Three Class 1 new drugs were approved clinically from Haihe Pharmaceuticals, Lijin Biological, and Lingke Pharmaceuticals

According to the information published by the Drug Review Center (CDE) of the State Drug Administration of China, three new class 1 drugs have obtained clinical tacit approval, namely, hai and drug PI3K alpha inhibitor CYH33 tablets, Rejin bioCD137 active antibody LVGN6051 monoclonal antibody injection, and Lingke Pharmaceuticals LNK01001 capsule (see table below).
it is worth mentioning that two products from Lijin Bio and Lingke Pharmaceuticals were approved for clinical trials in China for the first time.
data source: CDE.com.
medical mission map.
1, Sea and Drugs: CYH33 Mechanism of Action/Target: PI3K alpha This approved clinical adaptation: PI3K signaling path paths in specific solid tumor patients play an important role in regulating cell growth, movement, survival, metabolism, and angiogenesy.
in human cancers such as breast, colorectal and blood cancers, PI3K signaling path disorders occur.
, mutations in the cancer gene PIK3CA (code PI3K catalytic sub-units α) are present in about 2% to 5% of human solid tumors, involving a variety of tumor types such as breast cancer, ovarian cancer, colon cancer, glioblastoma, lung cancer and esophageal cancer.
CYH33 is a new, efficient and specific PI3K alpha inhibitor jointly studied by Haihe Pharmaceuticals and Shanghai Pharmaceutical Institute of the Chinese Academy of Sciences.
it inhibits tumor cell proliferation by inhibiting pi3K-mediated signaling paths and blocking cells in stage G1.
that CYH33 compounds have good safety and preliminary clinical efficacy.
May, the drug was approved in the United States for clinical studies of advanced solid tumors.
CYH33 is conducting a phase 1a/1b study in China for patients with advanced solid tumors, according to the China Drug Clinical Trial Registration and Information Disclosure Platform.
This time in China, CYH33 tablets were granted two clinical trials with the following adaptations: a) to be used in the treatment of advanced solid tumors with DNA damage repair (DDR) pathway key gene mutations or PIK3CA gene mutations;
2. Reciditant Biology: LVGN6051 Mechanism of Action/Target: CD137 This approved clinical adaptation: CD137 (also known as 4-1BB) intended for the treatment of local late stage or metastasis malignant tumors is a member of the tumor necrosis factor (TNF) family, expressed in several specific cell types, including active T-cells and NK cells.
the CD137 complex interacts with CD137 to trigger activation signals for all these cell types.
LVGN6051 is a monoclonal activated antibody developed by Regency Biology that targets CD137.
it stimulates the proliferation of NK and T cells by activating CD137 signal transductivity and produces anti-tumor activity, producing a lasting memory response.
LVGN6051 selectively activated CD137 locally in the tumor micro-environment, reducing normal tissue immune side effects, according to an earlier press release issued by Rejin Bio.
is the first time LVGN6051 has been approved clinically in China to develop treatment for local late stage or metastasis malignant tumors.
It is worth noting that in June this year, Lijin Bio has entered into a clinical trial with a subsidiary of Mercedon (MSD) to evaluate the effectiveness of LVGN6051 and Mercedon's PD-1 inhibitor Corinthus (Paboli Pearl Monoma) in treating a variety of advanced malignancies, including lung cancer, melanoma, gastrointestinal cancer and lymphoma.
3, Lingke Pharmaceuticals: LNK01001 This approved clinical adaptation: rheumatoid arthritis LNK01001 is a new class of drugs developed by Lingke Pharmaceuticals, this is the first time the drug was approved clinically in China, to be developed for the treatment of rheumatoid arthritis.
it is worth mentioning that the query CDE official website to accept the variety list, LNK01001 is also Lingke Pharmaceuticals' first declared clinical drugs.
, founded in March 2018, is dedicated to the discovery and development of new drugs for the treatment of cancer and immunologic and inflammatory diseases, and the company's founder, chairman and CHIEF executive officer is Dr. Wan Zhaokui.
2020, Lingke Pharmaceuticals has made a lot of progress.
January, the company successfully completed an tens of millions of dollars in round A financing led by Prudential Capital.
, the company also successfully completed a preclinical candidate compound outside China, with a down payment and milestone payment of nearly $200 million.
LNK01001 was approved clinically, marking the first clinical approval for Lingke Pharmaceuticals.
.