Policy support plus-size gene testing Cell immunotherapy enjoys dividends

In 2017, genetic sequencing giant Illumina caused a number of movements. From January 9th to 13th, Illumina unveiled NovaSeq, a next-generation sequencing system, at this year's JPMorgan Health Conference, saying it "aims to further reduce genome sequencing prices to $100 in the future";
Nova Seq, one of the most high-profile next-generation sequencing systems in the world, was described by Francis de Souza, President and CEO of Illumina, as "one of the most important inflection points in illumina's innovation history." Just as the first HiSeqX launch in 2010 reduced the cost per genome to $1,000, we believe that the system developed by the NovaSeq architecture, released today, will one day bring the price of a single genome down to $100.
industry source said: "This has left Illumina, who already has a huge advantage, out of several competitors of its kind." At
currently holds the largest market share in upstream equipment and consumables, which are the most profitable in the gene sequencing industry chain. According to public data, the world's major gene sequencing equipment companies accounted for 83.9 percent of sales in 2016, followed by Illumina at 83.9 percent, Thermo Fisher at 9.9 percent and Roche at 5.2 percent.
, on the other hand, Illumina continues to extend its reach into the midstream and downstream service markets. At JP Morgan Health Care's conference early last year, Illumina announced the creation of Grail, a blood genetic testing company for early cancer screening, with investors including Amazon founder Jeff Bezos and Microsoft founder Bill Gates.
" Grail is the first company in the field to offer asymptomatic liquid biopsy screening. At the time, Eric Endiccott, Illumina's global director of public relations, said that the vast majority of companies involved in next-generation sequencing were using Illumina's technology to develop liquid biopsies that provide services to analyze advanced conditions, monitor disease treatment processes or relapse, "but they are not yet able to screen asymptomatic populations." "
addition to this announcement of a partnership with a number of companies in the genetic data, analysis and services category, it is foreseeable that Illumina is constantly expanding the nuggets in the middle and lower reaches of the market."
Gene sequencing industry industry chain is divided into: upstream equipment, including sequencing equipment research and development manufacturing and supplies and reagent production;
recent years, the rate of iteration of gene sequencing equipment has been accelerating, and the cost of gene sequencing has also dropped significantly. In 1986, the first business used gene sequencing equipment came out, 19 years later the second generation of sequencing equipment appeared, from the second generation iteration to the third generation of equipment time reduced to 5 years.
At present, the field of gene sequencing upstream technology sequencer, reagents are mainly monopolized by foreign companies, due to the high technical threshold, it is difficult for later from this field to enter the market, and upstream giants are still through large-based investment and mergers and acquisitions, layout of the downstream market.
development and policy of the pharmaceutical industry are inextricable, the "Technical Guidelines for cell product research and evaluation" (draft for comments) issued less than a month, the industry has about 6 billion yuan of capital investment. Chen Weishui, deputy director of the Shanghai Food and Drug Administration, said the draft was a huge good for cell products companies.
cell products refer to live cell products derived from cells that meet ethical requirements and are manufactured through proper in-body culture and operation in accordance with the regulatory norms of the drug. In recent years, with the development and improvement of theoretical techniques such as stem cell therapy, immunocellular therapy and gene editing, the research and development of cell therapy as a drug has become a hot topic, providing new ideas and treatment methods for some major and difficult diseases.
In order to standardize and guide the development and research of such products, the draft for comments was issued on December 16, 2016 and ended on January 25, 2017, on the basis of reference to relevant guidelines at home and abroad.
This draft is not only a strong needle in the immunocellular therapy industry, but also a big shuffle, to promote the improvement of industrial threshold and regulatory efforts, so that the lack of core technology, non-standard enterprises self-elimination, the entire industry seriously in accordance with the norms of safety as the premise of development.
, according to Arie Belldegrun, chairman of Kite Pharma, it was noted eight years ago that the exhaustion of chemotherapy and radiotherapy techniques at the time could not change the fact that cancer was still progressing. KitePharma is increasingly focusing on cell therapy, a new treatment that has 2000 patients who have survived for seven or eight years. In addition to chemotherapy, the therapy captures T cells in the outer blood of tumor patients, which are precisely engineered to recognize and kill tumors, and then returns to the patient to kill tumor cells through targeted technology in the body.
December 2016, KitePharma announced that it had filed a Biological Products Licensing Application (BLA) with the U.S. Food and Drug Administration (FDA) for a rolling application for the treatment of KTE-C19 as a resuscable invasive B-cell NHL patient. "Europe is also applying, and the regulatory process is moving very fast and is expected to be approved by regulators this year." Arie Berdegrun says she hopes to bring the technology to China through scientific methods to keep patients safe and produce it in a reliable way.
January 10, Fosun Pharma announced the establishment of a Sino-foreign joint venture in Shanghai through its wholly-owned subsidiary, with a proposed investment of not more than US$80 million, to introduce KitePharma's CAR-T treatment product KTE-C19, which will provide leading treatments for patients with lymphoma and leukemia. Chen Saixuan, director of the Shanghai Institute of Hematology, said that CAR-T therapy has some clinical studies in the field of acute lymphoblastic leukemia and multiple myeloma, although the goal of curing malignant blood diseases has not yet been achieved, but a promising way to study how to cure cancer, an important step forward. However, there are still many problems to be solved, such as side effects during the treatment of cytokine storms, do not know how to deal with.
public information shows that cytokine storm, refers to the body infected with microorganisms caused by a variety of cytokines such as TNF-α, IL-1, IL-6, IFN-α, IFN-β and other rapid mass production of phenomena, is an important cause of acute respiratory distress syndrome and multi-organ failure.
" image point is that a person went out to call 1000 people to come in to help, with a gun to kill the tumor cells, the body is like 'fighting', a point after the 'explosion', the smoke nearby affected the next cells. "A doctor who has been involved in the CAR-T treatment process says that if a patient is observed to have elevated body temperature and fever symptoms within a day, the method is working. Some storms can be detected to determine which cytokine is causing it, and thus precisely regulate, but if there is no large amount of clinical data accumulation, no marker judgment, can only be speculated through traditional clinical performance, it is not easy.
Chen said: "In the malignant stage of the disease, whether to alleviate further cure or dangerous time still treatment, is a problem that needs to be studied." Because during treatment, cytokine storms can also affect a patient's life. In addition, further research is needed on the recurrence of diseases. So even now there are some cell therapy products at home and abroad, but in the course of treatment should also be careful to explore the best treatment options to achieve the best treatment results.
industry insiders say that in this process, not only need multi-party cooperation to strengthen basic research, but also strengthen clinical research, for the relevant departments of the state to provide some first-in-the-nation advice or strategic planning decisions, so as to contribute to the fight against cancer. (Sina Pharmaceuticals)