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Collaboration

Nov 10, 2021

Tianyi Zhang
Director of Investor Relations, NovaBridge Biosciences

Good morning and good evening. Thank you for standing by. This is Tianyi Zhang, IR Director of I-Mab Biopharma. Thank you for joining the conference call co-hosted by I-Mab Biopharma and Jumpcan Pharmaceutical. Earlier today, I-Mab and Jumpcan jointly announced that the two companies have established a commercial partnership on the only clinical-stage, pure protein-based, long-acting growth hormone, Eftansomatropin alfa, which is also known as TJ101. Today's conference, we will have the management team from both I-Mab and Jumpcan to give you more insights of the commercial partnership. Joining me today on the call from I-Mab's senior management team includes Dr. Jingwu Zang, founder and chairman of I-Mab. Mr. John Long, Chief Financial Officer of I-Mab. Mr. Jielun Zhu , Chief Strategy Officer of I-Mab. Dr. Weimin Tang, Chief Business Officer of I-Mab. And Mr. Yifei Zhu, Chief Commercial Officer of I-Mab.

We also have management team from Jumpcan Pharmaceutical. They are Dr. Jun Liu, General Manager of Jumpcan Pharmaceutical, and Mr. Wei Cao, Board Secretary of Jumpcan Pharmaceutical. Today's conference call will be divided into two parts. First, the management team will give an in-depth overview of the commercial partnership, then it will be followed by a QA session. Now, I'd like to turn the call to Dr. Jingwu Zang, founder and chairman of I-Mab, to share with you more details about this commercial partnership. Dr. Zang, please.

Jingwu Zang
Founder, NovaBridge Biosciences

Yeah. Thank you, Tianyi. Thank you all for joining the call today. At this call, we're very excited and pleased to tell you about our partnership with Jumpcan Pharmaceutical Group for commercialization of our TJ101, our differentiated long-acting growth hormone. Now, this marks another important milestone for I-Mab as we move towards an innovative pharma. Now, as shown on the slide number 4, I-Mab has grown from a startup company back in 2016 to an innovative clinical stage biotech company in a very short period of time. Our pipeline today has over 20 assets, innovative assets, including 10 clinical stage assets that are mostly in late stage clinical development.

I wanna highlight that three of four late stage assets, such as Felzartamab, TJ202, and our long-acting growth hormone, TJ101, and Lemzoparlimab, CD47 antibody, are rapidly progressing towards BLA. Our pipeline is not only innovative, but also getting closer to the commercialization stage. Last year, we have made a strategic decision to embark on a new journey to become a innovative biopharma. To achieve this goal, we're in the process of building our manufacturing facility and commercialization capability. In this regard, we have made remarkable progress on both fronts. As shown on slide number 5, for manufacturing capability, we will get our GMP facility ready by 2022 for pilot production, and by end of 2023 or early 2024 for commercial production. Now, what about product commercialization?

With our first BLA to be submitted for Felzartamab, our CD38 monoclonal antibody for multiple myeloma, we're in the process of building our own commercialization capability and establishing commercial partnership network. For example, we just signed a commercial partnership agreement with Sinopharm, a top pharmaceutical distributor in China. Also, as we communicated before, I-Mab will be focusing on hematologic oncology therapeutic area because our unique position and strengths with Felzartamab antibody and Lemzoparlimab CD47 antibody, another key asset to be partnered, which is another topic by its own right. Therefore, for TJ101, our differentiated long-acting growth hormone and a pediatric product that has a huge and growing market in China, it makes all the business sense to partner with a pediatric-focused commercial company. I-Mab can then focus on building our own commercial leadership in the hematologic oncology area.

We have been working hard to identify a ideal commercial partner for TJ101. Today, I'm very pleased to say that we have reached agreement with the best commercial partner for TJ101. Now, I would like to ask Jielun , our Chief Strategy Officer, to tell you about our commercial partner, Jumpcan Pharmaceutical Group, and the details surrounding the deal itself. Jielun .

Jielun Zhu
Co-Founder, CFO, and Chief Business Officer, Excalipoint Therapeutics

Thank you. Thank you very much, Dr. Zang. Hello everyone. I'm very happy to discuss with you and present to you our partnership deal with Jumpcan Pharmaceutical in China. If you turn to page seven, let me first give you a quick overview or for some of you, a quick review of Eftansomatropin alfa, our highly differentiated long-acting growth hormone. First of all, as many of you know, Eftansomatropin alfa or our code name is TJ101, is currently in a very advanced stage of clinical development towards the end of a phase III registrational trial in China for the PGHD or pediatric growth hormone deficiency indication.

We had started patient enrollment in late 2020, and we are on track to complete patient enrollment in early 2022 or early next year. Our planning is to be able to file BLA or NDA for this product in 2023, and hopefully in the earlier part of that year. This is the clinical development stage of the product. Let me also give you three important points of differentiation for this product. First of all, Eftansomatropin alfa is the only clinical stage 100% protein-based growth hormone in China. This product uses the natural long-acting growth hormone protein and the proven high Fc long-acting technology to extend the half-life.

Unlike the traditional PEG base or chemical linker base technology, we think on long-term usage basis, the high Fc fusion protein technology provides for potential better safety and easier usage compared to other potential competing products. That's the first differentiation. Secondly, in the middle of the bottom half of that page, you can see that this product has proven to have excellent and consistent efficacy and safety. On the chart, you can see this is taken from the phase II clinical trial done by our partner, Genexine.

In terms of the efficacy, in terms of the six-month growth velocity, you can see that on the three doses of Eftansomatropin alfa versus the control group, the daily Genotropin, all three active doses actually enjoyed numerical advantage over the comparator. Although they are not statistically significant, it gives you the sense that this is a very consistent efficacy. It has demonstrated very consistent efficacy, and we expect to be able to replicate this kind of efficacy in our phase III trial.

Lastly, on that page, we think the weekly administration versus the current daily administration, which is the mainstay in the Chinese market, is a very big advantage in terms of patient compliance and the usage, convenience of use. On the next page, I will talk a bit more about the market evolution, but it is very clear to us and the majority of the participants and observers in this market that the Chinese growth hormone market is going to have a very rapid evolution, transitioning away from daily short-acting growth hormone to longer-acting or long-acting weekly or bi-weekly injections.

In addition, we are planning now with our partner, Jumpcan, to develop a new formulation, for example, the auto-injector formulation, so that you know, the clinical benefit of this product can be maximized. Okay. Next page, you know, I was referring to on the last page, this is a very quick snapshot of what we expect to be the market dynamics from now, you know, to 2030, which is roughly the ten-year mark. We took this chart or these numbers from Frost & Sullivan, you know, a reputable market research firm. So they looked at the market last year, 2020.

The total market size was about RMB 5.2 billion . Out of that, 89% was taken by short-acting growth hormone or the daily injection versions. Only 11%, which is about, you know, RMB 0.6 billion , was the long-acting version. That was basically one product by GenSci. It's called Jintrolong. If you move forward 10 years in 2030, Frost & Sullivan is expecting the market to grow only on the 20% annual growth basis, CAGR basis, to about, if you do the math, it's about RMB 45 billion total market size. That is a humongous growth rate on its own, 20% CAGR, very big growth. That growth is driven basically by increases in the diagnosis rate and treatment rate.

For all the talk about the Chinese growth hormone market, it is still the PGHD indication is still undertreated and under-diagnosed. Only about 5.7% of the patients who should have been taking this product or should have been treated and diagnosed are actually treated. The number of patients who are actually consistently on treatment is even fewer. The market is going through explosive growth as we speak. More importantly, the second point, if you look at the long-acting portion of the market, the projection is for that portion of the market to grow from $0.6 billion - $22.5 billion. That is a CAGR of 42.6%.

That's a whopping explosive growth and that is based on the assumption that many of the patients who are currently on the cumbersome daily injection version will be migrated to the longer-acting version, more convenient, safer, and perhaps even more cost effective if you compare the total cost. So it is important to bear in mind that this market is going to be a multi-billion, you know, U.S. dollar market. Our product, as a very differentiated product, we think we'll be able to take a meaningful share of that growing market.

Last point on this page, on the bottom, you can see that this is a market with a very stable competitive dynamic. We expect to have a very stable competitive dynamic. We're not looking at many competitors. Right now, the market is dominated by one product, Jintrolong, which is the only approved long-acting version of the growth hormone. This product uses the traditional PEG chemical linker technology, which we talked about. There may be some long-term use safety concerns with this kind of technology. You know, besides us, there are two more competing products currently in similar phase of development. One by AnkeBio, and the other one by Eisai. Both of them are in phase III.

We think by year 2024-2025, there will be three to four products in the Chinese growth hormone market, long-acting growth hormone market. The market itself is big enough and growing fast enough to be able to give everyone a fighting chance. Certainly, given our profile and differentiation, we think we have a very, very real chance of taking a very, very substantial share of the market. Page nine. At this point, I would like to turn to Mr. Cao Wei, who is a member of the senior management and also the board secretary of Jumpcan. He will be able to give you some background of Jumpcan and also their leadership credentials in the Chinese pediatric market. Mr. Cao.

Wei Cao
Director, Deputy General Manager, and Board Secretary, Jumpcan Pharmaceutical

Thank you, Jielun. As Dr. Zang and Jielun previously discussed, the growth hormone market in China, particularly the long-acting growth hormone market, is expected to maintain rapid growth. Eftansomatropin alfa is the only pure protein product in the late-stage clinical development. Clinical results show strong efficacy while long-term safety has been validated with no PEG or chemical linkers leading to potentially safer long-term usage. Through our strategic collaboration agreement with I-Mab, we look forward to Eftansomatropin alfa becoming one of Jumpcan's core commercial products and our most important source of revenue growth in the future. Jumpcan is the leader in pediatric medicines in China. It is a top 100 pharmaceutical company in China.

Jumpcan's revenue in 2020 was RMB 6.2 billion, while 2021 Q1 to Q3 revenue reached RMB 5.4 billion, of which the pediatric segment accounts for over 60% of total revenue. Jumpcan has a solid existing pediatric medicine sales and a marketing team with over 300 and 500 medical representatives and retail specialists, covering over 23,000 hospitals ranging from first tier, second tier, and third tier cities in 30 provinces and cities across the country. The specific breakdown leads to over 1,700 tier three hospitals, over 3,700 tier two hospitals, and over 18,000 tier one hospitals and community clinics. Our hospital coverage includes 220 children's hospitals.

In terms of product sales, Jumpcan's main products includes Pudilan anti-inflammatory oral liquid, Xiaoer Chiqiao Qingre Granules, and Rabeprazole sodium and tarot capsules as market leaders. From the data of third-party market research, Jumpcan's Pudilan ranked first in market share in 2020 to treat pharynx and throat swelling caused by excessive heat and toxin accumulation. Meanwhile, Xiaoer Chiqiao Qingre Granules ranked first in market share for pediatric coughs in public hospitals in 2020.

While rabeprazole sodium and tarot capsules used in anti-ulcer therapy ranked first in China's national public hospital market share in 2025. These products are validation of Jumpcan's robust product pipeline and terminal sales capabilities. The company is confident that with Jumpcan's strong sales network and extensive pipeline in the pediatric fields, once it is approved for commercial use, the commercialization process will launch quickly, providing a better treatment option for millions of children in China.

Jielun Zhu
Co-Founder, CFO, and Chief Business Officer, Excalipoint Therapeutics

Okay, thank you very much, Mr. Cao, for the very detailed description. I would like to move on to page 10 and 11. These two pages give you the details of this partnership and the key terms. First of all, on page 10, I would like to make three quick points before we get into the nitty-gritty details.

I wanna say that this is a deal with three firsts. Okay. The first first is that this is the biggest, you know, the biggest domestic China BD deal, as far as we can see. You know, the total, not only in terms of the upfront payment, but also in terms of the total consideration, upfront payment is $35 million, and the total consideration is $350 million. Both of those numbers, we think, are history-making and bigger than the next number two or number three deals as we can gather data for. A very big deal and a very important deal.

The second point is you know the second is that this also is a very interesting model of cooperation between two types of companies or players in the Chinese biotech market. Companies like us, I-Mab, you know, a very fast growing biotech player transitioning to be a biopharmaceutical player in China. Part of partnering with Jumpcan, which is a traditional Chinese medicine and also pediatric focused player in China. We are actually pooling different resources to maximize the commercial benefit of this product.

We're maximizing, you know, I-Mab's leadership in innovation and the clinical differentiation of eftansomatropin alfa, this product, plus Jumpcan's leadership in the pediatric market in China, their existing sales network, their long-standing experience in this market. This is a very, very rare and shining example of using both sides advantages and strength to get this product to market as quickly as possible and get this product to as many patients as possible. The last point, important point, is also that this is also a one of the biggest partnership deal in the pediatric space globally.

Pediatric is a you know to some extent a niche market, but it's important for many patients, especially patients in China, to be able to recognize to have good products to get to patients. We hope that this deal highlights the importance of a market like pediatrics, especially in China. Now let me give you more details on the economic terms of this partnership. As I mentioned, the total consideration is $350 million or RMB 2.24 billion in total consideration. Out of the $350 million, $35 million U.S. dollars is the upfront payment payable upon signing the contract and shortly after.

The rest, $280 million, is the total milestone payments payable upon achieving development, registration and sales milestones. More importantly, we will also be able to share profits of this product in the Chinese market with our partner, Jumpcan, on a 50/50 basis, under which we are entitled to receive tiered low to low double-digit royalties on the net annual sales of this product. It's a, you know, even on economic terms, this is a true partnership. You know, we're sharing the upside from this product, you know, in addition to the milestone payments and upfront payment.

Lastly, in terms of how we work together, you know, with Jumpcan, I think we have more details on the following page, on page 11, if you look at the right-hand side of this page. This lays out the details of the specific areas where we will be working with Jumpcan, on this product going forward. First of all, in terms of clinical development, I-Mab will continue to lead the ongoing registrational trial for PGHD and complete the registration process, as the MAH holder. The two companies will share the CMC costs. The second area where we'll be working together very closely is to secure BLA approval and a commercial drug supply.

Again, I-Mab will be the MAH holder, MAH of this product, Eftansomatropin alfa, and I-Mab will supply the product at an agreed upon cost to Jumpcan. On that basis, I-Mab will also be able to recognize and record revenue on the ex-factory basis from this product, and again, also share the profit and the royalty in addition to that. It's important to keep in mind that this product is not leaving our pipeline. It is still very much an integral part of I-Mab's pipeline. Also, investors will be able to see the impact of this product economically and financially in our financial statements going forward.

Lastly, in terms of the commercialization and the future indications or future clinical developments, Jumpcan as our commercial partner, exclusive commercial partner in China, will be leading all the activities relating to commercializing eftansomatropin alfa in China, including frontline sales, market access, pricing, and et cetera. Jumpcan will also be leading the effort to develop additional indications beyond PGHD. For example, ISS, idiopathic short stature, and AGHD, adult growth hormone deficiency, and et cetera, to expand the indication space for this product and to maximize the commercial value. I-Mab will be providing the necessary clinical and other support in their efforts. Okay?

I hope you can see that this is a very organic, close working relationship going forward, and the two parties will also establish a joint governance committee, who will be meeting regularly to guide the next stage of the development for this product. We look forward to working very closely with our friends at Jumpcan and making this product widely accessible to our patients in China. Thank you very much for listening to our call. I think this marks the end of our prepared comments. I now open up the floor to any questions from investors and analysts. Thank you.

Tianyi Zhang
Director of Investor Relations, NovaBridge Biosciences

Thank you, Dr. Zang, Jielun , and Mr. Cao for the very comprehensive overview. Now we will start the QA session. If you have questions, please use the raise your hand function via Zoom, and we will unmute you and take your questions in order. Okay, the first question comes from Jill Wu at CMBI. Jill, please.

Jill Wu
Executive Director, Healthcare Sector, CMBI

Okay. Thanks, Tianyi. Thanks very much for taking my questions. This is Jill Wu from CMBI. Congratulations for this successful deal. Very impressive. And may I ask, how does Jumpcan look at the positioning of Eftansomatropin alfa within its pipeline? Will this long-acting growth hormone become Jumpcan's most important product? And how can we understand the competitive landscape for growth hormones in China? Thanks.

Wei Cao
Director, Deputy General Manager, and Board Secretary, Jumpcan Pharmaceutical

Okay, thanks for your questions. For the first one, in terms of the position of Eftansomatropin alfa within internal pipeline, Jumpcan will work closely with I-Mab to complete the product launch as soon as possible. Eftansomatropin alfa will be regarded as Jumpcan's primary product in the next 10 years. We plan to allocate the largest portion of our human resources, academic resources, and market resources to accelerate its commercialization. Second, as for the market competition of growth hormone in China, we know today, the growth hormone market is highly concentrated. We anticipate that high-quality products with a strong sales team will be able to obtain a relatively big market share. In terms of growth hormone types, there are several short-acting growth hormone and only one marketed long-acting growth hormone product.

The short-acting ones require daily injection, which often hampers patient compliance and adversely affects clinical outcomes. Therefore, there's a trend to use long-acting growth hormones to replace short-acting growth hormones. For long-acting growth hormone products, there's room for Eftansomatropin alfa to compete on the market. Eftansomatropin alfa is the only recombinant human growth hormone in its proprietary fusion protein format, a pure protein-based molecule with high Fc fusion technology. Its advantage lies in its long-term safety as compared to other chemically modified recombinant human growth hormone drugs. We anticipate a multi-billion-dollar market for growth hormones in the future. By combining Jumpcan's abundant marketing resources with the product advantage of Eftansomatropin alfa, we believe that we can secure a good position in the market. Thanks.

Tianyi Zhang
Director of Investor Relations, NovaBridge Biosciences

Thank you, Mr. Cao. The second question comes from Phil Zhao at Daiwa. Phil, please.

Phil Zhao
Sector Portfolio Manager and Investment Analyst, SAFE Investment Company

Okay, thanks for taking my question. This is Phil from Daiwa. So first, congratulations for signing the deal. I just have a very quick follow-up questions. Just wondering whether Jumpcan's, you know, the existing sales team is able to reach the endocrinology and the pediatric clinics with growth hormone related patient population. What is our detailed plan? Thanks.

Wei Cao
Director, Deputy General Manager, and Board Secretary, Jumpcan Pharmaceutical

Okay. Yeah, thanks for the question. In terms of the detailed plan, Jumpcan is a market leader and has deep expertise in pediatric therapeutics. Over the past two decades, we have established a broad pediatric network with academics, experts, and customer resources. In terms of academic resources, Jumpcan has established a long-term strategic collaboration with national academic organizations. These organizations include the pediatric branch of the Chinese Medical Association, the pediatric branch of the China Association of Chinese Medicine, and the pediatric branch of the World Federation of Chinese Medicine Societies to support the development of Jumpcan's academic activities in China. In terms of expert resources, we have established connections with the chairman and group leaders of the institutions just mentioned. In addition, we have strong support on clinical and scientific research, academic seminars and academic sponsorship, et cetera.

In terms of customer resources, Jumpcan's pediatric products currently cover more than 1,700 Tier-III hospitals, more than 3,700 Tier-II hospitals, and about 18,000 Tier-I and community hospitals, and over 6,000 clinics, including 220 children's hospitals. Our pediatric products cover all provinces and cities around China, with the exception of Hong Kong, Macau and Taiwan. All these efforts will enable our products to reach a large number of pediatric customers in China. Thanks.

Tianyi Zhang
Director of Investor Relations, NovaBridge Biosciences

Thank you, Mr. Cao, for the very detailed introduction. I think, due to time limitations, we will take one last question. The last question comes from Louise Chen at Cantor. Louise, please.

Louise Chen
Senior Research Analyst and Managing Director, Cantor Fitzgerald

Hi. Thank you for taking my question here. Congratulations. This TJ 101 partnership is another major business development milestone by I-Mab. When looking forward, what other catalysts can investors look forward to on the R&D and BD front? Thank you.

Jingwu Zang
Founder, NovaBridge Biosciences

Well, thank you. Thank you, Louise. This is Jing Wu. I just want to give you a quick answer on that question. Now, we have a total of 15 near-term catalysts to deliver, and we're on track to deliver them. This is very exciting because this year we have already achieved multiple catalysts and milestones. Now, within the next 6-8 months, we have another group of 15 catalysts, and they're all very significant. I wanna tell you that this catalyst can be divided into three categories. The first category is about data, clinical data readouts. In this category, we have four significant clinical data readout events. The first one is about lemzoparlimab in combination with rituximab for non-Hodgkin's lymphoma.

In the past week or so, we already talked about key clinical data. In December, at the ASH meeting, we will give we'll talk about additional data altogether. This is very exciting because this data will really position ourselves to initiate a registrational clinical trial sometime next year in China. The second data readout is also related to lemzoparlimab. This is in combination with PD-1 antibody for solid tumor. We expect to release the data early next year, and this is another significant milestone to look for. Third data readout is also about lemzoparlimab. This is even more significant because next year we're gonna talk about our ongoing phase II clinical trial in patients with AML/MDS.

This is again comprehensive phase II clinical data. We're very excited to, you know, to talk about this data, as you know, as we closing in. Then the fourth readouts is about uliledlimab, our CD73 monoclonal antibody in combination with PD-1 antibody for solid tumor. Sometime next year, we'll be in a position to release phase II data on uliledlimab. Those are the four data readout events to look for. Now, the second category is related to registrational and a clinical milestone. There are 8 altogether. The first one is felzartamab, our CD38 monoclonal antibody, we are on track to submit sBLA.

This is a very significant regulatory, registrational milestone. The second one is about completion of phase III patient recruitment for TJ101, our long-acting growth hormone in early 2022. This is gonna pave the way for us to complete this registrational phase III clinical trial and get ready to launch the product in 2023. The third one is a start of registrational trials, one or two registrational trials for Lemzoparlimab in 2022, next year. Potentially there are two registrational clinical trials. One is related to non-Hodgkin's lymphoma, the other is related to AML/MDS. There are five clinical milestones and those are initiation of phase II clinical trials.

We have an initiation of a phase II clinical trial for lemzoparlimab in combination with PD-1 antibody in solid tumor. Uliledlimab phase II clinical trial for solid tumor. Inotuzumab, our BCMA H3 monoclonal antibody to start phase II. Our long-acting interleukin-7 to start phase II. Last but not least, plonmarlimab, our TGN2 GM-CSF antibody to start phase II. Altogether, in a short time, we will start five clinical trials, both in U.S. and China. This is a very significant group of registrational and clinical milestones. Now, the third category is related to BD deals. We have been working on multiple BD deals in the past many months. In particular, I'd like to mention three significant BD deals.

The first one is a commercial partnership for TJ101. This is the topic for today's call. We're very happy today, we have closed this deal ahead of the expected time. We're very happy with that. The second one is still ongoing in an active discussion. This is a global partnership deal for our uliledlimab, CD73 monoclonal antibody. We're in active discussion with multiple big pharma groups. The third is really related to Felzartamab. We have an opportunity to partner with a potential company to work on autoimmune indications for Felzartamab, in addition to multiple myeloma, as I-Mab has been focusing on.

With the one closed, we hope to move forward to close the other two deals relatively soon. We're mobilizing all the resources within the company to really focus on those short-term catalysts to make sure that we deliver what we promise to deliver. Thank you, Louise, for that question.

Tianyi Zhang
Director of Investor Relations, NovaBridge Biosciences

Thank you, Dr. Zang. Thank you everyone for joining our conference today. If you have any further questions about I-Mab or Jumpcan, please feel free to reach out to I-Mab IR team or Mr. Wei Cao from Jumpcan. I wish you all have a good day or good evening.

Wei Cao
Director, Deputy General Manager, and Board Secretary, Jumpcan Pharmaceutical

Thank you, everyone.

Jingwu Zang
Founder, NovaBridge Biosciences

Thank you.

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