Anticipate the future | The 13 clinically urgent needs of new drugs from abroad are expected to be approved for sale in China in 2021

1, drug name: Stoxi monoantigen company: Baiji Shenzhou / EUSA Pharma drug mechanism: IL-6 inhibitor adaptation: multi-center Castelman disease Siltuximab is Baiji Shenzhou from EUSA Pharma introduced an IL-6 inhibitor.
public information, stoxides can be used to block the activity of elevated multifunction cytokine IL-6 detected in patients with multi-center Castleman disease.
first approved in the U.S. in 2014, the product has been approved for sale in more than 40 countries and territories around the world.
in China, two applications for the listing of injection stoxides were accepted on January 20 this year, jointly submitted by EUSA Pharma and Baiji Shenzhou to the Drug Review Center (CDE) of the State Drug Administration of China.
It is worth noting that the drug has previously been included in the CDE priority review for adult patients with multi-center Castelman disease who are used to treat human immunodeficiency virus (HIV)-negative and human herpes virus 8 (HHV-8) negative.
2, Drug Name: Dituxima Company: Baiji Shenzhou / EUSA Pharma Drug Mechanism: GD2 Target Monoclonal Antibody Adaptation: Neuroblastoma Dituximab Beta is a GD2 targeted monoclonal antibody introduced from EUSA Pharma, which can be combined with specific target GD2 overexpressed neuroblastoma cells.
it can induce a dual immune mechanism that allows the immune system to destroy cancer cells of neuroblastoma.
clinical studies have shown that the product can significantly improve patient survival.
in early November 2020, the application for the listing of a new drug submitted by Dittosi monoantigen in China was accepted by CDE.
, it has been included in priority reviews for the treatment of high≥-risk neuroblastoma patients up to 12 months of age.
3, Drug Name: Aitibant Company: Takeda Drug Mechanism: Anti-Peptide B2 Inhibitor Antagonist Adaptation: Acute Episode of Hereditary Angioedema (HAE) Icatibant It is a powerful selective anti-inflammatory peptide B2 subject antagonist, which treats the local swelling of the embolism of acute hereditary angioedema by suppressing the effects of the refractic peptide associated with local swelling, inflammation and pain symptoms of hereditary angioedema.
U.S., Aitbant was approved in 2011 for the treatment of acute episodes of hereditary angioedema in adults 18 years and older.
first submitted an application for the listing of acetic acid Aitide Bante injections in China in June 2020 and was accepted, according to CDE's official website.
October of the same year, the listing application was to be included in the CDE Priority Review, with the onset of hereditary angioedema for the treatment of adults, adolescents and children aged ≥2 years.
4, Drug Name: Apuster Tablets Company: Amgen/Celgene Drug Mechanism: PDE4 Inhibitor Adaptation: Plaque Psoriasis, Psoriasis Arthritis April (Celgene) apremilast is a new type of oral small molecule diosterase 4 (PDE4) inhibitor that works by dose-dependent inhibition of the release of tumor necrosis agent (TNF)-α by dose-dependent human membrane cells.
the product was originally developed by BMS's new base company, Amson announced in August 2019 that it had acquired a global interest in April for up to $13.4 billion.
the United States, Apuster has been approved for use in patients with plaque-type psoriasis, psoriasis arthritis, white plug disease-related mouth ulcers and other adaptive patients.
February 3rd, the application for the listing of the new Drugs of Thepester tablet, submitted jointly by Amjin and Xinji, was accepted.
previously, Apuster's adaptations to psoriasis arthritis and psoriasis had been added to the list of the first clinically in urgent need of new drugs from abroad.
5. Drug Name: Butylbenazine Company: Shandong Dr. Renfrida Pharmaceutical Drug Mechanism: VMAT 2 Inhibitor Adaptation: Huntington's Disease (HD) Public information shows that tetrabenazine is the first drug approved for treatment of Huntington's Disease in the United States.
The drug reduces the supply of monoamine compounds such as 5-serotonin, dopamine, and dethyrophetamine mainly by inhibiting the central nervous system's monoamine transporter protein 2 (VMAT 2) to produce pharmacological activity.
In August 2020, butyl benzene tablets submitted by Shandong Dr. Renfrida Pharmaceutical Co., Ltd. for registration of new drugs in category 5.1 were included in the priority review and approval process for the clinical urgent need for rare disease drugs that have not been listed overseas.
6, Drug Name: Injection with Virasi enzyme α Company: Takeda Drug Mechanism: Enzyme Replacement Therapy Adaptation: Goshey Injection with Velaglucerase α (Velaglucerase alfa) is a hydrolyzed lysosome-specific glucose glycosidease developed by Takeda's Shire, which has been approved in the United States for long-term alternative therapy (ERT) for type 1 Goshey disease in children and adults.
goshe disease is an endosomal recessive genetic disease caused by a mutation in the GBA gene, which leads to the deficiency of lysosome enzyme β-glucosin cerebrosine lipase, resulting in the storage of its substrate glucose cerebrosine lipids in various organs of the human body.
in China, applications for the listing of new drugs α velasins were submitted in China in February 2019 and accepted by CDE.
, the application is currently under CDE review and approval.
7, drug name: Fumaric acid dimethylate Company: Biogen Drug Pathology: Nrf2 signaling pathrapies Adaptation: Multiple Sclerosis (MS) Dimethyl Fumarate is an oral drug, is a heavy-duty product of Therbens for the treatment of multiple sclerosis.
that it may have antioxidant properties that regulate the immune response, reduce inflammation, and protect the brain and spinal cord from damage.
According to public information, in China, companies such as Yan Jian and Janssen have earlier jointly submitted applications for the listing of new drugs for fumarate methamphetate intestinal capsules, and have been given priority review by CDE for treatment of adult patients with multiple sclerosis: including clinical isolation syndrome, relapse remission, and active secondary progression.
application is currently under review and approval.
8, Drug Name: Mabarosawe Tablets Company: Roche/Shionogi Drug Mechanism: Cap Structure Dependent Endoenzyme Inhibitor Adaptation: Influenza A and B Mabarosavir Baloxavir marboxil is an "first-in-class" anti-flu drug developed by Japan's Yanoyi Pharmaceuticals and Roche, which inhibits virus replication by inhibiting cap-dependent nucleic acid in influenza viruses.
as the first single-dose oral drug for influenza viruses with a new mechanism of action approved by the FDA in nearly 20 years, Mabaloshavir offers a new solution for influenza treatment.
June 2020, Roche and genentech submitted two applications for the listing and CDE of two new mabarosawe tablets in China.
November of the same year, the application was included in the CDE's priority review for influenza patients 12 years of age and older, including those at high risk of influenza complications.
the application is currently under review and approval.
9, Drug Name: Ponatinib Company: Takeda, Ariad Pharmaceuticals, etc. Drug Mechanisms: Bcr-Abl Inhibitor Adaptation: Chronic Granulocytic Leukemia (CML); Acute Lymphocytic Leukemia; Leukemia Ponatinib for 3D Bcr-A bl kinase targeted inhibitors, T315I mutant Bcr-Abl kinase has an efficient specific inhibitory effect, can effectively solve the existing Imatinib as the representative of the targeted suppression of Bcr-Abl kinase CML treatment drugs common, due to kinase mutations caused by drug resistance defects.
was developed by Ariad Pharmaceuticals, which Takeda acquired in early 2017 through the acquisition of Ariad.
the United States, Ponatini has been approved for use in a variety of leukemias.
According to the drug clinical trial registration and information disclosure platform, Ponatini is currently conducting two clinical trials in China, namely, the International Multi-Center Phase 3 Trial for Philadelphia Chromosomal-Positive Acute Lymphoblastic Leukemia, and the Phase 2 Trial in China for Acute Lymphoblastic Leukemia and Chronic Granulocytic Leukemia.
10, Drug Name: Elliglusta Company: Genzyme Drug Mechanism: Ceramide Similar Inhibitor Adaptation: Type 1 Goshe disease Elligrusta capsule (eliglustat, Genz-Genz-112638) is a powerful, highly specific ceramide-like inhibitor approved by the FDA in August 2014 for the treatment of the rare genetic disease Goshe disease, a first-line oral drug for the treatment of Goshe disease.
The drug reduces the production of glucose ceramide by targeting glucose ceramide synthase, and is suitable for long-term treatment of adult patients with type 1 Goshe disease with weak metabolic, moderate metabolic and fast metabolic metabolic genotype P4502D6 (CYP2D6) metabolic genotype.
Based on the drug clinical trial registration and information disclosure platform, Sanofi's Kenzan has completed a Phase 3 international multi-center clinical study in China aimed at comparing the impact of oral Genz-112638 treatment twice a day on patients with type 1 Goshe disease who have received twice-daily treatment to achieve clinical stability.
11, Drug Name: Inanib Company: Agios Inc./New Base Drug Mechanism: IDH2 Inhibitor Adaptation: Acute Myeloid Leukemia (AML) Inanib (en) brought by Agios and New Base AG-221) is an IDH2 inhibitor approved in the U.S. in 2017 to treat adult patients with recurring or refractic acute myeloid leukemia with IDH2 mutations.
IDH2 mutation accounts for about 17% of AML.
by inhibiting the mutant IDH2 protein, the new drug is expected to play a role in controlling the condition, with studies showing a 23 percent full remission rate and 8.2 months of remission duration in AML with the IDH2 mutation.
noted that it has been approved by the FDA for priority review and orphan drug eligibility, and is the world's first approved drug for adult AML patients with IDH2 mutations.
based on the drug clinical trial registration and information disclosure platform, Inanib is currently conducting a Phase 3 clinical study in China to treat the effectiveness and safety of advanced acute myeloid leukemia.
12, drug name: Kananu mono-anti-company: Novartis drug mechanism: anti-IL-1?mono-anti-adhesive: the periodic syndrome Kananu monoantigen (canakinumab, ACZ885) is a selective inhibition of IL-1?human-source monoclonal antibodies, can be the key cell factor of inflammatory pathster IL-1?
can also aid the treatment of cancer patients by reducing the inflammatory response that promotes tumor growth.
previously, the product had been approved in the United States for a number of adaptations, including two subtypes of a rare auto-inflammatory disease called lysine-related periodic syndrome (CAPS).
in China, Kananu monoantion for CAPS adaptation has been included in the first batch of clinically urgent need for new drugs abroad.
novart has registered a number of International Multi-Center Clinical Trials of Kananu Mono-Resistance in China, based on the Drug Clinical Trial Registration and Information Disclosure Platform.
, a Phase 3 study on the treatment and prevention of gout attacks and a Phase 3 study on reducing the risk of cardiovascular events have been completed.
There are three other Phase 3 clinical trials under way, including a Phase 3 study in the first-stage treatment of advanced lung cancer in combination with Pabli Pearl monoantigen and chemotherapy, Phase IIIA and Phase III studies in adult subjects of phase II-IIICLC in assisted treatment, and phase III studies in adult subjects of phase II-IIIA and phase IIIB phase NSCLC.
13, Drug Name: Vinakalan Hydrodesic acid Company: Cardiome Pharmaceutical Mechanism: Sodium/Potassium Channel Blocker Adaptation: Atrial Fibrillation Vernakalan Hydrochloride is a new anti-arrhythmic drug developed by iome, which was first approved for sale in Europe in September 2010.
This is a selective act on the atrial ion channel of the mixed sodium / potassium channel blocker, in the recent outbreak of atrial fibrillation in the acute refracing of the effect is better, clinically used to treat atrial fibrillation.
, according to the drug clinical trial registration and information disclosure platform, hydrochloric acid Venacaran injection in China registered two clinical trials.
included a phase 3, prospective, randomized, double-blind, placebo-controlled, multi-center, and evaluation of the effectiveness and safety of vinakaran hydrochloric acid in patients with atrial fibrillation.