-stage clinical trials, and pay and payroll-related expenses from increased R&D headcounts. Selling, general, and administrative expenses were $54.4 million for the three months ended June 30th, 2021, compared to $23.8 million for the same period in 2020. The increase was primarily due to payroll and payroll-related expenses from increased commercial headcount and additional commercial activities. Zai Lab continued to expand its commercial operations in China. For the three months ended June 30th, 2021, Zai Lab reported a net loss of $153.3 million, or a loss per share attributable to common stockholders of $1.76, compared to a net loss of $88.6 million or a loss per share attributable to common shareholders of $1.08 for the same period in 2020. The increase in net loss was primarily attributable to additional strategic partnerships, increased R&D, and SG&A expenses for the reasons I just mentioned. As of June 30th, 2021, cash and cash equivalents, short-term investments, and restricted cash totaled $1.77 billion, compared to $1.19 billion as of December 31st, 2020. We would now like to turn the call back over to the operator to open up the line for questions. Operator? Ladies and gentlemen, we will now begin the question and answer session. To ask a question, please press star one on your telephone keypad and wait for your name to be announced. To cancel the request, please press the pound or hash key. Handy note, we request you to ask two questions per turn for time constraints. Once again, it is star one to ask a question. We have the first question coming from the line of Michael Yee. We have the firs t question coming from the line of Yigal Nochomovitz from Citigroup. Please go ahead. Hi. Great. Thank you very much for taking the questions. You have a very rich pipeline of in-licensed assets that are making their way through clinical development and now three approved products. Are you still as focused on the BD effort to bring in new assets into the company, or do you believe you have a sufficiently rich pipeline and will focus more on developing the assets that you've already got? Thanks. Thank you, Yigal. This is Samantha. Good morning. I'll let Jonathan to address the question. Hi, Yigal. Thank you for the question. I think at Zai, the BD strategy always follows with the company's growth strategy. This has really been evolution for us. I think we've been really positioning ourselves as the partner of choice in China. I think continue to execute on bringing globally best-in-class assets into our pipeline to complement within oncology, within autoimmune, and within infectious diseases. I think beyond that, we're also looking for transformative deals. We're also looking for opportunities to go beyond our existing therapeutic areas, just like we have done in the past with efgartigimod, with the general assets. I think we'll continue to do that. I think even beyond that, like we have done recently with the MacroGenics, with the odronextamab deals, I think even to support our discovery efforts. I think BD is always evolving, and I think it's multidimensional since for the growth of the company. Okay, thanks, Jonathan. I just had one follow-up. By my count, I believe you have 11 oncology products in your portfolio, with two already approved. That opens up the possibility of investigating combination strategies within your portfolio. That being said, I'd be curious to know which products do you believe would make the most sense to evaluate in combination clinical trials and in what tumor types? Thank you, Yigal. Alan, our President of Oncology Development, please take the question. Hello. Sorry, I was on mute. Thank you for the question. Yes, this is one of the great advantages that we have here at Zai Lab, given the large number of assets in the portfolio and additional ones forthcoming. I think that there are opportunities would exist, interestingly, in our gastric franchise and our lung franchise, I think, in particular, given the broad number of assets that we have in there and the targeted approach with which we have. We're looking at a number of different combinations that may be associated with KRAS, also combinations in one and also in gastric, with the various combinations that are available, including PD-1, or Marge, for two agents, MET, et cetera. I think that would give you a hint of some of the areas with which we're looking. Have I addressed your question? Yes. Thank you. Thank you. Thank you. We have the next question. This is coming from the line of Michael Yee from Jefferies. Please go ahead, ask your question. Hi, good morning. Good evening. We have two questions. One was on the recent Schrödinger deal, but just more broadly strategically, should we anticipate that you are going to do more deals that bring in more global rights, and with an intention of developing and bringing in more internally developed R&D programs rather than an in-license of other programs, rather instead developing your own internal and to do it globally? That's question one. How should we think about that? Question two is based on a comment around expanding outside your therapeutic areas. I think you have a very strong focus on oncology, et cetera. That's pretty well known. Can you just maybe expand upon the idea to go beyond oncology and to what other areas should we expect or could anticipate so we're not surprised? Thank you so much. Thank you, Michael. Tao, do you want to comment on the AI and the Schrödinger deal? Samantha. Mike, thank you very much for your questions. The Schrödinger collaboration is a pretty exciting new partnership for us. As you may know, they are the industry leader in physics-based computational chemistry platform and really have a very strongly existing track record. We have this collaboration with them really focused on a key area of R&D interest for Zai Lab, the DNA damage response pathway, on a very interesting target, which we'll disclose later. Really trying to leverage the capabilities of both companies, and obviously get Zai Lab global rights on this particular target. The AI area is a new promising area. We'll try to stay on the cutting edge. We're really trying to use external collaboration to complement our existing capabilities in areas such as AI discovery. Yeah, I think just to elaborate on what Tao was saying, the discovery technology platform collaboration, like Michael, you rightly mentioned, is a way for us to expand our discovery capabilities and to complement our existing discovery technology platforms for us to do internal global discovery and development. Having said so, we'll continuously do what we have done very well, which is bring assets with the differentiation, with the unmet medical needs, whether for China or for global. It's based on the fit with our pipeline. Thank you for question number one. Yeah. Go ahead. Makes sense. Yeah, both are important. Makes sense. Both are important. The idea of expanding therapeutically, could you comment on what areas? Yeah. Could be of interest? Yeah. We actually have many opportunities, more and more inbound interest from potential partners who have really give us a lot of credit for what we have done for the partnerships. We're actively looking. When we expand horizontally, we want to expand with anchor assets into a different new therapeutic area. That has to have, such as example, expand into the collaboration with argenx for efgartigimod, which offers a pipeline of product kind of opportunities. That kind of field, when we do expansion, we are looking for. I mean, horizontally, but vertically, we're always looking for more opportunities to complement our existing pipeline. Thank you. We have the next question. This is coming from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Oh, great. Thanks for the question. Maybe just if we could cover the dynamics around just investor questions that we've gotten and concerns that have been raised with regard to some of the volatility in shares in China, and where biotech fits strategically in terms of the Chinese government's focus on certain areas. I think, Samantha, you're uniquely well-positioned to comment on those concerns. Obviously, Zai is well outside of some of the concerns that have been raised for other companies with regard to how the company's accounting has been executed, things like that. Just maybe help us understand the importance and strategic positioning of the biotech industry in China and its importance to the continued growth and local growth in China. As a second question, Billy, I was just hoping you could give us a sense of the potential payments that we could see to collaboration partners as it relates to milestones that we should be thinking about for 2021 and 2022, given the very robust series of pipeline opportunities. Just one final question, should we see a meaningful data set, particularly either LUNAR or one of the other major data sets come forward, how are you guys thinking about manufacturing capabilities with your partner, Novocure, in the context of TTF, and how do you hope to address that? Thanks so much. Thank you, Seamus. The first question and is since you asked me to speak about this sector, and it's actually we do agree, we have seen lots of volatility, and also around China concept companies listed on NASDAQ. So we have done quite a lot of due diligence, myself also, and we spent time with different agencies to discuss with them what does that mean to Zai Lab and also, of course, Zai Lab's companies like that, biotech companies like Zai Lab. We, from our due diligence, of course, from our understanding, and I'm not sure we are representing any government bodies, but we believe that the actions that caused the recent market volatility are unrelated to Zai's particular business. Also recent events, including the Chinese government continues to support innovative biotech industry. The new CDE draft guideline issued on July 2 on cancer drugs raised the bar for innovation through drug development. This actually are very helpful for companies really focusing on differentiated first- or best-in-class product portfolios instead of focus on build many me-too or may know worse. They've been also recently reviewed the ICH guidelines membership status, which shows their continued strong commitment to harmonization, global harmonization. Also, quite honestly, other sectors are already very heavily regulated. If you're looking at the 14th China's economic five-year plan, biotech sector is considered one with a very strong supportive pillar industry. The focus really is on innovation and promote integration, innovation with biotech and accelerate the biotech and biopharmaceutical and the big boost in China and the innovation capability from fundamental side. From all the activities we involved, also including some minor details like for these sectors, first, they are piloting tax reduction plans in base in Shanghai, Pudong where we based on. There are many positive news. Of course, those are only perhaps not hidden to the public. What we have seen so far, we very confident on Zai Lab's fundamental growth. Billy, you want to address the second question? Yeah, sure. Hey, Seamus. I'll take a stab at second and third question. The question related to upcoming milestone, type of payments, as you know, Seamus, we don't give forward-looking guidance on those figures, but rest assured, it's immaterial compared to, let's say, the upfront portion or the actual royalty that kick in after the commercialization. You would have seen some disclosures along the way. I know that Turning Point announced yesterday, and they did disclose we made a $5 million payment because we achieved a certain development milestone. You can expect something along that zip code when we have a notable sort of development or regulatory milestone achieved. You can get a sense, right, Seamus, that in terms of materiality, it's quite limited compared to the upfront or royalty, which is at the one-time upfront and then at the back end. In terms of your question on sort of the ramping up volume and what that means in terms of manufacturing capabilities for Tumor Treating Fields, and I'll let Tao add any other additional comments, but, yeah, you're right. Your observation is right in that if LUNAR trial is successful with final phase III data out next year, we're talking about different level of scale. Are there opportunities to drive operating leverage at that volume, at that scale, especially China scale? These are the questions that we've been having these discussions with our partner. Thank you. Okay, thank you. We have the next question from the line of Anupam Rama from JPM. Please go ahead. Hey, guys. Thanks so much for taking the question. Specifically, there's been a lot of headlines on sort of Chinese regulators' proposed rules on oncology trials. Maybe you can talk about what the implications for development here are in the region for your broader pipeline. Then, Samantha, digging into your comments a little bit more on the PCAOB auditing and sort of what's going on in China there. You guys have PCAOB not reviewing your financials as a 10-K sort of risk. How are you strategically thinking about this situation and kind of addressing it over the long term? Thanks so much. First of all, Anupam, thank you for the question. You're asking about your elaborate on the July 2nd guideline first. Is that the first question? On the oncology proposed, yeah. Right. Okay, as I mentioned earlier, we think that guidance for industry, first of all, that's still guidance for soliciting industry's input. We really think that they're going to raise the bar for innovation for oncology development. As we all know, China has many, many PD-1 and PD-1 biosimilar V2s or maybe not worse, right? I think it's from many angles, it's not only you not really be respond. If CDE continue to support it, that really means it's not helpful for patients who already should have been exposed to the many approved products instead of exposed to the placebo arm. Secondly, what they're really trying to emphasize is actually closer to FDA for standard oncology, which is, number one, you have to show differentiation and to address unmet medical needs. Secondly, if there are already gold standard established, then you need to do comparative studies instead of placebo trials. I think that's the fundamental on that particular guideline. That fits very well with Zai Lab's strategy for novel pipeline. From day one, when we evaluate internally or externally to develop products, that's how we use the global standard to say whether it shows first-in-class or only-in-class. That's all the criteria. In terms of, you ask also perhaps about the overall, the country's future, right? About the government issue, many rules, policies, and again, those really have a lot to do with the overall government policies, direction of China's growth over the last 40 years. They also want to balance different industries and how to control monopoly, how to be anti-monopoly, and how to balance the population, which we've seen in the education sector, how to be able to provide the equal opportunities to 1.4 billion population. Having said that, those are not our area of expertise. Honestly, those have been debated for a long time, and I'm a little bit surprised, actually, the market reacted with that kind of negativity because this has not been as new. This has been long debated, even since 2018. On overall Zai Lab, we believe we're very well positioned for the future generation of biopharmaceutical companies have China exposure, but also continually expanding in U.S. continuously instead of just China for China, but really China for global and global for global. Those directions we're taking, I think it's all on the very positive trajectory, especially for companies that already are Zai Lab size. We believe that this give us a strong opportunity to continue to see growth and a strong growth from Zai Lab. Billy, you want to comment on anything else? Yeah, sure. Thanks, Samantha. Anupam, you asked about PCAOB. I'm just going to mention 2 quick broad points. First, just want to, you know, remind everyone here that we are a 100% privately owned enterprise with a very simple legal structure. No VIE. Never have, never will. Our financial reporting has historically been and continues to be on a U.S. GAAP basis and in accordance with PCAOB standards. As a domestic issuer now, which is why we're having a quarterly call with quarterly filings, we have also completed a full starting SOX audit historically as well, and ongoing. The second broad point is that we're, of course, we have significant infrastructure in China, but we do have eight offices around the world, and we're making investments in the U.S. as well. That, I guess without going through details, I can make the statement that we do plan to have options available to us, to significantly limit the risk that's been publicly kind of published so far. You can also look towards our 10-Q, our filings for additional info on those. Thanks for your question. Thank you. We have our next question. This is coming from Jonathan Chang from SVB Leerink. Please go ahead. Hi, guys. Thanks for taking my questions. First question, are there certain sub-sectors or spaces within Chinese biopharma that could be more or less vulnerable to changes in the regulatory landscape in the future? I think of companies like Zai Lab, as I said, that are focusing on innovation, focusing on bringing unmet medical needs to patients and for patients globally. I personally believe we are in the best sector in biotech. I got it. Maybe just second question, can you provide any additional color around how investors should be thinking about second half revenues, maybe specific to ZEJULA? Are there additional metrics you can provide to give us a sense of how ZEJULA is performing relative to competitor programs? Thank you. Billy? Yeah, sure. Thanks, Jonathan. We're obviously quite pleased with the sales momentum that we're seeing so far year to date. We saw a nice volume uptake, and market share gains. Our NRDL implementation, while early, it's off to a fast start. You saw our press release, citing that starting from the implementation date of March 1st till the end of June, we actually increased the number of hospital listings by over 7, or about sevenfold, which is actually closer to 850 than 800. We're quite happy with the implementation going so far and look forward to, of course, building on the momentum for the back half of the year as well. We're pretty confident, we're actually very confident that we will hit our internal goals. Jonathan, we're not yet giving full-year sales guidance just yet. You can see some statistics that we shared around hospital listings. Our hospital coverage is also expanding as well, and now we have over 2,000 hospitals in our coverage. Got it. Thanks for taking the questions. We have the next question. This is coming from Ziyi Chen from Goldman Sachs. Please go ahead. Sure. Thank you. Thank you for giving me the opportunity to raise questions. I looked at the pipeline actually this time, we have specifically listed out the internal R&D pipeline, which now we counted about 13 projects in target identification and about 10 projects in the range of lead optimization to phase I studies. A couple questions regarding the in-house discovery strategy. Number one is, Zai Lab team up with a couple of AR companies, actually, it's not only Schrödinger, but back in March, I see there's a collaboration also with AlphaMa. I'm trying to understand a bit more about in terms of building the in-house pipeline. Will external collaboration on the discovery side will be one of the major drivers or still you are building up a pretty strong in-house team. If we can know the number, how big the discovery team is now within Zai Lab, and particularly I think in terms of the pipeline, covering the oncology, autoimmune. In terms of a target selection, so is there any specific strategy you're going to be following, in terms of picking the right target to work on? My second question is still trying to get a sense on the PARP competitions, particularly towards end of this year, I think Zai Lab have a very good chance to get into the NRDL for the first-line indication. At the same time, we start to see some of the local competitors, including Hengrui Medicine, BeiGene. They are also being pretty aggressive in terms of marketing for their products. Of course, it's a third-line indication instead of a second-line, first-line. Based on our track, in 2nd quarter and 1st half this year, probably Zai Lab already got about 25%-30% market share in the PARP market. If you guys get the first-line indication, what kind of market share we should be looking at in two to three years' time? Thank you. Thank you, Ziyi. On the first question related our in-house discovery, I think as you can see in the news release, we announced our internal discovery pipeline with global rights. I'd just like to remind the audience, this is a seven years old company, and five years we invest in internal discovery, increasingly invest in this internal discovery with our in-house platforms. As well as the expansion of, like we talked about earlier, MacroGenics, bispecific platforms. We talked about working with Schrödinger and other universities, which we did not really feel it's material enough to expand or to elaborate. Having said so, what I'm trying to say is, I'm very pleased with the five years internal discovery effort. We started with very small team in Shanghai. Now the team is expanding, not only in Shanghai, but in Suzhou, in San Francisco Bay Area. We're also going to very soon announce our opening of Boston, Cambridge, Massachusetts site, and more focused on global development and also focusing on all kinds of business activities. That's, I think, the first thing I want to say. Secondly, I think we are no longer working within a wall for R&D, because we are in a different phase of drug development. There are constantly technologies and which we, as a one company, cannot have it all. With that, we understand we need to collaborate. We need to collaborate with companies have AI capabilities or companies have strong computational chemistry capabilities or companies have strong bispecific platforms and which complement what we don't have, but which doesn't mean we will not continue to add internally other technology platforms. All of this I am saying, going forward, you will continue to see we have more and more collaborations, some with academics, some with the mature companies. Our intention is not say we do not want to continue our licensing model. What works, we're not going to fix it. We'll continue as we accelerate internal discovery, we'll also continue to look for the best unmet medical needs and/or first-in-class assets to complement not only for our China rights pipeline but also global pipeline. Zai Lab now is in this scale, and we have the capacity, we have the people, and I think this is where we're going. In terms of specific targets with those details, hopefully, because of the time of the day, we can bring this on the sidebar, or we can talk about this in upcoming R&D Day. Thank you, Ziyi. Billy, you want to address? Yeah, sure. Ziyi's question regarding this one? I'll take your second question about ZEJULA in relation to NRDL and some competition that you referenced in Hengrui and other domestic companies. Just to reiterate, ZEJULA is the only PARP approved for all comers in the first-line setting. It is a once-daily monotherapy, excellent safety profile, and has the ability to cross the blood-brain barrier, and we already have it in the second-line for NRDL. We actually believe that's already been positioned as the best-in-class PARP for ovarian cancer patients. You also mentioned next year with first-line volume taking off potentially, what does it look like in terms of market share? While we won't give guidance, I know you've heard us historically say that we're confident that we can be the market share leader, and we stick by that. I also like to point you towards some ex-China statistics. In the U.S. right now, ZEJULA has a 51% market share in first line, and in Japan, they have 68% market share. Again, we're not giving the exact percentage for China, but we have a very robust strategy on how to firmly establish ZEJULA as the best-in-class PARP inhibitor, and we're making very good progress toward that end. Also on NRDL, for first-line ovarian cancer, it is eligible for negotiation this year. Actually, at the end of July, the NHSA published a review list for the drugs that are eligible for NRDL negotiation, and ZEJULA is included, so we'll leave it at that. Thank you for your question. Yeah. I think, Ziyi, also you correctly pointed out we're the only all-comer first-line monotherapy approved in China and eligible for NRDL inclusion for next year. Yeah. Sure. Thank you so much, Sam and Billy. Thank you. The next question comes from Yang Wang from Red Sea. Please go ahead. Thanks, and congrats, management, for the nice commercial progress in China in the second quarter. I have two questions. First is Tumor Treating Fields competitive landscape in China. In the last year, we are starting to see a few domestic China companies starting conducting their Tumor Treating Fields device clinical trial in China. Potentially in next few years, we're going to see clinical data from those studies. I just want to have management comment on competitive landscape in the long term in term of Tumor Treating Fields device in China. That's my first question. I think that's a good question you ask, Yang. First of all, as you correctly mentioned, it's a local company still in clinical development stage, and still focused on a very narrow indication, and which we do not know how the result will come out. That's in the next couple of years we'll see. It's too early for us to say whether there is any competition, because we also expanding, and as you've seen, we have many other indications, large trials ongoing. Some already are past phase II, going into phase IIIs. Those are all large indications. We are very comfortable at this stage with our own data. Even if there any drugs, we welcome more or any treatment options. Once sure, it's proven to be successful, there are going to be people want to come up. Whether it's me-too, or meaner worse, or whether it's even qualified meaner worse, we'll see. By then, Zai will have very strong footprint in the areas we are in. We have very strong confidence in this particular opportunity. We've been working optimally ever since we relicensed. We got very quick approval. We got into the clinical guidance, so basically, doctors put this already into the treatment guidelines. We'll see, but we are very optimistic. Great. Thanks for color. My second question is about our KRAS drug. I noticed in our press release, which did not mention our kind of clinical plan for KRAS. We just licensed from Mirati. Can you comment on that? Alan, do you want to cover that? Sure. Thanks, Samantha, and thanks for the question. A couple of comments. One, we're extremely excited at Zai to be partnering with Mirati on this very interesting and wonderful molecule in KRAS. As a former thoracic oncologist, having spent over 20 years trying to come up with something for KRAS, this is extremely exciting. We had the opportunity to participate in all of the mono and combo global trials. We also have the potential to run exploratory local studies within our own pipeline assets, such as with the PD-1 and LAG 3 and PD-1, et cetera. It's a bit early to comment on what local studies we'll do, but what I'd like to emphasize is that we will be participating with Mirati in their global studies. There'll be more to come as we move further along. Okay, thanks. Thank you. Thank you for the question. Thank you. That concludes our question and answer session for today. I would now like to hand the conference over to our host for any ending remarks. I think maybe Samantha's on mute. Oh, basically, we are done with the Q&A? Yeah, Q&A is done, Samantha. Okay. Thank you, operator. Sorry for I was on mute. I didn't pick up your sentence. Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you periodically on our progress throughout the year. Operator, you may now disconnect this call. Thank you all. Certainly. Ladies and gentlemen, that concludes our conference call for today. Thank you all for your participation. You may disconnect now.