Lemzoparlimab, highly recognized by AbbVie, is an innovative CD47 monoclonal antibody independently developed by Tianjing Bio, which is used to treat a variety of cancers. It is also one of the most promising research drugs in many patent innovation R&D pipelines of Tianjing Bio.
At present, immunotherapy targeting CD47 is regarded as the next "hope" to conquer cancer after PD-(L) 1.
Six months ago, Gilead bought 47 biotech companies specializing in the research and development of CD47 pathway inhibitors for $4.9 billion. Once a sensation in the industry, it will become the second largest merger of biopharmaceuticals by 2020.
Although no monoclonal antibody against CD47 has been approved for marketing in the world, according to incomplete statistics, more than 20 companies are developing products against CD47, including not only monoclonal antibodies against CD47, but also bispecific antibodies against CD47 and other targets, and more than a dozen of them have entered the clinical research stage, including the most famous 47, Hengrui and Xinda.
Among many CD47, why does the astrobiology project stand out?
Dr Zang Jason Wu, founder, honorary chairman, chairman and director of Tianjing Bio, proudly said that the CD47 antibody of Tianjing Bio is the most advanced in the world.
Because, although blocking CD47 has been considered as one of the most promising methods to prevent cancer cells from being detected and attacked. However, due to the combination of CD47 and red blood cells, severe anemia and other hematological side effects may occur during the treatment, which hinders the development and clinical application of CD47 antibody as cancer treatment.
Therefore, the CD47 projects of many pharmaceutical companies around the world have been seriously affected, and some even stopped research and development.
However, Tiandao Bio has realized the severe challenge of this side effect since its layout began four years ago, so it made a differentiated design at the beginning of research and development.
Through ingenious antibody design and screening, Tianjing biological research team found a CD47 antibody named lemzoparlimab, which has strong binding capacity with cancer cells and can minimize the impact on red blood cells. Lemzoparlimab binds to CD47 molecules on the surface of tumor cells through a unique recognition region. Happily, the same area of CD47 on the surface of red blood cells is shielded by a large number of sugar chains, and the natural barrier formed by sugar chains can prevent lemzoparlimab from unnecessarily combining with red blood cells, thus avoiding being swallowed by antibody binding.
At present, lemzoparlimab(TJC4) has completed the first phase of clinical (climbing test) in the United States. From the clinical data, it is obviously different from other CD47 antibodies, which proves that it successfully avoids hematological side effects such as severe anemia. In the global clinical research stage, no other CD47 antibodies with similar properties have been found.
It is reported that the specific clinical data will be officially announced at the annual meeting of the Global Society for Cancer Immunotherapy (SITC2020) held in the second half of this year. Among them, some data of climbing test for patients with acute myeloid leukemia (AML) will be published at the annual meeting of American Hematology Association (ASH2020).
Based on the advantages of its drug molecules, the global and China clinical research and development process of lemzoparlimab(TJC4) will be faster.
In addition to monotherapy, at present, lemzoparlimab and Keytruda? (Pammonoclonal antibody) and rituximab? Combination therapy trials (rituximab) are also being conducted in China and the United States, mainly for the treatment of patients with solid tumors or lymphoma.
After cooperating with AbbVie, Tianjing Bio will also cooperate with the world's leading venetoclax (Venclexta? ) carry out joint development projects.
Three unique innovations
? Innovation of "Winning at the Starting Line"
According to Dr. Zang Jason Wu, Tianjing Bio has been focusing on global innovative biopharmaceuticals and competing with global biopharmaceuticals companies from the very beginning.
Therefore, in addition to the global standards of product standards, Tianjing Bio has successfully built two product pipelines in the world and China, namely, the China R&D pipeline with low risk and rapid product listing and the global R&D pipeline with global competitiveness and high risk and rapid proof of concept.
▲ "Two-wheel" development strategy of celestial organisms
Driven by the two-wheel R&D strategy, clinical verification (phase I clinical or partial phase II clinical) can be completed quickly through the mature system in the world; Then accelerate the clinical development suitable for China patients in China, so that new drugs can be listed in China earlier to benefit patients.
? "Faster" is beneficial to clinical innovation
The way of innovation, the patient is supreme. All new drug innovations are truly valuable only if they are beneficial to patients. Dr. qi said to him. The same is true of celestial beings.
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The first step to accelerate the clinical benefit: transforming from R&D company to a full value chain company integrating R&D, clinic, production and sales.
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Translational medicine:
Translational medicine was formally put forward by the National Institutes of Health (NIH) in 2003, and has become the "development code" of the world's top pharmaceutical companies. Its important role in reducing the risk of new drug development and accelerating the clinical speed has been proved more and more.
As a global innovative biological company, Tianjing Bio has established translational medicine research departments in China and Shanghai.
Production base:
From 2065438 to May 2009, Tianjing Bio decided to establish a research and development and GMP production base in Hangzhou, focusing on the clinical development achievements of its innovative drug pipeline in China and the United States.
Commercialization team:
In July 2020, Tianjing Bio announced the appointment of Mr. Zhu Yifei as Chief Commercial Officer, reporting directly to Dr. Zang Jason Wu, founder, honorary chairman and director of Tianjing Bio. The appointment took effect in August 2020.
Zhu Yifei, the newly appointed chief commercial officer, used to be the sales general manager of Qilu Pharmaceutical Group and the chief commercial officer of Baekje Shenzhou. He has rich commercialization experience in the field of biomedicine, and is currently rapidly establishing a commercialization team of Tianjing Bio.
Dr Zang Jason Wu said that due to two milestones, celestial beings have officially entered the 2.0 stage. That is to say, it will become a comprehensive global bio-innovative drug company covering the whole value chain of R&D, clinic, production and sales. Really turn "innovation" into "value".
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Step 2: Further overseas cooperation.
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Zhu Jielun, chief financial officer of Tianjing Bio, said that, for example, the cooperation with AbbVie has formed an important synergy for the accelerated listing of Tianjing Bio's new products in terms of capital, production and data.
Funds: used to promote the research and development of innovative drug pipelines and global clinical trials, and expand the global commercialization capacity, thus forming a very good virtuous circle.
Production: As a global manufacturer in hummel, Abby has established a very powerful biopharmaceutical production process system. It can improve the production technology and product quality of Xianjie and produce the greatest commercial value.
Data: Tianjing Bio will share clinical data of Abway global cooperation. These overseas data can help promote the clinical development of China faster, and may even be listed before the world.
Dr Zang Jason Wu said that the cooperation with AbbVie laid a foundation for the development of innovative pharmaceutical companies in China in the future. It is not only the industry's recognition of immortals, but also the beginning of China's innovative drugs gaining global recognition.
The whole innovative medicine industry in China is developing rapidly. After a period of follow-up, more innovative medicine enterprises in China will access global sales. "The United States also adopts this business model, because sales are still the strength of big companies, so whether it is China or American companies, choosing to cooperate with big companies can maximize the commercial value of these innovative drugs."
It is reported that TJ-202 (fizetomazumab), the first product of Tianjing biotherapy for multiple myeloma, is expected to be listed in China in 2022. With the listing of TJ202, it will drive other products to form synergistic value. By 2024, three or four new products will be listed one after another.
? Capital cooperation innovation in the form of "venture partner"
Tianjing Bio has been favored by high-quality capital since its establishment. In three years, it has raised more than 500 million US dollars of investment from China and the world's leading medical, health and biotechnology capital. If the pipeline financing of $41800 million is added, the accumulated funds raised are close to $6,543,800+0 billion.
▲ Tianjing Bio-financing Process
In June 2020, 5438+ 10 successfully landed on Nasdaq. Up to now, Tianjing Bio's share price has risen by more than 170%.
Dr Zang Jason Wu said that making innovative drugs is not a "one-man show" of a company, but must have a complete ecosystem, including talents and capital.
And the cooperation between immortals and capital is not just money.
20 16 10 19 Tianjing Biological Completion 100000 USD Series A financing, with the investor being Kangqiao Capital. Since then, Kangqiao Capital has invested for three consecutive rounds, becoming one of the largest investors in Tianjing Bio.
Cambridge Capital is more like the co-founder of Tianjing Bio, promoting its pipeline development and team building throughout the chain.
Just like the previous cooperation with Cambridge Capital, for strategic reasons, we can see that the consortium led by Gaochun Capital includes other well-known Asian-American biotechnology investment funds in addition to gic, a Singapore government investment company. They are all mature investors in the field of big health. At the same time, Gao Xian will have the right to nominate a representative to the Tianjing Biological Board of Directors. Gao Yan Capital will provide suggestions to Tianjing Bio in the process of its transformation into a comprehensive pharmaceutical company.
Gao Yan Capital is an excellent model in the field of big health in recent years. In addition to the complete industrial matrix in the upper, middle and lower reaches, it is also unique in resource integration.
▲ Gaochun Capital Big Health Field Matrix
Using Gaoling's resource matrix, celestial beings can find more partners and cooperation projects.
In addition, through the resources of high-tech medical institutions (including research hospitals for hematological tumors and solid tumors), we can combine Industry-University-Research and cooperate with clinical experts to better and faster benefit China patients.
Innovative drugs are the crown jewel of the pharmaceutical industry and the driving force for the growth of the global pharmaceutical industry in the future.
Driven by the policy, capital, technology and talent bonus, China's innovative drugs have entered a golden age, and we have seen many enterprises contribute their strength from all dimensions of the industrial chain.
From R&D to international cooperation, to commercialization and capital cooperation, Tianjing Bio has set a good example for the development of innovative drugs in China.
We also see that China is gradually building a stronger innovative drug ecosystem, which will better promote the global rise of innovative drugs in China.