10 new drugs declared clinical in China from Goli, Sanofi, Anjin / Baiji Shenzhou and so on.

Today, China's State Drug Administration Drug Review Center (CDE) recently announced that a number of new drugs in China declared clinical trials, and was accepted.
these innovative drugs include CD137 astrists, FASN inhibitors, BTK inhibitors, tau protein positive electron photography tracer, etc., from Tiange Pharmaceuticals, Gori, Anko immunity, Sanofi, Hengrui Pharmaceuticals and other companies.
the product in an antho-section of this article.
1, Xinxu Medicine: 18F-APN-1607 injection mechanism / target: tau protein positive electron photography tracer 18F-APN-1607 is a Tau protein positive electron photography (PET) tracer, has been launched in the United States for Alzheimer's disease multi-center phase 2 trial.
, this is the first time the product has been declared clinical in China.
according to the bulletin, the 18F-APN-1607 is unique in that it can identify other rare diseases with 4-repeats (4R) tau protein stacking in addition to the tau stacking protein that identifies Alzheimer's disease.
the product has the opportunity to be more widely used in the detection of tau-related diseases of tau protein distribution patterns.
note that Celgene has previously authorized Celgene to use the product in clinical trials around the world.
2, Tianji Pharmaceuticals: ADG106 mechanism of action / target: CD137 astigation ADG106 is an exciting all-human monoclonal antibody developed by Tianxuan Pharmaceuticals to target the unique cousin of CD137, and is currently conducting clinical trials in China and the United States to study its safety in late-stage recurring metastasis and refrectable solid tumors and non-Hodgkin's lymphoma.
CD137 (also known as 4-1BB) as a tumor necrotic cause (TNF) complex super-family member, is clinically proven to be an effective way to stimulate the proliferation of CAR-T cells.
the target has important regulatory functions in CD8-T cells, DC cells, and natural killer (NK) cells, and has been a high-profile target in the field of tumors and autoimmunity.
3, Goliath: ASC40 Act mechanism/target: FASN inhibitor ASC40 (TVB-2640) is a fatty acid synthase (FASN) inhibitor, developed by Sagimet Biosciences, a "first-in-class" innovative drug, which Goliath owns through its subsidiaries in Greater China.
in China, a Phase 2 clinical trial evaluating TVB 2640 for the treatment of patients with non-alcoholic fatty hepatitis is under way.
According to a press release, in June this year, the product reached the primary therapeutic endpoint in a published Phase 2 clinical session called FASCINATE-1, significantly reducing liver fat content in non-alcoholic fatty hepatitis (NASH) subjects by 61% in the 50 mg dose group.
4, Anko immunity: CD24Fc injection mechanism / target: CD24 CD24Fc is a new treatment under OncoImmune that regulates the host's inflammatory response to tissue damage, and has extensive significance for the study of the pathogenesis of cancer, autoimmune diseases, metabolic syndrome and transplant anti-host disease (GvHD).
, CD24Fc has completed Phase 2a clinical trials for acute graft anti-host disease (GvHD) after receiving a hematopoietic stem cell transplant (HSCT) in leukemia patients.
in June, the product received FDA approval to go directly to Clinical Phase 3 trials in the U.S., according to an oncology website, and the company is rapidly advancing randomized double-blind trials for patients with new coronary severe cases.
5, Sanofi: SAR442168 Mechanism/ Target: BTK inhibitor SAR442168 is an oral Bruton tyrosine kinase (BTK) inhibitor that can cross the blood-brain barrier, this time for the first time in China declared clinical.
BTK is important for the development and function of a variety of immune cells, including B lymphocytes and macrophages.
researchers believe that by inhibiting BTK, adaptive and congenital immune cells associated with nerve inflammation in the brain and spinal cord can be regulated.
April, the product reached a major and secondary endpoint in a Phase 2b clinical trial for patients with multiple sclerosis (MS), significantly reducing MS-related lesions in the patient's brain, according to a press release.
Sanofi is expected to launch four phase 3 clinical trials for patients with re-hair and progressing MS.
6, co-drug biology: UB-621 injection mechanism / target: humanized IgG 1 monobody antibody UB-621 is a humanized IgG 1 single antibody drug developed for herpes simplex virus (HSV).
according to the company's announcement, it can prevent the virus from invading the host and suppress infection by using a mechanism of high affinity with the target of gD protein on the epidural of the virus (HSV-1 and HSV-2).
, the product has been tested in healthy human volunteers for Clinical Phase 1, which has been shown to be safe and well-to-do and does not produce anti-drug antibodies.
last June, it received FDA approval to conduct a clinical Phase 2 trial in patients with resuscuted genital herpes caused by HSV-2 infection.
is the first time the product has been declared clinical in China.
7, Hengrui Medicine: Hypoppa ethanolamine tablet action mechanism / target point: TPO-R astrogen Hypopa ethanolamine tablet is an oral absorption of small molecule non-peptide-promoting platealine production hormone (TPO-R) astration developed by Hengrui Pharmaceutical.
According to public information, it can bind to TPO subjects on cell membranes, activate signal transducting paths, stimulate the differentiation and proliferation of human bone marrow progenitor cells to cytocytes, and promote the maturation of cytocytes, thereby increasing plate plateplate production.
According to the drug clinical trial registration and information publicity platform, Hengrui Pharmaceuticals has carried out more than ten clinical trials on the registration of hypopharmic ethanolamine tablets, of which the study of primary immunocompetitive plateroid reduction, thyroid reduction caused by chemotherapy of malignant tumors and other adaptations has entered the phase 3 clinical stage.
, Hengrui Pharmaceuticals has submitted five applications for listing of the product in China and was recently included in the CDE's priority review.
8, Fosun Pharma: Malay acid Avaquopa tablet action mechanism / target point: TPO-R astrogen Malay acid avalancopa tablet is an oral platealine-producing protein-producing perturbation agent, the first small molecule innovation drug introduced by Fosun Pharma.
it was officially approved for listing in China in July this year, and the product is called Su Keyin, which is used to treat adult patients with chronic liver disease (CLD)-related plateroid reduction in diagnostic or surgical procedures.
In addition to CLD-related plateroid reduction, Avatropopa is actively working in areas such as plateiac reduction (CIT) and immunocompetitive plateroid reduction (ITP) due to chemotherapy, according to the press release, and is expected to provide innovative treatment options for more thyroid reduction patients in China.
9, Amgen /Baiji Shenzhou Drug Type: Small molecule candidate AMG 650 clinical trial application in China by Amgen and Baiji Shenzhou jointly declared, this is the first time the product declared clinical in China.
AMG 650 is an oral drug candidate for small molecules and is currently undergoing Phase 1 clinical trials in advanced solid tumors, according to amsin.com.
10, Pumis Bio: PM8002 Injection Drug Type: Innovative Biologics PM8002 Injection is an innovative biologics of Pumis Bio, this time for the first time in China declared clinical.
: The Drug Review Center of the State Drug Administration of China. Retrieved Aug 21, 2020, from the company's official website and public information.