Yesterday, the 2024 Service Trade Fair opened. A reporter from Beijing Youth Daily came to Hall 2 of Shougang Park. In the specialized and new exhibition area, two seemingly inconspicuous bags of cell injection attracted the attention of the audience. Both products are gene cell therapy drugs for advanced cancer. Among them, China's first lymphoma gene therapy drug is about to submit a product marketing application. This product will not only break foreign monopoly and achieve domestic disruptive technological breakthroughs, but is also expected to create global breakthroughs in related fields. Behind this is the result of the unremitting efforts of a group of young science and technology innovation teams led by Dr. He Ting from Tsinghua University who have "sharpened their sword for ten years". They adhere to the mission of "making cancer no longer a terminal disease" and complete the transformation "from 0 to 1", bringing more hope to Chinese cancer patients.
A paper ignited entrepreneurial passion
When He Ting was studying for a doctorate in the Cancer Biology Laboratory of Tsinghua University, his main research direction was the regulation of tumor microenvironment. At first, he never thought about starting a business, only how to research cancer. "It may have made some contributions to scientific research at that time, but its practical application value was very limited."
Until he saw an academic paper published in the world's top medical journal. It mentioned that in clinical trials, CAR-T cell drugs were used to treat a relapsed and refractory acute leukemia, and the complete remission rate exceeded 90%. "This is a very astonishing data. At that time, few people in China were engaged in gene cell drug research. Many leukemia patients were basically incurable and their survival period was very short." He Ting said that this paper gave him the idea of starting a business. , "I really hope to do something that can really change the current status of some disease treatments and some people's lives. To achieve this, it may be more appropriate to choose to start a business instead of doing scientific research in the laboratory." Since then, He Ting started The road to research on CAR-T cell drugs.
What is CAR-T cell drug therapy? He Ting explained that this treatment mainly uses “car-t technology”. T cells are a type of immune cells in the human body. Their main function is to patrol the body, discover and eliminate cells infected by viruses or bacteria, and tumor cells. "We can simply understand T cells as 'killers' in the body, but some tumor cells are very cunning and can evade recognition and attack by T cells through a variety of mechanisms. Therefore, researchers have an idea, is it possible These T cells are trained so that they can recognize and eliminate specific tumor cells. "Based on this idea, CAR-T cell technology was born," He Ting said.
developers extracted the patient's own T cells, and after gene editing, these T cells installed a special "key"-like molecule on the cell surface. This molecule is car, and the T cells with car molecules are car- T cells. When researchers inject CAR-T cells back into the patient's body, they will travel around the body holding the "key". Once they come into contact with tumor cells with specific "locks", the CAR-T cells will be activated. And kill and eliminate tumor cells.
"Surgery and radiotherapy are both local treatments for tumors; although chemotherapy can treat tumors throughout the body, its systemic toxic and side effects are the most serious among tumor treatments. He Ting said that it was not until the emergence of gene cell drugs represented by CAR-T technology that it truly brought hope for the effective treatment of advanced cancer. "Car-T cell therapy is a type of immunotherapy . It can kill tumor cells throughout the body in a targeted manner without causing serious adverse reactions. Compared with other treatments, it has a very high cure rate. Rate.”
The twists and turns of a doctoral team’s entrepreneurial journey
After graduating from Tsinghua University with a PhD in biology, He Ting and two Tsinghua classmates who were also studying cancer made up their minds to start a business together. In this way, Beijing Yimiao Shenzhou Pharmaceutical Technology Co., Ltd., co-founded by three doctoral students, was established in Haidian.
When it comes to starting a business, He Ting believes that the most important thing is to stick to your dream. “The mission of ‘making cancer no longer a terminal disease’ has always supported us in developing car-t technology to this day."He Ting said that now 10 million patients around the world are killed by cancer every year. Cancer has developed into the second leading cause of death in the world and has become synonymous with "terminal illness" in people's eyes. There are about 100 kinds of cancer, and their genetic mutations The directions cannot be completely consistent, and the complexity and difficulty of industrialization of car-t technology are unprecedented.
In the process of entrepreneurship, Yimiao Shenzhou's growth is roughly divided into three stages. The first stage is to conquer key technologies, like a " "Laboratory" will create an independent research and development platform; the second phase of new drug registration and application will accelerate the commercialization layout; the third phase will achieve commercial production capacity and launch, expanding the application of new technologies and new treatment areas.
During the development process, He Ting We soon encountered the problem of talent shortage. “Our founding team has a strong R&D background, but as a biopharmaceutical company, the R&D system, production system, and clinical system are all very important, and we need to make up for the shortcomings of the start-up background as soon as possible. "He Ting said, "For an organization, there should be no shortcomings, which requires constant filling of positions. "In the early days of
, He Ting took many detours and even spent two years failing to recruit the right person. He laughed and said that he encountered a recruitment "Waterloo." "For example, during the registration and application stage, we interviewed many candidates with backgrounds from multinational companies. , he was well-spoken and had a good background, but he found out after recruitment that everything was wrong. Later we realized that it is impossible to find people who are excellent in all aspects, but we must find and bring out the most outstanding aspects of each person. What is more important is to see whether his inner goals, wishes and values are really consistent with ours. "He Ting said, "A top CEO is a top headhunter. "
After nearly 10 years of innovation, entrepreneurship and in-depth research, He Ting's team has grown rapidly from a few people to one of the largest R&D teams in China's car-t field, with the number of employees expanding from three to more than 300. "Our core executives There were more than ten people, and I was always the youngest among them. I think for startups, the CEO of the company should find the best people to work with, so that the team can continue to meet greater challenges. "He Ting said, "In this team, I have always felt that I am a relatively ordinary person in terms of IQ and experience, but I can let people who are more experienced and smarter than me join this team and work with me. To fight is something that makes people proud. ”
Today, He Ting has transformed from a young laboratory doctor into the leader of an innovative pharmaceutical company with a global vision. He has become an outstanding representative in the field of gene cell drug innovation and research and development in Beijing, leading the technology in the car-t field in Beijing. Innovation and achievement transformation.
A precise "fight against cancer cells"
As an innovative drug company, He Ting leads a team that focuses on gene cell drug technology to cure advanced cancer. He clearly remembers the first time he launched car-t treatment. Experience.
That was a little boy suffering from leukemia “I was so nervous that I couldn’t sleep. I hope the clinical trial will be effective, but I am worried about adverse reactions. "He Ting said that CAR-T treatment will activate a strong immune response. After the treatment started, the patient initially had a fever, with the most severe temperature reaching nearly 40°C. He Ting worked with team members to care for and monitor the patient's condition.
Finally, the patient’s body temperature was under control, and in the subsequent data graphs, the cancer cell content in the patient’s blood was gradually reduced... “Ten days after treatment, the cancer cells in the peripheral blood completely disappeared, and a month later, the cancer cells in the bone marrow also completely disappeared. disappears and the curve drops to zero. The effect is surprisingly good. "
Later, the patient's father was invited to the Yimiao Shenzhou Annual Meeting and told how the little boy went through chemotherapy again and again after suffering from cancer, with ineffective despair and pain, and then was cured by car-t. “Many colleagues cried. For the first time, everyone intuitively felt the meaning of their work: every experiment and the cells produced in every link carry the lifelong dedication and hope of patients and their families. He Ting said, "When we see a patient walk out of the hospital after successful treatment and see his family get new hope, this sense of mission is unprecedented and can unite the team.""
It is precisely because of this that when the team led by He Ting faced difficult moments in the entrepreneurial process, whether it encountered technical difficulties or encountered difficulties that were difficult to solve in clinical development, as well as various aspects such as funding and production, This is a new challenge, and the entrepreneurial team has never been intimidated by difficulties.
“More than 4 million patients in China will be diagnosed with cancer every year, and many of them will not survive long. Gene cell drug therapy is still in its infancy in China. Even overseas, despite more than 30 years of technical research experience, their industrialization journey only takes six or seven years. "He Ting said that in the 10 years since its establishment, Yimiao Shenzhou has completed the transformation "from 0 to 1". In July 2022, it successfully obtained the "Drug Production License" for car-t cell therapy products, becoming the first in Beijing and one of the few in the country. There are not many gene cell drug companies that have been approved for the "Drug Production License" for car-t cell therapy products.
Looking to the future, He Ting is full of confidence, "I believe that with the efforts of our generation, we have the opportunity to further develop. Create more independently developed new technology platforms and products, and treat more patients around the world starting from China. I think the next ten years will be a golden decade. One day, cancer will no longer be a terminal disease. ”
Live
The first domestic lymphoma gene therapy drug was unveiled at the Service Trade Fair
At the 2024 Service Trade Fair, Yimiao China brought two products to Hall 2 of Shougang Park and displayed them in the specialized and new exhibition area. Including the company's first self-developed car-t cell product - im19 car-t cell injection
Yimiao Shenzhou car-t cell product - im19 car-t cell injection (photo/reporter Yuan Yi)
. Speaking of this innovative anti-tumor drug, He Ting couldn't help but recall a clinical trial experience many years ago. At that time, Mr. Zhao was unfortunately diagnosed with diffuse large B-cell lymphoma, a type of tumor that is extremely malignant. After traveling to many places to seek medical treatment, he underwent multiple radiotherapy and chemotherapy treatments, which cost hundreds of thousands of yuan. However, his condition was not relieved, and he eventually entered a critical stage where there was no cure. When Mr. Zhao and his family were desperate, they took the doctor's advice. Mr. Zhao received im19 car-t cell therapy independently developed by Yimiao Shenzhou He Ting's team. His condition was partially relieved one month after treatment, and he was discharged successfully after three months of complete remission.
He Ting said proudly, "After Mr. Zhao was cured, we learned during a follow-up that he had fertility needs, and then established an academic medical team with Beijing Cancer Hospital and Peking University Third Hospital to successfully help him conceive a baby through artificial insemination and in vitro fertilization technology. . We not only saved lives on the verge of death, but also helped them give birth to new lives and created miracles. Before this, there has never been a case in the world where a patient with advanced cancer successfully gave birth to offspring after being cured by CAR-T. "
After nearly ten years of innovative research and development, im19 car-t cell injection has obtained drug clinical trial approval for three hematological tumor indications. Among them, the research on the end-line treatment of diffuse large B-cell lymphoma has completed Phase II Clinical trials show good clinical efficacy and safety data, and a drug marketing authorization application is expected to be submitted in the fourth quarter of 2024, and is expected to be approved for marketing next year. He Ting said that after the im19 car-t cell injection is approved for marketing, it will effectively fill the domestic market. There is a gap in the market for independent CAR-T products in the field of lymphoma indications, bringing new hope to hundreds of thousands of lymphoma patients in China.
In addition, Yimiao China also has a latest CAR-T product for the treatment of advanced colorectal cancer. —im96 car-t was unveiled at this year’s Service Trade Fair. This product has been undergoing clinical trials at Peking University Cancer Hospital. A patient with rectal cancer who used it for nearly four months showed objective remission of the disease on imaging, which brought great benefits to the patient. Great hope. According to reports, im96 is likely to be the world's first major breakthrough in the treatment of advanced solid tumors in the field of CAR-T.
He Ting said that based on the good results of the company's self-developed CAR-T cell products in the treatment of advanced cancer. , Yimiao Shenzhou is also actively preparing for overseas development strategies, with its main target markets being Southeast Asia and the United States.“We hope to fully demonstrate the company’s R&D strength and meet more partners through the CIFTIS platform.”
Dialogue
Let more Chinese patients afford gene cell therapy in the future
Interviewer: He Ting, founder and CEO of Yimiao Shenzhou
(Photo provided/Yimiao Shenzhou)
Beiqing Daily: Gene therapy is very expensive. When new drugs are launched next year, can the cost of treatment be reduced?
He Ting: Car-T cell therapy products have made great breakthroughs in advanced cancer research in recent years. But as a new technology, it still has a lot of room for improvement, including production capacity, cost and other aspects. At present, the car-t products that have been launched overseas are basically priced at hundreds of thousands of dollars, and the overseas products that have been introduced in China are priced at more than 1 million yuan. Since the beginning of our business,
has insisted on "independent research and development". We have conquered a series of core technologies at the Haidian R&D headquarters, independently developed a one-stop gene cell drug technology platform, and achieved self-research and production of the entire process. From drug discovery, process development to clinical trials, and even marketing applications, all can be achieved through a complete set of self-developed solutions, thereby significantly reducing costs and allowing more Chinese patients to afford them in the future.
Beiqing Daily: What are the difficulties in treating cancer with car-t technology?
He Ting: First of all, cancer is not a disease, but a type of disease. There are more than 100 types of cancer recognized by the World Health Organization. The problem with car-t technology in treating cancer is that each type of cancer requires the development of a separate product, and the development of a new anti-cancer drug is very costly and time-consuming. Secondly, CAR-T technology has shown excellent efficacy in the treatment of lymphoma, leukemia, myeloma and other blood tumors, but it still faces multiple challenges and slow progress in the treatment of solid tumors.
To cope with the challenges, we are actively deploying the domestic leading car-t product pipeline. Currently, the product pipeline has expanded from blood tumors such as leukemia, lymphoma, and bone marrow cancer to solid tumors such as liver cancer, gastric cancer, and colorectal cancer. At the same time, a new generation of gene cell drug technology platform including CAR-T for solid tumors has been built to break through the current poor effect of CAR-T in treating solid tumors. So far, we have treated more than 300 late-stage cancer patients in China, half of whom have regained a new lease of life and returned to normal life.
Beiqing Daily: Imagine what the industry will look like in the next ten years?
He Ting: At present, the five-year survival rate of cancer patients in my country is about 30%, while in developed countries it has reached 70% to 80%. But I believe that in the next ten years, more and more scientific and technological companies with independent cell therapy drug technology will rise and develop rapidly in China, and domestic self-developed CAR-T drugs will show explosive growth. It is predicted that hundreds of CAR-T drugs will be approved for marketing in the future, which will allow more cancers to be effectively treated, and some cancers will no longer be considered terminal diseases in people's eyes.
At the same time, the next ten years will also be a critical period for domestic self-developed car-t technology to break the overseas monopoly. We will truly usher in the era of "domestic production is king".
Text/Beijing Youth Daily reporter Wang Bin
editor/Li Tianji
