Good day, ladies and gentlemen, and thank you for standing by. Welcome to Brii Biosciences Limited 2021 Annual Results and Business Update Conference Call. At this time, all participants are in 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 Brii Bio 2021 Annual Results and Business Update Conference Call. Our annual results announcements can be found on the investor relations section of our company website. Joining today on the call from Brii Bio Senior Management Team are Dr. Zhi Hong, our Co-founder, Chairman, and Chief Executive Officer. Mr. Rogers Luo, our President and General Manager of Greater China. Dr. Li Yan, our Chief Medical Officer, and Dr. Ankang Li, our Chief Financial and Strategy Officer. Dr. Hong will provide a high-level overview of our key programs, company strategy, and future development plans, followed by Mr. Luo, who will summarize further details about our HBV and COVID-19 programs, and our overarching prioritizations of R&D and commercial efforts in China. Dr. Yan will provide updates on central neuroscience programs as priority for the U.S. Dr. Li will then provide a brief summary of our full financial results and corporate strategy, including business development plan. After the management team's presentation, we will open the Q&A session to take questions. 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 announcements and this discussion. The company does not undertake any obligation to update this forward-looking information, except as required by law. I turn the call over to Dr. Zhi Hong, our Co-founder, Chairman, and CEO. Dr. Zhi Hong, please go ahead. Thank you, Chris. Thank you all for joining us, and welcome to our 2021 financial year results and the business update call. It has not been long since our last call. We are very pleased to update you with our latest progresses. Less than four years ago, we launched the company with a mission to be the best public health-inspired biotech, tackling some of the world's greatest public health challenges with breakthrough innovation and insight. We have done just that. Almost all our programs aim to address huge disease burden and social stigma from diseases of HBV or HIV infection to mental illnesses. These goals cannot be accomplished by one organization alone. Partnership with investors, governments, and societies are needed to truly deliver much needed support and innovation to those who need it. We made significant progress in 2021 to bring us closer to reaching these goals. I look forward to further advancing our mission in 2022. Early in 2021, we completed a Series C financing, moved our HBV functional cure program into combination studies in the APAC's countries or region. Together with our partner, Vir Biotechnology, we are currently testing four different combination of HBV therapeutics. With the support of our investors and partners, and the promise of transformational therapeutic options, we completed our IPO listing on the Hong Kong Stock Exchange in July 2021, raising nearly HKD 2.8 billion. As we continue to move our COVID-19 antibody combination therapy from the clinic to regulatory submission, the world have faced resurgence in COVID-19 with the Delta and Omicron variants, revealing the critical and urgent need for safe and effective therapeutic options. As of December 2021, we are honored to be the first company in China to successfully develop and gain biological license application or BLA approval from China's NMPA for the COVID-19 treatment. In less than 20 months, we're able to move amubarvimab, romlusevimab, which the COVID-19 antibody combination therapy, successfully from the laboratory through clinical trial to gain the regulatory approval. Just last week, National Health Commission of China added our neutralizing monoclonal antibody combination to its COVID-19 diagnosis and treatment guideline, the ninth edition, marking a critical breakthrough in COVID-19 therapeutic drugs in China. Our emergency use authorization, EUA, remains under active review by U.S. FDA and is pending on satisfactory completion of FDA's inspection of the manufacturing site at our contract development and manufacturing company, CDMO. Today, we're working closely with governments and local authorities under our shared goal of delivering our important COVID-19 therapy to patients in need in China and around the world. The ongoing COVID-19 surges in Hong Kong, Shanghai, and other cities throughout China reaffirm our belief that the combination of public health tools, such as the effective treatment, masking, border access control, and broader access to vaccines, will all be needed to end the pandemic. Apart from COVID-19, our overarching business strategy is set on our long-term goals to address increasingly prevalent infectious disease and the serious diseases. First among these, and perhaps most important for China, is chronic hepatitis B, or HBV infection, where we are the leader in the race to identify a functional cure. Searching for a cure of HBV will be the top priority of our China team, which has led to clinical investigation of our phase II clinical stage asset in various combination. Postpartum depression is another example how we are leading the industry in searching for a truly transformational therapy for women who suffer from these terrible mental illnesses, who unfortunately lack support or understanding or empathy from those around them. The current standard of care is simply inadequate. Awareness of the disease is insufficient, further exacerbated by the gaps in our healthcare system and the lack of treatment options. Our U.S. team is leading the effort in launching our clinical trial in women who are either diagnosed with PPD or at high risk of developing PPD. 2022 will be an exciting year for our CNS programs with BRII-296, which is the single treatment option moving to the clinical trial in U.S. for both treatment and prevention of postpartum depression. BRII-297, a new chemical entity, will enter phase I study in U.S., expanding our R&D effort in central nervous system diseases. I would also like to touch upon our endeavors for new HIV treatment and some background on the activities surrounding islatravir, also known as EFdA. First and foremost, while the U.S. FDA has put a hold on all trials related to islatravir or EFdA since December 2021 due to the observation of decline in CD4 cell count in some subject, there were no safety concern, nor any decrease in CD4 cell count in our phase I study of BRII-732, which is the prodrug of islatravir or also known as EFdA. The clinical hold by U.S. FDA on BRII-732 was a decision made out of abundance of caution by both BRII and the agency. The last multiple rising dose cohort had not yet been dosed at the time and is no longer needed, which means our phase I study has completed. The data will be presented at a future scientific conference in the second half of 2022. Based on the published data and information disclosed by Merck, the safety finding of CD4 cell count decrease is both dose and time dependent. We believe, based on our phase I study, we can define a selective safe dose of BRII-732, and then that will be applications. As such, we will meet with FDA and discuss our plan to investigate and to further develop BRII-732, with the aim of lifting the clinical hold in the second half of 2022. We hope to proceed with the development of our once weekly oral combination of BRII-732 and BRII-778 as soon as we can. For our multi-drug extensively drug-resistant MDR XDR Gram-negative antibiotics, we are working in collaboration with our partners, Qpex, where we own the license right for the development and the commercial activities in Greater China. Right now, Qpex is progressing BRII-636, BRII-672, and BRII-693 in parallel with the goal of moving all three assets to pivotal studies in the near future. By design, BRII will consider participation in these trials by joining and conducting the phase III studies in China, where there will be a critical need for these important hospital antibiotics. Leveraging the data from early U.S. studies and participating in late-stage trials in our licensing territory is part of our strategy to bring these critical medicines to market quickly without incurring significant early trial costs and risk. The last program I would like to highlight is BRII-658, epetraborole, which we licensed from AN2 Therapeutics for the treatment of refractory non-tuberculosis mycobacteria, and also known as NTM, infections. This is life-threatening lung diseases, often affecting many patients in U.S., in Japan and China. AN2 Therapeutics, which is based in the U.S., already filed their S-1 prospectus and IPO registration in March 2022. BRII-658 is a novel, completely novel antibiotic that has a potent and a broad-spectrum activity against mycobacteria and many other bacterial pathogens. AN2 is developing epetraborole as a once-daily orally administered treatment for patients with NTM, with the initial focus on treatment-refractory Mycobacterium avium complex, also known as MAC, which is a very severe lung disease. AN2 is expected to initiate the registration phase II/III study in the first half of this year, 2022. The U.S. FDA has granted AN2 the orphan drug, qualified infectious disease product and fast track designation for epetraborole in treatment refractory NTM MAC lung disease. Our aforementioned achievement are also gaining traction in the capital markets with our addition to the eight Hang Seng indexes and the Hong Kong Stock Connect in the fourth quarter of 2021, which raises our visibility and added to our higher liquidities. We're also honored to have received more than 10 awards from prestigious media and financial industry outlets that highlights our accomplishment in 2021. Being a very small and a young biotech, we are pleased to be recognized for our mission to tackle the world's greatest challenges in public health. In 2022, we strive to do more. With our forthcoming inaugural ESG report, we will highlight our convictions around our corporate social responsibilities, and especially those that further integrated our values across each aspect of our company while advancing public health at a global scale. Our momentum and success in 2021 have pushed us to the next phase in commercialization and manufacturing. This has significant implication in our longer term business strategy and planning, which may accelerate our growth, expand our business opportunities. Our pipeline is very unique and strong, aimed to change the way how patients are cared for, at the same time eliminate social stigma rooted deeply in many communities facing public health inequities. Lastly, we see a remarkable opportunity to tap into patients' insight while creating our medicines. Following our patient-centric values, we are embarking on new investment into patient advocacy to establish relationship, share knowledge, ultimately guide us in our clinical development endeavors, and to better serve our patients in need of innovative medicines. With that, I would like to turn the call over to Mr. Luo and our President and General Manager of the Greater China, who will provide additional details on our ongoing focus in HBV clinical development, as well as COVID-19 antibody commercialization in China projects. Please go ahead. Thanks, Zhi. Hello, everyone. It's a great pleasure to speak with you today, and I would like to echo Dr. Hong. Thanks for joining us on today's call. Our R&D pipeline holds great potential globally with our resource focused on tackling large disease burdens around the world. As many of you know, we have operations in both U.S. and China, and our programs are designed to strategically maximize how we assign disease indications geographically. In China, our team is dedicated to finding a functional cure for HBV and introducing new cures for multi-drug and extensively drug-resistant gram-negative infections, and tuberculosis and non-tuberculosis mycobacterial infections through our partnership with Qpex and AN2. The reason we are developing these medicines here in China is simply because China is also the largest market for these disease indications. As we bring our programs through clinical developments, we can enroll patients faster, the need is greater, and if approved, we stand ready to have the largest patient populations in the world first. Taking a closer look at our Chinese clinical operations and achievements in 2021, we're proud of what we have accomplished so far, particularly with our HBV assets, BRII-179 and BRII-835. More recently, in February of this year, we completed patient enrollment in our phase II APAC study that combines BRII-835, which is VIR-2218, and BRII-179, also called VBI-2601. Our strategy has always focused on eliminating immunosuppressants and boosting sustained immunological control. We think both elements are needed to achieve the result we want. That study has been fully enrolled with 90 patients from New Zealand, Australia, Singapore, Hong Kong, Taiwan, South Korea and Thailand. We are on track to report top line interim data at the end of the year. With this combination therapy, we could provide the solutions to accomplishing our goal of using a functional cure. Our expectation is that the top line interim result will give us more guidance for how we will proceed. With positive data, we would like to consult with the Chinese Center for Drug Evaluation, CDE, after an NMPA, and submit an Investigational New Drug application to initiate the pivotal study in 2023. Meanwhile, we are also focusing on educating internal, external key stakeholders on our scientific topics, care pathways and patient outcomes. The team in China has engaged very well with external stakeholders about the value of HBV function cure and its impact on eliminating the social stigma of HBV infections. For BRII-835, we expect to announce the safety and the viral activity findings of the phase II BRII-835 monotherapy study conducting in mainland China in the coming weeks. This will be the first report that demonstrates an siRNA therapy treatment in the mainland Chinese patient population. Our partner, Vir, also is evaluating the combination of BRII-835 and an HBV surface antigen neutralizing antibody, VIR-3434 in a phase II study. We are working very closely with Vir to mutually agree on the proof of concept criteria as we have the exclusive option to license VIR-3434 for development in Greater China. Should the proof of concept criteria be met, we will likely exercise the options in the second half of 2022 and bring VIR-3434 into our HBV clinical portfolio, accelerate and combine our others, HBV clinical candidates. For BRII-179, it has the potential to break immunotolerance to induce or restore B-cell and T-cell responses, providing a durable immune response to HBV. In December last year, we began dosing non-cirrhotic chronic HBV subjects in the phase II combination study, where we are looking for the safety and efficacy of this novel recombinant folding therapeutic vaccine when it's added to the existing standard of care, which is the therapy of pegylated interferon alpha and NRTI. Right now, we expect to enroll approximately 120 patients for the first part of the study, which is phase II in the second half of 2022, and expect the top line interim result will be available in the first half of 2023. Earlier in 2021, we successfully completed our phase Ib/IIa study evaluating BRII-179 in conjunction with VBI, where we led the trial's clinical design and study implementation in APAC. Shortly thereafter, our data were accepted and presented at the International Liver Congress in June 2021. This promising human proof of mechanisms data reinforce the potential of BRII-179 to be a critical component in the development of a functional cure for chronic hepatitis B, which could have patients and healthcare providers manage the effects of this devastating disease and greatly curb the disease progression. On top of these two ongoing trials, according to our partner Vir's annual report on Form 10-K filed with the U.S. Securities and Exchange Commission on February 28 this year, additional data from the phase II trial of VIR-2218 or BRII-835 in combination with pegylated interferon alpha and the phase II MARCH trial of VIR-2218 in combination with VIR-3434 may be presented at a scientific conference throughout 2022, and some of the clinical trial sites are in Ukraine and Moldova. Vir is monitoring the situation, determining any impact resulting from the current conflict in this region. Now we are moving to the COVID-19 program. Both our China and the U.S. teams work on our COVID-19 combination therapy, as it was important to develop our therapeutics with a global approach. As Dr. Zhi Hong just mentioned, in March this year, the National Health Commission of China added amubarvimab and romlusevimab combination to this COVID-19 diagnosis and treatment guidelines, the newest addition for the treatment of COVID-19. The program was also part of the NIH-sponsored global phase II/III study, allowing for inclusion of diverse patient populations and broad coverage of variants. Our ability to rapidly gain BLA in China and our pending EUA approval from the U.S. FDA gave our teams the experience in executing a global study with high international standard. The experience and knowledge we gain from going through this process bode well for our future clinical studies and regulatory filings, and we hope to replicate this process even more efficiently in the future. As a small company that has been granted with this first BLA approval in less than 20 months, we are in the process of building our commercialization team in China to support potential stockpiling and commercialization in the future. Meanwhile, we are leveraging our public and private networking with Tsinghua University and other stakeholders, as well as our contract development and manufacturing companies and other manufacturing capabilities. We believe that our antibody therapy continues to maintain neutralizing activity against the Omicron variants, due to its high dose and exposure, which is predicted to remain sufficient, significantly above the observed IC90. Our U.S. FDA application remains under review by the U.S. FDA and is pending on satisfactory completion of their FDA inspections of the manufacturing sites at our CDMO. Given the unique nature and mechanism of EUA, we cannot predict when and what decision U.S. FDA will make, but we are working closely with our CDMO to respond to every regulatory inquiries. We are in active discussions with various governments regarding stockpiling and commercialization of our antibody therapy. With that, I would like to turn the call over to Dr. Li Yan to review more details on our recent clinical trial efforts in the U.S. Dr. Li Yan, please go ahead. Thank you, Rogers. Hello, everyone, and thank you for joining our earnings call today. As Zhi and Rogers have already given many details on our efforts in infectious disease, I would like to turn your attention now to our CNS programs, especially detailing some of our efforts in addressing the unmet medical need for patients suffering from various depressive disorders. Since the onset of COVID-19 pandemic, globally, we have seen a sharp increase in the number of people burdened with depression. We are investigating BRII-296 and BRII-297, two novel psychiatric pharmacotherapeutics that could bring new treatment options for patients with postpartum depression, major depressive disorder, as well as other depressive disorders. As a synthetic version of a naturally occurring neuroactive steroid, BRII-296 is developed internally at Brii, leveraging our long-acting medicine development platform. It is administered as a single intramuscular injection compared to the current standard of care for PPD, which requires a 60-hour or 2.5-day continuous IV infusion in a hospital setting because of the severe side effects, including loss of consciousness associated with the current standard of care. You can obviously see the advantage of patient convenience with BRII-296. As a single injection, BRII-296 also provides 100% patient adherence. Furthermore, BRII-296 allows mothers to receive the treatment without any disruption of breastfeeding, therefore maintaining the very important mother-infant bonding. During the past year, we have already completed more than 10 cohorts of investigation in our phase I study in the U.S. for BRII-296. We're now in the final stage of optimizing our dose selection and anticipate the completion of our phase I study in the second half of 2022. Accumulating phase I data already confirmed the desirable and long-acting PK profile of BRII-296 and have established a satisfactory safety profile. We are planning to discuss this program with the U.S. FDA to initiate two studies in patients with severe postpartum depression or in patients with high risk of developing postpartum depression, i.e., two clinical studies in PPD prevention and in PPD treatment settings, respectively. We believe that BRII-296 has the potential to transform the paradigm of postpartum depression treatments as well as more importantly, for patients with high risk of PPD, so in PPD prevention. BRII-297 is a new chemical entity discovered internally. It is a GABA-A PAM positive allosteric modulator of GABA-A receptor. BRII-297 is being developed for treatment of various depressive disorders as well as potentially for neurological disorders. We've already held a pre-IND meeting with U.S. FDA last year, and we've aligned the regulatory and the clinical strategy to bring BRII297 to the first time in human clinical trial and beyond. We plan to submit the IND application to the U.S. FDA in the second quarter of this year and subsequently initiate the phase I investigation of BRII297. With that, I'm now going to turn the call over to Dr. Ankang Li, our Chief Financial and Strategy Officer, to review our financial update and business development strategy. Dr. Li, please. Thank you, Dr. Li Yan. As a reminder, the financial figures I will be reviewing today are in RMB, unless otherwise noted. For 2021, our other income was RMB 99.0 million, representing an increase of 17% compared with RMB 84.6 million in 2020. The increase was due to additional income recognized from PRC government grants in the 2021 period. Our research and development expenses were RMB 494.6 million in 2021, representing a decrease of 43.5% compared with RMB 875.5 million in 2020. This decrease was primarily due to decrease in third-party contracting costs relating to COVID-19 programs. Administrative expenses for 2021 were RMB 208.4 million, representing an increase of 101.6% compared with RMB 103.4 million for 2020. The increase was primarily due to the increase in employee headcount. In total, our comprehensive expenses for 2021 was RMB 4.2 billion, representing an increase of 206.2% compared with RMB 1.2 billion for 2020. The increase was primarily attributable to the RMB 3.0 billion increase in fair value loss on financial liabilities through profit or loss, or in short, FVTPL, associated with fair value increase of our preferred shares. I want to note that this is a non-cash item and purely an accounting adjustment. We do not expect additional charges like this in 2022 and beyond because all preferred shares have been converted into common shares at our IPO. Excluding non-cash charges and expenses and listing expenses, our adjusted loss for the period improved to RMB 480.7 million versus RMB 888.7 million in 2020. As of December 31, 2021, our bank and cash balance, including restricted bank deposits and time deposits, was RMB 3.3 billion, compared with RMB 1.1 billion at the end of 2020. The increase was primarily attributable to the proceeds received from our Series C crossover financing and HKD 2.8 billion in proceeds from our IPO. As our executives introduced earlier, this year, we will focus on both advancing our existing programs and expanding our pipeline. Our pipeline growth will come from both in-house discovery and external partnerships, and we expect to add a number of new programs to our pipeline this year. Our licensing strategy is designed to expedite global regulatory approval, including accelerating our partners' global program in China and our in-house discovery programs in international markets. This concludes our prepared remarks. We will now open the call for questions. Operator, please go ahead. Thank you. Hello, operator. I think we can start with the Q&A session. Thank you. Dear participants, we'll now begin the question and answer session. As a reminder, if you wish to ask a question, please press star and one on your telephone keypad and wait for your name to be announced. The first question comes from the line of Sean Wu from Morgan Stanley. Please ask your question. Thank you very much for taking my question. Congratulations for management for all the clinical progress and also cure. The neutralizing antibody is now part of the treatment regimen for Chinese government dealing with the COVID-19. I have, like, the first question is about the neutralizing antibody timing. Can you hear me? What's your expectation, like, how much the government would stockpile for this? And also in the setting of prophylaxis, like, many patients, actually, one of my clients told me specifically, she's very worried about her elderly, you know, grandmother. She may be, like, immunocompromised that cannot take a vaccine. Now, how your neutralizing antibody may help her out? That's my first question. My second question is about your HBV functional cure. Clearly, this is a very hot area and it's of very keen interest for a lot of people in China who have been previously infected with HBV. What are the major readout dates for people to see how you guys have made progress in this regard? Thank you. Well, thank you, Sean, for the question. Let me answer the HBV functional cure question first, and I'm gonna ask Rogers Luo to answer your first question with the COVID-19 antibody commercialization effort as well as the potential prophylactic indication. Maybe I can chime in a little bit on the neutralizing activity against BA.2. For the HBV functional cure, yes, we absolutely agree that this is something that is very, very important for patients, especially patients in China. We are conducting, as we mentioned, four different combinations of therapeutic options or combinations with our partner Vir. The data already read out with the combination of the siRNA and the pegylated interferon. I think Vir will provide additional data, hopefully, at the EASL meeting in June. They are conducting another combination with our siRNA across the neutralizing antibody. I think that data is also becoming available depending on the invasion in Ukraine and see whether or not that's gonna impact the data, the recruitment. For us, as we mentioned, our combination study, the siRNA plus therapeutic vaccine is fully enrolled. It's just a matter of time for us to read out the data, which we project to be the end of this year. We'll have this top line interim data, which is at the end of treatment. That should give us a good indication in terms, what is the probability of success in achieving a much higher functional cure rate compared to the current standard of care. Now the other combination of therapeutic vaccine plus pegylated interferon therapy in the partially responded patient population, that one has started beginning enroll, and then we believe we can complete enrollment in the second half of this year. We think the initial data will read out in the first half of 2023. These are the programmatic milestones. Also we mentioned that we have principally agreed with the POC criteria with Vir, and then we believe that when they continue to deliver data to us and they're showing the efficacy and safety data of 3434, which is neutralizing antibody, we may exercise our option at the second half of this year. These are in a way that is almost like licensing milestones. These are the major milestones or capex in our mind in the next 12-18 months. Thank you, Rogers. Yeah. Yes. Let me ask the first follow-up question regarding the China commercialization. As you know, we have been actively engaging China central government, different agencies things, ever since last year. As you know that the current outbreaks, two outbreaks in Shanghai and other cities, you know, make us, you know, have been more actively engaged with those government agencies. Since last week, since the announcement of the new treatment guideline of COVID-19, we have been approached by more than 10 provinces and cities governments, asking for purchase of our antibodies. You can see there's huge demand in the local level as there are already 28 provinces has new COVID-19 cases reported increased in recent months. The need is there and we are being very actively negotiating with them. Also you can see from the reimbursement payer part. In China, the biggest payer is the Chinese government, the China Bureau for Reimbursements. They have published their kind of policy and encouraging local government to list all the products in the new guidelines into their reimbursement list. As of now, we already know that some of the provinces already list our antibodies into their reimbursement list as a which is to be reimbursed for. I think in the later months, maybe weeks or months, there will be more provinces will list our product in their reimbursement list. That's on the payer side. Talking about their antibodies' role for the elderly or immunocompromised or suboptimal responders to the vaccines. As you know that long-acting neutralizing antibodies plays an important role in to enhance their immune protection for the people from COVID-19 infection, with no other long-acting antibody has been approved for their prophylaxis, pre-exposure prophylaxis and also post-exposure prophylaxis in other countries. Our antibody is also a long-acting antibodies. In theory, these antibodies can also enhance their immune protection for the people. We are currently have one study actually in progress organized by the National Clinical Research Center for Respiratory Diseases. They are doing a small study evaluating our antibody in the cancer patients and see how the infusion of our antibody can compare with not inject the antibody compare with the neutralizing activity of the patients. At this, we are exploring the prophylaxis indication in China. As of now, I think this is we haven't get the indication as of now, so we are exploring now. Yeah. Thank you. Thank you, Rogers. I just wanna add that in a recent study conducted by investigator at the Singapore, we found our antibody combination therapy was very effective in preventing the infection by the Omicron variant. That give us additional confidence that our antibody remain active against Omicron variant. Well, thank you, Sean, for the questions. Thank you very much. Thank you. The next question comes from the line of Roanna Ruiz from SVB Leerink. Please ask your question. Great. Hi, good morning, or good evening to everyone in China. I had two questions on the COVID program. Regarding your EUA for your 196/198 antibody regimen, are there any updates on the FDA's inspection of your manufacturing sites? You know, I think you mentioned you were working with your CDMO to respond to requests. Are these fairly straightforward? You know, how quickly do you think you can work through those? Yeah. Thank you for the question. I think we... Yeah, obviously, FDA inspection unit have conducted the first remote inspection. They have shared their inspection observations with our CDMO, and our CDMO have responded. The FDA has also looked at the response and then engaging our CDMO directly and in addressing some of the inquiries and some resolution to some of the observations that they have. Unfortunately, in this case, we can't really predict when FDA will take a decision and what decision they will make, as we said in the corporate update. We can't really comment any further other than the discussion is ongoing. There is the response and inquiries are ongoing between FDA our and our CDMO. Yep. That's fair. Interesting. I was also curious for the antibody regimen. You mentioned it was recently added to the National Health Commission of China COVID diagnosis and treatment guidelines. I'm curious, what does that mean in terms of building physician awareness, education, and interest in your treatment regimen? Well, thank you very much again. Yeah. I'm gonna ask Rogers to comment on that. Yes. Because the new Diagnosis and Treatment Guideline for COVID-19 was just announced last week. Actually, we already have three real kind of online training programs have been done in China. We are currently working with some of the educational agencies to plan for much broader education in China. That's from our side, but also from their National Health Commission of China. They also plan to arrange some activities, educational activities to educate the doctors all of China, especially for those doctors working in the infectious disease hospitals which are treating COVID-19 patients. There are around 2,000 hospitals specifically designated to treat the COVID-19. I think in three months, I would say there will be many education programs ongoing, either from the government side, also from the medical community to train the doctors and healthcare professionals, which will be released by then. Thank you. Yeah. Thank you, Roanna. I hope that answers your question. Sorry, go ahead. It does. Thanks. It does. It's helpful. Last one for me. I was curious, you mentioned your PPD program and looking at prevention as well. How do you plan to identify patients proactively here for your therapeutic? And, you know, what are you going to use, biomarkers or symptoms, or how are you thinking about approaching that? Great questions, Roanna. I'm going to ask Dr. Yan to answer your questions. Yan. Yeah. Hi, Roanna. For PPD prevention, what our current approach is to identify patients with high risk of developing PPD. There are very detailed research in the past that in terms of identifying these high-risk patients, this includes mothers who had suffered from PPD from their previous childbirth. For example, if the mother is given a second child and she suffered from PPD from her first delivery, this, you know, mother will have a high risk of PPD development in a second childbirth. In addition to the previous PPD episodes, mothers who suffer from other depressive disorders and other psychiatric disorders, they also tend to have a higher risk of developing PPD. If you take these risk factors together, it is estimated that you could have as high as one in four, every 25% of the mothers could suffer from PPD with high risk factors. That's our current approach. Of course, in conducting the trial, we will also take the opportunity to collect the samples and do some preliminary and biomarker research to identify if we could have a biochemical marker so that will more precisely help us identify these patients in the future. If I may add, Roanna, we're also looking to conducting some retrospective and prospective biomarker study through public-private partnership. As you know, that there is no such a biomarker study in the past because there's no treatment option. Now we think there is a treatment option to prevent PPD. Therefore, the need for a biomarker study to understand the risk of women developing PPD has become much higher. Because this is the first program ever being look into the prevention paradigm. I think there's a greater interest that we'll be able to bring together and then conducting such important biomarker research, which we do believe is something that deserves a lot of attention. We're going to work with public funders and through public-private partnership and looking for this opportunity to investigate this biomarker study. Thank you for the questions. Great. Thanks a lot. Thank you. The next question comes from the line of Wang bin Zhou from CICC. Please ask your question. Hi. Thank you. Thank you for taking my question. This is Wang bin Zhou from CICC. I have two questions. First is about our HBV portfolio, and now we have mRNA and a preventive vaccine. We also have the option to license a neutralizing antibody called the VO3434. Since Vir has disclosed early pharmacodynamic data, do we have any comments on this product and when we expect to license in this product? Yeah, this is my first question. Well, thank you, Wang bin Zhou, for the question. The line wasn't very clear, but I believe you're asking, you know, whether or not there's any new data coming from the neutralizing antibody. I think Vir has disclosed early on, pretty much on a cohort by cohort basis, look at the antiviral activity in the first 6 milligram and the 18 milligram and the 75 milligram. I think they're pushing the dose higher to 300 milligram. I believe that's the top dose they will go. I think they clearly identify a dose-dependent response. Which aided them to start designing their combination study, which they will be testing at the therapeutic doses, which is gonna be at 75 milligram or higher, which they believe will be the important doses. Obviously, the dose, some of this data have not been published, so we can't really disclose that. We're looking forward to re-look at both the data from their monotherapy study as well as their combination study with siRNA at this therapeutic dose. Those data will be available to us soon, we hope, and then we can use that data and make a decision on whether or not we're gonna exercise the option or not. I hope I answered your questions. Okay, got it. The second question is for our HIV product. We paused the clinical study in last December due to the side effects that occurred in the clinical trial of islatravir. Can you show us more information about the side effect and when we can expect our study to restart? Yeah. Sorry, I mean, your line is really broken. I'm not sure I completely understand. Are you asking the question what's our expectation in terms of when we're gonna be able to lift the clinical hold on the HIV program, the seven-three-two? Yeah. Just when we can restart our project, and can you give us more information about the side effects that occurred in the clinical trial of islatravir? Yeah. I'm gonna try to answer your question, but your line is really broken. I'm not sure I completely got it. Forgive me if I didn't get the answer right. Here is what we know. I mean, there's a lot we don't know, but there are some we know. We know that there are daily regimens and weekly regimens and monthly therapies that Merck were conducting, and this was a pretty massive number of studies. They have seen a dose-dependent increase in decline of CD4 cells. In some of the cases, some of the doses were pretty significant and very profound, and which is the reason that got FDA concerned. We believe their monthly dose, where they see significant CD4 cell count, that one is being put on the full hold, full clinical hold. The weekly oral combination with a novel NRTI, the Merck 8507, that was also put on the full hold. In fact, if you look at the data, the NRTI seems to also contribute to the decline of CD4 cell count. We believe that regimen is gonna have major issues because you not only have to investigate islatravir, you also have to investigate the role of the NNRTI, which is gonna be really, really complicated. The only regimen that FDA allowed them with a partial clinical hold is the daily therapy regimens at 0.75 milligram. In that cohort, they allow all the enrolled patients to continue to be dosed, which we believe is where the FDA is comfortable with the safety margin by that regimen. That's the kind of thing that we're looking at, you know, how we're gonna be able to identify a safe dose from our phase I study, which we believe we have identified a couple doses that are within the safety margin that we believe FDA has considered to be safe. Therefore, this is something that we're gonna propose to meet with FDA soon and then discuss and as soon as we can to lift the clinical hold so that we can continue the study and move into the combination study with seven-seven-A as soon as we can. I hope that answered your questions. Yeah. Yeah. It's all clear. Thank you. Thank you. The next question comes from line of Valerie Yu from Teng Yue Partners. Please ask your question. Hello. Valerie Yu. Can you hear me clearly? Hello? Hello? Hello? Yes. Yes, we can hear you. Go ahead. Great. Okay. Thank you. It's like, I'm also hearing the line was, like, kind of broken. My first question is regarding any update on the Chinese government procurement negotiation process on our new licensed antibody, since Paxlovid's already, there's some rumors around, Paxlovid has already purchased by Chinese government with hundreds RMB per case. I don't know whether this is kind of like the price that we think would be reasonable to us. Okay. Thank you, Valerie, for the question. I'm gonna ask Rogers to respond. Rogers, please go ahead. I didn't hear very clearly because the line is just, like, not very clear. But if I understand it right, you are asking for the price of our antibody and also comparing with the prices for the small molecules. If I understand it right. For our case. Yeah. We have not finalized our pricing, so we cannot discuss it at this point. For the Pfizer small molecule, we heard there is already a price in the market. In our case, I think neutralizing antibody has a different role and value versus the small molecule, as we just discussed, in terms of the treatment window. Our product can use for the patients within 10 days after the symptom onset. Also about their drug-drug interaction. You know, we know the small molecule has a lot of drug-drug interaction, and also about their liver and kidney function with the small molecule, they have some limitations. Furthermore, our antibody has to enhance their immune kind of protection for the patients for reinfection or getting infected with COVID-19. Roles are not the attributes of the small molecule, so we have different role to play, and I think we provide different value over the small molecule. Regarding the price, as I just mentioned, we haven't finalized our price, so at this stage. Thank you. Yeah. I think a lot. What is our progress and update regarding the new central negotiations with our government procurement? We haven't come to that stage to negotiate on the pricing, right? Because it's just been, you know, getting to the reimbursement listing. As I just mentioned, the biggest payer in China is the National Healthcare Security Administration. They just published their policy saying that they ask the local payer, which is the payer at provincial level, to list all their products recommended in the treatment guidelines to be listed in their reimbursement list. They're not talking about negotiation on the price. I can provide an example here, which is the Jiangsu Province, which is a very big province, has a large population at the coastal province. In their announcement, they already put our antibody into their reimbursement list, and it says they put the product at the A list, which is fully reimbursed, and they are not mentioning about price. It's the government that will pay for it. As in our case, we haven't finalized our price. Once we finalize our price, I think it can be fully reimbursed. That's the situation. Thank you. I see. We're already getting the reimbursement list, but there's no exact volume procurement schedules from the government even the provincial government yet. We don't know the volume, and we don't know price. Yeah. As of now. It is procurement. We just received. Yes, as of now, because we, you know, we have already received, as I mentioned, many purchase requests from more than 10 provinces, cities. They are not. Some of them mention about volume. I cannot tell here. Some of them didn't mention about the volume because they say, "Oh, we'll ask, you know, for volume to purchase our product for stockpiling." Some of them ask for the clinical treatment. They, some of them, you know, have not been asking for the volume. We cannot, at the current stage, predict the volume because another factor is that as the evolving pandemic situation in China, you know, you can see that, today I think announced the numbers of new cases is about 5,000 new cases reported. It also depending on how the pandemic will be evolving, right? That will largely impact the volume they need. Thank you. I see. Just a property that, normally, for example, for Yeah. Tamiflu, normally we negotiate with the national reimbursement government, while in our case we're going to the provincial government, not the national list. Is there any reason there? No. Usually, the mechanism is usually that national negotiations happen at the end of the year. We're now at the beginning of the year. I think COVID-19 is very different from the routine kind of update of the national reimbursement list. In our case, it's even more special because we haven't finalized our pricing. Our product are not currently commercially available at this stage. Usually the product has you know, if you're looking at the traditional kind of negotiation on price, the product has been has to be on the market, has to be approved, and the negotiation always happens by the end of year. For the five small molecule case, it's even very special. I think what we heard is that the central government has a kind of negotiation with the company's headquarters. That's what we heard. We don't know. It's not confirmed. It's very special case. I guess because of the newly released treatment guideline, there are only two products listed in this antivirus, specific anti-antiviral treatment, one is the small molecule and one is our product. I think probably in the future, there will be some negotiation. As of now, we already get some reimbursement in the provincial level listing. It's quite special, quite different from the traditional mechanism because of the emergency. Thank you. Yeah, my last question here is, could you please update the manufacturing capacity target for 2022? Sorry. For the manufacturing capacity, we are, you know, actively working with our CDMO to scale up the capacity. It also depending on the commercial order and government supply, and also the evolving of the pandemic. I think if there is a need in the market, I think there will be a solution, and the capacity should not be a kind of problem, because if you're looking at how much inactive vaccines China produce, it's about five billion doses, right? I think that of course on the Chinese government's full support to control the pandemic because it's very special cases. I think in that case, if there is huge demand, I think other stakeholders like the government or other stakeholders will begin, I think, will support to meet the urgent needs of the market. Thank you. It was knowing that we have around like 1 million case capacity in this year. Just wondering, considering the recent change in our CDMO supplier, will this number get decreased or as this year will be a new year, so there's more capacity from them, this number will increase? It's very dependent on, as I just mentioned, it's very much dependent on the commercial order and the stock, and the government stock. I cannot. I just can't tell about it that much. Okay. Thank you so much. Yeah, appreciate it. Thank you. Thank you. The next question comes from the line of Abby Hong from Haitong International. Please ask your question. Um, with the- Yeah. Thank you. Yeah. Thank you. Sorry. Due to the time, I think, that's gonna be the last question. Thank you. Please go ahead. Okay. Thank you for taking my question in the last minute, sir. I have one question. For program 297, it's a very interesting, challenging area in depressive disorders, I believe. I want to know more about the research because I believe there's another benzodiazepines, which is short-term and off-label use in depressive disorders, targeting GABA-A. Is that just a similar version to this off-label just or it's different? In what way it's different? It is. It, yeah. Thank you. Thank you for the question. I'm gonna ask our CMO, Dr. Li Yan to answer this question. Yeah. As I mentioned, 3297 is a new chemical entity that we discovered internally, and it is a GABA-A PAM. It's a different class of molecules. It acts on both intra and intersynaptic. It has a different mechanism of action as compared to the off-label other benzodiazepine use. And just to give you a little bit more details about this, we designed the drug so that it has a different PK profile, and we have put in some additional clinical features that could potentially make this drug more suitable for certain indications. We have multiple indications that we could choose for this molecule to develop, and this will be decided based on emerging phase I data that we will see once we start the phase I study. Okay. Thank you. Yeah. Thank Yeah. Thank you for the question. Obviously, you know, there are more than 10 different indications. We think it relates to various depression disorder, movement disorder and other mental illnesses. We believe having more product will help us to better cover the different indications. Obviously with different clinical features and improved clinical features allows us to have a lot more flexibility to address all those indications. Now with that, I think let's wrap up this call. I wanna thank you all for joining this call. I know we're a bit past the time and, you know, as the CEO of the company. I truly appreciate you are, you know, really supporting us and paying attention to us and being interested in us. As I said before, when we comes to addressing a big public health challenges, there's no one person alone, no one company alone, no one country alone, or no one university alone can deal with this all together. This obviously requires all of us working together, including the investors investing in company like us, because we are going after a major public health issue that making the public safer in which we all resides in. I really appreciate this, the genuine support. I know sometimes you feel that we have not given you the full answer as much as we can. The reality is, you know, there is a lot of uncertainty with a lot of the, for example, the pandemics and how it's gonna evolve. I think we do actually appreciate the most recent change as we see very obviously in our discussion with the government, that there is a transition from zero COVID into a more sophisticated, integrated tools to address the pandemic, which we've been educating the government along the way and then pointing to that as the most important way to end the pandemic. I think for us to end the pandemic, it's just not gonna be about how we control the pandemic through isolation and quarantine and diagnosis. I think for us to truly end the pandemic, we need a variety of tools that we can address to help the society to get back to normal. Where there's a lot of uncertainty in our journey in your investing hypothesis, but we do believe that by helping company like us, we are doing a huge deal for the society. I hope at the end of the day, you walk away with that thought in your mind. We should not be alone here dealing with this. The government must and should step up to help. Obviously, various government at different part of their journey in terms of how they understand and address this ongoing pandemic. We hope in the near future, the policy will change. There will be more integrated approach to address this pandemic. With that, I wanna thank you all for your time and your attention for us. Thank you for your continued support to our company, which is truly a great company called Brii Biosciences. Thank you very much. That does conclude our conference for today. Thank you for participating. You may all disconnect. Have a nice day.