In recent years, immunotherapy has become one of the hotspots in the field of cancer treatment research at home and abroad. In the 2013 Top Ten Scientific Breakthroughs published by Science magazine, immunotherapy ranks first, and it is expected to become the next step in surgery and chemotherapy. A new generation of cancer treatment methods after radiotherapy and tumor targeted therapy.
At present, tumor immunotherapy research is in full swing around the world. As of September 2017, 26 kinds of immunotherapy have been approved by the US FDA. The varieties include immunomodulators, tumor vaccines, cell therapy, oncolytic viruses, and targeting. In terms of the number of CD3 bispecific antibodies, 940 varieties are in the clinical development stage, and 1064 varieties are in the preclinical stage. Among them, immunological checkpoint inhibitors and cell therapy research are the hottest. As of now, globally Five anti-PD-1/PD-L1 antibodies and two CAR-T products have been approved for marketing.
China's oncology immunotherapy research is also actively in the process. In 2017, the clinical application of CAR-T therapy submitted by Nanjing Legendary Biology and the application for Cinda monoclonal injection of Cinda's lymphoma for the treatment of Hodgkin's lymphoma were accepted. Let people see the opportunity to overtake the Chinese corner.
On September 28th, hosted by Shanghai Zhangjiang (Group) Co., Ltd., Shanghai International Medical Park Group Co., Ltd. and Shanghai Zhangjiang Biomedical Base Development Co., Ltd. hosted the third season of 2018 "Zhangjiang Life Science Salon - Jinqiu to the immunotherapy" Held in Shanghai International Medical Park, this salon will focus on the hot topics of the immunotherapy industry, explore the development trend of the industry, and jointly explore the strategic opportunities in the era of immunotherapy innovation.
Two valleys linked, the immunotherapy layout leads
In August 2017, the Shanghai Municipal Government formally approved the principle to agree to the construction plan of Zhangjiang Science City. It is clear that the total planned area of ​​Zhangjiang Science City is about 94 square kilometers. Based on the Zhangjiang Hi-Tech Park, it will be transformed into new knowledge and technology in China and the world. The place of creation and the cultivation of new industries, modern new livable urban and municipal public centers, world-class science city.
Zhang Wei, deputy director of Zhangjiang Hi-Tech Park Management Committee, said: "In the more than a year that Zhangjiang Science City was approved, the Shanghai Municipal Government and Pudong New Area focused on the construction of Zhangjiang Science City and vigorously promoted the construction of key projects. Since the linkage of institutional and institutional innovations, Zhangjiang Science City has continuously accelerated the 'magnetic effect' and 'field effect'. Up to now, Zhangjiang Science City has gathered the most advanced technology industry R&D institutions, the most active innovation and entrepreneurial power, and the most Strong financial capital trading power, the most innovative and effective service system, all provide an excellent opportunity for the industry to move toward the commanding heights. In this, the development of the 'medical industry' cannot be underestimated."
Zhangjiang “Pharmaceutical Valley†and Shanghai International Medical Park “Medical Valley†are the two major fist areas of Zhangjiang Science City. They play the maximal advantage of their respective “medical industries†and are closely linked to form the advantage of “Pharmaceutical Valley New Drug Research and Development Industry + Medicineâ€. The cluster advantage of Gu Modern Medical Service Industry creates a platform for the arrival of the big health era of all-factor integration, and creates a core drive for the linkage development of the entire industry chain.
According to Xia Duo, general manager of Shanghai International Medical Park, Zhangjiang Pharmaceutical Valley is the main carrier of the national major new drug innovation project. Its high-density coverage of pharmaceutical research and development industry is nearly 20 square kilometers, accounting for 1/5 of the planned area of ​​Zhangjiang Science City. At the same time, Yaogu is in a leading position in many sub-pharmacies, forming a complete industrial chain including bio-pharmaceuticals, chemical preparations, modern Chinese medicine, etc., ranging from new drug development to drug screening, pharmacological evaluation, and clinical Research, process research, pilot scale-up, and finally to the registration chain, the innovation chain for mass production, and the service chain for circulation services and medical assistance.
Shanghai International Medical Park has formed a high-end medical device industry cluster represented by Siemens, Dräger, Anlujie, MicroPort Medical, and Yisi Medical. The industrial output value accounts for about 20% of Shanghai, and the product line can cover comprehensiveness. More than 85% of hospital medical equipment , specific products include surgical instruments, interventional equipment, medical high-frequency equipment, clinical testing and analysis equipment.
At the same time, Shanghai International Medical Park has also formed a high-end medical service area with the representative of Shanghai Proton Heavy Ion Hospital and Shanghai International Medical Center, and has gathered a number of high-quality high-end specialist hospitals and multi-institutional comprehensive hospitals, including National Children's Medical Center, Fudan University Affiliated Tumor Hospital East Hospital, Dezhou International Hospital, Elizabeth International Maternity Hospital, Sino-German Friendship Hospital, etc., and will plan to build a shared laboratory site, share clinical research platform, clinical trial platform The industrial platform featuring the same will release more potential space for the development of diversified medical institutions.
“It has to be mentioned that in the field of immunotherapy, the 'two valleys' layout is the first echelon. Among them, four companies with leading CAR-T technology in the world, of which three have been laid out in the medicine valley, Pharmacy Enterprise Youkadi is currently registered with the original CFDA to declare the number of CAR-T products and the largest number of indications. In addition, Sibman Bio has many patented technologies for CAR-T treatment, and it is the only one in Nas. Dak's listed Chinese cell therapy biotechnology company, in the PD-1/PD-L1 layout, a number of drug companies are also making technological breakthroughs, rapid layout, and rushing to the market. In the Valley, focusing on gene therapy drug development, Basic research and clinical grade AAV (gland-related) industrial preparation of Heyuan organism, as an upstream enterprise of immunotherapy, it produced a batch of clinical AAV virus vectors for lung cancer and liver cancer by the end of 2017, which is expected to get a phase I clinical Approved, it may become the first clinical AAV virus carrier in China and even in the world, as a kind of Apumai creature that cultivates 'fertile soil' for immunotherapy, which focuses on animal fines. The development and mass production of serum-free medium, and obtained nearly 100 million yuan of strategic investment in April this year, which is the largest single financing in the field of cell culture in China so far. In May this year, the world's first nano-gun treatment of lung cancer clinical trial Completed at Shanghai Oriental Hospital, the nano-gun was developed by the Shanghai International Medical Park Enterprise Bian Bio, and the project of Bian Bio's 'Clinical-Inducible Lentiviral Vector Mass Production Technology for CAR-T' was awarded 2016. The first place in the China Innovation and Entrepreneurship Competition (biomedical industry) finals enterprise group, this project is the first to propose a clinical-grade lentiviral vector that can express chimeric antigen receptors in China." Xia Duo introduced.
Finally, Xia Duo pointed out: "Whether it is from immunotherapy or in other medical industry segments, the industrial development linkage between Medicine Valley and Medical Valley will form an increasingly better complementary advantage. In the future, the two valleys will Uniformly playing Zhangjiang brand, forming a synergy of brands and strengthening the core competitiveness of Zhangjiang's life and health industry."
Policy plus code to boost capacity
In order to achieve rapid development of an emerging industry, in addition to advanced technology, capital driving, and talent pooling, it is also necessary to speed up the run-up at the official policy level.
"2017 is the first year of the outbreak of immunotherapy. In this year, the US FDA approved two world-class CAR-T treatment products for hematological tumors, and one is Novartis's Kymriah for the treatment of B cells. Precursor acute lymphoblastic leukemia, the other is Kite Pharma (acquired by Gilead) for the treatment of relapsed or refractory large B-cell lymphoma Yescarta, in China, although there is no CAR-T at this stage Therapeutic products have been approved, but the relevant national functional departments have successively issued a number of policies to encourage and support the development of immunotherapy," Fu Dazhao, director of Shanghai Biomedical Technology Industry Promotion Center, in his "Shanghai Biomedical Industry Development Status and Support Policies" Said in the keynote speech.
At the end of 2016, the State Council’s “13th Five-Year Plan†bio-industry development plan was released, proposing the development of therapeutic vaccines, ribonucleic acid (RNA) interference drugs, and stem cell, chimeric antigen receptor T cell immunotherapy (CAR-T) and other biological treatment products. And for the first time, the establishment of an individualized immune cell therapy technology application demonstration center; in June 2017, the Ministry of Science and Technology and other six ministries jointly issued the "13th Five-Year Plan for Health and Health Science and Technology Innovation", requiring the strengthening of stem cells and regenerative medicine. Key technologies such as immunotherapy, gene therapy, and cell therapy accelerate the clinical application of cutting-edge technologies in biotherapy, innovate therapeutic technologies, and improve the level of clinical treatment. In December 2017, the original CFDA released the technical guidance for research and evaluation of cell therapy products. Principle (Trial), clarifying the drug properties of cellular immunotherapy products; in January 2018, the State Intellectual Property Office released the latest edition of the "Intellectual Property Key Support Industry Catalogue", clearly proposing that the central government of stem cells, immune cell therapy, etc. The key development directions of the State Council’s documents are listed as key support .
"In addition to the national document number, the attitudes of local governments are very clear. In terms of Shanghai alone, it is mentioned in the "Planning of Medical Science and Technology Innovation" 13th Five-Year Plan, focusing on stem cells and regenerative medicine. In the direction of support, and will draw a major municipal-level special project to promote implementation; in the "Implementation Opinions on Promoting the Healthy Development of Biomedical Industry in the City", it is proposed to give priority to the development of biological products, accelerate the research on immune cell therapy, stem cell and gene therapy. In this year's latest issue of 'Health Service Industry Development 50', it is also explicitly mentioned that orderly development of cutting-edge medical services, including the development of cell therapy, gene therapy, liquid biopsy technology, and the promotion of standardized and standardized application of new individualized biotherapeutic products, Create an industrial cluster of immune cell therapy, stem cell therapy and genetic testing." Fu Dazhao introduced.
Fu Dazhao believes that although immunotherapy still has a long way to go in China, including some technical problems, it needs to be overcome, but as technology becomes more mature, it will be at the forefront as an important treatment. Coupled with the blessing of the first policy, the future of immunotherapy is worth looking forward to, and the accelerated development of the industry is bound to be a matter of course.
According to Fu Dazhao, the Shanghai Municipal Science and Technology Commission is currently researching and preparing to make a municipal-level major project on cell therapy to help solve the technical problems of cell therapy.
Industry big coffee, all about immunotherapy, spring and autumn and warring states
It is undeniable that immunotherapy is also facing many challenges while it is full of development prospects. For example, many of the tumor immunotherapy varieties under study are concentrated on certain targets. CAR-T therapy is the mainstream of current cell therapy, and there are many limitations. Including some patients with blood cancer, such as short duration, poor penetrability in solid tumors, limited tumor killing effect, cytokine storm, off-target effect and other toxic side effects and difficult to scale preparation.
From left to right: Xiao Zhihua, Chairman and General Manager of Shanghai Haiaopu Biotech Co., Ltd., Pan Weidong, Chairman and President of Hefei Biotechnology Shanghai Co., Ltd., Yang Guanghua, President and Chairman of Shanghai Bion Biomedical Technology Co., Ltd. Ye Yang, Chief Operating Officer of Shanghai Core Biotech Co., Ltd., Dai Chengxiang, General Manager of Stem Cell Division, Sibbi Biotech Co., Ltd., Chen Rulei, Executive Vice President, Jiahe Biopharmaceutical Co., Ltd.
Yang Guanghua, chairman of Shanghai Bion Biomedical Technology Co., Ltd., said that CAR-T therapy works well in the treatment of hematoma, but it is not satisfactory in the treatment of solid tumors. The reason is because a prominent feature of solid tumors is heterogeneity. Even for the same patient, tumors in one site do not necessarily express the same tumor-associated antigen, even in the same tumor lesion. The antigen can cover all tumor cells. The high degree of heterogeneity makes the treatment of solid tumors greatly difficult, and the choice of target has become a major challenge for CAR-T treatment of solid tumors. At the same time, the in vivo homing and activation of CAR-T cells is also a difficult problem. How to accurately inject the infused CAR-T cells from the peripheral blood to the tumor site and play a killing effect is still a huge challenge. . At the same time, cytokine storms, targeted/target-target toxicity, etc. are also two large mountains in the CAR-T therapy.
In addition to technical problems, safety issues, and market approval issues are also a hurdle that immunotherapy can't do. Dai Chengxiang, general manager of the stem cell division of Sibbi Biotech Co., Ltd. pointed out: "There are too many companies that are currently deploying CAR-T treatment. Even if they are targeting the same indication, because the clinical trials are different, the corresponding clinical data will be different. How to approve an appropriate indication for the market also needs to focus on it."
For the marketization problem, Chen Rulei, executive vice president of Jiahe Bio-Pharmaceutical Co., Ltd., is more optimistic: Although there are many companies doing immunotherapy, how will this market evolve in the future? I personally think that some enterprises still have opportunities. For example, PD-1, the development of this drug is not the same as the development of other anti-tumor drugs. In addition to the combination of drugs, because it is a broad-spectrum product, it can't be said which one can be eaten. Later, there will still be opportunities, such as By selecting different indications, selecting different criteria for enrolling patients, and developing differentiatedly, in the future, this market is not as inseparable as a whole iron plate. If you find the right direction, each company will have its own market. "
In the process of market-oriented products, price is naturally the most concerned. As Chen Rulei said, the cost of drugs is always a very sensitive and very important topic. There is a joke abroad, what is the biggest side effect of drugs? It is the price, especially the new drug. Currently, the two approved CAR-T therapies in the world, Kymriah and Yescarta, are priced at $475,000 and $373,000, respectively. If one day, the two products entered China, or the localized CAR-T The treatment is approved, how should the pricing range be estimated?
Dai Chengxiang believes that if CAR-T therapy is priced at US$475,000 in China, it will not work. It is better to send it directly to the United States for treatment, but if it is priced at 300,000 to 500,000 RMB, This price is likely to be accepted, because a bone marrow transplant, if there are no other complications, about 500,000 is almost the same, if CAR-T treatment can be set in such a price range, and the treatment effect can be alleviated More than a year, or after the relief, give the patient a chance to transplant a bone marrow. After that, it can be relieved for more than five years. I can have such an expectation. I believe it is still very marketable.
Chen Rulei said that the price of the product including the price of immunotherapy should consider the direct production cost, the overall cost of the supply chain, the market sales scale, and the policy environment.
This view was also recognized by Xiao Zhihua, chairman and general manager of Shanghai Aopumai Biotechnology Co., Ltd. Xiao Zhihua pointed out: "Before, for the more popular anticancer drugs abroad, we believe that the price is two-thirds of the foreign countries. Reasonable, but after these products are included in medical insurance, the most direct reduction of the price is more than half of the direct waist, which is undoubtedly a major positive for the patients, so in fact, for the entire industry, the company's research and development costs, the environment The policy system must be considered together."
Regarding the price issue, Pan Yidong, chairman and president of Heyuan Biotech Shanghai Co., Ltd., did not directly express his position, but he pointed out that enterprises can do this by reducing production costs, such as product production, which can be entrusted to third-party organizations. The imported consumables can be replaced by domestically produced consumables, the production costs are directly reduced, the cost is reduced, and the final product price is naturally reduced.
Although the status quo of immunotherapy is still not perfect, including technology, safety, market, price and many other issues have yet to be explored and discussed, but as the most popular anti-tumor therapy, everyone can still be the future of immunotherapy. During this period, this confidence in immunotherapy was confirmed by Ye Yang, the chief operating officer of Shanghai Core Micro Biotechnology Co., Ltd. Ye Yang said: A few years ago, our customer volume was double digits, probably only a few dozen Cell-based companies have carried out sample storage or cell storage, but since last year, the number of these companies and the number of cells stored have risen sharply. That is to say, everyone is looking forward to the development of the field, they are very Actively lay out and explore.
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