Where are the hot spots in the field of Amgen preempting the huge layout of MNC such as Johnson and Johnson and Pfizer?

It is worth noting that this is the first time in China for the 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.
years, the development of tumor immunotherapy has paid more and more attention to the therapeutic potential of lysovirus drugs in various diseases such as malignant tumors.
In 2011, German scientist Jean Rommelaere first referred to lysovirus therapy as tumor immunotherapy, and the most "outstanding" ability of lysovirus is to turn "cold tumors" into "hot tumors" that enhance the immunogenicity of the tumor's microenvironment and trigger a widespread tumor immune response.
this new tumor immunotherapy is gradually accepted by the general public because of its high efficiency, good targeting, high safety, small side effects and low cost to tumor cells, and has become an important branch of tumor immunotherapy.
is also known as one of the most promising and promising treatments for malignant tumors in the future.
2001 Global Accelerated Lysovirus Field Layout According to the Evaluate Pharma database, global sales of LYV products in 2019 were $668 million.
currently, the world's listed lysovirus products include AMSE's T-Vec and Shanghai 3D Biotechnology Co., Ltd.'s Ankeri.
fact, as early as 2005, China approved the world's first lysovirus (recombinant human adenovirus injection, Acre) on the market.
the mention of Ankeri, it is important not to mention The inventor of Ankery, the main founder of tumor-soluble immunotherapy, who owns compassip and Dabershu® two new national Class I drug inventions, Zhai Dechao.
As the first national Class I drug of its invention, Acre is mainly targeted at head and neck tumors mainly caused by nasopharyngeal cancer, and has a number of industry-leading advantages, over the years has successfully saved thousands of cancer patients, including many terminal cancer patients.
10 years after Ankery went public, another lysovirus product, Amjin's T-Vec, appeared.
2015, the FDA approved Amgen's herpes simplex virus injection talimogene laherparepvec (Imlygic, commonly known as T-Vec) as a local treatment for non-removable lesions in patients with melanoma who relapse after the first surgery.
T-Vec is the first and only FDA-approved lysovirus therapy, and T-Vec has since been approved for listing in Europe and Canada, respectively.
's approval of T-Vec has caused the "heat" of the lysovirus sector to rise, and the global pharmaceutical giant's spending on the sector has not stopped in recent years.
T-Vec, BMS followed suit in 2016 with PsiOxus to develop a tumor-soluble adenovirus; Exclusive development rights for next-generation lysosovirus immunotherapy; in 2018, Mercedon acquired Viralytics, an Australian biotech company with patented lysovirus, for $394 million; May 2018 Johnson and Johnson's Jansen acquires U.S. biopharmaceutical company BeneVir Biopharm in a deal that includes BeneVir's proprietary T-Stealth lysate platform; $4.5 billion acquisition of Austrian lysosovirus company ViraTherapeutics, including VIRAT's main candidate for the development of lysosovirus treatment platform VSV-GP; Co-development of five new types of armed lysoma pox virus (vaccinia viruses).
It's not hard to see how the world's largest pharmaceutical companies are gaining access to lysovirus research and development pipelines primarily through license-in or mergers and acquisitions in the forward-looking layout of innovative pipelines around treatments that have broad market prospects but lack effective treatments.
with more MNC entry, the future will usher in a more effective lysovirus market and the expansion of adaptive disorders.
investors also believe that the size of the market is expected to usher in an outbreak of growth.
not only the global pharmaceutical giants, many domestic pharmaceutical companies have entered this field.
recent years, more than ten lysolytic virus products from Bin club biology, Kanghong biology, health hall, Ano biology and other companies have entered the clinical trial stage in China.
2020, a number of domestic pharmaceutical companies have also accelerated the layout of the field of lysovirus.
May 11th, 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 to treat pancreatic cancer and melanoma.
July 14, Yuanda Pharmaceuticals announced that it intends to obtain approximately 9.7% of the equity and one board seat of Shanghai Bank Deep Biotech Co., Ltd. for 30 million yuan, thereby gaining the exclusive global development, production and commercialization interest of the global innovative blistered oral tumor virus (VSV-GPM) developed by the latter for the treatment of colorectal cancer.
August 7, Shanghai Pharma announced that it and Shenzhen Ino 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).
application for the project was approved in August 2019 and is currently in the group of patients in phase I clinical trials for solid tumor adaptation in Shanghai Fudan University Oncology Hospital and other institutions.
application for the project was also approved by the FDA in May 2020.
in the tumor incidence and prevalence rate increased year by year, the rapid growth of the market background, domestic pharmaceutical companies in the field of lysoplasma virus research and development strength is also not to be underestimated.
more and more domestic pharmaceutical enterprises through independent research and development or the introduction of foreign technology products and other ways to devote themselves to this highly market potential field, and made great progress.
02 Lycomovirus-ICB strong joint with PD-1/PD-L1 antibody and other immuno-checkpoint inhibitors, the ability of lysolytic virus to create "hot tumors" for further strengthening the response rate of immunomodulation checkpoint inhibitors provides new possibilities.
of preclinical trial data have also demonstrated the great potential of the link between lysovirus and immuno-checkpoint inhibitors.
Cell, an internationally renowned journal, published in 2017 a weighty clinical data on the combined treatment of melanoma patients with PD-1 antibody Keytruda and lysovirus T-Vec, which showed that the combined treatment increased the response rate of such patients to 62 percent and significantly improved the expected remission rate compared to single-use Keytruda or T-VEC therapy.
currently, combination therapies account for more than 50% of known clinical trials of lysovirus worldwide.
domestic and foreign pharmaceutical companies are competing to explore the potential of immunocommunication therapy for lysovirus tumors.
checkpoint inhibitors work by disabling the immune escape mechanism of cancer cells, but PD-1/L1 inhibitors do nothing for "cold tumors", Tecentriq treatment of bladder cancer Phase 3 clinical failure, Bavencio treatment of gastric cancer Phase 3 clinical failure, Opdivo treatment of glioblastoma Phase 3 clinical failure ... For most cancer species, the objective remission rate of PD-1/L1 inhibitors in a single drug is only about 20%-40%.
the emergence of a combination therapy of the lysolytic tumor virus, for checkpoint inhibitors, is undoubtedly a carbon delivery in the snow, or will become a winning weapon to break through the bottleneck.
example, Pelareorep, Ancolytics Biotech's proprietary lysosovirus product, is an intravenous intestinal lone virus, and according to Oncolytics, Pelareorep has now been tested in collaboration with four immuno-checkpoint inhibitors (Bavencio, Keytruda, Opdivo and Tecentriq).
addition to clinical trials conducted in a joint four PD-1/L1, the industry is generally optimistic that such combined therapies will be used in more cancer types in the future.
years, the pace of domestic pharmaceutical companies to explore the application of lysovirus and tumor immuno combination therapy is also accelerating.
, April 23, 2019, Shanghai Pharmaceuticals announced that Ankeri received the "Drug GMP Certificate" issued by the Shanghai Municipal Drug Administration.
announced that Ankeri has been approved to cooperate with eight Shanghai Sanjia Hospital to carry out post-market clinical re-evaluation research work to expand new adaptive disorders, and the clinical research of Ankeri joint PD-1 antibody treatment of advanced solid tumors jointly conducted with Tianjin Medical University Second Affiliated Hospital has also received ethical approval.
with the domestic tumor immuno-checkpoint inhibitors approved for market, Ankeri is expected to become one of the important options for PD-1 and PD-L1 drugs.
addition, the country also successfully ushered in the first approved clinical PD1-lysovirus combination therapy.
On April 15 this year, binocular biotechnology recombinant GM-CSF somatic tumor type II herpes simplex virus (OH2) injection (Vero cells) obtained clinical acquiescing in the joint Han-China bioPD-1 (HX008 injection) for non-surgical removal, standard treatment of failed advanced solid tumors (such as breast cancer, melanoma, head and neck cancer, soft tissue sarcoma, liver cancer or liver metastasis tumor, etc.) treatment, for the first approved clinical.
It is understood that Binco Biotech's OH2 injection monodharma has entered phase II clinical stage, since 2020, OH2 injection has been approved a number of clinical trials for combined PD-L1 or PD-1 treatment of solid tumors.
said it would be the first to launch three Phase I clinical trials in China in which OH2 injections are used in association with Keytruda, HX008 and LP002 (Hodeoco, PD-L1).
With more and more research and clinical data showing that lysovirus can enhance tumor response to immuno checkpoint inhibitors such as PD-1/PD-L1 antibodies, the "strong combination" of lysovirus with immunotherapy may offer hope for more cancer patients.
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