Brii Bioscience Ltd

Ladies and gentlemen, thank you for standing by and welcome to BRIE Biosciences Limited 2021 Interim Financial Results and Business Update 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. It is now my pleasure to turn the call over to Ms. Chris Fang, Director of Investor Relations. Please go ahead, Chris.

Thank you, operator. Welcome to BreVal 2021 Interim Financial Results and Business Update Conference Call. Our interim results announcement can be found on the Investor Relations section of our company website. Joining me today on the call from CompanySide Senior Management Team are Dr. Z. Hong, our co-founder, chairman, and chief executive officer Dr. Li Yan, who is our chief medical officer, and Dr. An Kang Li, our chief financial officer. Dr. Hong will provide us a high-level overview of our company strategy, market, and future development plan, and Dr. Yan will walk us through some of the key programs on the development, including our infectious disease and central nervous system programs. Dr. Li will then provide a brief summary of the financial results of the six months ending June 30, 2021, before we turn the call back over to the operator to take your questions. During the Q&A session, our Executive Director, President, and General Manager of Great China, Mr. Rogers Law, and our Senior VP, Dr. Zhu Qing, and VP, Head of Infectious Disease David Magones will join us to share more details. Before we start, we would like to remind you that today's discussion may contain forward-looking statements, which involve a number of risks and uncertainties. Actual results and outcomes may differ materially from those mentioned in today's announcement and this discussion. The company does not take any obligation to update this forward-looking statement except as required by law. Now, I will turn the call to Dr. Holmes, our co-founder, chairman, and CEO. Dr. Holmes, please go ahead.

Thank you, Chris. Thank you all for joining us. It is my pleasure to welcome you all to our first Financial Results and Business Update conference call. As we report our results for the first half of 2021, I would like to highlight what a landmark year it has been for us already. As a company dedicated to public health and focusing on infectious disease and central nerve system diseases, we have made great strides in progressing our clinical programs. In July, we successfully completed our IPO on the Hong Kong Stock Exchange. We are a biotech company with operations in China and the United States. and are committed to advancing therapies against significant infectious diseases such as HPV, HIV, multi-drug resistance, and extensive drug resistance from negative infections, and other illness such as CNS diseases, all of which have significant public health burdens in China and worldwide. We are achieving this vision with the business model that combines internal discovery as well as in licensing and partnership. With our listing on the Hong Kong Stock Exchange, we raised approximately 2.78 billion Hong Kong dollars in gross proceeds. And our IPO ushers a new era for our company as we leverage our in-house research and R&D expertise in licensing and collaboration capabilities to solve significant and medical needs. Our goal is to bring health benefits to those who are deeply impacted by these diseases and to societies in China and around the world. And I'm very thankful to our exceptional management team and devoted employees and their commitment and hard work. Our investors and the new public shareholders for their ongoing support and faith in our ability to make positive impact to society. With our IPO, while our IPO marks a huge milestone for us, I would like to take this moment to highlight several runs of financing prior to our IPO. Since our inception in 2017, we have raised a total over 400 million US dollars. We believe this is a testament to how our mission resonates with investors and public and how we have grown from zero to one and one to many in just a few years, successfully building a robust pipeline of innovative product candidates focusing on impression diseases and CNS diseases. Our business model, which combines internal discovery and in-licensing, has allowed us to develop a rich pipeline of more than 10 innovative clinical stage candidates in a relatively short period of time, making us ideally suited to address those life-threatening diseases. As we move forward, we'll continue to build on this business model and creating more pipeline opportunities. With the infectious disease representing the third largest therapeutic area in the global therapeutic market and posing a massive threat to public health due to their contagious nature, we believe our role as a strong and emerging player in this industry is pivotal. And we are fully committed to finding better treatment, prevention, and cure. So far, we have completed one, we are completing one phase three studies and conducting several ongoing phase two trials as well as many phase one studies. I would like to highlight just a few of our product candidates. Unlike the current standard of care of muke therapies or Pagolida interferon therapies that rarely achieve cure for HPV infection, our most advanced clinical candidate, Brie179 and Brie835, have the potential to be the first functional cure treatment for HPV, allowing patients to live a normal life without indefinite treatment. In China alone, the HPV cure market is projected to grow significantly from $15.9 billion from just $1.6 billion in 2019 to $15.9 billion in 2034. Our focus in the next 12 to 18 months is to generate data supporting the use of our combination of Brie 179 and Brie A35 in patients with XQD infection, giving us a significant lead to address this growing market opportunity. And most recently, we have received a clearance in August from NPA to initiate yet another combination study in Phase II with Brie 179 and Paglete Interfund. the study will start in China. Following the emergence of COVID-19 pandemic in early 2020, there have been significant difficulties of business across the globe and the people from all walks of life. We are fortunate to have been able to step up to the everyday challenges of the pandemic with minimum disruption to our operations while also keeping our employees safe. We also remain on track to deliver various key product milestones in 2021, prioritizing our work on COVID-19. The ongoing pandemic has once again underscored the pressing need for R&D investment in public health arena. We have moved quickly for the antibody treatment of COVID-19, potentially the first approved neutralizing antibody treatment in the greater China area. a cocktail of two human non-competing neutralizing antibodies, Brie-196, Brie-198, which were developed with our partners at Tsinghua University and Shenzhen Serb People's Hospital. This antibody therapy has the potential to be a SARS-CoV-2 antibody therapy with broader coverage of emerging variants and long-lasting treatment benefit for up to 3.6 months. With the resurgence of COVID-19 cases in July and the discovery of the Delta variant in large Chinese cities, BriBio rapidly initiated a phase three study in China to investigate our antibody treatment in patients with the COVID-19 Delta variant. We were also able to quickly complete enrollment of a global phase three study of our 3-196 and 198 cocktail therapy in the US government-sponsored NIH NIAID ACTIV-2 master protocol trials with over 100 clinical sites participating from various countries. This will also be the first pivotal study completed by the ACTIV-2 team, giving us significant lead time compared to other programs or assets in the ACTIV-2 trials. The interim data has shown that our combination therapy have a statistically significant reduction of 78% in the rate of hospitalization and deaths. With more data forthcoming from all 846 study participants expected in the third quarter, we'll be looking to submit emergency use authorization application to gain approval from the United States FDA and for emergency treatment in the United States by the end of the year. Since May of this year, we have been working with the government agency and hospitals in China to provide our antibody to COVID-19 patients on a compassionate use and emergency use basis. So far, close to 400 patients in China have been treated with our antibody cocktail, providing significant use experience to Chinese patients and physicians. We are also developing a novel treatment options for people living with HIV. Our oral therapy treatment regimen offers a once weekly single tablet regimen and greatly, potentially greatly simplify compliance, one of the significant HIV treatment issues. The current standard of care requires patients take medication every single day for the rest of their life, making it very challenging to keep up. We hope our once weekly oral therapy regimen have the potential to improve the quality of life of HIV patients by eliminating the daily reminders of their illness associated with the daily treatment. 3778 and then 3732 would offer a more discreet and non-invasive way for patients who are taking their medications, potentially improving HIV treatment adherence and in turn minimizing the emergence of resistance We currently have two phase one trial ongoing in our initial target market of the United States, the major global HIV drug market. Our second therapeutic area focuses on innovative therapies to address CNS diseases. CNS diseases also represent a major and growing disease category, including psychiatric and neurologic disorders that negatively impact the structure or function of the central nerve systems. often with debilitating results. Depression, for example, is one of the most common and serious medical conditions affecting an estimated 264 million people globally and across a wide range of depressive disorders. Postpartum depression, or PPD, and major depressive disorder, or MDD, are two of the more serious and severe forms of depression. This is where we're currently focusing our effort with Brie 296, undergoing phase one study in U.S. We are excited to see what the future holds for us as a company. We are encouraged by our clinical advancement. Brie Bioscience's deep commitment to developing therapy that combat infectious diseases and other illness representing a significant public health threat and very large disease burden. and requires a focus on transformative approaches with potential curative and preventive therapies instead of incremental improvements over the standard of care. These approaches require robust R&D expertise and deep knowledge and insight of infectious diseases, both of which we have. And we plan to expand and grow from strength to strength. Our highly experienced and competent in-house R&D team and strong scientific advisory board comprising world-leading scientists and physicians, industry expert and diverse board of directors, and our extensive R&D collaborations with pharmaceutical and biotech companies, research institutions, and our strategic capability partners. All of this positioned us well to bring new therapies to China and US market And we expect to continue to invest heavily in R&D as we push the boundary of modern medicines. In terms of business development, over the years, we have partnered and collaborated with several global pharmaceutical companies for various therapies. The combination of in-housing and in-licensing and then collaboration and supplementing with our internal R&D capabilities has served us really well. We will proceed with this strategy path, strategic path, as long as it benefits our development capability and our company. In the long run, we will look to leverage our internal R&D insight and expertise to expand our innovative pipeline. We expect the rest of 2021 to be an exciting time. Our priorities for the remainder of the years will be first to complete the enrollment of 179 and 835 for the functional cure combination therapies for HPV in the ongoing phase two study in the Asia-Pacific countries and regions. Second, to analyze the food data sets and food sets of results from the completed trial of the three 196 and 198 antibody cocktail therapies and submit regulatory files with the goal to secure clearance of near-term emergency use authorization for the COVID-19 in the U.S. and, similarly, emergency use in China. Third, progress our program in HIV and CNS disease area. We are heavily focused on securing near-term stockpile and commercialization of our COVID-19 antibodies as a matter of public health priority and progressing our core program in HPV. Now, with this overview, let me now turn the call over to Dr. Yen, our chief medical officer, who will review the status of our key development program with you in greater detail. Dr. Yen, please go ahead.

Thank you, Dr. Hong. Hello, everyone, and thank you for joining us today. I'd first like to look at our infectious disease program. Starting with HPV functional cure program, Our lead candidate in clinical development, BRIT179, the therapeutic vaccine, which we are currently developing both as a single agent and in combination with a complementary therapeutic candidate, BRIT835, small interference RNA. In combination, BRIT179 and BRIT835 may represent a novel HPV functional cure regimen. that encompasses two different mechanisms of actions. On the one hand, by removing immunosuppressive viral antigens through the sRNA gene silencing mechanism. On the other hand, by stimulating the host's HPV-specific immunity with a therapeutic vaccine. The highly differentiated scientific insight supports the potential of this combination regimen to break immune tolerance and to achieve a high functional cure rate against HBV infection. BRAVE179 is a novel recombinant protein-based HBV immunotherapeutic candidate that builds upon three antigen components of VBI prophylactic HBV vaccine and is designed to elicit, host, and enhance the B-cell and T-cell immunity. In May this year, we completed a phase 1B2A study in multiple Asia-Pacific countries and regions. Shortly after, in June, we presented the trial results at ESO conference, demonstrating that BRID179, the therapeutic vaccine, was very well tolerated with positive safety profiles in non-cirrhotic chronic HPV patients under Duke treatment. In this proof-of-mechanism study, it was also demonstrated that BRY-179 indeed induced both B- and T-cell immune responses, supporting continued development of BRY-179 as a potential functional cure candidate for chronic HPV infection. Just a few weeks ago, we received IND clearance from China's NMPA to begin a phase two trial with BRE 179 in chronic HPV patients who are receiving standard of care of PEC interferon and nuke treatment. This is one of our multiple regimens in our strategic combinations to advance the HPV treatment pipeline. Our other candidates under development for HPV functional cure is BRII835, which is an SRNA subcutaneously administered, and it is a liver-specific targeting SRNA. BRII835 silences all HPV virus-derived transcripts and effectively reduces HPV viral proteins, including the surface antigen of HPV. BRII835, therefore, has a potential to restore post-immunity against HBV. We're currently compiling and analyzing the data from a Phase II clinical trial of RAID-835 in China, which was designed to evaluate and characterize the safety, durability, PK, as well as antiviral activity of two doses of RAID-835 in Chinese patients. We expect them to report top-line results in the coming months. While Bray-179 induces HPV-specific B-cell and T-cell immune responses that may sustain immunological control, Bray-835 targets the production of immunosuppressive HPV antigens that impair the host immune system. This viral antigen knockdown reduces and eliminates secreted viral antigens to prevent proper post-functioning of HPV patients' immune system. The multiple combination trials investigating BRAID179 and BRAID835 are ongoing as planned to fully leverage these different maximum actions to achieve HPV functional cure. Looking at our candidates for COVID-19, Our in-house developed Brie-196 and Brie-198 therapeutic antibodies were designed in-house by our majority-owned subsidiary, PSB, and are being evaluated as a cocktail therapy administered as a sequential IV infusion. As neutralizing antibodies, Brie-196 and Brie-198 may also provide up to six months of potential protection in high risk of population to contracting SARS-CoV-2. As Dr. Hong just elucidated, the phase three active two trial, where we recently completed patient enrollment, evaluated outpatients at high risk of a clinical progression who presented with a symptomatic of COVID-19 in both early treatment setting, considered to be five days or less following symptom onset. and late treatment setting, six to 10 days following symptom onset. The participants enrolled were evaluated for the combined primary endpoint of hospitalization and the death relative to placebo in the 20 days after treatment. Following the evaluation of 69% of participants through the primary endpoint evaluation, our antibodies demonstrated a statistically significant risk reduction of 78% with a risk ratio of 0.22 and a 95 confidence interval between 0.05 and 0.86. In the combined endpoints of hospitalization at the death compared to placebo, the p-value is 0.000014 zeros. Of the 837 participants enrolled within 10 days of symptom onset and with a high risk of clinical progression, 12 treated patients were hospitalized compared to 45 patients received the placebo. And there were only one death in the active arm compared to nine deaths in the placebo arm. The ACTIV-2 study design provides a very unique opportunity to evaluate two things. One is how long the symptom onset prior to initiating therapy. And the second, the circulating SARS-CoV-2 variants of concern, how these two things may impact the clinical outcomes following treatment with the combination of BRAVE-196 and BRAVE-198. In addition to the interim analysis, current in vitro data using pseudovirus suggested that combination of 196 and 198 retained activity against major SARS-CoV-2 variants of concerns, including commonly identified beta, gamma, epsilon, delta, and lambda variants. We expect to report more conclusive data from the study once we finish the analysis of the full set of patient follow-up in the third quarter. Now turning to our in-house developed HIV program. Current treatment for HIV uses combination antiretroviral therapy of RRs, which uses a nucleotide or non-nucleotide reverse transcriptase inhibitors. These inhibitors interrupt HIV replication through inhibiting reverse transcriptase. And RTIs function at the active site of reverse transcriptase, while an RTI affects allosteric sites. But when we combine Brie-779, Brie-778, and Brie-732, this regimen offers three distinct maximum action. In addition to NRTI and NNRTI, this combination regimen also offers a third mechanism, nucleoside reverse transcriptase translocation inhibitor, or NRTTI. in a single tablet. The active metabolite of Br732 EFDA triphosphate suggests potential for once-weekly dosing, as EFDA triphosphate has been shown to have a half-life greater than 120 hours in human primary peripheral blood mononuclear size, PBMC, which consists of lymphocytes and monocytes. key tissues for HIV infection, and the viral reserve. For H778, the extended release formulation of FDA-approved reprimand is projected to provide an effective trial concentration on day eight, equal or similar to the minimum effective concentrations of reprimand. We expected to report top-line clinical results from our ongoing Phase I studies in the fourth quarter of 2021 and the first quarter of 2022 for BRY-778 and BRY-732, respectively. Our final program in the infectious disease area are our MDR and XDR gram-negative programs, which we licensed from QPACS. These programs include three therapeutics, BRY-636, a broad-spectrum IV beta-lactamase inhibitor, in combination with an IV beta-lactam antibiotic. The second program is BRI-672, a broad-spectrum oral beta-lactamase inhibitor in combination with an oral beta-lactam antibiotic. And then the third program, BRI-693, a next-generation IV polymyxin for the treatment of gram-negative bacterial infection. Ongoing phase one studies for BREE 636, BREE 672, and BREE 693 are currently being conducted by QPACS in Australia. Currently, we plan to file IMD applications with an MPA for BREE 636 in the first half of 2022, BREE 672 in the first half of 2023, and BREE 693 in the second half of next year. We intend to join QPAC's global phase three studies to conduct the clinical investigations in China to support the registration of these three innovative antibiotic assets in China. That concludes the update on our infectious disease programs. Now I'm going to turn to our CNS program. We're currently developing BREE296, our novel proprietary approach to address the challenges associated with current treatment for postpartum depression. BRAVE296 is a synthetic version of naturally occurring neuroactive steroid administered as a long-acting single injection via intramuscular administration. BRAVE296 potentially provides more convenient delivery and less side effects than the currently approved drug for postpartum depression. Based on our preclinical pharmacokinetics study, we expect the BRAID-296 will be gradually released from the injection depot, allowing a continuous titration to reach maximum plasma exposure of Cmax, and then gradually tapering of drug concentration in the plasma to complete the drug release. We believe that RAID-296 will be safe and tolerable without the risk of loss of consciousness that limits the use of recurrently approved PPD therapy, possibly due to sudden changes of drug levels in patients. Following regulatory approval, we began dosing patients in a phase one study of 3296 in the United States in early April this year. So with this update, I would now like to turn the call over to our Chief Financial Officer, Dr. Ang Kong Lee, to review our financials. Dr. Lee, please.

Thank you, Dr. Yen, and thank you all for your participation today. As a reminder, the financial figures I will be reviewing are in RMB, unless otherwise noted. For the first half of 2021, our other income was $46.3 million, representing an increase of 102%, compared with $22.9 million for the first half of 2020. The increase was due to additional income recognized from government grants in the 2021 period. Our research and development expenses were $157.6 million in first half 2021, compared with $265.7 million for the first half 2020. The decrease was primarily due to the decrease in licensing fees. Excluding licensee fees, the R&D expense increased by $26 million, mainly due to the initiation of Phase II clinical studies for our HIV program and the Phase I study for our postpartum depression program. Administrative expenses for first half 2021 were $68 million, compared with $41.2 million for the same period in 2020. The increase was primarily attributable to the increase in employee headcount. In total, our comprehensive expense for first half 2021 was $2.9 billion, compared with $293.5 million for first half 2020, representing an increase of 895.4%. The increase was primarily attributable to the $2.7 billion increase in fair value loss on financial liabilities through profit or loss, or so-called FVTPL, associated with the fair value increase of our preferred share. We do not expect additional charges after IPO. Excluding these FVTPL charges, listing expenses, and share-based compensation expense, our adjusted loss for the period improved to $152.8 million versus $273.6 million for a comparable period in 2020. As of June 30, 2021, our bank and cash balance, including restricted bank deposits and time deposits, was $1.45 billion, compared with $1.1 billion as of December 31, 2020. The increase was primarily attributable to proceeds from our Series C financing and does not include the $2.8 billion proceeds from our IPO in July. This concludes our prepared remarks. We will now open the call to questions. Operator, please go ahead.

As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. Once again, it's star one to ask a question. Your first question comes from the line of Sean Wu from Morgan Stanley. Please ask your question.

Thank you very much for taking my question. Thank you for this very comprehensive office. on your COVID-19 in regard to COVID-19 funds. So, I have a question on the COVID-19 antibodies. Number one, the results, of course, appear very strong, but there were more deaths in your control. Are there similar trials? So, can you see more color on that? Number two, now you have results. Sean, I see your line. Yeah.

Excuse me, the line of Mr. Shandos. Go ahead. It's really broken.

I can't really... This line dropped.

I think the first question... This line is really bad.

Um... I think the first question asked was about why there were more deaths in our control arm compared to other trials. I believe that was the first question. I did not get the second question, unfortunately.

So, Sean, I think If that's the question, let me try to give you some colors on the trial, the study population. In fact, I'm going to invite our project physician, Dr. David Margolis, to shed some color on the study design as well as the study population. David?

Yeah, thanks, Dave. So, it's an insightful question and highlights, I think, some of the differences between this ACTIV-2 study relative to some of the others that have been conducted either earlier this year or even late last year. There was a significant focus to make sure that the ACTIV-2 study enrolled the highest risk individuals for clinical progression. So the criteria that were set forth from the protocol insisted that individuals were either 60 years of age or above or had other significant comorbidities that have been understood to increase the chance of more significant clinical disease. The other aspect of ACTIV-2, which is quite important and quite unique, is that it did go into a number of international sites in Mexico, Brazil, Argentina, and South Africa most significantly where we have seen a significant disease burden and also, you know, rapid spread of new variants including the Delta variant. So it's possible that the combination of the high-risk criteria in ACTIV-2 as well as the international footprint and perhaps the expansion of different variants of SARS-CoV-2 led to a relatively high-risk population. And you see that outcome in both the deaths where we saw nine deaths in the placebo arm, one death in the but also in the higher rate of the overall aggregate endpoint. There's 11% of events occurred in the placebo arm for hospitalization and death, and that's significantly higher than we've seen in other studies.

Your next question comes... Yes, he's not online yet. He's not. Yes, your next question comes from from UBS. Please ask your question.

Yeah, thank you for taking my question. Here, I've got two questions here. The first is about our HPV functional cure. It's excellent that we are developing SINA and therapeutic vaccine combo therapy as a functional cure. So the scientific rationale seems exciting. we noticed that we are the only company investigating this therapy. So are you aware? Is there any other companies who are doing the, who are going to investigate the same combo therapy? If not, what is the concern of our competitors on this? And my second question is regarding our BD strategy. We have many novel in-house developed drugs with first-in-class potential, could you elaborate a bit more on out-licensing plans for these trucks, such as what kind of partners are we looking for? And on the other hand, since our pipeline are in relatively early stage, are we considering in-licensing some late-stage assets to quickly get to the commercialization stage? And what criteria do we have for in-licensing candidates? Thank you.

Thank you, Tianjin, for the questions. Let me try to answer your questions. I think for the first question regarding the combination of SRNA and the therapeutic vaccine, we are aware of two other companies that are investigating that two combination, namely J&J and then GSK. We do know there are more companies working on SRNA, and then there are also other companies working on therapeutic vaccine. But for people who have both assets to combine with, those are the two companies that we're aware of. I think our therapeutic vaccine program is the most advanced program. So therefore, in that combination, we hold some advantage over others. Regarding our BD strategy, I think we're obviously looking at the options of both in-licensing as well as out-licensing. And I think given that we have our internal program, we're actively evaluating opportunities, whichever is going to benefit the company and maximizing the value creation and generation, we will consider that with an open mind. We will not change our strategy. I think we're not going to be seduced by the stage of the compound because, you know, I've said this before. Sometimes people often measure the value by the stage of the compound. We're coming from the position that sometimes we probably don't even want to spend a million dollars on a phase three asset. We may actually spend hundreds of millions on a preclinical stage asset. So it's going to have to really be something that we have to make a judgment in terms of the degree of innovation, and then how they're going to address the MI need. I think those are something that we will continue to press forward with that strategy, not affected by the stage of the asset. I hope I answered your question.

Yes, very clear. That's very helpful. Thank you.

Once again, if you wish to ask a question, please press star 1 on your telephone and wait for a name to be announced. Once again, it's star one to ask a question. You have a follow-up question from the line of Sean Wu from Augustan Lee. Please ask your question.

Sorry, I was dropped there. previously without finishing my question. So my first question is about your child's design and results from the initialized antibody. As we can see, you had nine deaths versus one on the second mom. Of course, that's very promising. The nine deaths actually quite high for the population of the moderator to patient population. I would like to know more about why that's the case. And that's the first question. Number two question is about your timeline of filing for U.S. EUA. And then do we expect that to happen? And then where would we see that kind of, because this is produced in China. So I heard that in the U.S. so the timeline for that. And then number three, some client of mine is asking this question. whether your trial is considered as a pivotal trial globally. It's like whether the data is enough for China approval or you need to do some clinical trials in China and also the potential of stockpiling in China. Thank you very much.

Okay, Sean. I think that's a very good question. Thank you for the question and sorry about the technical difficulties of the line. So on the first question, I believe David has answered some of the questions. Let me just recap the answer that he had already provided. I think the study population is very unique in a few regards. I think number one, I think we have a longer treatment window, i.e., we do not exclude patients from a late presentation to the clinic since the onset of symptoms. If you remember that both Lili and Veer and Regeneron, they have limited their time from symptom onset to three days, five days, and seven days, respectively. And the reason for that is because they believe by treating early, they have a better chance of demonstrating better efficacy. And in our study, we're actually more inclusive because we consider the real world a situation where not everybody can come to the healthcare center timely. So we expand the treatment window to up to 10 days following a symptom onset. So we believe that could potentially enroll more high-risk, you know, more patients that potentially could progress to a more serious disease. That's number one. Number two, we also increased the selection criteria of older age and other comorbidities, and we believe that's very important, and also the emerging variant that we do not quite know whether or not they have the same variables or same, you know, a degree of causing mortality or not. I think that's something we may interest to be seeing whether or not the deaths is coming from the new variant. And certainly, I think we are expanding into international sites. I think those international sites could potentially provide a patient that could potentially have more mortality. Obviously, as we unpack the data, we'll be able to provide that answer. I think your second question regards to the timeline of EUA. In the U.S., I think we're constantly negotiating with FDA. I think FDA is already made aware of the report, the interim study data, so they fully anticipate that we are preparing the data and submitting an application for emergency use authorization. I think we also made China's NIPA aware of our progress. We're also discussing with the regulatory agency in China, NIPA, with regard to our progress and regulatory filing timelines in China. We're working on this with the common agency. Regarding the stockpiling activity, obviously, we are considering that. We have the channel open in the United States with the government agency with regard to potential dialogue. I think in China, I'm going to invite our general manager, Roger Schwab, to maybe give you a quick update in terms of what is our plan in China, which we think is very important. As you mentioned, this antibody is coming out of China, and we obviously have a very strong interest in making this antibody available we have already make this antibody available and the compassion use program emergency news to close to 500 patients already and we're going to continue we have donated uh quite a bit of those therapies and we're very proud to be able to help the chinese government to address the recent outbreaks i want to ask roger to specifically talk about you know what is our plan for potentially stockpiling uh discussion in china rogers

Yeah, thank you, Dr. Hong. We have been engaging different government authorities in the central government since very early. So there's a lot of discussion with different government bodies already happening. And with the available phase three data, interim data readouts, I think we'll be more actively have been more actively in discussion with them in the last several days. I think the goal is, you know, potentially will be the first approved neutralizing antibody in China. There are plans in place, but, you know, as of now, we are still in the discussion. So as you are already aware, we already provided prior antibody for emergency use for more than 450 patients in China. In those cities have small outbreaks from Shenzhen, Guangzhou, to Nanjing, Yangzhou, and also Zhangjiajie and Zhengzhou. And we already had the The phase three trial leading by Dr. Zhongnan Shan, that small trial for the first part has already finished their inclusion. So we are collecting data. Hopefully we'll have that phase two data available in coming months. So with all the data in hand, we are facilitating and speed up the submission to the CDE once we'll get all the material available. So that's the status from China. Back to you.

Thank you.

You have a follow-up question from the line of Chen Chen from UBS. Please ask your question.

Yes, thank you. I have two following-up questions. The first one is regarding our HIV drug. As we all know, There are HIV in China for free from the government. So how do we see the potential of our once a week HIV drug in China? And for this asset, is there any catalyst for this asset? This is my first question. And my second question is about talent. So for biotech firms, talent is quite important. So how do we attract and retain talent? And how are we going to develop our R&D team? Thank you.

Well, thank you, Qinqin, for the two good questions. I think with regard to the HIV drug, obviously, as we mentioned, this is a global asset. The major market is in the U.S. and ex-China. But we do believe the the the China's HIV healthcare system is evolving and changing. Again, I'm going to invite Rogers will to comment on that because he was the GM for Gilead. So I have a lot of experience in dialogue with the with the government agency with the reimbursement agency. I think he had successfully introduced some of the dealers HIV program to reimbursement program but before he and I'm going to just talk a little bit about the talent attraction and retention. I think it's very important we keep the company highly visible, and I think keep our mission very clear, keep our pipeline very differentiated. I think it's the moment of like this COVID-19 program that really have elevated the company's, you know, visibilities in our industry. I mean, rarely you can see a company within not even four years, we have the potential to become a revenue company from actually our internal program. So that to me is a work record breaking, you know, at least in China that, you know, you're going from discovery to, to commercial in less than two years. I think that's remarkable. I think those are the situations that tend to attract talent. In terms of retaining talent, I think that's something that we absolutely need to focus on. In fact, we just had a board meeting and we discussed the very topic in terms of how we're going to retain our talent in both U.S. and China. You know, the market right now, the global job market is very tight, and we fully recognize this. And thank you for all the support that we're getting from our investors, including our people from China and then from Global Fund and other investors that we were able to work with. I think this is an important topic for us. With regard to catalyst for HIV, we believe the catalyst will be finishing the Phase I program so that we can select those and have a discussion with regulatory agency, in this case FDA, and to commence our Phase II combination study. I think that will be the catalyst for the program. Now I'm going to ask Rodgers to comment on the HIV commercial opportunity in China.

Thank you, Dr. Hong. As you know, the China HIV market is ongoing a dramatic change in two aspects. Number one is that the patient demographics has shifted from low-income patients who donated or sell their blood in many years ago and now switch to affluent patient population so they have a high willingness to pay and high affordability. So you can see in last two years the the market size of the China non-free drug market has dramatically grown. Number two is that more innovative HIV drugs has already been getting into the national reimbursement drug list through the national negotiation mechanism. You can see already Jim Moyer is already getting into that. And so we see that the model, that kind of market dynamic also changed, which will boost the sales of the more modern kind of therapies. As you know, the products in the free drug program are suboptimal. So more patients, as the patient dynamic change, they are willing to pay for their more modernized therapies as well as for their reimbursement drug, probably in the reimbursement drug list. So that's the, we do see there's a huge potential in the China HIV market in the coming years with their policy change and with their patient demographic change. Thank you.

To the bottom line, I think the demographic is changing in China and from the early days in the poor villagers to now affluent population are being affected. So we do believe the affordability in China is evolving.

Yeah, thank you. Our following up question. So what is our pricing strategy for this once a week HIV drug?

Sorry, Tianjin, what is the, you mean the, what strategy?

What is the pricing? Pricing strategy. Pricing strategy. Okay. So it is going to be substantially high. Yeah.

So, Tianjin, I'm sorry that typically in this kind of call we do not discuss pricing strategy, but needless to say there's significant benchmark that can be done in the U.S. market and EU market, as you know, Some of the benchmark medicines are typically being charged at this point in the U.S., for example, annual expense about $40,000 a year. I think that's the current pricing as the therapy evolves. I think that pricing may change, but we think this is something we're looking at evolving pricing as we go forward. I think in China, I think Rogers have already commented in the free drug market, that's free, so patients don't pay for anything. The government pays for everything, so the pricing is very, very small. But the patients really have very suboptimal therapies. They're not the most modern therapies yet. But for the very most modern therapies that are in the reimbursement program, I think, Roger, you may be able to comment on some of the pricing of Gilead's drug. Maybe we can just provide some benchmarks. But we just don't discuss pricing strategy at this point. Number one is too early. Number two, as a company principal, we just do not talk about pricing strategy at this point. Roger's?

Yeah, as Dr. Hong mentioned, we don't disclose pricing strategy here, but you can easily find their benchmarks. For example, with modern therapies in the national reimbursement listing, for example, Jin Boya, the price of Jin Boya. That's a once-a-day treatment regimen. We have this advantage in terms of compliance of the therapy as we have the once-a-week convenience over once-a-day. So you can see probably we have some premium over that kind of benchmark. So that's what I can say. Thank you. Back to you.

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