China's cell therapy field of blue sea is now far from the world's leading way.

Following the anti-cancer target drug, may be in the near future, China will also introduce the corresponding facilitation policy for cancer cell treatment.
although this is only a trend, but I believe that the arrival of this day, China's related enterprises will be a huge shock.
in recent years, cell therapy research and development is in full swing, according to the new drug research and development monitoring database (CPM) shows that up to now, China's stem cell therapy research projects accounted for about 10% of the world, immunocellular therapy clinical research accounted for about 1/3 of the world, has become the second largest market after the United States.
expects the FDA to approve 40 to 60 cell and gene therapies by 2030 alone.
, with the continuous increase in scientific research investment and the strengthening of technical strength, the clinical research on cell and gene therapy in China is increasing year by year, with the number of new additions to the United States.
China, has become one of the most active areas of cell therapy clinical research in the world. "In the past, the struggle between humans and tumors was mainly through surgery, chemotherapy, radiotherapy and other means, " said Dr. Fu Dazhao, director of the Shanghai Biopharmaceutical Technology Industry Promotion Center,
car-T Development.
but now, driven by technological progress, health needs, economic development and other factors, humans have ushered in a fourth treatment opportunity - cell therapy, and the future pharmaceutical industry must be the era of cell therapy.
" Cell therapy will become the next medical star cell therapy is in recent years in the field of medicine "net red", but also one of the most promising research directions, about it has been written myths.
earlier, in 2012, emily Whitehead, a six-year-old girl diagnosed with acute lymphoblastic leukemia, became the world's first child to undergo experimental CAR-T therapy at the end of her life.
this case became the most classic case of cell therapy, car-T drug therapy, and one of the original motivations for subsequent research on CAR-T therapy, inspired by this case, the researchers believe that the occurrence of cancer disease will close the door to human survival, but the arrival of cell therapy, especially CAR-T therapy, will open another sunny window for the world.
in recent years, cell therapy has also been a dominant part of the world, especially in the field of cancer treatment has made unprecedented breakthroughs.
, CAR-T therapy as a different from traditional drugs, as the pharmaceutical giant Novartis CAR-T drug Kymriah and Gilead through the acquisition of Kite's CAR-T therapy Yescarta has been approved, CAR-T therapy has become the most popular cell therapy, but also known in the industry as "CAR-T New Year."
, for the treatment of recurrent or refractive children, adolescents (2-25 years) B-cell acute lymphoblastic leukemia (ALL), the product is called Kymriah, Novartis priced $475,000 per treatment.
Yescarta, which treats patients with large B-cell lymphoma in adults who are unresponsive or recurrent after receiving at least two other treatments and a specific type of non-Hodgkin lymphoma, is listed in the U.S. for $373,000. According to the
Drug Comprehensive Database (PDB), Yescarta's sales in 2019 were $456 million, up 73 percent from a year earlier, while Kymriah's sales in 2019 were $278 million, up 266 percent from a year earlier.
see ingenuity in the market for these two drugs, and gradually, many Chinese drug companies have entered the CAR-T treatment layout.
global, China's cell immunotherapy enterprises engaged in a variety of cell therapy research and development.
half of top 10 companies funding cell immunotherapy have two or more cell immunotherapy.
, CAR-T, TCR-T and NK cell therapy are the research and development directions of the two doors.
80 cell immunotherapy enterprises, 56 enterprises engaged in CAR-T research and development, accounting for 75%, 15 enterprises engaged in TCR-T research and development, accounting for 20%, 15 enterprises engaged in CAR-NK research and development, accounting for 20%.
, TIL and CAR-NK, DC cell therapy research and development enterprises are also among the best.
cell therapy China market layout difficult as a new immunotherapy has become the focus and hot spot of cancer therapy research, there is no doubt that CAR-T cell therapy is the next flavor of the era.
but unfortunately, there are not many athletes on the CAR-T track at the moment.
" after the launch of the two products, although there has been some growth in sales, but did not meet expectations.
on the one hand, may be related to its market pricing, on the other hand, new cell therapy products after the market needs market adaptation, such as clinical use of doctors feedback, product follow-up evaluation tracking process, a variety of treatment methods to compare the evaluation, which also leads to, from a commercial point of view, the future of the cell therapy industry is broad, but this road is very tortuous.
," said Dr. Fu.
Not only that, but there are still many gaps between the layout of Chinese pharmaceutical companies in the cell therapy market compared with those of the United States.
specifically: First, basic research U.S. tumor immunoastic basic research originality is very high, and China is relatively lacking, especially lack of innovative research with clinical transformation potential; China because of the relatively late start, clinical equipment design is relatively simple; Fourth, clinical talent and team building the United States has excellent cell therapy clinical scientists and more mature professional medical team, but China is precisely lack of such talent, which also makes clinical research operability is poor;
However, China's cell therapy policy has undergone many changes, until 2016 NMPA gradually established the mechanism for cell therapy to accept and approve drugs.
in addition, under the current two-track management, China's CAR-T cell preparation and quality control and international giants gap is still large;
but most of China's clinical institutions or hospitals lead, the role of pharmaceutical companies is mainly to support or provide viruses, under this model is difficult to effectively encourage domestic enterprises to participate in THE industrialization of CAR-T therapy.
, then, subject to the above-mentioned multi-factor constraints, at present, China's only four pharmaceutical companies in the cell therapy layout mainly based on international cooperation - Kite Pharma and Shanghai Fosun Pharma, Juno Therapeutics and Shanghai Pharmaceutical Sinjuno, Novartis and Shanghai Xibiman, Nanjing Legend and Johnson and Johnson, in order to promote the commercialization of CAR-T products in China.
in fact, such a model has also been recognized by the market.
, using Nanjing Legendary Bioas as an example, established a partnership with Johnson and Johnson, and on June 6, 2020, the Company is in the U.S. NASDAQ Capital Markets, is currently fully promoting the rapid commercialization of the car-T drug LCAR-B38M/JNJ-4528 global clinical trial, and plans to submit to the FDA in the second half of 2020 JNJ-4528 for the treatment of multiple myeloma biological products licensing application.
multi-help to break the cell therapy barrier for companies that want to lay out cell therapy in China, there are undoubtedly many challenges.
especially under the normal state of advanced technology may be in the policy and regulation of the implementation of the more lag, and only to solve this problem, advanced technology can really play its maximum role for patients.
, Nanjing Legendary Biotech Company Chief Scientific Officer Dr. Fan Xiaohu believes that, at present, China's pharmaceutical companies in the layout of cell therapy, the main short board is mainly reflected in downstream construction, and only all enterprises and institutions are involved in the real realization of all-round cooperation between industry, science and research, the entire industry can achieve standardized development.
"a truly innovative drug that can improve the cure rate of patients should not be in any way hindered in the commercial development path, we must pool multi-resources to effectively promote its commercial production and operation, to achieve the ultimate goal of curing and saving people."
in addition, cell therapy research and development enterprises, only combing and perfecting the downstream channels, upstream reagents, supplies, equipment providers can also be smooth development.
," Dr. Fan Said.
in fact, according to Medical Geography, at present, China's relevant functional departments on the cell therapy support policy has been constantly improved.
for example, on March 29, 2019, the National Health and Health Commission issued an example on soliciting the Measures for the Management of Clinical Research and Conversion Applications in Somatic Cell Therapy (Trial) (Draft for Comments) (draft for comments), which further clarified that medical institutions, as the subject of responsibility, conduct clinical research on new technologies such as somatic cell therapy, and obtain safety effectiveness data, can apply for clinical application and charges.
the document is not only concerned about the cost of research and development for medical institutions and the cost of patients, the future of somatic cell treatment regulatory agencies is also a matter of concern.
another important industry policy is the "Technical Guidelines for Clinical Trials of Immunocellular Therapeutics Products" (Draft for Comments) issued by CDE on July 6, with a view to providing more targeted advice and guidelines for applicants for drug research and development and research conducting clinical trials of drugs, and various policies are also actively contributing to the development of the cell therapy industry.
in addition to the policy of the promotion, the local action is also spared no effort. On May 26 this year, the
held a signing ceremony for key industrial projects in Zhuhai.
Zhuhai city will vigorously introduce and nurture innovative and competitive high-quality enterprises in the field of health.
focus on research and development and production of high-end medical devices and innovative drugs, plans to invest a total of 2 billion yuan, introduce Internet intelligent management concepts and eco-building standards, build an accelerated base for the biopharmaceutical industry, build an investment incubation platform for the medical industry, and focus on the introduction of bio-innovative drugs (such as genetically engineered drugs, cell therapy drugs, active proteins and peptide drugs and new drug preparations) and other industries.
experienced decades of setbacks and precipitation, cell therapy field in CAR-T, TCR-T, TIL, NK, DC and other breakthrough research progress.
and with more and more domestic pharmaceutical enterprises stationed in this field, but also face many challenges.
stand at the forefront of industrial technology, how should China's pharmaceutical enterprises choose the track? How should the field of cell therapy develop in China?