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Yaozhi data shows that in this period (July 2 to July 9), 27 new drugs were approved for clinical trials (40 acceptance numbers); another 39 varieties (60 acceptance numbers) clinical applications were accepted by CDE.
More dynamics are as follows:
New Drug Clinical Application·Newly Approved
In this issue, 27 new drugs (40 acceptance numbers) have been approved for clinical trials, including 18 domestically produced Class 1 new drugs
.
The clinically approved innovative drugs include NMDA antagonists, JAK inhibitors, Bcl-2 inhibitors, GAS6/AXL inhibitors, TIGIT monoclonal antibodies, IL-1β monoclonal antibodies, etc.
1.
AZD4205 capsules
The drug is a JAK1 kinase inhibitor jointly developed by AstraZeneca and Dizhe (Jiangsu) Pharmaceutical Co.
, Ltd.
2.
BGB-11417 film-coated tablets
The drug is a class 1 new drug independently developed by BeiGene.
It is a highly selective and potentially "best-in-class" Bcl-2 inhibitor.
It has demonstrated anti-tumor activity in hematological tumor models and has Certain potential advantages
.
In September 2020, the BGB-11417 film-coated tablet was submitted for the first time in China for clinical application and was accepted by CDE.
3.
MN-08 piece
The drug is an NMDA inhibitor independently researched and developed by Magpie Pharmaceutical.
The approved indication is pulmonary hypertension this time
.
Preclinical studies on animal models of pulmonary hypertension have proved that MN-08 is not only a clear treatment, but also superior to the clinically used drug sildenafil
4.
NTQ1062 tablets
The drug is the first class 1 new drug declared by Nanjing Zhengda Tianqing in 2021, and it is intended to be used for the treatment of patients with locally advanced or metastatic solid tumors
.
The specific target was not disclosed
5.
Phenylethyl isothiocyanate liquid hard capsule
JC-5411 (Phenylethyl Isothiocyanate Liquid Hard Capsule) derived from cruciferous vegetables was independently developed by Jesse Medicine and is intended to be used for advanced prostate cancer
.
It is reported that JC-5411 directly inhibits the androgen receptor AR by: 1) directly inhibiting; 2) inhibiting the activity of the transcription factors Sp1 and Foxo3a of the upstream gene of AR; 3) inhibiting the expression of the prostate specific antigen PSA, a downstream factor of AR.
6.
Porphyrin tablets
The drug is a small molecule drug targeting thioredoxin (TR) developed by Shanghai Yuanxi Pharmaceutical Technology, and is intended for the treatment of liver fibrosis
.
Porsellenine tablets are the world’s first clinically approved first-innovative drug.
7.
Cioroni capsules
The drug is a new chemical structure with global patent protection independently designed and developed by Microchip.
It is a multi-target multi-channel selective kinase inhibitor
.
It is a small molecule anti-tumor original innovative drug, which can selectively inhibit multiple kinase targets such as Aurora B, CSF1R and VEGFR/PDGFR/c-Kit
.
This approved indication is for patients with advanced triple-negative breast cancer who have failed the treatment of anthracyclines and taxanes with Cioroni capsules alone or in combination
.
At present, Cioroni is carrying out phase three clinical trials of single-agent treatment of small cell lung cancer and combined paclitaxel treatment of ovarian cancer, as well as different phases of research for the treatment of multiple indications such as liver cancer, lymphoma, and other neuroendocrine tumors
.
8.
MT1013 for injection
The drug is an innovative bifunctional peptide independently developed by Mecoot.
This time it has been approved for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease undergoing maintenance hemodialysis
.
MT1013 developed by Mecoot is a dual-target functional peptide.
Preclinical studies have shown that this molecule has extremely high safety and effectiveness.
Compared with the marketed drugs, it not only achieves the same PTH-lowering effect, but also can significantly reduce Risk of Calcemia
.
9, 3D-229 injection
The drug is a "first-in-class" GAS6/AXL inhibitor introduced by Sidi Medicine from Aravive.
The cooperation contract and development and commercial milestone payments are up to 219 million U.
S.
dollars
.
Preclinical studies have confirmed that 3D229 can neutralize its activity by binding to GAS6, thereby selectively inhibiting the GAS6-AXL signaling pathway
.
Approved this time in China is a randomized, double-blind, controlled, adaptive phase 3 clinical study, which aims to evaluate the effectiveness and safety of 3D229 combined with paclitaxel in the treatment of platinum-resistant recurrent ovarian cancer.
The study will As part of the 3D229 international multi-center phase 3 clinical trial
.
10.
BAT6021 injection
The drug is a Class 1 therapeutic biological product under Biotech, with the target of TIGIT, and the proposed development indication is advanced malignant solid tumors
.
It is reported that a number of TIGIT monoclonal antibody drugs are undergoing clinical trials around the world.
Among them, Roche Tiragolumab has made the fastest progress, and it is already in combination with the PD-L1 inhibitor Taishengqi (Atezizumab) for the treatment of non-small cells.
Phase III clinical stage of lung cancer (NSCLC)
.
Other domestic TIGIT targeted drug being developed as well as Baiji Divine BGB-A1217, Cinda biological IBI939, complex macros Hanlin HLX53, Jun real biological JS006, Sitan Wei biological mAb-7 and so on
.
11.
SKB336 injection
The drug is a humanized innovative monoclonal antibody targeting FXIa/FXI developed by Kelun Botai, a subsidiary of Kelun Pharmaceutical, and is intended to be developed for the prevention and treatment of thromboembolic diseases
.
Non-clinical research data confirmed that SKB336 injection has high affinity and selectivity for the endogenous coagulation factors FXI and FXIa, but has no effect on other exogenous coagulation factors and downstream coagulation factors of the common pathway
.
No antibody drug with the same target of SKB336 has been approved for marketing in the world
.
12.
Recombinant anti-IL-1β humanized monoclonal antibody injection
Sansheng Guojian Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection (SSGJ-613) was approved to carry out systemic juvenile idiopathic arthritis, and periodic fever syndromes (including cold inflammation related periodic syndromes) , Tumor Necrosis Factor Receptor-related Periodic Syndrome, Mevalonate Kinase Deficiency/High Immune Globulin D-Periodic Fever Syndrome, Familial Mediterranean Fever)
.
Preliminary experimental results show that SSGJ-613 has a good affinity and inhibitory effect on IL-1β
.
At present, there is no anti-IL-1β antibody with China's independent intellectual property rights on the domestic market
.
13.
Efgartigimod injection
The drug is a "first-in-class" therapy targeting FcRn developed by argenx, and is intended to be developed to treat primary immune thrombocytopenia and pemphigus
.
In January 2021, Zai Lab obtained the exclusive rights to the drug candidate in Greater China from argenx through a cooperation of up to 175 million U.
S.
dollars
.
Number of clinical studies being carried out worldwide Efgartigimod, according to indications include myasthenia gravis, pemphigus vulgaris, autoimmune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy, and the like
.
New Drug Clinical Application·New Acceptance
In this issue, CDE has newly accepted clinical applications for 39 new drugs (60 acceptance numbers)
.
Among them, 27 varieties (37 acceptance numbers) are domestic new drugs, and 12 varieties (23 acceptance numbers) are imported new drugs.
More developments are as follows:
Data source: Yaozhi data