Koren, Yangzijiang... 57 new drugs reported clinically! Zhengda Qing the first inhaler class 1 new drug debut, Qilu's first oral dissolved membrane came

Hengrui Pharma 3 billion varieties of the next city; Qilu's first oral solution film preparation is about to be approved; two chinese medicine class 1 new drugs declared on the market; the first dual-target CAR-T products were approved clinically; Zhengda Tianqing's first inhaler new drug declared clinical; Yangzijiang, Enhua ... 32 domestic class 1 new drugs debuted.
15 new drug listing applications new progress, Qilu, green leaf attack high-end preparations December 26, 2020 - January 8, 2021, 15 new drugs (28 acceptance numbers) of the listing application has been reviewed and approved status updates.
four new domestically produced drugs have been approved for the market, including Sovantini of Huang Pharmaceuticals, Apatini of Hengrui Pharmaceuticals, etc., and five new drugs have been approved for import, including Lilly's Abemaciclib tablets and Mercado's Lavelin Ramif dinginofove tablets, etc.; Six drugs, such as the o nitrogen flat-mouthed dissolved membrane of Ziru and the remixed microbes of lipe ketones for injection of green leaf pharmaceuticals, were changed to "in-approval" status of the listing application.
(2020.12.26-2021.1.8) New drug listing application review status update domestic class 1 new drug Sovantini capsule was approved for market, the product is and Huang Pharmaceutical independently developed a new oral tyrosine kinase inhibitor, with anti-angiogenesic and immunomodulation dual activity.
The approved adaptation is a late-stage non-pancreatic neuroendocrine tumor, a second adaptation (pancreatic neuroendocrine tumor) has been reported, Sovantini is expected to become the world's first innovative neuroendocrine tumor treatment covering all site sources.
Hengrui Pharmaceutical's Apatini 2 adaptive disease was approved for the treatment of advanced hepatocellular carcinoma, the product has been carried out in China more than 20 clinical trials, of which the ongoing Phase III clinical 10, mostly combined drugs.
total sales of more than 3 billion yuan in 2019 in China's public medical institutions and physical pharmacy terminals in Chinese cities, according to the company's website.
Novartis's hydrochloric acid olotatin eye drops are an upgraded version of olotatin eye drops hydrochloric acid, which increases the concentration of olotatin hydrochloric acid to 0.2%, not only continues to maintain the mechanism of dual-effect antisensitivity (antagonists and stable hyperhidrocyte membrane), but also reduces the frequency of use, for domestic allergic conjunctivitis patients to bring more convenient and effective treatment of new options.
two new modified drugs are about to be approved for the green leaf pharmaceutical injection with lipe ketone slow release micro-ball and Qilu pharmaceutical's O nitrogen flat mouth solution membrane, are psychostatific drugs.
meters net data show that in 2019, China's public medical institutions terminal Lipe ketone, O nitrogen flat market size of more than 1 billion yuan, 4 billion yuan, currently no Lipe ketone injection slow release microball, O nitrogen flat mouth dissolved membrane preparations listed for sale.
Concorde Fermentation Kirin's Broshu monoantigen is a fully humanized monoclonal IgG1 antibody for fibroblast growth factor 23 (FGF23), which is about to be approved for entry into the domestic market.
Broshuda is the first FDA-approved drug to treat X-series hypophosphateemia (XLH) in children and adults 1 year of age and older, has been recognized by the FDA as a breakthrough therapy and orphan drug qualification, is a member of the second batch of clinically in urgent need of new drugs abroad, has been included in the priority review on the grounds of rare disease treatment.
Ashatan potassium tablets are an angiotensin II blocker developed by Takeda and will soon be approved for sale in China for the treatment of primary hypertension.
first approved for listing by the FDA in 2011, with global sales of 76.7 billion yen in 2019.
9 new drugs applied for the market, two Chinese medicine class 1 new drugs hit December 26, 2020 - January 8, 2021, 9 new drugs (14 acceptance numbers) to be listed applications to obtain CDE contractor.
two varieties (2 acceptance numbers) are domestic new drugs, all of which are chinese medicine class 1 new drugs, and 7 varieties (12 acceptance numbers) are imported new drugs.
From the point of view of drug types, 5 varieties (9 acceptance numbers) are chemicals, 2 varieties (3 acceptance numbers) are therapeutic biological products, and 2 varieties (2 acceptance numbers) are Chinese medicines.
(2020.12.26-2021.1.8) was sponsored by the domestic / imported new drug market application for two Chinese medicine Class 1 new drugs declared for listing, for Tiansli's Kun Yining particles, Jianmin Pharmaceutical's stomach capsules.
Kun Yining particles are developed using modern technology to treat women's peri-menopian syndrome of innovative traditional Chinese medicine, with a small amount of use, high effective component content, rapid effect and so on;
AbbVie's Upatinib tablet is an oral Janus kinase subtype 1 (JAK1) selective inhibitor, a second-generation Janus kinase inhibitor, highly selective, approved by the FDA in 2019 for moderate to severe active rheumatoid arthritis, in the study of adaptive disorders including ulcerative enteritis, psoriasis arthritis, Crohn's disease and other inflammatory diseases.
22 new drugs were approved clinically, HengRui, and Huang, Kangfang ... Between December 26, 2020 and January 8, 2021, 22 new drugs (31 acceptance numbers) were approved for clinical trials, of which 17 varieties (25 acceptance numbers) were approved Domestic new drugs (11 for 1 class of new drugs), 5 varieties (6 acceptance numbers) for imported new drugs;
(2020.12.26-2021.1.8) Approved clinically approved domestic/imported new drug AK104 injection is a new generation of anti-tumor immunotherapy drugs, It is the first dual-resistance product developed by Kangfang Bio using its unique Tetrabody dual-resistance platform, and the first PD-1/CTLA-4 dual-specific antibody to enter clinical trials in the world.
the product has a number of adaptive disorders in the development of Phase II clinical, including non-horned differentiation type or undifferentiated nasopharyngeal cancer, recurrence or difficult to treat external T-cell lymphoma.
BGB-A1217 injection in Baiji Shenzhou is a monoclonal antibody with global intellectual property rights targeting T-cell immunoglobulins and ITIM domain proteins (TIGIT), which has been approved for clinical use of new adaptations.
the product is currently in China and Australia to carry out phase 1a/1b clinical trials, combined with PD-1 single anti-reilly-pearl monoanti-anti-treatment of advanced solid tumors.
Shanghai Hengrun Dasheng class 1 new drug anti-human CD19-CD22 T cell injection is the first approved clinical dual-target CAR-T therapy, intended for the treatment of recurrence / difficult treatment of B cell acute lymphoblastic leukemia.
clinical research data show that dual-target treatment for CD19 and CD22 is effective and relatively safe, but similar products at home and abroad are in clinical phase I or preclinical stage.
57 new drug clinical applications were undertaken, Zheng Tianqing, Yangzijiang, Colum ... Between December 26, 2020 and January 8, 2021, 57 clinical applications for new drugs (87 acceptance numbers) were accepted by CDE contractors, of which 42 varieties (62 acceptance numbers) were domestic new drugs (32 new drugs of class 1) and 15 varieties (25 acceptance numbers) were imported new drugs.
from the drug type, chemical drugs, therapeutic biological products, Chinese medicine has 30, 20, 7 respectively.
(2020.12.26-2021.1.8) to undertake the domestic / imported new drug clinical application stone drug two class 1 new drug application clinical.
SKLB1028 capsule is a multi-target tyrosine kinase inhibitor intended to be developed for the treatment of non-small cell lung cancer, acute granulocytic leukemia, etc., SYHX1901 tablets for the first time declared, no information about the product.
estave is a specific inhibitor acting on neural anenase, the current domestic market dosage forms include capsules and granules, Dongsan medicine has been approved for production.
In order to consolidate the market, Dongsian Pharmaceuticals in July 2020 submitted the application for the listing of estave dry suspension agent, is currently in the review and approval, this declaration of clinical estave slow release tablets for the product's fourth dosage form.
Q-1802 freeze-dried powder needle for recombinant anti-Cludin 18.2 and PD-L1 humanized dual-specific antibodies, is the first clinical declaration project of Kai healing biology, is also the only one accepted by the National Drug Administration Of Claudin18.2/PD-L1 dual-specific antibody drugs, in all aspects of pre-clinical data have excellent performance.
Lerociclib tablet is a potential "best-in-class" oral cell cycle protein-dependent kinase 4/6 (CDK4/6) inhibitor developed by G1 Therapeutics, which has exclusive development and commercial rights in the Asia Pacific region (excluding Japan).
Lerociclib is currently conducting two Phase I/II clinical studies worldwide to treat breast and non-small cell lung cancer.