Hengrui IL-2 derivative therapeutic drugs declared clinical

Small pills recently, Hengrui Pharmaceuticals issued an announcement, its independent research and development in the research PEG modified IL-2 drug SHR-1916 domestic declared clinical trials, has been accepted by CDE contractor, intended for the treatment of advanced malignant tumors.
it is worth mentioning that this is the first declared clinical domestic IL-2 derivative therapeutic drugs, Hengrui priority layout.
source: CDE's ancient immunotherapy drug IL-2 human leukocyte interleukin-2 (interleukin-2, IL-2), also known as T-cell growth factor (TCGF), which expands the lymphocyte population in the body and improves the function of the cell effector makes it anti-tumor.
as an ancient immunotherapy drug, as early as 1992 and 1998, the FDA approved the IL-2 drug Aldesleukin for advanced kidney cancer and malignant melanoma.
However, IL-2 is used in clinical treatment at a high required dose, which is accompanied by severe therapeutic toxicity, such as severe hypotension and vascular leakage syndrome, and patients treated with IL-2 must be hospitalized for close observation to avoid accidental life-threatening conditions, which greatly limit the clinical use of the drug.
the structure of IL-2 drugs to further improve efficacy and reduce clinical toxicity has become the direction of development.
cases that have been implemented abroad In November 2017, the MD Anderson Cancer Center in the United States released clinical data on NKTR-214 combined PD-1 monoantigens for patients with advanced tumors, and that drug use reduced 72% of tumors when used in solid tumor therapy.
NKTR-214 shines throughout the 2018 ASCO annual meeting, and its effectiveness in treating PD-1 inhibitors has attracted attention.
NKTR-214 This new IL-2 cytokine immunostidant is CD122-dependent anthyst, a modified product of IL-2, with 6 additions to each IL-2 molecule Polyethyl glycol PEG, after injection in tumor patients, these 6 PEG modifications will gradually fall off, forming an active form of drugs, through the isogenous djubial IL-2 subject pathway (IL-2R beta?) Provides continuous signal transductivity and can also stimulate the proliferation of CD8 plus T cells and NK cells in tumor environments through regulatory T-cells.
first declared clinical IL-2 derivative SHR-1916 Hengrui actively layout IL-2 derivative therapeutic drugs, the first time in China declared clinical trials.
SHR-1916 for injection can promote the proliferation of CD8-T and NK cells by activating the JAK1/JAK3/STAT5 signaling path, according to the announcement.
SHR-1916 this derivative contains one or more amino acid mutations in the region combined with IL-2 subject α subi (IL-2R alpha) and has a eliminated or reduced affinity to high affinity The affinity of the subject (IL 2R alpha/β/γ) and retains the affinity to the medium affinity γ (IL 2R beta/γ) is good for medicinality.
compared to IL-2 itself, SHR-1916, an IL-2 derivative, has reduced activation of regulatory T-cells and is not affected or increased in immune-effect cell activation.
the domestic layout of IL-2 derivatives treatment drugs other players in addition to Hengrui medicine, the current domestic Lynda biology and Junshi biological also laid out IL-2 derivatives treatment drug field, the progress is fast and slow, the way to take different.
And Hengrui SHR-1916, Xinda Bio has also adopted an independent research and development model, in the research products have been given to reduce IL-2R alpha affinity, improve IL-2R beta affinity preferred mutation bits, and established a mutant library, and through the introduction of glycosylation points, reduce or eliminate the binding with IL-2R alpha.
different from the above two development models, Junshi Bio has reached cooperation agreements with external companies to introduce IL-2 derivatives in the research products, while taking into account the short-term and long-term IL-2 derivatives layout.
September 2020, Regeneron signed a partnership agreement with Anwita Biosciences for an advance of $2 million and a milestone payment of $86 million, bringing in the latter's IL-2 family of products.
August 2020, Junshi Bio introduced Zhidao Bio's IL-2 drug LTC002 with an advance payment of 21 million yuan and a milestone amount of 938 million yuan.
the field of autoimmune diseases, the field of research and development pipeline reserves as a domestic pharmaceutical company leader, the current market value of Hengrui Pharmaceutical exceeded 600 billion.
In 2020, the performance of Hengrui Pharmaceutical's anti-tumor, surgical drugs/anesthesia, copicides and other business sectors remained bright, with operating income of RMB19,413 million in the first three quarters of this year, up 14.57 percent year-on-year.
the development and layout of therapeutic drugs in the field of autoimmune diseases, Hengrui's pipeline products are abundant and worth looking forward to, including selective JAK inhibitors SHR0302, BTK inhibitors SHR1459, IL -17A single-anti-SHR1314, IL-5 single-anti-SHR1703, IL-4R single-resistant SHR-1819, TYK2 inhibitor RS1805, etc.