New research and development hot spots have emerged in the field of medicine, and a large number of pharmaceutical companies have invested heavily in the layout.

Recently, the Drug Review Center (CDE) of the State Drug Administration issued a notice on the public consultation on the Guidelines for the Design of Clinical Trials of Lysovirus-type Drugs (Draft for Comments).
It was mentioned that, in view of the fact that there are no relevant guidelines for the design of clinical trials of lysovirus-type drugs in China, CDE has drafted the Guidelines for the Design of Clinical Trials of Lysovirus-type Drugs on the basis of full research on the research and development of the same varieties at home and abroad and the technical requirements of related clinical trials.
, this is the first time in China for lysovirus-type drugs issued clinical trial design guidelines.
not only has there been no guidelines in the country, but even international advanced drug regulators such as ICH, EMA and FDA have yet to release them.
It is understood that the current tumor immunotherapy of the lysovirus is an important direction, the principle is the natural presence of the pathogenic virus genetic modification to form the lysovirus (Oncolytic virus, OV), the use of cancer cells in the distortion of the signaling path (such as anti-cancer gene insisnation or defects) selective replication in tumor cells, resulting in tumor cell cleavage and death.
experts say the lysovirus has the potential to be another major breakthrough after immuno-checkpoint inhibitors.
compared with other tumor immunotherapy, lysolysis virus has the advantages of high lethality, good targeting, small side effects, and a variety of ways to kill tumors to avoid drug resistance and low cost.
these advantages, lysovirus drugs are showing increasing market potential and are becoming the backbone of the anti-tumor drug market.
industry expects its global market size to grow from $43 billion in 2016 to nearly $100 billion by 2022, accounting for more than half of the anticancer drug market and a compound annual growth rate of 14.6 percent.
's huge market prospects have caused the "heat" of the lysovirus sector to continue to rise, and in recent years the global pharmaceutical giant has invested heavily in the layout of the field is accelerating.
In addition to Amgen's T-Vec and Shanghai 3D Biotechnology's Ankery, BMS teamed up with PsiOxus in 2016 to develop a tumor-soluble adenovirus; in 2017, AbbVie received three next-generation lysovirus immunotherapy treatments from Turnstone. In 2018, Mercadon acquired Viralytics, an Australian biotech company with a patent for the lysovirus, for $394 million, and in May 2019, AstraZene, together with Transgene, developed five new types of vaccinia viruses.
, in the research and development of lysovirus, China has been in the forefront of the world.
2005, recombinant human type 5 adenovirus injection (Ancory) was listed in China, nearly 10 years before Amjin T-vec was listed, but for various reasons it was not widely used in clinical practice.
However, as the market for lysovirus continues to heat up, in January 2019, Shanghai Pharmaceuticals announced that it would launch a re-listing program for Amkeri, and many domestic pharmaceutical companies have begun to enter the field.
At present, China has a number of enterprises involved in lysozytovirus, about 10 enterprises are currently through self-research or introduction of products are in the clinical stage, on behalf of the company has Hengrui Pharmaceuticals, Ano Pharmaceuticals, Bin club biology, Oyuan and Force Biology.
2020, a number of domestic pharmaceutical companies have accelerated the layout of the field of lysovirus.
E.e., on May 11, Tiansli announced that its controlling subsidiary, Tiansli Bio, had signed a C-REV License Agreement with Japan's Bao Bio, which introduced a lysovirus product for the treatment of pancreatic cancer and melanoma.
August 7, Shanghai Pharmaceuticals announced that it and Shenzhen Alsoo Micropharma Technology Co., Ltd. signed a licensing agreement, will invest no more than 1.15 billion yuan to introduce the global innovative lysovirus product T3011 (intra-tumor injection).
information, T3011 (intra-tumor injection) is a new generation of recombinant herpes lysate virus, and clinical trials for multiple solid tumors are currently under way in China, Australia and the United States.
Overall, lysovirus products have undergone a hundred years of development, preparation technology has basically matured, although large-scale industrialization still needs to be solved, clinical application level of the industrial production of viral vectors is also facing a number of challenges.
the industry believes that, with the continuous development of clinical research and the maturity of technology, the commercialization of lysovirus is expected to usher in a major outbreak in recent years.
.