12 new class 1 drug batch clinical, from Sanofi, Yingpai Pharmaceuticals and other companies | Cde...

As of February 7, 2021, a total of 3,712 clinical trial applications had been approved for "implied approval", according to the Drug Review Center (CDE) of the State Drug Administration of China.
this week added 58 new clinical trials, including 25 category 1 innovative drug applications (excluding complementary applications), involving 12 drugs from companies such as Sanofi, Indo-Pharmaceuticals, Retest Pharmaceuticals, Corned Bio, Sea and Pharmaceuticals.
this article will share some of the approved clinical new drug information (ranked in no order).
1, Sanofi: Venglustat Adaptation: Normal chromosomal polycystic nephropathy Venglustat is an oral therapy that crosses the blood-brain barrier and is designed to inhibit abnormal accumulation of a substance called glucose ceramide (GL-1), which works in the production of glycolipids.
By inhibiting the activity of glucose ceramide synthase, venglustat is able to treat a variety of rare diseases caused by genetic mutations in the metabolic pathways of glycolipids, including: Gaucher disease type 3, GBA-related Parkinson's disease, Fabry disease, and normal chromosomal polycystic nephropathy (ADPKD).
, Venglustat has been approved in China to conduct clinical trials in adolescent and adult Goshe disease patients.
The clinical study of the drug was approved for normal chromosomal polycystic nephropathy, which is a common single gene disease caused by mutations in the PKD1 or PKD2 genes, and is also the main cause of end-stage kidney disease.
2, Yingpai Pharmaceuticals: IMP7068 tablets of adhesives: advanced solid tumor IMP7068 is a ResearchWee1 inhibitor developed by Yingpai Pharmaceuticals.
wee1 is an important kinase associated with the DNA Damage Repair (DDR) path path, involved in the regulation of cell cycles and plays a key role in G2/M checkpoints.
that Wee1 is one of the proven targets of cancer drug research, and there is a synthetic lethal effect with the widespread TP53 gene mutation in tumor cells.
, there are other Wee1 inhibitors in multiple tumors, especially tumors with TP53 mutations, demonstrating the clinical efficacy of proof-of-concept.
preclinical studies showed that IMP7068 showed good safety, toerability and pharmacodynamic characteristics in animals, and showed high anti-tumor activity in multiple tumor cell strains and animal models.
November 2020, Indo-Pharmaceuticals announced that IMP7068 had received implied approval for FDA clinical trials.
3, Re-Extreme Medicine: MAX-10181 Tablet Adaptation: Advanced solid tumor MAX-10181 is a new generation of PD-L1 inhibitors developed by Re-Extreme Medicine.
new theoretical hypothesis for tumor immunotherapy involving PD-1/L1 path paths, according to a previous press release issued by Reege Pharmaceuticals.
the core of this theoretical hypothesis is not only concerned with the pharmacological effects of the drug itself, but also with the penetration of the drug in tumor tissue and the distribution of the microenviron environment, which is the theoretical basis for their development of a new generation of PD-L1 inhibitor MAX-10181.
in human-based tumor mouse models, MAX-10181 has shown good tumor suppression.
4, and Meta-Edith Bio: Injection Oba01 Allergy: DR5-positive non-small cell lung cancer; DR5-positive lymphocytic leukemia Oba01 is an antibody association drug (ADC) that targets DR5.
DR5 is a subject of tumor necrosis factor-related induced apoptosis ligation (TRAIL), which is widely expressed in many tumor tissues, including lymphocytic leukemia, lymphoma, lung cancer, breast cancer, ovarian cancer and bladder cancer, and is not expressed or less expressed in normal tissues and cells.
when rail or anti-DR5 inflammatory antibodies bind specifically to DR5 on tumor cells, the cell death signal transduction path can be activated, specifically killing tumor cells.
, DR5 has become a recognized new target for cancer treatment.
public information shows that Heyuan Adis Bio was founded in 2018 by Heyuan Biotechnology (Shanghai), Rongchang Bio (Yantai), Yantai Industry International Biopharmaceutical Innovation Incubation Center, etc. as a founding shareholder.
5, Corned Biology: CBP-201 Injection Adaptation: Asthma CBP-201 is an efficient anti-IL-4R alpha monoclonal antibody developed by Corned Biology.
IL-4R alpha is the cell surface protein required for IL-4 and IL-13 signaling, and IL-4 and IL-13 are two key Th2-promoting cytokines, which significantly overlap their biological activity.
CBP-201 for the treatment of moderate to severe endexual dermatitis and a variety of other inflammatory Th2 diseases.
, CBP-201 has been approved in China to conduct clinical studies in patients with moderate to severe endexual dermatitis.
this approved clinical trial is asthma.
6, Sea and Drug: HH2301: IDH1 mutant advanced solid tumor HH2301 is a new, efficient, specific mutant isochlic acid dehydrogenase 1 (IDH1) inhibitor, IDH1 mutation in bile tube cancer, cartilage sarcoma, glioma and acute myeloid leukemia (AML) and other tumors widely occurred.
HH2301 showed significant anti-tumor activity in multiple solid tumor xym transplantation models (PDX models) from patients with IDH1 mutations.
May 2020, the drug has been approved clinically in the United States for the treatment of IDH1 mutations in solid tumors including advanced bile tube cancer, cartilage sarcoma and glioma.
7, Runjia Pharma: RP901 tablets of adhesive: osteoarthritis according to Runjia Pharmaceutical press release, RP901 is the company's own research and development of a class 1 small molecule new drug, in the body can play an osteoptic protection role, improve osteoarthritis symptoms.
Jiasheng, Chairman and CEO of Lurunjia Pharmaceuticals, said in a press release that no similar target products have been approved for listing and that the company will actively promote the RP901 research and development project.
public information shows that Runjia Pharma has established a product pipeline of more than 12 drug candidates, covering bone degenerative diseases, neurodegenerative diseases, malignant tumors, drug-resistant pathogen infections and other diseases.
2019, Junshi Bio has reached a partnership with Runjia Pharmaceuticals to obtain a 50% interest in two small molecule anti-tumor drug programs, Pan CDK Inhibitors and PI3K Alpha Inhibitors of Runjia Pharmaceuticals.
8, Dongsan Pharmaceuticals: HEC73077 tablets of adaptive disease: diabetic kidney disease HEC73077 is a new class 1 drug developed by Dongsan, the drug this time obtained four clinical trials implied license, for the adaptive disease is diabetic kidney disease.
diabetic nephropathy is one of the most important long-term complications in diabetic patients.
estimates that about half of people with type 2 diabetes develop diabetic nephropathy, and that there is a huge unseeded need for clinical trials.
9, Zhengda Qing: TQA3810 tablets of adaptive disease: chronic hepatitis B TQA3810 tablets are Zhengda Tianqing developed a class 1 new drug.
the drug this time obtained two clinical trials implied permission to single or co-use nucleoside (acid) drug chronic hepatitis B.
is one of the world's most significant infectious disease threats, with more than 290 million people infected worldwide, according to public data released by the United States.
infection is the main cause of liver disease, the current treatment is difficult to cure it, patients urgently need new treatment options.
on the approval of these new drugs for clinical studies in China and hoped that their follow-up studies would proceed smoothly and bring more treatment options to patients at an early time.
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