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Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
Good day, everyone, and thank you for standing by. Welcome to Brii Biosciences first half of 2022 earnings conference call. Our interim results announcement can be found on the Investor Relations section of our company website.[Operator Instructions]. Please be advised that today's conference is recorded. This is Chris Fang, Director of Investor Relations of the company.
Joining us today on the call Brii Bio's executive management team are Dr. Zhi Hong, Chairman and CEO; Mr. Rogers Luo, President and General Manager of Great China; Dr. Li Yan, Chief Medical Officer; Dr. Susannah Cantrell, our newly appointed Chief Business Officer; and Dr. Ankang Li, Chief Financial and Strategy Officer.
Dr. Hong will first provide an overview covering our strategic pipeline and organizational development, followed by Mr. Luo, who will provide an update on our recently commercialized COVID-19 therapy and our priorities in China.
Dr. Yan will then review overall R&D structure and our U.S. priorities. Dr. Cantrell will review our business development strategy. Dr. Li will then go over our financial status, after which we will open the call to take your questions.
Before we start, we would like to remind you that today's discussion may contain forward-looking statements, which involve several risks and uncertainties. Actual results and outcomes may differ materially from those mentioned in today's announcement and this discussion.
In addition, any forward-looking statements represent our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent dates. We specifically disclaim any obligation to update such statements.
With that, I will now turn the call over to Dr. Hong. Dr. Hong, please go ahead.
Thank you, Chris. Good morning. Good evening. Good day. Welcome, everyone, to joining our call today. I'm pleased with our interim results and the progress we have made towards our near- and long-term goals across our pipeline development as well as organizational expansion.
Since Brii's inception in 2018, we have been on a mission to tackle the biggest public health challenges of our time through breakthrough innovation and insight driven by the fundamental patient insight.
At Brii, we firmly believe that disease and scientific innovation have no borders, and our international teams in China and the U.S. are committed to do and adapt in collaborating ways that maximize our collaborative strength in various areas of expertise in both key markets as well as all the areas around the world.
And while our U.S. and China team currently have separate therapeutic area of focus, we are united in our operations around our capabilities and our shared vision to deliver world-class medicine to our patients.
We just recently celebrated the company's fourth year anniversary. We are proud that our unique global approach has produced a robust and dynamic pipeline of promising therapeutic candidates as well as a number of other recent and remarkable company achievement.
First and foremost, we have reached a commercial stage of growth as organization with our COVID-19 program as well as expanded the depth and the breadth of our senior executive leadership team with 3 key personnel appointments.
To that end, I would like to welcome Dr. Susannah Cantrell as our Chief Business Officer; Dr. Eleanor, or Ellee, de Groot as our Chief Technology Officer; and Dr. Aleksandar or [ Alex ] Skuban as our CNS Disease Therapy Area Head. As accomplished global leaders, their collective decades of diverse experience in their respective functional areas will serve well into the future.
With these new additions to our leadership team, we are well positioned to leverage each of our senior executives unique leadership skills and industry experience to extensively execute across our broad therapeutic development strategy.
Together, we are working to deliver a positive impact to patients, public health and society as we invest in medicines that have the potential to make a profound difference in many people's lives. Please refer to our recent announcement in our company website for further information about our growing corporate executive team and their roles and responsibilities.
Now let's turn to our recent pipeline [ developments ]. Our team achieved commercialization of our long-acting amubarvimab, romlusevimab, COVID-19 combination antibody therapy in China, only after 27 months following the initial discovery.
We'll carry forward the experience from our COVID-19 program to expand, advance our other public health-inspired clinical programs. Here, our goal is to bring proven and meaningful long-term therapeutic solutions to patients and to the healthcare community. With our commercial effort underway, we have turn -- we have returned our focus to our primary program, working to develop a functional cure for HBV. Most recently, in July, we strengthened our core HBV portfolio by exercising our option to in-license another therapeutic candidate from our partner Vir Biotechnology. BRII-877, also called VIR-3434, is an [indiscernible] and broadly neutralizing monoclonal antibody against HBV, showing great potential from multiple ongoing clinical studies. Together with our current assets, our portfolio of HBV therapeutic candidates is the most advanced work worldwide, and we're poised to deliver the search for a functional cure for HBV.
Along with Vir and VBI, we have multiple ongoing Phase II combination therapies, with the new data expected in the fourth quarter of this year or early next year.
Another core project spearheaded by our China team is our Multidrug-Resistant and Extensive Drug-Resistant Gram-negative Infection program, where we see an increasing need for a viable solution around the world, especially in China, especially the [ October ] as demonstrated by the sales data, recently approved antibiotics in China.
As our partner diligently advanced our clinical program, the U.S., we are working closely with them to track and inform strategic development of our in-licensed therapeutic candidates for continued development in China. Currently, our partner Qpex Biopharma is moving the development timeline along as expected, with 2 pivotal studies planned to begin in 2023. And we plan to submit IND application to China and [ FDA ] in due course. Moving on to our international, our global self-development programs. Firstly, in our CNS disease therapeutic area, with a focus on mental health.
We continue to build our team of industry leaders across the business and execute on our strategy to progress BRII-296 for the treatment and prevention of postpartum depression, as well as BRII-297 for the treatment of various anxiety and depressive disorders.
Our newly joined CNS Disease Therapy Area Head, Dr. Aleksandar Skuban, who we introduced at the top of the call, brings important expertise in this space that will enable us to continue to lay a strong foundation for ongoing development as well as spending further indications to maximize the value of BRII-296 and BRII-297.
In addition, we continue to invest in establishing meaningful patient advocacy and engagement initiatives as part of our strategic approach to incorporate fundamental patient experience and insight into every step of our clinical development.
Starting with our PPD program, we have sponsored a number of mental healthcare events this year. Rolled up our people strategy by participating in community efforts to raise awareness of maternal mental health.
Our employees are inspired to join the Postpartum Support International in their local chapter of climb out of the doctors and event, which provide first-time testimony of patients need, and that will help to drive awareness of societies' stigma associated with postpartum depression. Our HIV program with BRII-732 remains on hold, out of abundance of caution as the U.S. FDA further investigate islatravir, of which BRII-732 is a proprietary product. We have received initial response from FDA, providing specific guidance on requirements to lift the clinical hold.
We are working closely with the agency to align our understanding on the safety signal identified in the islatravir-related studies. Our aim is to lift the clinical hold as soon as we can in 2022 and proceed with the development of our once-weekly oral combination of BRII-732 and BRII-778.
With that overview, I would like to turn the call over to Mr. Luo to provide an update on our operations in China and COVID-19 antibody commercialization effort. Rogers, please go ahead.
Thank you, Dr. Zhi and hello, everyone. Thank you for joining us today.
As we just discussed, our China team is strategically focused on our HBV faction program. This is an area where we see the most opportunities to contribute significantly and meaningfully in therapeutic impact for patients in the region. In addition, as mentioned, we recently launched our [indiscernible] antibody combination therapy for COVID-19 in China. So our current primary goal in China are twofold.
Firstly, our key goal with our operations in China has been the commercial launch of our anti-COVID-19 program. It has been an honor to be the first company in China to provide a domestically originated treatment option for COVID-19 after successfully kicking off the first dispatch and those prescriptions in July.
Our therapy is one of the very few neutralizing antibodies that still remains the neutralizing activity against all current variants of concern. During the recent epidemic in China, of which the BA.2 and BA.4 and 5are the dominant variants -- sub-variants, our antibodies have been increasingly delivered to the patients in need.
We expect that this product may have potential to play a greater role in anti-epidemic efforts and [ cater ] to the national anti-pandemic policy.
With that said, after 3 years of experience in outbreaks of COVID-19 and its resurgence, we now know that vaccines alone are not enough to prevent infection, especially infections in patients who have compromised immunity.
Therapeutic [ free ] exposure prophylaxis and post-exposure prophylaxis, especially with antibody treatment, have been shown to be effective for protecting one or more patients and healthcare providers.
With the support of Chinese government's hospitals and investigators, our ongoing work is gearing towards real-world experience of our long-acting amubarvimab and romlusevimab, this combination in [ trial and ] peak.
The other key focus for our China team is HBV development. We aim to be the first company to find a functional cure for HBV. Part of our unique approach to advance our clinical development and achieve rapid commercialization is to leverage potential combination treatments, utilizing our robust portfolio of promising HBV assets. Currently, we have 2 ongoing combination trials in China, BRII-179, the [indiscernible] vaccine and on top of pegylated interferon alfa plus NRTI therapy and [ BRII-179 ] and BRII-835 in combination.
For our BRII-835 and BRII-179 combination, we have completed patient enrollment and expect to report interim top line data by the end of the year and submit an IND application to the [ CDE ] for [indiscernible] study in 2023, if possible data is achieved, positive data is achieved. For ongoing community studies with BRII-179, which is PEG-IFN-alpha plus NRTI therapy, we continue to enroll patients in the first part of this Phase IIa and IIb study and anticipate that all patients will be enrolled by end of the year, with ensuring top line results expected in the second quarter of next year. With our newest assets addition to HBV treatment, BRII-877, or VIR-3434, 2 trials led by Vir are on the way and new data were presented at the annual EASL International Liver Congress in June.
Leveraging Vir's [ findings ] in the U.S., we have the ability to move strictly in China to later stages of clinical development and ideally push through the regulatory process in an accelerated amount of time.
Working in tandem with our partner companies in U.S. and our [ Brii colleagues ], we have [ worked for ] the future commercial opportunities in China while we simultaneously advanced our U.S. portfolio.
Here to discuss a little bit more of our overarching R&D capabilities and other medical indications we are addressing is Dr. Yan, Li. Please go ahead.
Thank you, Rogers. Good morning, good evening, everyone.
As you can see, we are developing a world-class R&D enterprise. Our cross-border organic operations are one of our competitive advantages that uniquely positions us for accelerated commercialization opportunities.
So with our presence in both geographics, U.S. and China, we utilize our respective strength to expedite discovery, development and the delivery of innovative medicines that have the potential to transform the care for millions of patients around the world.
We plan to further expand this unique capability of our R&D organization in 2022. With the planned expansion of our HBV and CNS pipeline, we are considering establishing additional laboratories that serve our international goals such as advancing our U.S. capabilities. We will continue to keep you posted on that front as those discussions and the decisions are unfold.
As we continue to grow our company, we are investing in our people and a pool of talented R&D professionals, who have supported the successful recruitment of additional key leaders.
We have built our product candidate pipeline by leveraging our in-house R&D capabilities, external collaborations and support from our strong scientific advisory Board and [ veteran ] investors.
Additionally, we have R&D collaborations with global pharmaceutical and biotech companies, leading CROs, CMOs, CDMOs as well as research institutions and other strategic partners.
With our plans to expand our R&D efforts in CNS indications, particularly in depressive disorders, we've made some critical new hires, particularly Dr. Aleksandar Skuban, who will lead our entire CNS development effort.
We are pleased to welcome Dr. Skuban, who has more than 20 years of experience in global pharmaceutical R&D as we ramp up the development of our clinical assets for postpartum depression as well as other depressive disorders.
Mental illness and depression, in particular, are among the most common CNS disorders in the world, having increased over the last several decades due in part to an aging population.
According to our recent report, anxiety and depressive disorders increased during the COVID-19 pandemic by 25%, resulting in more than 300 million people impacted by significant depressive disorders.
The postpartum depression is our primary area of focus at present, and it is currently lacked of effective and convenient treatment options. It's one of the most common psychiatric conditions that impact new mothers after giving birth.
With BRII-296 and BRII-297, we are looking to significantly improve the current standard of care with a rapid onset and a sustained reduction in depressive signs and symptoms for these new mothers, as well as to provide improved adherence, convenience via single treatment in an outpatient setting versus requiring patients to be admitted to a hospital setting to receive the treatment.
Patients would not have to repeat the therapy, hospitalization would not be required, nor would patients need to be responsible for remembering taking daily doses.
More importantly, BRII-296 has negligible exposure to breastfed infants, making it potentially safe and a unique antidepressant option for mothers who wish to continue to breastfeed their infants, which are the majority of the mothers.
During the first half of 2022, we completed the necessary early developmental work, including formulation development, short-term toxicity studies with BRII-297. We have submitted the IND to the U.S. FDA, and we plan to initiate the first time in human study for this exciting asset in the fourth quarter of this year.
So with that, I'm going to turn over the call to Dr. Cantrell, our new Chief Business Officer, to discuss our upcoming business objectives. Susannah?
Thank you, Li, and good day, everyone. I'm pleased to be speaking with all of you on behalf of Brii Biosciences. One of the reasons I was drawn to Brii was the impressive progress the company has made establishing a core development pipeline in such a short period of time, along with the patient-centric culture and the fact that we are at such a pivotal stage of growth.
I'm thrilled to bring my experience of leading international teams to the table as we work to translate promising science into meaningful solutions for patients that are facing the burden of significant infectious diseases and CNS diseases around the world.
In addition to our in-house R&D capabilities, we simultaneously work with other industry leaders through collaborative licensing agreements. We currently hold the development and commercialization rights to a number of partner assets in Greater China. As we build our core business in Greater China, we are also seeking global partnerships with industry in order to accelerate bringing world-class medicines to broader patient populations. This approach allows us rapidly turning science -- promising science into therapeutic avenues and highlight the strengths and capabilities of each organization.
Enacting this strategic vision carries with it a great deal of planning to drive long-term pipeline expansion and commercial growth. We are dedicated to meeting these goals with respective strengths that are aligned with our major markets, China and the U.S.
I'd now like to turn the call over to our Chief Financial and Strategy Officer, Dr. Ankang Li. Ankang, please go ahead.
Thank you, Susannah. We are all excited to have you and other new executives on team. Welcome, everyone, who has joined us on today's call. As a reminder, financial figures I will be reviewing today are in RMB unless otherwise noted.
For the first half of 2022, our income was RMB 38.2 million, representing a decrease of 17.4% compared with RMB 46.3 million in the first half of 2021. The decrease was mainly due to the decrease in income recognized from PRC government grants by RMB 17.8 million.
This decrease was partially offset by the increase in bank interest income of RMB 9.7 million attributable to the increased bank and cash balances after our initial public offering on Hong Kong Exchange.
Our total comprehensive expense for the first half of the year was RMB 217.7 million, representing a decrease of 92.5% compared with the RMB 2.9 billion for the first half of 2021. The decrease was primarily due to the decrease in fair value loss on financial liabilities at FVTPL.
Our research and development expenses were RMB 258.5 million in the first half of this year, representing an increase of 64% compared with the counterparts of last year. This increase was primarily due to the increase in third-party contracting fees as well as employing costs for continuous development in clinical trials.
Administrative expenses for the first half of this year were RMB 95.5 million, representing an increase of 40.4% compared with RMB 68.0 million for the first half 2021. The increase was primarily due to the increase in the employee headcount as well as increasing stock-based compensation expense for employees.
We established a streamlined commercial team to better support the launch and distribution of our amubarvimab and romlusevimab combination therapy. As a result, we started to incur selling and marketing expenses, which primarily consists of employee-related costs and prelaunch activities.
As of June 30, 2022, our bank and cash balance, including restricted bank deposits and [ time ] deposits, was RMB 3.2 billion compared with RMB 3.3 billion at end of 2021. The decrease was primarily attributable to payout of the operations and third-party contracting costs.
As we continue to advance our existing programs and expand our pipeline to both in-house discovery and external partnerships, our current funds should be able to support us into 2025.
We look forward to delivering continued shareholder value as we advance innovative therapies with significant unmet medical needs and large public-held burdens from patient-centric [ bench bonds ].
This concludes our prepared remarks. We will now open the call to your questions. Chris, back to you. Thank you.
Yes. Thank you, Ankang and all the presenters. [Operator Instructions] So the first question is coming from the Chen Chen from UBS.
And I have one question about HBV functional cure. I noticed that we got 2 siRNA-based combination therapies. Right now, both at Phase II trials in China.
So can the management please give us more color on the end point for these 2 trials? Say, whether it is something like the percentage of patients whose hepatitis B surface antigen decrease to what level and last for how long?
And also, may I ask like what is the rationale behind these 2 trials? And which one do you think has a higher chance of success?
Thank you, Chen Chen, for the question. Let me try to answer these questions. I think there's a number of questions in there. I just want to make sure that we are currently conducting 2 combination studies. One is the combination of siRNA plus our therapeutic vaccine 179.
The other one is actually our therapeutic vaccine 179 plus pegyl interferon. This is on top of -- this is a highly selective patient that once they become partially responding to the ongoing pegyl interferon that we'll be adding to our therapeutic vaccine 179.
You are correct that we're investigating other siRNA combination because our partner Vir Biotechnology is also conducting several combination studies, this including the combination of siRNA [ waste ] pegyl interferon and the combination study of siRNA plus the neutralizing antibody 877.
And then there's one more combination they are looking at, that is the triple combination, i.e., the pegyl interferon plus siRNA, plus neutralizing antibody.
So all of this will poise to deliver top line data towards the end of this year or early next year, and we're very excited to look at which one is going to give us the top line data that we want. With regard to the primary endpoint, we're obviously looking at clearance of surface antigen. And more than that, we're looking for a sustained clearance of surface antigen. And this includes some maximum suppression or maximum reduction of surface antigens.
And we do believe with the combination of siRNA and broadly-neutralizing antibody, as the data we have seen so far, it has the potential to achieve the maximum reduction of surface antigen in the broadest patient population, given the mechanism action of the 2 assets.
So the primary endpoint will be looking at the maximum reduction of surface antigen, the clearance of surface antigen and the durability of that surface antigen reduction. Thank you.
Thank you, Chen. Operator, let's just move to the next question from Sean at Morgan Stanley.
Congratulations on your progress in the clinical front and also the hiring of these key executive. I have just a couple of questions. One is about our HBV program. Chen Chen asked about these 2 clinical trials and your clinical end point. I would say like, do you have any kind of sense like which amount, the functional cure may be actually considered as kind of adequate of approval, 20%, 30%? I mean that's something people have been talking about for quite a while.
And also now that you have exercised your option to in-license [ VS ], another kind of siRNA. Do you have any kind of -- are you thinking about reprioritize or like you are just going to do combo amongst that of 3 assets? And how do you priority those kind of programs? And when do we expect to see some results that will kind of on the way forward? That's the question about HBV. Another question is about your neutralized antibody cocktails, they are launched and hope you can do well. And as you may know, is these neutralizing antibodies accrued in Shenzhen, that's for preventative kind of -- It's just like a vaccine may be better for the people, who have immune compromise systems? So in China, I think you're doing some clean trials on data front as well. Can you report a bit of your progress in that product?
Well, thank you, Sean. Let me try to answer your first question, and I'm going to defer to Rogers to answer the second question with regard to COVID, the reported, the AstraZeneca prep in Shenzhen, and core plans in China for that.
So with regard to the HBV functional cure, I think there is an industry consensus that if we can achieve a functional cure of 20% to 30%, that will be great. I think, as you know, the current function of cure are about 5% to 7%. Sometimes people report 9%, mostly involving pegyl interference. So that's the current standard of cure. So I think double that or triple that will be a significant advance.
And -- you are correct, we have multiple programs that we think if we can -- we have conducted 5 combination study that will give us more information in terms of how we can combine them in such a way that we can achieve even higher functional cure. Obviously, there's a lot to be learned once we finish the study of those combination study. I think in the next -- in the next 12 months, and we'll learn a lot about all these different combinations of how to further improve them. And I think that's really what I can say on the HBV function of cure front.
And I'm going to ask Rogers to comment on behalf of COVID, Rogers?
Yes. So thank you for the good question. So as we just mentioned, there is the -- has a COVID-19 and neutralizing antibody in [indiscernible] free trade zone for the FRAP indication, but that's only limited in the small area. Patient -- People have to travel to to get their injection. So I think that's clearly [indiscernible] for FLAP and FLIP, in China because, as you just mentioned for those people with compromised immunity, they won't have this neutralizing antibody for a prevention.
So we are actually generating some data. We are working with Professor, Gilead Science. There's a small trial, planning and ongoing we're trying to generate some data, but that's not fully indication. So we also plan to do some real life study to gain experience for those populations. And this #2.
#3 is actually, we are actively discussing with CDE to see how we're going to moving forward to fill the in China for the prevention. So that's basically what we are doing now.
May I ask a follow-up question to Dr. Hong. For your HBV functional cure, it appears 3434 is additive to 835, so do you plan to acquire a regimen with 3434 plus 835 and with 179 plus interferon for the last . Maybe if you have those 4 together, you could get even higher kind of functional cure. That's just like the people have been doing with [ TB ], you have multiple things -- just you have lots of things working together. I'm just kind of curious with this.
Yes, Sean, I mean, I think that's correct. I mean directionally speaking, obviously, with the HBV patient population are quite heterogeneous and diverse and their underlying functional immunity may be different. So we do anticipate that multiple modality will be needed. I think 2 is probably the minimum as you just said, and that we're looking to the new data as we will be informed in the next 12 months to decide whether or not how we are going to combine more on therapeutic modality, that they will be combined at the same time or we can combine it at a different time. I think all of those will be informed in the current citing, we're laying that out.
I think if you ask me, are we going to throw the kitchen sink at the patient or not? I think we need to be careful about the safety, making sure that we don't do this. And in emergently create safety issues for the patients. So I think we just need to be a little bit more thoughtful in terms of how we're going to combine it.
And I think the question -- if your question is are we looking to combine more therapeutic modality to achieve a higher functional cure rate, the answer is yes. And really the detail -- the dabble is in the detail in terms of how we're going to combine them, how we're going to combine and use some simultaneously? Or are we going to combine them in a staged fashion? So very good questions and more to come, more to learn and I'm very much hopeful that we can share more information as we go.
The next question is from Roanna. Roanna?
Hello. Can you hear me now?
Yes, great.
Okay. Great. So 2 quick questions, one on the COVID program. Just curious, how is the commercial launch going with your antibody regimen in China? And I was curious specifically, how many total cities or provinces have you shipped courses to so far? And what's that growth or demand going to look like going into the end of this year?
And my second question on the HIV program. I noticed you mentioned you got an initial response from the FDA about the clinical hold and addressing some questions from them. Curious if you could share some additional information about that or how you're thinking about responding to the FDA, et cetera?
Well, thank you very much, Roanna and I'm going to ask Rogers to answer the first question with regard to the active commercial activity of COVID antibody in China. And then I'm going to ask David Margolis to answer the question related to HIV. Rogers?
Yes. Thank you for the question. So -- since we commercially launched the product in early July, it is already more than one month past. So we supply several thousand doses to all places where there is a small rate of small dynamic cities and provinces, so that is the current situation. Regarding what our projection for the rest of the year, I would say it very depends on whether we'll still apply the Zero COVID Policy, that's number one. And number two, how this variant will evolving. So it's hard to predict how much, how many costs will be for the sales in the rest of the year.
And I would add that we are talking to the government regarding how we're going to manufacture more antibodies and how we can determine on the stock power to purchase. I think all of these are in active discussion, and we can't really share any information until those materialize. So we're working actively in discussion with the government.
David?
Yes. Thanks Zhi , and thanks for the question on our HIV portfolio. So as you know, BRII-732 is a prodrug of EFdA. And in parallel with global clinical hold that was placed on the program, BRII-732 is also placed on FDA clinical hold.
As you mentioned, we have been engaging with the FDA on a strategy to lower the overall exposure of EFdA in a way that continues to allow us to dose once weekly and our recent engagement was specifically around that point and also around the number of steps that we need to take preclinically to continue to evaluate the hold.
So we received a number of really robust and specific assertions from the FDA about the work that we've done and they gave us feedback on our proposed strategy. And so we feel like we're -- we continue to be in a good place, working closely with the FDA to execute on that strategy. Fundamentally, it's just going to be a requirement that we established at the exposures we proposed will be safe with respect to CD4 signal in patients and also produce additional nonclinical or preclinical work to help support that assertion.
So we're on track to continue to generate that data and the recent FDA feedback was very helpful to us to give us specifics and how to go about doing that.
So next question is from [ Roy ]. [ Dr. Roy ] from the JMP Securities.
I had a couple. On the 179 plus 835 Phase II trial, is it a clinical trials [indiscernible] and it looks like the trial also has a triple combination cohort, including pegyl interferon. It's actually a cohort to include the new -- is that correct? And will you present data on that cohort this year as well? And then do the patients when they come off therapy, do they come on all therapy simultaneously? I had a question on the COVID headlines.
Yes. So it's -- yes, your understanding is correct with regarding the Vir's combination side.
And then for the antibody -- do you have any sense on the FDA mind through the EUA and can you shared recent feedback from the agency regarding the application?
Okay. For the EUA question, I'm going to ask David to answer what is the current status for the U.S. discussion FDA. David?
Yes, thanks. So all I can really confirm is that we remain under emergency authorization review. The FDA has been focused on ensuring that they do all the necessary inspections and overviews, the manufacturing status. Some of the time line, there has been limited due to access to travel. But fundamentally, we continue to answer questions FDA poses and we remain actively under review and it can't speak definitively to the FDA's time line.
Our next question is, please [ David ] from UBS.
Thank you. And many congratulations for the progress. And so -- I actually have a question that's on HBV, that we see a trend that's using continuously [ RA ] drugs to reduce the antigen titan has several pathways later on to achieve functional cure, that includes like vaccine, like interferon and some use of PD-1, PD-L1, to stimulate the new response. So may I ask any comments from the different pathways on the second step and we have any advantage on these parts?
Yes. So I mean that's a good question. I think when we started BRII, 4 years ago, we kind of focused on 2 major pathways. One is to reduce neuro-suppressive HBV product, specifically the surface antigen. There are many scientific reports have suggested as well as some of the clinical data suggests that having a large amount of circulating surface antigen has not been very helpful and a cut the holes from recovery or restoring their immune responses against the virus, that's probably one of the way the virus use to perceive itself in the host.
And the second pathway is trying to restore and induce strong B cell as well as T cell response. I think you correctly noted that where people using the RNA interference as a way what [indiscernible] to do the first part and then people looking at therapeutic vaccine or the [ weaponized ] neutralizing antibody in the case of VIR's antibody to induce T cell response for the other people trying checkpoint modulators, [ TRRs ], innate immunity agonists, multiple ways in trying to strengthen and reduce the higher immune response.
We think all of this approach are currently still at play. I think there's a number of programs, as you know, that has been terminated due to the lack of clinical evidences, we've seen in the past with the Capsid inhibitor with other approaches, I think more and more we see the approach gearing towards the direction that we are hoping and then -- and would that be enough? Probably not, and we're still thinking about what else can we do.
And one thing that we want to do as a company is to really focus on having had the function of cure as a matter of public health, and then we will continue to invest in this area where along broadly on 2 pathways, i.e., remove the immunosuppression, on one hand -- on the other hand, safely induce the immune response. Thank you.
So next question is from Everbright Securities.
So first, I would want to ask what's the current progress of our COVID antibody like for filing NDA overseas other than the U.S.?
And my second question is, so for the GSK's ASO drug, I think it's like a 28% response rate or cure rate. So I would like to know what's the reason for it? Does it work on the rest of the population? And does it mean, say, like for siRNA, it only works on like 20% to 30%. And for the rest of the population, we still need to find another way to cure them?
I'm going to ask David to comment on the global of COVID. And David, maybe you can give a brief a discussion on that? I will do the GSK growth.
Yes. So certainly, as we've met the pandemic with our COVID program, we've wanted to make sure that our antibodies were available anywhere they might be useful. And that's involved in gauging a number of agencies really around the world over the last 12 to 18 months. So we have been in conversations. We don't have active applications right now with other agencies. So we're focused on discussing with them whether or not given the evolution of variants and their own evolutional therapeutics, they may continue to be opportunities.
Our commercial presence, manufacturing presence has been focused on meeting the China market. So as we explore other potential market opportunities, we need to also make sure it matches with our manufacturing capacity.
So I'd say we step cautiously in engaging with other agencies to make sure we meet the unmet medical need and also have the manufacturing capacity ready for them, although those conversations continue.
And I will say in the APAC region, there has been interest, and we continue to explore possibilities of expanding within APAC in terms of commercial use.
And just to add on that question, I think many countries around the world, I think the U.S. FDA EUA is the most recognizable mechanism for approval. So with the delay in the inspection of our CDMO, I think this -- a lot of this engagement are also be on hold because people want to see what will be the outcome of this EUA approval. So that's where that is.
With regard to the GSK antigens oligonucleotide candidate. I think this is a program that I actually created. So I know it is very well and this was created in 2009, in the collaboration with [ Zions ]. I think it's very interesting. I think why we only see 30% function -- actually is not the function of the cure rate. It's like the surface antigen clearance.
And there are multiple hypotheses. One is the target site and is obviously targeting the DR2 site. That's the site that may be a question whether or not due to integration of the HBV genome into the human chromosome, what or not that site is lost or not. So I think that's one question people have some consideration to say if the site is lost into integrated copy of the surface antigen over [ waiting ] for them and that surface antigen will not be clear because the target side, the antigen's target side is worse.
I think the other thing, it could be simply just because the overwhelming amount of the antigen being produced and we now have the capacity to just stoichiometrically clear them. And also GSK seemed to think there may be additional [indiscernible] action at play, which they proposed a potential TRA mechanism. So it's not clear whether or not in those patients, what percentage patients will have a functional TRA-immune activity within the deliver and offer that particular patient.
So I think all of that, you can have positive side, but the reality is that we see a 30% in staged clearance of surface antigen as GSK continue to follow them. I think many of them have rebounded. So clearly, the goal of the function of cure is not to have a stage clearance of surface antigen we're looking for a sustained clearance of surface antigen. So that's the current status.
I'm sorry, I can't answer all the questions because I just don't know, even though this is the program that I have been -- this has been a great chart of my -- since 2009.
Okay. Just a quick follow-up. So for -- if it's like overwhelming antigen, could we just simply raise the dose? And also another question is like because I know the GSK ASO has been like 3 years. So why it's so slow for them to finish their clinical trial?
It's all good questions. I'm afraid I can't say much other than what you just stated and observed. It is taking time to develop these therapeutic options. So I think that's -- that's really all that is. I don't think I can offer any insight because I've left a company for more than 4.5 years now.
Okay. Thank you. And the -- due to the time limited, I will give the last question to Wangbin from CICC and then our CEO, Zhi Hong for the closing remarks.
So I have a question about our [ BT ] strategy since we have -- now we have a new CPO. So could you -- should we expect more BT deals coming?
The short answer is yes. Obviously, you said that -- we're very happy and excited to have Dr. Cantrell, who joined us, really helping us to conduct both inbound as well outbound partnership opportunities. I don't know if Susannah, do you want to add any further comment to that. Susannah?
No, I agree that the short answer is yes. And I think you heard in the beginning of the call, when we discussed with the CNS indications and to just depressive disorders alone, there's been a tremendous increase. And with the program we have, there's certainly ability to address a large patient population there, as we expand beyond PPD, but there are many other indications that we could look at other modalities and MOAs. And we will certainly pull together strategy and do the proper search and evaluation to bolster up our internal pipeline. But short answer is yes.
Okay. Thank you -- thank you very much. I think based on Chris' guidance that I think it's time for me just to provide some closing remarks.
And first off, I want to thank you all for joining the call. As a company, we are very proud of what we have done to develop the COVID Therapeutics. I really want to thank my entire company, my partners and our employees and their families. And I can't tell you how much effort the entire staff of Brii has devoted into this area. And -- and this is something that we feel very proud of ourselves.
Second, I want to make sure that it's becoming clear that we're -- we're obviously learning a lot about HBV and then being a leader in this area, we clearly have a lot of insight in terms of what we're seeing coming from the different combinations. And this is the area that we absolutely want to win, and we're going to double down and invest and focus in this because it's a huge house issues in China. We see a big, big opportunity for us in HBV functional cure.
I think -- we are also very excited for the CNS program. And for the first time, now we're moving into a clinical trial in a target patient population, we're very excited be able to develop our variable proprietary formulation and finish our Phase I study and have a dose selected and moving forward to the target patient population.
There's no question that we're at the very beginning of the company inception that we do not know anything about COVID. But what COVID have taught us is something very important, not only in terms of infectious diseases. Also, at the same time, we're seeing a very silent and in parallel, huge mental health issues and I would say, a separate pandemic. And we're very lucky to be a company to be able to be in that position to help address both pandemic. And I think that's something that's very, very important.
I want to thank you all. I know many of you have really spent a lot of time following us and understanding our strategy. I want to thank all our investors who are supporting great -- what a wonderful company that has stepped up to the challenge during this very difficult time of our life. And I just want to thank you all for supporting us, and I look forward to your continued support to Brii. Thank you.
Thank you, Zhi and operator, and thanks for your participation, and I will close the line now. Thank you for joining. Have a good day.