More than 10 Chinese innovative drugs qualified for FDA fast track!

Public information shows that this year, AxaPharmaceutical, And Huang Pharma, Soyuan Bio and other Chinese companies to develop innovative drugs have been granted fast-track qualification by the U.S. FDA.
Fast Track eligibility is part of the FDA's program to accelerate drug reviews, to accelerate drug development for serious or fatal diseases to meet unfinished medical needs.
in recent years, more and more innovative drugs developed by Chinese companies have gone international and obtained FDA fast-track qualification.
this qualification means that these new drugs have shown potential to meet unfinished medical needs in early trials, and pharmaceutical companies can have more opportunities to communicate with the FDA to speed up the entire development process.
Today, we will take stock of China's innovative drugs that have been qualified by the FDA for quick access in recent years.
(limited to space, the following only excerpts of some drugs to introduce) 1, Baiji Shenzhou: Zebutini target: BTK Zebutini is a self-developed by Baiji Shenzhou an oral BTK small molecular inhibitor, its characteristics are to maximize the specific binding of BTK targets, thereby minimizing off-target effects and the toxic side effects.
in the United States, Zebbutinib has been granted by the FDA as an "orphan drug qualification", "fast-track qualification", "breakthrough therapy" and "priority review qualification", which is the first China to obtain the FDA's four special channel qualification seeking to develop new anti-cancer drugs.
November 2019, the FDA approved Zebutinib for the treatment of treated cell lymphoma.
in China, Zebutinib was approved in June this year through a priority review process for patients with adult cell lymphoma who have previously received at least one treatment and for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in adults who have previously received at least one treatment.
, Zebutini's listing applications in Europe and Israel have also been accepted.
2, and Yellow Medicine: Furionteinib Target: VEGFR furinib is a small molecular angiogenesis inhibitor developed by Hutchison Whampoa Pharmaceuticals, which is developed by Hutchison Pharmaceuticals, and its main target is the VEGFR kinase family (VEGFR1, 2 and 3).
the product inhibits tumor growth by inhibiting VEGFR phosphorylation and downstream signal transduction on the surface of endothelial cells in blood vessels, inhibiting the proliferation, migration and tube cavity formation of vascular endothelial cells.
2018, chloroquine is the first innovative drug approved by Hutchison Whampoa Pharmaceuticals in China through a priority review.
at present, Hutchison Pharma is developing furanquine in the world.
June 2020, epinequine was granted fast-track status by the U.S. FDA for the treatment of patients with metastatic colorectal cancer.
it is understood that Hehuang Pharma is planning to launch a phase 3 registration study in the United States, Europe and Japan for the treatment of refractive metastatic colorectal cancer.
3, and Yellow Medicine: Sofantinib Target: VEGFR, FGFR, CSF-1R Sofantinib is a small molecule oral tyrosine kinase inhibitor whose mechanism is to inhibit vascular endothelial growth factor receptors (nrit) VEGFR) and fibroblast growth factor receptors (FGFR) block tumor angiogenesis and inhibit the concentration-stimulating factor-1 receptor (CSF-1R), which promotes the body's immune response to tumor cells by regulating tumor-related macrophages.
at the same time, because the drug has a dual mechanism of anti-tumor angiogenesis and immunomodulation, it may be well suited for combination with other immunotherapy.
currently, Sofantini is being used in China and the United States as a single drug therapy or in combination with other tumor immunotherapy to carry out research on neuroendocrine tumors (NET), biliary cancer and other solid tumors.
April 2020, the FDA granted Sofantini Fast Track eligibility for the treatment of advanced and advanced pancreatic neuroendocrine tumors and non-pancreatic NET patients who are not suitable for surgery. Earlier in the
, Sofantinib was also granted an FDA-granted orphan drug for the treatment of pancreatic neuroendocrine tumors.
4, AXA Medicine: HQP1351 Target: BCR-ABL/KIT HQP1351 is an oral third generation BCR-ABL/KIT inhibitor developed by AXA Pharmaceuticals.
BCR-ABL kinase region mutation is one of the important mechanisms of acquired drug resistance, HQP1351 has significant effects on BCR-ABL and its various mutants (including T315I mutations), and is to be developed to treat patients with chronic myeloid leukemia (CML) who are resistant to first- and second-generation tyrosine kinase inhibitors (TKI).
May this year, HQP1351 was awarded the U.S. FDA's Orphan Drug Qualification and Fast Track Qualification for CML patients who have failed to treat specific genetic mutations in existing TKI treatments. On June 18,
, AXA Pharmaceuticals announced that it had submitted to the State Drug Administration (NMPA) a new drug application for HQP1351 for the treatment of patients with CML chronic and accelerated periods with T315I mutations, the first NDA submitted since the inception of AXA.
5, Fosun Pharma: ORIN1001 Target: IRE1 ORIN1001 is a first-of-its-kind (first-in-class) small molecule drug developed by Fosun-Basedon, a subsidiary of Fosun Pharma.
public information shows that ORIN1001 is a new selective inositol (IRE1) inhibitor designed to develop the treatment of advanced solid tumors.
June 2019, ORIN1001 was granted fast-track status by the FDA for the treatment of recurrent, refractive, metastatic breast cancers (including triciacymal breast cancer).
in China, the drug has been approved for clinical practice, the main indications of the study are breast cancer, prostate cancer, liver cancer, pancreatic cancer, ovarian cancer and other advanced solid tumors.
6, Rongchang Biology: Teitasip Target: BLyS/APRIL Teitasip is a bio-new biological drug developed by Rongchang Bio, which inhibits both BLyS and APRIL cytokines, which overexpression is closely related to a variety of B lymphocyte-related autoimmune diseases.
currently, Tethip is mainly developed for the treatment of systemic lupus (SLE).
April this year, Tethip was granted fast-track eligibility by the FDA to treat systemic lupus.
it is understood that Rongchang Bio plans to conduct phase 3 clinical trials of SLE worldwide in the first half of 2021, including the United States, Europe and other countries.
in China, Rongchang Bio submitted to NMPA in October 2019 a conditional application for approval of a new drug for the treatment of SLE, which has been submitted to narep for sale and has been included in the priority review.
in addition to SLE, Teitasip has conducted post-clinical trials in China for six other B-cell-mediated autoimmune diseases, including two registered clinical studies.
7, Zesson Technology: Newcastle Target: ErbB2/ErbB4 Newcading (recombinant Newland Green) is the first in-house research and development of Zesson Technology's potential first-in-class new drug.
this is a recombinant protein drug derived from the naturally occurring newmultipeptide fragments of Newlandin in the human body.
its innovative mechanism of action is to activate the erbB2/ErbB4 receptor tyrosine kinase expressed in myocardial cells to regulate gene and protein expression, promote myogenic recombination, increase myocardial contraction/diastolic, and reverse ventricular reconstruction.
August 2019, Newcastle was granted fast-track status by the U.S. FDA to treat chronic heart failure.
in China, Zesheng Technologies has submitted a conditional listing application from Newcastle in 2018 and has been included in the priority review.
8, Jun Santitai: HTD1801 mechanism of action: multi-functional small molecule drug HTT1801 is an oral multi-functional small molecule drug, is composed of two active groups of ion salts of a new molecular entity, is currently in China, the United States and Canada and other places to carry out clinical trials.
the product has been granted fast-track status by the FDA twice in 2018 for the treatment of primary sclerosing choline and non-alcoholic fatty hepatitis (NASH).
May, HTD1801 reached major and several important secondary endpoints in a Phase 2a clinical trial in patients with NASH Combined Type 2 Diabetes (T2DM).
studies have shown that HTD1801, as an oral drug, takes it alone or in combination with other drugs, and has a unique place in the treatment of NASH-combined diabetes.
9, Xuno Pharmaceuticals: Ebexa Target: HDAC Abes he is a new type of histone deacetylase (HDAC) inhibitor, it by increasing the degree of acetylization of intracellular histones, improve the expression level of p21 and other genes, etc., inhibit the proliferation of tumor cells, induce cell differentiation or apoptosis.
in the United States, Abes has been granted two fast-track qualifications: one for a single drug treatment for four-wire follicular lymphoma, and the other for Abes and pesperpani with first- or second-line treatment of renal cell cancer.
currently, Ebes is conducting clinical trials for a variety of cancers in the United States, China, Europe and other places.
in China, Ebesis is conducting a phase 2 clinical trial for single drug therapy for recurrent/refractive diffuse large B-cell lymphoma.
10, TheDrug: Contecamine Drug Type: Contezolid (Contekamine) and its predecessor, Contezolid acefosamil (MRX-4), are the next generation of prostenella antimicrobials designed to reduce the risk of adverse blood reactions and monoamine oxidation inhibition caused by these antimicrobials.
the product is effective against multidrug-resistant Gram-positive bacteria, including the highly threatening methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci.
September 2018, the FDA granted Contezolid and its predecessor, Contezolid acefosamil, the status of qualified infectious diseases for the treatment of acute bacterial skin and skin tissue infections.
in China, Contekamine has submitted a new drug listing application in January this year and has been included in the priority review.
11, Soyuan Bio: DB102 (enzastaurin) Target: DB102, such as PKC beta, PI3K, and AKT, was originally developed by Eli Lilly and Company, and Soyuan Bio now has a global rights to the drug.
July 2020, Soyuan Bio announced that the FDA had granted DB102 fast-track eligibility for first-line treatment of glioblastoma.
, DB102 is a world-first small molecule serine/suthine kinase inhibitor, acting on PKC beta, PI3K and AKT and other tumor field key tumor targets, with the direct effect of inducing tumor cell death and blocking tumor cell growth, as well as inhibiting tumor-induced vascular growth indirect effect, to develop treatment of the initial treatment of high-risk high-risk diffuse b lymphocyoma and glioblastoma (GBM).
, sofar, a Phase 3 clinical trial has been launched and conducted at the International Multi-Center.
, DB102's international multicenter phase 3 clinical trial for GBM for the treatment of new diagnoses has been approved in the United States and China and will be launched this year.
12, Tudor Biology: TERN-101 Target: FXR TERN-101 was originally developed by Lilly, and In 2018, Tudor Bio received a global exclusive development and commercialization interest in three NASH small molecule candidate drugs, including TERN-101.
October 2019, the FDA has granted TERN-101 Fast Track status for non-alcoholic fatty hepatitis (NASH).
it is known that TERN-101 is a powerful non-bilitic acid faniol receptor (FXR) agonisant, FXR is a highly expressed nuclear receptor in the liver and small intestine.
bile acid is a natural ligand of FXR, and its binding and activation with FXR is essential for regulating cellular pathways of bile acid synthesis, lipid metabolism, inflammation and fibrosis.
in China, TERN-101 has been approved for clinical research on NASH.
references: the official websites and public information of each company.
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