02 A product that “overtakes in corners”
This time, lemzoparlimab, which is highly recognized by AbbVie, is independently developed by I-Mab and is used to treat various cancers. The innovative CD47 monoclonal antibody is also one of the most promising research drugs in I-Mab’s many patented innovative R&D pipelines.
Currently, immunotherapy targeting CD47 is hailed as the next major "hope" to conquer cancer after PD-(L)1.
Six months ago, Gilead acquired Forty Seven, a biotechnology company specializing in the development of CD47 pathway inhibitors, for a total amount of US$4.9 billion. It once caused a sensation in the industry and became the second largest merger and acquisition in biopharmaceuticals so far in 2020.
Although no CD47 monoclonal antibody has been approved for marketing globally, according to incomplete statistics, more than 20 companies are developing products targeting CD47 targets, including not only CD47 monoclonal antibodies, but also CD47 monoclonal antibodies. Bispecific antibodies against CD47 and other targets, more than a dozen of which have entered the clinical research stage, including the most famous Forty Seven, Hengrui, Innovent, etc.
Among the many CD47s, why does I-Mab’s project stand out?
Dr. Zang Jingwu, founder, honorary chairman and director of I-Mab, proudly said that I-Mab’s CD47 antibody is at the forefront of the world.
Because, although blocking CD47 has been recognized as one of the most promising methods to destroy cancer cells to evade detection and attack. However, because CD47 binds to red blood cells, hematological side effects such as severe anemia may occur during treatment, which hinders the development and clinical application of CD47 antibodies as a cancer treatment.
Therefore, the CD47 projects of many pharmaceutical companies around the world have been seriously affected, and some have even stopped development.
I-Mab has been aware of the serious challenge of this side effect since it started its layout four years ago, so it made differentiated designs at the beginning of research and development.
Through ingenious antibody design and screening, I-Mab's scientific research team discovered a CD47 antibody called lemzoparlimab. This antibody has a strong binding force to cancer cells and can also target red blood cells. Impact is minimized. Lemzoparlimab binds to the CD47 molecule on the surface of tumor cells through a unique recognition region. Fortunately, the same area of ??CD47 on the surface of red blood cells is shielded by a large number of sugar chains. The natural barrier formed by sugar chains can prevent lemzoparlimab from unnecessary binding to red blood cells, thus avoiding being phagocytized due to antibody binding.
At present, lemzoparlimab (TJC4) has completed the first phase of clinical trials (climbing trial) in the United States. From the clinical data, it is obvious that the differential advantages compared with other CD47 antibodies have been successfully avoided. Hematological side effects such as anemia. And in the global clinical research stage, no other CD47 antibodies with similar properties have yet been discovered.
It is reported that specific clinical data will be officially announced at the annual meeting of the Global Society for Immunotherapy of Cancer (SITC2020) in the second half of this year. Among them, some data from the ramp-up trial for patients with acute myeloid leukemia (AML) will also be announced at the American Society of Hematology Annual Meeting (ASH2020).
Based on the advantages of its drug molecules, the global and Chinese clinical development process of lemzoparlimab (TJC4) will be faster.
In addition to monotherapy, currently, combination treatment trials of lemzoparlimab and Keytruda? (pembrolizumab) and Rituxan? (rituximab) are also being conducted in China and the United States, mainly for the treatment of entities. cancer or lymphoma patients.
After cooperating with AbbVie, I-Mab will also launch a joint development program with its world-leading venetoclax (Venclexta?).
03 Three distinctive innovations
? Innovation that “wins at the starting line”
According to Dr. Zang Jingwu Introduction: Since the establishment of the company, I-Mab’s positioning has been to focus on global innovative biopharmaceuticals and compete with global biopharmaceutical companies.
Therefore, in addition to product standards benchmarking against global heights, I-Mab has successfully built two product pipelines globally and in China, namely, a Chinese R&D pipeline with lower risk and “fast product launch”, and a Chinese R&D pipeline with Global competitiveness, higher risk, “rapid proof of concept” global R&D pipeline.
▲I-Mab’s “two-wheel” development strategy
Driven by the two-wheel R&D strategy, clinical verification (Phase I clinical or part of Phase II clinical) is quickly completed through the world’s mature system; Then, clinical development suitable for Chinese patients will be accelerated in China, so that new drugs can be launched in China earlier to benefit patients.
? Innovation that benefits clinical practice “faster”
In the way of innovation, patients come first. All new drug innovations are truly valuable only when they benefit patients. Dr. Zang Jingwu said. And the creatures in the sky are doing the same.
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The first step to accelerate clinical benefits: Transform from a research and development company to a full value chain company integrating research and development, clinical practice, production and sales
Translational medicine:
"Translational medicine" comes from After it was formally proposed by the National Institutes of Health (NIH) in 2003, it became the "development code" of the world's top pharmaceutical companies. Its important role in reducing the risks of new drug development and accelerating clinical trials has been increasingly proven.
As a global innovative biotechnology company, I-Mab has established a translational medicine research department in Shanghai, China.
Production base:
In May 2019, I-Mab decided to establish a R&D and GMP production base in Hangzhou, focusing on the production of clinical development results of its innovative drug pipeline in China and the United States. .
Commercialization team:
In July 2020, I-Mab announced the appointment of Mr. Zhu Yifei as chief commercial officer, paying tribute to Zang Jing, founder, honorary chairman and director of I-Mab The fifth doctor will report directly and will be officially effective from August 10, 2020.
The newly appointed chief commercial officer Zhu Yifei has served as the sales general manager of Qilu Pharmaceutical Group and the chief commercial officer of BeiGene. He has rich commercialization experience in the field of biomedicine and is currently rapidly establishing the commercialization of I-Mab Biotech. team.
Dr. Zang Jingwu said that since the two milestone events, I-Mab has officially entered the 2.0 stage. That is to say, it will become a comprehensive global innovative biopharmaceutical company covering the entire value chain of R&D, clinical, production and sales. Truly transform "innovation" into "value".
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Accelerate the second step of clinical benefits: further overseas cooperation.
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Zhu Jielun, Chief Financial Officer of I-Mab, introduced, For example, this cooperation with AbbVie has formed an important synergy in accelerating the launch of I-Mab's new products in terms of capital, production, data and other aspects.
Funding: used to promote the research and development of innovative drug pipelines and global clinical trials, and expand global commercialization capabilities, thus forming a very good virtuous cycle.
Production: As the manufacturer of the global drug king Humira, AbbVie has established a very powerful biopharmaceutical production process system. The production process and product quality of I-Mab can be better improved to generate maximum commercial value.
Data: I-Mab will share clinical data from AbbVie’s global collaboration. These overseas data can help to advance clinical development in China more quickly, and may even be launched globally before then.
Dr. Zang Jingwu said that the cooperation with AbbVie has laid the foundation for the future development of China's innovative pharmaceutical companies.
It is not only the industry’s recognition of I-Mab, but also the beginning of further global recognition of China’s innovative drugs.
China's entire innovative drug industry is developing rapidly, and more Chinese innovative drug companies will be connected to global sales after a period of time. "This business model is also used in the United States, because sales are still the strength of large companies, so whether it is a Chinese or American company, choosing to cooperate with large companies can maximize the commercial value of these innovative drugs."
< p> It is reported that I-Mab’s first product, TJ202 (fezetuzumab) for the treatment of multiple myeloma, is expected to be launched in China in 2022. With the launch of TJ202, other products will be driven to form synergistic value. By 2024, three or four new products will be launched one after another.? "Entrepreneurial partner"-style capital cooperation innovation
Since its establishment, I-Mab has been favored by high-quality capital. Within three years, it has raised funds from leading medical companies in China and around the world. Health and biotech capital investment exceeds US$500 million. If you include this US$418 million PIPE financing, the cumulative funds raised will be close to US$1 billion.
▲I-Mab’s financing process
Successfully logged into NASDAQ in January 2020, and so far, I-Mab’s stock price has increased by more than 170%.
Dr. Zang Jingwu said that making innovative drugs is not a one-man show performed by one company, but must have a complete ecosystem, including talents and capital.
And the cooperation between I-Mab and capital is not just about capital.
On October 19, 2016, I-Mab completed a Series A financing of US$10 million, with the investor being Cangqiao Capital. Since then, Kangqiao Capital has made three consecutive rounds of investment, becoming one of the largest investors in I-Mab.
Kangqiao Capital is more like the co-entrepreneur of I-Mab, promoting its pipeline development and team building throughout the entire chain and cycle.
Just like the previous cooperation with Cambridge Capital, for strategic considerations, it can be seen that in addition to the Singapore government investment company GIC, the consortium led by Hillhouse Capital also includes other well-known Asian and American biotech companies. Technology Investment Fund. They are all investors with mature plans in the field of health. At the same time, Hillhouse will have the right to nominate a representative to the board of directors of I-Mab. Hillhouse Capital will provide advice and suggestions for I-Mab during its transformation into a comprehensive pharmaceutical company.
Hillhouse Capital is an excellent example of layout in the field of health in recent years. In addition to a complete industrial matrix of upstream, midstream and downstream industries, it is also unique in resource integration.
▲Hillhouse Capital’s large health field matrix
Using Hillhouse’s resource matrix, I-Mab can find more partners and cooperation projects.
In addition, through Hillhouse’s medical institutional resources (including research hospitals for hematological tumors and solid tumors), we can integrate more industry, academia and research, and cooperate with clinical experts to bring new drugs to Chinese patients better and faster .
Innovative drugs are the crown jewel of the pharmaceutical industry and the future growth driver of the global pharmaceutical industry.
Driven by the simultaneous promotion of policies, capital, technology, and talent dividends, China’s innovative drugs have entered a golden era in which a hundred flowers bloom. We see many companies making their own contributions from all dimensions of the industrial chain. power.
From R&D to international cooperation to commercialization and capital cooperation, I-Mab has set a model for the development of innovative drugs in China.
We have also seen that China is gradually establishing a stronger innovative drug ecosystem to better promote the rise of Chinese innovative drugs in the world.