NovaBridge Biosciences (NBP) 2020 Q2 法說會逐字稿

Good day, ladies and gentlemen. Thank you for standing by, and welcome to the I-Mab Biopharma 2020 Interim Financial Results and Business Update Conference Call. (Operator Instructions)

It is now my pleasure to turn the call over to Jielun Zhu, I-Mab's Chief Financial Officer and Director. Please go ahead, Mr. Zhu.

Thank you, Rachel. Welcome to the I-Mab 2020 Interim Financial Results and the Business Update Conference Call. Earlier this evening, we issued a press release providing a review of our financial results for the 6 months ended June 30, 2020, as well as an overview of our recent corporate highlights and upcoming milestones. The press release can be accessed on the Investors portion of our corporate website, at http://ir.i-mabbiopharma.com/.

Joining me today on the call from I-Mab's senior management team are Dr. Jingwu Zang, our Founder, Honorary Chairman and Director; Dr. Joan Shen, our Chief Executive Officer and Director; and Mr. Yifei Zhu, our Chief Commercial Officer. Mr. Zhu recently joined I-Mab and will be driving our commercialization efforts in preparation of our first product launch in China.

Dr. Zang will provide a high-level overview of our recent achievements and upcoming milestones. And Dr. Shen will comment on the status of our key development programs in greater detail. I will then provide a brief summary of our financial results for the 6 months ended June 30, 2020, before we turn the call back over to the operator so we may take your questions.

Please note the discussion today will contain forward-looking statements relating to the Company's future performance and are intended to qualify for the Safe Harbor from liability, as established by the U.S. Private Securities Litigation Reform Act. Such statements are not guarantees of future performance and are subject to certain risks and uncertainties, assumptions and other factors. Some of these risks are beyond the Company's control and could cause actual results to differ materially from those mentioned in today's press release and this discussion.

A general discussion of the risk factors that could affect I-Mab's business and the financial results is included in certain filings of the Company with the Securities and Exchange Commission. The Company does not undertake any obligation to update this forward-looking information, except as required by law.

During today's call, we will also discuss certain non-GAAP financial measures for comparison purposes only. For a definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial measures, please see the financial results news release issued earlier today.

Now I will turn the call over to Dr. Jingwu Zang, our Founder, Honorary Chairman and Director. Dr. Zang, please go ahead.

Thank you, Jielun. Thank you all for joining us today. I'm very pleased to welcome all of you to our 2020 interim financial results and business update conference call.

This is an exciting time for I-Mab. We have made substantial progress in pipeline development as well as corporate development over the last several months. And we are on our way to becoming a leading, fully integrated global [biopharmaceutical] (corrected by the company after the call) company.

Firstly, on the pipeline development side. We continue to make remarkable progress across all programs in our pipeline. Lemzoparlimab or TJC4 is an exciting drug molecule discovered and developed internally. And it is highly differentiated from some other clinical stage anti-CD47 molecules in development. We have recently completed the Phase I, dose-escalation clinical trial in the U.S. and the results have largely validated the key differentiations of lemzoparlimab in safety and a favorable [pharmacokinetics] (corrected by the company after the call) profile in cancer patients. Joan will provide more details on the clinical data as well as our clinical development plan for lemzoparlimab in a few minutes.

TJD5, our differentiated anti-CD73 antibody, continues to advance in a Phase I dose-escalation clinical trial in patients with advanced solid tumors in the U.S., and our parallel clinical trial with TJD5 in combination with PD-1 antibody is on track in China. We look forward to safety [data] (added by the company after the call) and PK/PD results from our U.S. trial that are expected to be available in the fourth quarter of 2020. Like CD47, we believe CD73 represents another promising immuno-oncology target that may make a significant difference in the treatment of cancers.

TJM2, our anti-GM-CSF antibody, is currently being evaluated for its role in the treatment of cytokine release syndrome associated with severe COVID-19. This development program exemplifies not only our commitment to innovation to deliver new therapeutic approaches to address unmet medical need, but also our ability to leverage our strength in regulatory and clinical development capabilities to quickly react to a global health crisis such as COVID-19. We are now on track to advance an ongoing [Part 2] (added by the company after the call) randomized, placebo-controlled pivotal clinical study to evaluate the efficacy, safety and cytokine levels in 120 patients with severe COVID-19 in the U.S. Now in addition, we recently initiated a Phase 1b study with TJM2 in patients with rheumatoid arthritis.

TJ202, our CD38 antibody in our China portfolio, is being evaluated in two parallel registrational studies in China for the treatment of multiple myeloma. The trials are on track for patient recruitment in 2020. We expect to file a BLA for TJ202 around mid-2021 or in the third quarter in 2021.

We also look forward to progressing the ongoing Phase II clinical trial for TJ301, our differentiated interleukin-6 inhibitor, towards completion, in patients with ulcerative colitis.

Further, we expect to obtain R&D approval for a registrational trial for TJ101, our long-acting growth hormone for pediatric growth hormone deficiency. Similarly, we plan to initiate a Phase II clinical trial for TJ107, our long-acting interleukin 7, for glioblastoma patients with lymphopenia. We're very excited about getting these 2 clinical assets started in Phase II and Phase III clinical trials, respectively.

Secondly, on the corporate development side, while rapidly advancing our pipeline developments with great execution efficiency, we have begun to build our commercialization capabilities. In this regard, I want to highlight the recent appointment of Mr. Ivan Yifei Zhu as our Chief Commercial Officer.

Mr. Zhu has more than 20 years of successful commercialization experience and held senior executive positions at global, domestic pharma and biotech companies. He will focus on building and developing I-Mab's commercialization infrastructure, strategies and preparing the Company for future product launches. Mr. Zhu is a great addition to our management team.

As part of I-Mab's plan to expand our global footprint, in May, we've announced the opening of I-Mab's Hong Kong office, serving as a regional hub for the Company's capital markets and Investor Relations activities. In addition, we plan on building an R&D center in San Diego starting in late 2020, to focus on translational medicine, biomarker analysis and innovative formulation research, which will support the rapid progression of innovative pipeline globally.

As I mentioned at the outset, I-Mab is well positioned to become a leading, fully integrated, global biopharma company focusing on immuno-oncology. With more and more clinical milestones achieved, the innovative potential of our pipeline has become more visible and validated, as exemplified by lemzoparlimab or TJC4. Looking ahead, we are very excited and confident in our science and increasing capabilities to deliver value, through innovation to patients as well as for our shareholders.

Thank you for your attention. I will now turn the call over to Dr. Joan Shen, our CEO, who will review the status of our key development programs in greater detail. Dr. Shen?

Thank you, Dr. Zang. Now I will be focusing my discussion on our Fast-to-Proof-of-Concept portfolio first. Today, my focus is the 3 molecules: lemzoparlimab or TJC4, uliledlimab or TJC5, and plonmarlimab or TJM2. These programs are currently simultaneously developing in both U.S. and China.

The first one is our TJC4 or lemzoparlimab which, as Dr. Zang mentioned earlier, is our highly differentiated CD47 antibody. It is designed to [minimize] (added by the company after the call) inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating it from other antibodies of the same class currently in development. There are 2 Phase I/II studies ongoing in both U.S. and China.

In U.S., as Dr. Zang mentioned, we have recently completed the first part of the study which is the dose-escalation study demonstrating the tolerability, safety and the PK profile without any priming dosing strategies. The study has conducted a dose range of 1 to 30 milligrams per kilo. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. The full clinical data will be released separately and presented at an appropriate scientific conference later this year. Please stay tuned.

The same study has been now proceeded as planned into a combination treatment with pembrolizumab in patients with severe type of solid tumors through a collaboration with [MSD] (corrected by the company after the call) and is also proceeded with a combination treatment with Rituximab in patients with Non-Hodgkin's lymphoma.

Simultaneously, in China, we are also developing Phase I/II trials in patients with hematologic malignancies such as relapsed or refractory AML and MDS. Despite the COVID-19 interference, the trial is ongoing smoothly, and data from this trial are expected to be available in early 2021.

The second compound I'm going to share with you is our TJD5 or uliledlimab. It is a differentiated CD73 antibody. As Dr. Zang mentioned, it represents another promising immuno-oncology target under clinical development globally. We believe the key differentiation when compared to some of the other clinical stage antibodies of the same class is related to its novel epitope, which works through a unique intra-dimer binding mode, resulting in a complete inhibition of the enzymatic activity and avoiding the aberrant pharmacologic property known as the "hook effect".

It is currently being evaluated in U.S. in a Phase I dose escalation study in combination with [atezolizumab] (corrected by the company after the call), which is under collaboration with Roche. We are assessing the safety, tolerability and preliminary efficacy. The preliminary data are expected in the fourth quarter of 2020.

In the same time, uliledlimab is being evaluated in another Phase I study in China for its safety, tolerability, PK/PD and potential efficacy, primarily in patients with solid tumors, including lung cancer, as a single agent and the combination therapy with a PD-1 inhibitor in collaboration with Junshi [Biosciences] (corrected by the company after the call).

Now the third compound, TJM2 or plonmarlimab. This is our neutralizing antibody targeting the GM-CSF, an important cytokine that plays a very critical role in acute and chronic inflammation. As we reported earlier, since March, we are developing it to treat severe patients with CRS associated with COVID-19.

This study has been divided in 2 parts. First part is a multi-center, double-blind, randomized, placebo-controlled, three-arm study to assess mostly the safety profiles. We were able to complete the study in early May. It has been demonstrated, assessed by a safety committee which gave us green light for proceeding to the second part.

The second part is focusing on assessing the efficacy, safety and tolerability. As Dr. Zang mentioned, it's a much larger scale of the study, which currently is ongoing smoothly in the United States. We are also in discussion with the FDA closely to finalize our clinical protocol, making it a potential registrational trial in the United States.

As Dr. Zang mentioned, again, we recently initiated a multiple-dose, Phase 1b study with plonmarlimab in patients with rheumatoid arthritis in China. We are also proceeding this for additional indications in autoimmune disease areas as well as some of the rare diseases. In the same time, we will also look at the prevention and the treatment of CRS associated with CAR-T treatment.

Beyond these 3 product candidates, our early-stage pipeline of novel monoclonal antibodies is rapidly advancing towards clinical development in both the U.S. and China. We expect a series of IND submissions to the United States FDA, including for TJ210. This is a novel monoclonal antibody directed at C5aR for cancers through a partnership with MorphoSys. We also plan to initiate development of TJ210 in China.

Another exciting early-stage program is our TJ-CD4B, a duel targeting property combining Claudin 18.2 and 4-1BB that is uniquely structured to supercharge T cells in a Claudin 18.2-dependent manner, enhancing anti-tumor immunity while potentially minimizing toxicity. In June 2020, I-Mab and ABL Bio, our partner, presented this preclinical data on this highly novel asset at AACR Virtual Annual Meeting. We expect to file a U.S. IND in early next year.

Now I will move on to our Fast to Market China portfolio. TJ202 or felzartamab is a differentiated CD38 antibody originally developed by our partner, MorphoSys. We own an exclusive license to develop and commercialize in Greater China. It is currently in development for the indication of multiple myeloma and autoimmune diseases such as SLE.

We believe felzartamab is potentially highly differentiated compared with the currently marketed CD38 antibody. First, in a similar pre-medication condition such as with dexamethasone, TJ202 has demonstrated a significantly shorter infusion time and a lower infusion reaction rate. Secondly, unlike the current marketed CD38 antibody, it does not show to down-regulate CD38 expression on the surface of bone marrow myeloma cells in vitro, potentially maintaining the sensitivity of myeloma cells for repeated treatment.

As Dr. Zang mentioned, we are conducting 2 parallel registrational trials as a third-line monotherapy and a second-line combination treatment with lenalidomide, both in patients with multiple myeloma in Taiwan and the Mainland, simultaneously. These 2 trials are all ongoing, and the recruitment progression remains on track. The Company expects to complete a BLA submission in 2021 as we targeted. This will be our company's first BLA submission.

Now another Phase III compound, TJ101 or eftansomatropin, which is originally developed by Genexine. This is a very highly differentiated long-acting growth hormone that is being developed as a weekly injectable treatment for pediatric growth hormone deficiency as compared to currently available daily regimens. We believe it has the potential to address an important clinical need and to cover a significant market gap. Our IND application for a registrational trial has been accepted in June of this year, and we expect to obtain the IND approval in the fourth quarter of 2020.

For TJ107 or efineptakin alfa, we expect to initiate a Phase II clinical trial in lymphopenic patients with newly diagnosed GBM in the fourth quarter of 2020.

Lastly, for our TJ301 or olamkicept, our IL-6 inhibitor, we are conducting a Phase II clinical trial in ulcerative colitis. We expect to complete the recruitment in September actually for 90 patients, and then the top line results are expected to be released by early 2021. After clinical efficacy and differentiations are validated, we plan to develop it in other inflammatory indications in which IL-6 plays a role.

With that update, I will now turn the call back to Jielun who will discuss our financial results. Jielun?

Thank you, Joan. Now let me turn to review our financial results for the 6 months ended June 30, 2020.

As of June 30, 2020, cash and cash equivalents, restricted cash and short-term investments totaled RMB1.6 billion, or USD221.1 million, compared with RMB1.2 billion as of December 31, 2019.

Now let me turn to the revenue. For the 6 months ended June 30, 2020, net revenues were nil, compared with RMB15 million for the 6 months ended June 30, 2019.

Now R&D expenses. R&D expenses for the 6 months ended June 30, 2020, were RMB442.3 million, or USD62.6 million, compared to RMB265.1 million for the same period in 2019. The increase in R&D expenses was primarily due to increases in our CRO service fees to advance the Company's pipelines, higher share-based compensation and higher employee salary and benefits expenses due to increased research and development head count.

Now the administrative expenses. Administrative expenses for the 6 months ended June 30, 2020, were RMB171.4 million, or USD24.3 million, compared to RMB574.6 million for the same period in 2019. The decrease was primarily due to reduced share-based compensation expenses of RMB268.9 million, or USD38.1 million.

For the 6 months ended June 30, 2020, I-Mab reported a net loss of RMB582.9 million, or USD82.5 million, compared to a net loss of RMB857.3 million for the same period in 2019. Non-GAAP net loss, which excludes the share-based compensation expenses, was RMB353.1 million, or approximately USD50 million, compared with a non-GAAP net loss of RMB491 million for the same period in 2019.

With that, we would like now to turn the call back over to the operator so we can go ahead and take your questions. Rachel?

(Operator Instructions) Your first question comes from the line of Xipeng Feng of CICC.

This is Xipeng Feng from CICC, and congratulations on the excellent pipeline results.

We can't hear you. Can you get closer to the phone?

Okay. How about this? Can you hear me now?

It's better.

Okay. This is Xipeng Feng from CICC, and congratulations on the excellent pipeline results. I have 2 questions actually. And firstly, it's about CD47 antibody or lemzoparlimab. Well, I noticed that no DLT or severe hematologic adverse events were observed in all DLT-evaluable patients. And now I think the market may keep an eye on the future R&D plan regarding the potential indications and even specific programs. And currently, we see combo therapies for CD47 antibody and we also noticed that the Company has already achieved a layout in the CD47-related bispecific programs, well, including CD47 and PD-L1, CD47 and GM-CSF. I just wonder, could you please share some more colors on future R&D plans on these bispecific?

All right. This is Jingwu Zang. Maybe I can take your question. You have 2 questions. Maybe I'll start to first address your question related to bispecific antibodies. In our pipeline, we do have 2 CD47-related bispecific programs. Both of them, at this point, are at CMC, preclinical stage.

One is CD47 GM-CSF which is designed as a fortified CD47 antibody to more effectively treat solid tumor as GM-CSF works synergistically to enhance tumor-killing M1 macrophage. Okay. We're quite excited about this molecule because it's specifically designed to enhance intended clinical efficacy for solid tumor through activation of M1 macrophage.

The other bispecific program is CD47, PD-L1. We are also quite excited about this program because it is designed to combine 2 powerful immune pathways, PD-L1 and CD47, to work together to achieve a better treatment efficacy.

We are, at this point, advancing both programs in the CMC and preclinical stage. And we expect to file IND sometime next year in the U.S. to get clinical trials started. We're very excited about these 2 programs because we believe that they have an intrinsic quality to become potentially a second-generation CD47 treatments. This is the first question.

The second question is related to our program -- CD47 program. As we just mentioned on this call, we just completed the dose escalation study just a few weeks ago. Now we are in the process of analyzing and digesting all the clinical data, PK/PD data we recently generated from both our U.S. trial and China study. Now we are currently finalizing our clinical development plan.

Today, I don't have all the details for our clinical development plan to share with you, but I can tell you that our strategy for clinical development of TJC4 is twofold. First, we will focus on AML and MDS as the first indications for product registration, both in the U.S. and China. Okay. And our ongoing trial in China will expand to a pivotal study aiming for registration. And we will start a parallel clinical trial in patients with AML, MDS in the U.S. sometime soon next year. The first purpose is really for registration for AML, MDS.

Now secondly, we are also working on solid tumors. And currently, in the U.S. trial, we will expand to a combination study with PD-1 antibody for solid tumor and also with Rituxan for Non-Hodgkin's lymphoma. And we will soon get a trial advanced to a certain point where we can collect sufficient data to make a judgment in terms of safety and some early efficacy signal. Now the solid tumor studies will be carried out both in the U.S. and China very soon.

Okay. And actually, the CD47 antibody is my first question. And my second question is about the TJM2 or plonmarlimab. And I just wonder would it be possible that this Phase II study for cytokine release syndrome can be or may be regarded as a registrational trial? And what's the potential attitude from FDA?

Yes. I would direct your question to Joan to address.

Yes. I think you've got the right point. We have successfully like advanced it from Phase I to Phase II by having like smaller trials. We've been focusing in safety early in May, now we are full Phase II. Exactly like you wondered, we started the communication with FDA. And then we are in the final stage of completing or making agreement of our endpoint and the population. Most likely, we will be able to advance to the potential registrational trial from here now.

Okay. Congratulations again for your excellent pipeline results.

Your next question comes from the line of Louise Chen of Cantor.

Congratulations on the TJC4 data today. So I had 3 questions for you. First one is, how have health care reforms created an opportunity for China-based biotechs to become innovative organizations? Second question is, do you believe the domestic Chinese market could become a leading market globally? And if so, when would that be? 3 years, 5 years, 7 years from now? And then last question is where would TJD5 fit into the treatment paradigm if it is approved and why?

Thank you for the question. For the first 2 questions, I would like to direct them to Jielun, our CFO. Jielun, could you elaborate on the first 2 questions?

Sure, Dr. Zang. I'm trying to remember your 2 questions. The first one is about how health care reforms presented an opportunity for China-based biotechs to become more innovative. I think we share this view with a lot of our peers that this is the golden age for China-based biotech companies to grow and become globally competitive. There is a confluence of a number of driving forces that have, sort of, converged to make this happened.

The first one is, obviously, on the regulatory side with China entering the global ICH system with more reforms in the drug approval process, making it possible for scientific and clinical data to be exchanged more freely cross-border and introducing more flexibility in the drug approval process. This is something that we haven't really seen 5 or 10 years ago. But we are now seeing a lot of the flexibility being injected into the drug approval process.

The second factor, I think, is related to funding or financing. We have seen just an exploding growth from biotech VC and PEs, both outside of China and also in China, funding a lot of the promising biotech ventures from funding phase also through to the IPO. And the other important point here is also that we have seen the opening up of a lot of the regional capital markets. For example, the Chapter 18A market in Hong Kong and also the STAR Market in Shanghai. And these markets now allow pre-profit and pre-revenue companies to go public and raise funding. This is something that we didn't see 5 or 10 years ago, again.

And I think the next point is about talent. We're just seeing increasing amount of or number of returning scientists and clinicians going back to China, and they cover all of the key aspects of the biotech value chain from early-stage discovery, to CMC, to clinical and regulatory. And they play a very important role in terms of forming the next exciting biotech ventures in China.

And I think the last one is about reimbursement. It used to be that a lot of the insurance dollars in China were paying for generic drugs or me-too drugs. We're seeing effort from the insurance administrators to recycle the insurance dollars and prioritizing payment to cover really innovative drugs. And I think this is one of the driving forces to support the next leg of growth for innovative drug companies.

I think the next question you asked is about whether we believe the Chinese market will be a leading or one of the leading markets globally. And if so, would that happen in 3 or 5 or 7 years? We are actually very optimistic in the growth aspect of the Chinese market. I think you can look at a lot of the statistics. The Chinese pharmaceutical market is now the second largest in terms of single nation-state pharmaceutical sales. And if you look at a lot of the reputable market research firms, including Frost & Sullivan, maybe McKinsey and others, the consensus is the Chinese market will keep growing at a fairly respectable 5% to 10% annual growth rate over the next 5 to 10 years.

Again, a lot of the driving forces for sustaining this growth is what I talked about earlier; the demand for better standard of care, the insurance program being more focused on the innovative therapies, emergence of a new generation of biotech companies like us and even perhaps a more diversified payer structure with more commercial insurance coming into the picture to pay for these innovative drugs. We think going forward, and it's very likely that in the next 5 to 10 years, China will catch up in terms of the pharmaceutical market, catch up to the U.S. and then become a leading market for innovative therapies, not only for multinational companies but also for local biotech companies and pharmaceutical companies in China.

Now I can address your third question regarding TJD5, CD73 monoclonal antibody. CD73 is a very promising immuno-oncology target. It's globally competitive. Currently, there are about 5 companies at clinical stage, including TJD5, our CD73 monoclonal antibody. Now TJD5 is a differentiated CD73 antibody. As Joan already mentioned, it works through an intra-dimerization mechanism to avoid the hook effect. It has defined clinical advantage of sort of other CD73 antibodies.

Now TJD5, our CD73 antibody, works synergistically with PD-1, PD-L1 therapies, as it creates a favorable tumor microenvironment for PD-1, PD-L1 to work more effectively. You can imagine that this monoclonal antibody is positioned clinically to combine with PD-1, PD-L1 therapies to potentially increase patient's clinical response rate and, hopefully, efficacy of the PD-1, PD-L1 therapies. And this is the consensus in the field how CD73 would work synergistically with PD-1, PD-L1 therapies.

Now we are conducting clinical trials in both the U.S. and China. The U.S. study, as mentioned earlier, is in combination with PD-L1 antibody in solid tumor. And the China study is in combination with a PD-1 antibody in solid tumor. And our Phase I data, the dose escalation safety, PK/PD for our U.S. study will become available by the end of 2020. I hope that we addressed your questions.

Your next question comes from the line of Zhongping Yuan of Huatai Securities.

Congratulations on our breakthrough in TJC4. And now I have 2 questions here. The first question involves the competition in the CD47 market. I noticed that Innovent has just initiated a Phase 1b and a Phase III clinical studies of its CD47 antibody, IBI-188, for the treatment of MDS and, as just explained by our interim report, our company will conduct a Phase IIa trial in China. So I'm very curious that it's possible that IBI-188 will lead the competition of CD47 antibody in Chinese market. Also, I'm also interested in one of our peers on the TTI-621 of Trillium. This drug has demonstrated some certain possibility in its clinical study. And this possibility is rarely observed for other candidates. So what is the cause of this therapy and what did our company do to avoid it? Yes, this is my first question.

All right. Thank you for the question. I can address your questions. First of all, I'd like to say, our CD47 antibody is globally competitive. And I will address this in 2 ways; one is quality or differentiation, the other is speed. In terms of differentiation, our TJC4 stands out as highly differentiated CD47 antibody because it binds minimally to red blood cells by design and has shown its clinical advantages as it does not induce severe anemia and other hematologic side effects in both preclinical studies and now clinical studies. And we're very excited about this differentiation. That's one aspect related to the quality of the molecule and the differentiation of the molecule.

Now the other aspect is speed. With the clinical advantages of our TJC4, we are rapidly advancing our clinical development plan in both the U.S. and China. As you can imagine, our antibody is well tolerated in the clinical studies. It behaves as one of the regular antibodies with safety and also a more favorable PK profile.

We know our program is very competitive at this point, but we're not in a position to comment on other companies' programs. But we know that we are already advancing very fast, both in the U.S. and China. And we have a very clear clinical development plan, how to move forward now with demonstrated clinical advantages of differentiation.

And then your second question related to Trillium's molecule. Now Trillium's molecule, this TTI-621, is associated with dose-limiting thrombocytopenia. Now it's quite clear that thrombocytopenia induced by this molecule, TTI-621, is mediated through IgG function of the molecule because CD47 is also expressed on the platelets. With effective function of IgG1, you expect to have thrombocytopenia because of the elimination of the platelets. And this is really the underlying mechanism for thrombocytopenia induced by TTI-621.

Okay. And I have got one more question about our plan for commercialization. And we noticed that Mr. Yifei Zhu has joined the Company and he will be in charge of our commercialization plan. And could you tell us what's the current and the target head count of our sales team and what will be the major candidates in the near future, for example, in the late 2020?

Thank you for the question. I would direct your question to Mr. Zhu, our newly joined Chief Commercial Officer.

Okay. Thank you for your questions. And first of all, I just got on board with I-Mab, and I'm very excited about the Company's pipeline. And it's the huge commercial potential as the products are clearly differentiated. As our initial product series related to the hematologic malignancies such as TJ202 and the TJC4, and we will initially focus on building our commercial capability in hematologic market.

With regard to the TJ202, it will be the first of our drug to market in China. We are very excited about this product launch and are strategically preparing for it with the formation of our own commercial team. The general plan is to form our own core immuno-oncology sales team of 150 to 200 people. Focusing on the most important 280 tertiary and also the specialized oncology hospitals in China. We may do this in phases to match the TJ202's commercialization process. We'll start the team hiring process soon.

Your next question comes from the line of Jill Wu of CMBI.

I have 2 questions. One question is in relation to TJC4. We understand that the Company may have been in discussion with potential partners for collaboration of this product. Could you please give us some update on that front? And my second question is about TJ-CD4B. This is a quite innovative bispecific antibody. Could you please give some color on the potential indication of this molecule?

All right. Thank you for the questions. I can address your question. Now your first question. As discussed earlier on this call, our TJC4 stands out as a highly differentiated CD47 antibody. It has really attracted a lot of interest from big pharma groups around the world. They have been seeking a differentiated CD47 antibody. Now we have been approached by potential partners for collaboration and the discussion is ongoing. And today, I can say we will update the market as soon as it's finalized.

Your second question is related to bispecific Claudin 18.2 and 4-1BB. Now this bispecific antibody has first-in-class potential. It's very unique. It's a combination of Claudin 18.2, a new tumor-associated antigen related to gastric cancer, pancreatic cancer, and this is combined with our 4-1BB antibody. And this 4-1BB antibody is a conditionally activated 4-1BB. Let me explain. The 4-1BB has to rely on Claudin 18.2 in this case to engage its target on tumor cells in order to get activated. Without 18.2 engaging the tumor cells, 4-1BB is not activated. That design is very smart. It can potentially reduce the systemic exposure of 4-1BB because 4-1BB is known to induce liver toxicity. This antibody is designed to avoid systemic toxicity, especially the liver toxicity.

This antibody at this point is at preclinical development. We expect to file in the first quarter next year to get clinical trial started in the U.S. And this particular bispecific antibody is positioned clinically to treat cancers, gastric cancers and pancreatic cancers.

Operator, just to let you know, we can only take one more participant's question due to time.

Your last question comes from the line of Claire Wang of China Renaissance.

Congratulations on very good progress in clinical trials. Just wondering for the TJM2 you indicated for severe COVID-19 patients, wondering if it could be used as a substitute for steroids or other hormones as a treatment?

Thank you for your question. I'd like to direct your question to Joan.

Yes. Thank you, again. I think this is a very good question. Some people have wondered. There are a lot of science, which is backing up that corticosteroid treatment has its biggest concern in terms of its broad immune system suppression, which could lead to more severe systemic infection and harm to lungs or other important organs. If you look at the data, almost all the cases, especially in severe cases, the lab results showed that all the immune cells, especially T cells, have been compromised significantly. Under these circumstances, corticosteroids could very likely compromise even further putting patients in more dangerous situation for more infections.

GM-CSF is very different. It works in upper streams of cytokine release. It just works as a switch. The switch off and on of the cytokine release very focused on targeting the cytokine release, as has been in the literature reported. It is very specifically related to cytokine release associated with COVID-19. We believe GM-CSF has its uniqueness for targeting the cytokine release associated with COVID-19 without compromising the general immune systems. If that works out, and we definitely believe it has much better advantages over steroid treatment. I hope that has answered your question.

I would now like to turn the call back to the management for closing remarks. Please go ahead.

Again, thanks everyone for participating in the call. Yes, Jielun, go ahead.

Yes. On behalf of the management, we would like to thank everyone who joins this call this morning or tonight, depending on where you are. Unfortunately, given the time constraint, we may not be able to take everyone's questions. But rest assured, we will find other opportunities to keep the dialogue open with investors and analysts. Thank you again for your time today. Have a nice day or night. Thank you. Bye-bye.