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Earnings Call: H1 2021
Aug 31, 2021
Okay. Thank you, everyone. Thank you for standing by and welcome to I Mab 2021 Interim Business Update and the Financial Results Conference Call. Earlier today, we issued a press release detailing I Mab's significant pipeline progress and the corporate highlights during the first half of 20 21 and upcoming milestones for the rest of 2021 as well as a review of our financial results for the 1st 6 months in 2021. The press release can be accessed on the Investor portion of our website.
Joining me today on the call from I Mab's senior management team are Doctor. Jing Wu Zhang, our Founder, Chairman and Director and Doctor. Zhong Shen, our Chief Executive Officer. Doctor. Zhang will provide a high level overview of our recent achievements and the strategy going forward.
He will then highlight the progress we have made in our key clinical programs and upcoming milestones and catalysts. Doctor. Shen will then comment on the status of other important clinical assets and the corporate achievements. I will then provide a brief summary of our financial results and our preparation for the dual listings in Greater China before we take questions from the audience for Q and A. Now without much ado, I will turn the call over to Doctor.
Zhen, our Founder, to start the call. Doctor. Zhen?
Thank you, Jialun. Thank you all for joining the call today. We are very excited to report to you the remarkable progress that companies has made since the beginning of this year. First of all, let me set a stage to tell you where we focus our efforts and resources at a corporate level to generate the most value for the company and our investors. The 3 of us today will then walk you through the progress in detail.
Now on Slide 3, our corporate focus is twofold with overarching goal to move our clinical pipeline towards product portfolio. On 1 hand, we focus on team execution to rapidly advance the pre BLA and innovative late stage core assets such as felazartamab, TGA101, TGA107, lansoparumab, unilevelumab towards BLA or registrational trials. In parallel, we have been developing the next generation of even more innovative immuno oncology assets through what we call 2nd wave innovation characterized as a novel or differentiated by specific antibodies and 3rd wave innovation characterized as a super antibody enabled by transformative technologies. As a result, our pipeline today is not only innovative and globally competitive, but also clinically advanced with the 1st BLA to be submitted in Q4 this year. On the other hand, we are building our future to bring the company to the next level on a clinical stage biotech to a global biopharma.
In that regard, we have made great progress in building our manufacturing facility in Hangzhou and a commercialization capability to prepare for product launch in China. Now let me walk you through the pipeline developments and the recent progress. On Slide 5, we provide an overview of I Mab's pipeline. The progress within the past 12 months, especially since the beginning of this year, has rapidly advanced the pipeline to the stage where our pipeline today is not only innovative and globally competitive, but also clinically advanced. We have now 1 BLA submission, 2 registrational trials ongoing, 7 Phase II and 8 Phase I clinical trials in both U.
S. And China. Now the focus of our pipeline is placed around the 6 core assets as highlighted within the red box because of the potential to become highly differentiated medicines if successfully approved. On Slide 6, I'm excited to report that we have achieved so far 13 pipeline milestones since the beginning of this year, including 7 new R and Ds or trial starts, 4 positive data readout events that are considered critical to further developments of the key assets, which we will give you more details later at this presentation. We are on track for BLS submission for felsartumab in Q4 2021 this year.
Now on Slide number 7, we have successfully completed some registrational trial for 3rd line feldsachemab for multiple myeloma. Now the top line results have met the primary and the secondary endpoints. More importantly, the study has confirmed clinical advantages of feosartumab in terms of shorter injection time, which are loss conveniently used at an outpatient setting and a lower injection reaction rate. Its safety advantages can offer a better treatment option for elderly patients and patients with severe complications. BLA submission now is on schedule for the Q4 this year and the company is in preparation of product launch in terms of market access, inclusion in the national drug reimbursement, less sales strategy and so on.
Now the registrational trial for second line treatments for multiple myeloma is on track and the enrollments of nearly 300 patients will be completed by the end of next month in September. In addition, we plan on filing a new R and D to explore a first line treatment option for multiple myeloma by combining feldsartumab with 1 of our own clinical assets in our pipeline. On Slide number 8, regarding TGA101, our long acting growth hormone, the registrational trial is on track for patient enrollment. There are 165 patients are to be enrolled, which will be completed by early 2022. And we are very excited by the outlook of the growing gross home market in China.
And I believe TGA-one hundred and 1 has a significant market potential. As we communicated previously, we have been seeking a commercial partnership with 1 of the pharmaceutical companies who have a pediatric product portfolio and a well established commercial channel and a specialized sales force. Now I'm happy to report that the business negotiation has advanced to the Tunxi stage. We hope to finalize the deal and report back soon. On Slide number 9, lanceopolymer, our highly differentiated CD47 antibody, we have made remarkable progress in clinical developments of lanzopolymab in both U.
S. And China, which we hope will lead to registrational trials next year in 2022. Our ambition is to launch lenozaparumab as the first CD47 antibody product in China and facilitates the global development of our partner AbbVie for global registration. Here's the summary. Firstly, Lanzoparlimab in combination with rituximab for non Hodgkin's lymphoma.
Our U. S. Trial is on track and has generated early clinical results, which we are very excited about. As a result, we recently submitted an abstract to present the clinical data at ASH this year and I hope to share the clinical results sooner if possible. While the U.
S. Trial is ongoing, we have prepared multiple clinical sites in China to join the clinical trial in September next month to expand and facilitate this study. We hope that the current clinical trial will lead to a registration of study for non Hodgkin's lymphoma in 2022. Secondly, lenzepartumab in combination with AZA for AML MDS. I Mab is on track to complete an abbreviated Phase 2 clinical trial in China.
As the clinical trial is progressing, we have already seen encouraging early clinical efficacy signals and we are very excited about that. We plan to complete all the patient enrollments within this year and I hope that the current study will also lead to another registrational trial in 2022 in China. In the U. S, our partner Ababeam is conducting a global clinical trial with ACA and venetoclax in patients with AML MDS and we are very pleased to mention that we have been working together very well with AbbVie. Thirdly, lamsoparumabine is temporal for solid tumors.
Our U. S. Trial is progressing to include more cancer patients for better clinical efficacy assessment. More complete clinical data will be hopefully available by the end of this year or early next year. We will report clinical data by that time.
In China, we have obtained R and D approval to start Phase 2 clinical trial with a basket design to focus on selected tumor types that we believe are more susceptible to this combo treatment. To summarize, in terms of safety, so far a total of 86 patients in U. S. And China having dosed with the drug and the safety profile continues to be very good. Here I wanted to emphasize that for lansoparlimab, no priming dose is needed throughout.
We remain very excited and confident with more clinical efficacy data coming out from multiple clinical trials. Our current goal is to focus on team execution to facilitate clinical trials in both U. S. And China, so that we will be in a better position to potentially initiate registration of studies in 2022. On Slide number 10, regarding urolitinumab, our highly differentiated CD73 antibody, our U.
S. Phase 1 clinical trial in competition with Ateezol, a PD L1 antibody for solid tumors was completed early this year. We're very excited by the clinical data and presented detailed results at ASCO this year. In short, the ORR observed with a udalatinib in combination with Ateezol is the highest among all clinical stage CD73 antibodies as we are aware. We believe this may be attributable to the differentiated property of unilacinumab as it is designed to avoid the Hoppe effect.
Now, ulilacinumab is safe and well tolerated. RP2D at 20 milligram per kilo is determining. It is also important to note that there's a good correlation between clinical response and a higher CD73 expression in the biosimilar tumors specimens. Now, the 3 tumor specimens with a higher CD73 expression match exactly with these 3 clinical responders. And they are the same patients as shown in the 3 red dots on the lower middle figure, Slide number 10.
And this is very exciting because it may provide the opportunity to stratify patient cancer patients who are more suitable to this combo therapy in order to increase the profitability of success. We'll be moving ahead to start a Phase 2 clinical trial in solid tumors in U. S. This year and continue to complete the current Phase II clinical trial in China in solid tumor. And we will have more data to share next year.
On a separate note, we are in continued discussions with selected pharma partners for potential global partnership for udelatinib. Now I will ask Doctor. Sen to elaborate on the progress in TGL-one hundred and 7, our long acting interleukin-seven for cancers and pronglodimab, our GM CSF antibody for cytokine release syndrome associated with severe COVID-nineteen. Doctor. Sun?
Thank you, Doctor. Jiang. So yes, for our pomodimab in Tj TGA M2, as we have reviewed earlier this month, our interim analysis results from our Phase twothree studies, This is a study designed for treating the cytokine releasing syndrome associated with severe COVID-nineteen. And the primary endpoint and second endpoint in from the interim analysis have shown a very positive trends. So in particularly, the patients without ventilation and baseline, a positive trend of 7% differences has been observed in treatment group of inverse placebo, which is very comparable to the effect size observed in lenizumab, which is another GMC cell for humanigen.
And the mortality rate is 5% in gromatinib comparing with 13% in placebo arm by day 30 and then approximately 10% improvement in recovery rates by day 14 and then day 30 in crosmanimab compared with placebo arm. So all of these are very major primary and secondary endpoints. And then safety wise, it's well tolerated. And then also, it's worth to note that the biomarkers listed in the slides have shown a positive trend also towards the clinical outcome. So moving forward, considering the delta outbreaks still ongoing in U.
S. And other countries, we're continuing these Phase twothree studies in the United States. But in the same time, we are also seeking to explore additional indications associated with CRS. Particularly, we are in provision for CRS associated with sepsis led by Professor. Shuanwen Hong from Hua Shan Hospital in Shanghai.
And then our R and D is prepared to submit before the end of this year. Next cycle. Yes. So for this, our epineptokin alpha, which is the TG-one hundred and 7, we have been a licensing from our partner, Genesent from Korea. Since then, we have conducted 2 studies.
First is Phase Ib studies for the patients with lymphopenia after chemo or radiation therapies. And these studies full results have demonstrated its safety profile and the PKPD correlations. And the full data set has submitted to Cisco this year, and it will be published then. The second study is our GBM study. It's for Phase II studies for the GBM patients.
This has been in full enrollment of this year. And then another exciting news is our partners, Genesys and its subsidiaries, NIT, have issued very exciting results both in GBM and also in another treatment in combination with PD-one. So based on those data sets, we are in full preparation for the 3rd studies, which is for also pembrolizumab combination therapy in our additional studies with solid tumors as a best kept trial design, in particularly to look at the TNBC and head and neck cancer patients and also guided by biomarkers. So these studies will also be initiated towards the end of this year. So I will give back Doctor.
Jiang to continue the rest of the presentation. Doctor. Jiang, please.
Yes. Thank you, Doctor. Chen. Now let's move on to discuss about our efforts and progress in generating the next generation of innovative assets to expand our pipeline. On Slide 13, while we focus on delivering the clinical milestones of the 1st wave clinical assets, including the 6 core assets as we just discussed.
The company has made significant progress in generating the 2nd and the 3rd wave innovative assets. The first wave innovative assets represented a portfolio of highly differentiated monoclonal antibodies or fusion proteins such as lansoparlimab, unilablimab, felsatamab, enoblituzumab and so on. With 1 exception, they are all in Phase II or Phase III clinical trials and they are very advanced. The 2nd wave innovative assets are represented by bispecific antibodies with either first in cost or best in cost potential. The 2 most advanced bispecific antibodies, TJL1-fourteen BB and a TGA CD4B that's Cardin 18.2-fourteen BB are in Phase 1 clinical trials in the U.
S. Now the 3rd wave innovative assets are characterized by emerging portfolio of super antibodies that are enabled by transformative technologies. Some of the drug candidates are expected to advance to the R and D stage by the end of 2022 or 2023. We believe they represent truly cutting edge drug candidates in the field of oncology globally. On Slide 14, our bispecific antibody portfolio is designed to convert immunologically cold tumors that are resistant to immunotherapy, HOT tumors for better treatment efficacy.
More importantly, these bispecific antibodies are enabled to address the current unmet medical needs in oncology where a majority of cancer patients do not respond to checkpoint inhibitors. 2 most advanced assets, as I mentioned earlier, entered Phase 1 clinical trials in the U. S. Early this year. Both use the conditional activation of 41BB, which is an important differentiation to avoid systemic toxicity induced by 41BB.
Other bispecific antibodies are at preclinical stage moving towards R and D. Now on Slide 15, early this year, we announced a discovery initiative to generate the 3rd wave innovation. This new generation of antibodies are not regular monoclonal antibodies or bispecific antibodies. Internally, we call them super antibodies because they are enabled by transformative technologies to perform unique drug properties that are otherwise not possessed by regular antibodies. For example, we are working on drug candidates using our partners, messenger RNA platform to deliver formulated messenger RNA drugs that can produce therapeutic antibodies inside a patient body.
This is truly transformative if it's proven in clinical trials. Another example is to utilize complex platform to generate intracellular antibodies that can get into cells to target otherwise intractable intracellular drug targets. There are more examples here. We will continue to update you as we make a progress with this novel superantibodies. Now on Slide 16, we look forward to delivering a set of 15 critical milestones before the end of this year.
In the interest of time, I'm not going to go through the entire list but to mention a few critical milestones such as the start of registration of studies for Lanzepartumab and pre BLA milestones for TGL-one hundred and 1 and felsulfirumab second lung treatment. We're determined to meet these goals and set a solid foundation for even more advanced pipeline development in 2022 next year. Now let me switch gear to talk about how our pipeline will create short value and how we're going to build a future. On slide number 18, while we focus on our efforts and resources to deliver on the top line to create short term value, we have made great progress in building our future to transform the company on a clinical stage biotech to a global biopharma. Now more detailed administration is on Slide 19.
To achieve this goal within the next few years, firstly, we have been upgrading our global R and D and established a new R and D facility in San Diego to focus on translational medicine and formulation to support and facilitate our innovative top line globally. Secondly, we are on track with the construction of our manufacturing facility in Guangzhou. The pilot plant will be ready by mid next year and commercial production by end of 2023. As a matter of fact, our PD laboratory has already started to function to take down our CMC projects in Hangzhou. Thirdly, we have built our initial commercialization capability with a porting and a commercial strategy to move forward.
The team has already started to prepare for the product launch of felarsartumab. Our initial commercial strategy is really to focus on hematologic malignancies by leveraging our unique position with fealsartimeb as a backbone drug for multiple myeloma, 3rd line treatments, 2nd line treatments and potentially Swiss line treatments. Lanzoparlimab as a backbone drug for leukemia, AML, MDS as well as lymphoma when combined with a CD19 or CD20 antibody. Currently, we are actively seeking commercial partnerships and in licensing opportunities to further enrich our initial HemOn focused commercial portfolio to potentially become a leader in the HemOn therapeutic area in China. And the commercial portfolio for solid tumors will follow after 2024 with udelivlimab and other innovative assets moving from clinical trials towards BLA.
Now I will ask Doctor. Sun to discuss about some other items related to awards, recognition and how we made efforts to strengthen the company's corporate governance and social responsibilities. Doctor.
Sun? Thank you, Doctor. Chen. Yes, I just want to expand it a little bit on how we, as a company, continue to grow to take on the responsibilities as a reputable company. And then because of that, we have obtained numerous awards for our innovation and then our growth.
So on this slide, just to mention a few as you can see. So the first 1 is the Institution Investor Award for top ranking and top CFO and secondly is the T Plus Excellent Employer Award and the thirdly is the Top 50 Enterprise of technology power. Those are just representing of our recognitions by the industry and the society. Next slide. And as Doctor.
Zhen also mentioned, as we take on the steps for advancing our company, we also need to become a diversified and highly governed standard and socially responsible corporate. So we received the highest first time ESG rating among China based biotech companies from MSCI 2020, as you can see from the first 1. And we also build women leadership councils to promote female leaders' career development. We now have twothree of female employees and over 30% of women Board of Directors. We have also newly formed independent ESG committee with me and 2 other independent Board members as a committee to set over the ESG strategies.
We also made multiple donations for disaster reliefs, including donations of medical supplies and COVID-nineteen outbreaks and donations to Henan Charity General Federations for the rescue and restructuring of the flaccid regions in Henan Province and etcetera. So our company continue to build the infrastructure as well as the overall organization and governance to become more reputable and representative of our societies. So from there, I will let the Jie Lun to continue the financial report. Jie Lun, please.
Thank you, Doctor. Chen. Now let me turn to review our financial results for the 6 months ended June 30, 2021. That's on Slide 23. First of all, as of June 30, 2021, total cash, meaning cash, cash equivalents, restricted cash and short term investments, totaled RMB4.8 billion or US79.2 million dollars compared with RMB4.8 billion as of December 31, 2020.
We are very well capitalized for the size of the opportunities in front of us and our vision to become a fully integrated biopharma company. Our strong cash balance provides sufficient funding and the strategic flexibility through major value creating milestones in relation to TJ-two 0 2, TJ-one hundred and 1, TJC-four and TJD-five over the next 1 to 2 years. Now let me turn to the revenue side. For the 6 months ended June 30, 2021, net revenues were RMB17.8 million or US2.8 million dollars compared with NIO for the 6 months ended 2020. Revenues generated for the 6 months ended June 30, 2021, solely consisted of revenues recognized in connection with I Mab's strategic collaboration with AbbVie, and our collaboration with AbbVie has been going very well.
Now let me turn to the R and D expenses. Total R and D expenses, meaning the core R and D expenses plus the ESOP related share based compensation for the 6 months earlier this year were RMB593 million or $91, 800, 000 compared with RMB442.3 million for the same period in 2020. The increase in total R and D expenses was primarily due to the increased CRO service fees to advance the company's broad pipeline, especially for key assets, including lamzoparlimab, TJC-four milliladlimab, TJD-five and the abdensolmetropine alpha TJC101. Now within the total R and D expenses, as you can see, we have broken down for you the cash versus non cash expenses. So the non cash share based compensation expenses accounted for RMB112.7 million or $17, 500, 000 for the 6 months ended June 2021, compared with RMB132, 700, 000 for the 6 months ended June 30, 2020.
The overall growth in R and D expenses for the 6 months earlier this year reflected the rapid growth or progress of the company's pipeline assets. Now let me turn to administrative expenses. Total administrative expenses for the months ended June 30, 2021 were RMB451.5 million or US69.9 million dollars compared to RMB171.4 million for the same period in 2020. The increase was primarily due to higher share based compensation expenses, which we have broken out for you here, increased professional service expenses, including 1 time expenses and expansion in payroll as a result of increased headcount, driven by new hires we have made in preparation for the company's future commercialization and the product launch in China. Within the total administrative expenses, share based compensation expenses accounted for RMB222 1, 000, 000 or $34, 400, 000 for the 6 months ended June 30, 2021, compared with RMB97.1 million for the 6 months last year.
1 time expenses, which consisted of listing related expenses and other expenses, were RMB69.9 million or US10.8 million dollars for the 6 months ended June 30, 2021. There were no 1 time expenses 1 time administrative expenses for the same period last year. Now if you look at the core administrative expenses without the share based compensation and the 1 time fees, they track the growth in our non R and D staff base and the operating footprint very well and demonstrate the necessary investment we are already making for commercialization in China. Now 1 more point, the last point on expenses. I would say that the broad expense profile with the core R and D and administrative expenses is highly consistent with our strategic ambition of transitioning into a fully integrated biopharma company, built on strong internal R and D, partnership, manufacturing and commercialization capabilities.
We are investing for the future. Last 1 on the P and L. For the 6 months ended June 30, 2021, I Mab reported a GAAP net loss of RMB1.07 billion or US166.7 million dollars compared with a GAAP net loss of RMB582.9 million for the same period in 2020. Non GAAP net loss, which excludes the share based compensation expenses, was RMB729.4 million or US113 $1, 000, 000 compared with non GAAP net loss of US353.1 million dollars for the same period in 2020. Next page.
This is the last page in the prepared remarks section. In this page, I want to give you a quick update on where we are in preparing for the dual listings in Greater China. Our Board approved the preliminary listing plan on the STAR market in Shanghai in late July and we subsequently entered into a tutoring agreement with CICC, 1 of the most well known investment banks in China to kick off the process. The tutoring application package was accepted and registered with the Shanghai branch, Shanghai Bureau of the China Securities Regulatory Commission on August 20. In the meantime, we are also taking steps to plan an additional listing in Hong Kong's Chapter 18A market.
We strongly believe that the dual listings will broaden and diversify our existing shareholder base, de risk some of the geopolitical concerns and potentially bring down our overall cost of capital. We expect these dual listings to be completed by the end of 2022. Now with that, we'd like to end the prepared remarks for this call and start the Q and A session. Please ask your question by pressing the raise your hand button in the Zoom panel. We'll take your questions 1 by 1.
Thank you.
Thank you for the detailed and deep dive update. Now we'll have started Q and A session. So if you have questions, please use the raise your hand function via Zoom, and we will unmute you in orders. Our first question comes from Terry
Congrats on the progress and thank you for taking my questions. On the prolineb, what level of details should we expect for the top line readout of our HER trial at ASH? And what is the efficacy bar for this program to move forward? And my second question is for the partnership with AbbVie, when do you expect the next milestone payment? And also, any solid tumor trials in discussion will be led by FDA in the U.
S? Thank you very much.
Yes. Thank you, Kelly. This is Jing Wu. Let me first address your first question. Now our U.
S. Trial of the lenzoparumab in combination with rituximab in patients with non Hodgkin's lymphoma showed really excellent clinical results. Firstly, it has further confirmed the safety profile of lanceopalimab. Again, in this trial, the safety is very good and we did not give patients a primary dose because it was not needed because of the safety profile. Secondly, we observed very encouraging clinical efficacy signals.
Although at this time, I'm not in a position to give you all the details. But as I mentioned, the past few months, we submitted an abstract to ASH this year and we are prepared to release the clinical data at ASH in November. And hopefully, if possible, we will find an opportunity to release the data earlier. Now Kelly, let me emphasize 3 points regarding lenzupatinib. First of all, in terms of the speed of clinical development, as we discussed, our ambition is to launch Lanzupatinib as the first CD47 antibody product in China and also help ecobee to achieve the global registration.
And we have been accelerating multiple clinical programs by leveraging the advantages in both U. S. And China. Now as a result, we have 3 parallel lines of clinical development, non Hodgkin's lymphoma, AML, MDSS solid tumors. And we have made remarkable progress in all 3 lines.
Now most importantly, we're very excited that the current progress may potentially lead to registrational trials in 2022 next year. And this is a really good speed to move this asset into a late stage or pivotal stage of development. Now second point is that in terms of safety advantages of lansoparlimab, so far there are a total of 86 patients have been dosed in the U. S. In the trials in the U.
S. And China. The safety profile remains very good and no priming dose is needed in our clinical trials and together they are important clinical differentiation. But clearly, the 3rd point is in terms of clinical efficacy. We have seen good clinical efficacy signals in solid tumors with monotherapy of Lenzepartumab as we reported last year.
We expect to see even better efficacy signals in selected tumor types from our current clinical trials in combination with pembro. This is a combo study and we hope to see a better clinical efficacy signal. We have seen we have also seen a very encouraging clinical efficacy signals in non Hodgkin's lymphoma in combination with rituximab as I mentioned earlier. We submitted this abstract already. At the same time, in our abbreviated Phase 2 clinical trial in China, we've also seen very encouraging clinical efficacy signal in patients with AML MDS in combination with AZA.
Now at this point, although the efficacy data are preliminary at this time, they are among the best efficacy signals seen so far with clinical stage CD47 antibodies around the world. Now for the second question, I would direct to Jieren to talk about payments, the expected payments from AbbVie.
Sure. Thank you, Doctor. Zhang, and thanks Kelly for the question. So let me address your question regarding the IV payments. We expect to receive 3 payments, 3 milestone 3 additional milestone payments in the next 12 to 18 months.
The next milestone payment we expect to receive second half of this year, that's a $50, 000, 000 payment. And then the following 2 payments successively will be received sometime next year. Those 2 are related to the initiation of pivotal trials to be initiated by AbbVie in the U. S. The total from the 3 payments will be $175, 000, 000 in total.
In addition to that, as Doctor. Zena alluded to earlier in the presentation, we also have the RMB10 1, 000, 000, 000 we also have the bispecific program, which is part of the scope of the partnership we signed last year. They will also if we move forward with AbbVie on that, they will also bring additional upfront payment and milestone payments. Now let me broaden my answer a little bit. In addition to our continued payment streams from AbbVie, we also have existing partnerships with other players like CSPC in China.
In addition, we are also as we've discussed in the earlier part of the presentation, we we're also looking at potential partnerships for TZD5, udilabimab and the commercial partnership in relation to the long acting growth hormone and perhaps other assets, innovative assets in our pipeline. Those additional milestone payments from existing partners and also new milestone payments and upfront payments from potential new partners will bring 100 of 1, 000, 000 of dollars over the next 1 or 2 years if things progress well. So we are very confident about our about the visibility and the stability of our top line and the earnings as we move forward, because we have a model where we can realize significant value of our pipeline assets before they are even brought to the market by doing the POC studies in the U. S. And the striking very, very good partnerships with players, big players outside of China.
So I just want to emphasize that and it's important to look at that as we move forward in our next few reporting cycles.
Thank you, Doctor. Zhang and thank you, Jialun. Our next question comes from Louise Chen. Please go ahead, Louise.
Hi. This is Jen Kim on for Louise. Thanks so much for taking our questions and congrats on all the progress. We had 1 broader question. So there have been a lot of headlines regarding, I guess, regulatory uncertainty around China.
Can you walk us through how you're navigating through this uncertainty and how you think about your fundamental value as an innovative player in the biotech space? Thanks.
Thank you, Luis. I would ask Jialen to elaborate on this question.
Thank you for the question. A very good question. I will try to answer your question perhaps on 3 to 4 different levels. First, let me start with the broad macro picture, which we have no control over, but it's important anyways. I think the regulations in China, they are targeting the Internet giants that show the tendency to monopolize as well as sort of sensitive industries like the tutoring industry and the food delivery and so on and so forth.
But based on our own experience dealing with regulators and different levels of government in China, we strongly believe that biotech is not only an industry that they will not target, but is actually 1 of the industries that they are actively promoting. It is very important to realize that biotech industry is 1 of the hard tech industries in China, which will help create a lot of social benefits and externalities for the government in China. So it's important to realize that. And also because biotech industry is not an industry where foreign ownership is banned or restricted, So most of as I remember, as far as I can remember, all of the biotech companies do not need to adopt the VIE structure, which is also I believe 1 of the topics that brought some concerns from investors. So short answer on the macro picture is we think and I think most of our peers would agree that biotech industry will actually receive increasingly more support from the government in the from different levels of government in China.
And I would add to this point that recently, if you look at some of the Western KOLs, for example, Ray Dalio from Bridgewater, the Head of MSCI China and the Capital Group, they've all made relatively optimistic remarks about the what's called the investability of Chinese stock market and also overall the picture about regulation in China. So I would encourage you to look at that as well. I think the second point is in relation to our own business model and the quality of our assets. We have a very, very highly differentiated pipeline. Our pipeline has either 1st mover assets or highly differentiated potentially best in class assets, both in China and globally.
So we think that some of the issues you may be seeing in China, for example, the cost containment from the NRDL, perhaps in relation to sectors like PD-one, we think we're relatively insulated from that because, a, our assets, for example, CD47, lamzopolymab, most of the value we think will be coming from territories outside of China, for example, by our partnership with AbbVie. And we'll continue to do that for other assets like CD73 and other assets down the road. So if you look at a lifecycle of assets like that, we think that the economic value of these assets will not be limited. Most of the value will not be limited to the market in China. Secondly, even in the Chinese marketplace, because we're not in crowded or super crowded sectors like PD-one or PD L1 and maybe others, our experience and estimation is that because of the highly differentiated nature of our assets and the less crowded competition structure in these segments, we think we'll face a less harsh or more accommodative pricing structure in China, even in the Chinese marketplace.
So if you combine these 2 points, we think we're relatively well positioned in terms of dealing with some of the potential headwinds you may be seeing in the NRDL tendering process. The third point I want to make is, as I discussed the financial section in the early part of this call, we're actually actively diversifying our listing values. So we have kicked off the store market listing process in Shanghai. We're also considering an additional dual listing in Hong Kong. All of that will also help us to manage some of the geopolitical risk and also diversify our shareholder base.
And I think potentially, it probably will also lower our overall cost of capital. So very, very good. We think we're making very good moves to manage that part of the risk space. And then lastly, the biopharma sector or biotech sector in China has seen some relatively big volatilities in the last few weeks, and we're probably no exception to that. But I want to emphasize that the volatility in the stock price has nothing to do with our fundamentals.
As you can see, we're making so much progress in the last in the 1st 6 months of this year. We're actually making significantly more progress than we thought when we did the business planning at the end of last year or beginning of this year. We are very, very happy with where we are and we're optimistic about the future of this company. We had been in close communication with some of the major shareholders of the company and they share the same view with us and they are they remain long term supporters of the company. So I want to end on that note and give the flow back to the host.
Thank you, Dylan. Due to time limitation, we will take 1 last question. So the last question comes from Joe Catanzaro. Joe, please.
Great. Thanks so much for taking my questions and congrats on all the progress. Maybe 2 quick ones from me. So you guys are pretty specifically
thinking
specifically thinking about ulevalumab and what partner deal terms you're interested in there and maybe whether we could see a potentially similar deal term and structure as the AbbVie Lenzo partnership? And then as a follow-up, Doctor. Zhang, you mentioned longer term value creation coming from the growing early stage pipeline. So maybe as we look beyond some of the mid later stage assets, what programs do you see as having significant opportunity for value creation with some early proof of concept data over the next couple of years? Thanks.
All right. Thank you, Joe. Great questions. Let me first address your first question on the BD side of things. We are actually working on several assets for potential BD partnerships globally and also domestically in China.
On the global front, we have been discussing with potential global partners for partnerships for TJD5, uililadolumab, as I mentioned earlier. We're actually in discussion with several other companies for bispecific antibodies or even newer assets coming from our pipeline. So those deals are very similar to the deals we made last year with AbbVie on lens of Panama. And we're very excited and moving forward continue moving forward with those discussions. And at 1 point, we would feel comfortable to release the terms and discuss those deals.
So that's 1. And on the second front, we are in turn sheet with several companies and we are about to select 1 company to solidify our commercial discussion for TGA101, our long acting growth hormone. And this is going to be a big and visible deal in China and exemplifies or signifies how biotech companies like I Mab working together or partnering with big pharmaceutical groups in China in order to maximize the value of our commercial products like long acting goes home. And at the same time, this year we have successfully closed 7 BDOs and those are relatively early stage assets. I talked about messenger RNA platform.
I talked about complex intracellular platform. So those deals will help us to build the 3rd wave innovation with the super antibodies as mentioned earlier. So altogether, we're very active on the BD France globally and domestically in China. And hopefully before the end of this year, we might be in a position to close a few deals. If not, it will be early next year.
So we're quite excited to look forward to it. Now your second question, as discussed today in our presentation, our pipeline is a very innovative and clinically advanced and quite rich with the 3 waves of innovation. Now in addition to lancelloparumab, ulielaglimab
and pramadimab
that are highly visible in our pipeline. There are actually a few other exciting assets that are making their ways towards late stage and to the same level of excitements. 1 is TGA-one hundred and 7. We discussed a little bit about this particular asset. This is a Phase II asset we are working on in China.
So we have already started a Phase 2 clinical trial in patients with GEM and the other clinical trial we are about to start Phase II trial in combination with pembro for cancer treatments. So this is a very exciting asset now moving towards late stage. By next year, we shall have more data to report. And it's important to mention that our partner from South Korea has generated quite a lot of data in relation to the role of TGA-one hundred and 7 in the treatment of cancers in terms of combination therapy with pembro in patients with triple negative breast cancer. They have seen pretty good ORR way above monotherapy with pembroke.
And they have also seen very good efficacy signals from their trials in patients with GBM. So this is an important asset moving toward late stage and it becomes more and more visible. And the other assets is and noveltuzumab, the B7H3 assets, It's also a Phase II asset we licensed for Microgenics. And we have done quite a lot of internal work with a preclinical stage. And we pretty much based on all the data, we pretty much picked out how to move forward very quickly to get through Phase II, Phase III and to launch the product.
And the strategy is quite clear. Now people will hear more about the progress on this particular Phase 2 asset. Now since we have few minutes, maybe I would ask June to see whether you have additional points to add.
Okay. Yes. Thanks, Doctor. Jain. I just want to probably elaborate a little bit more on both compounds, which are both in the Phase III stages.
So for our TGA-one hundred and 7, which is being produced a lot of data from our partner, Genexent and its subsidiaries, NIT. So in particularly, on their you can check that out from their webpage. At their report on the GBM studies, the ALC increases by 1 to 4 folds and a 1 year survival rate of 83.3%, which is definitely above the standard of care. So another important data we also presented on last year's CITIC showed a combination treatment with pembro achieved an ORR of 28% on the TNBC. So this is also very encouraging.
So we are going to we have submitted the IND to pursue the basket trial design on this TNBC as well as head and neck cancers and also a few other tumor types guided by our translational medicines. And so this is 1 study. The other 1 in NAFLING, which Doctor. Also Doctor. Zhen mentioned earlier, we had quite a few exciting data coming out of our translational medicine work.
In addition to the Microgenics Phase II data, we believe it has great potentials for combination treatment for solid tumors, especially its combination with checkpoint inhibitors as well as other chemo combos. So we are also submitting the IND actually September this month for a back speech trial design for pursuing the solid tumor types, including lung cancers. So these 2 are also in full speed for Phase II. Hopefully, in the near future, we can accelerate it to the registration trials. So I want you to start from here.
Thank you, Dong and Doctor. Shen. And thank you, everyone, for joining our meeting today. So if you have further questions about IMAX, please feel free to reach out to the IR team. And we hope to connect with you in other formats soon.
Have a good day. Bye bye. Thank you.
Thank you, everybody.
Have a
good day and a good night. Bye
bye. Bye.