"Pharmaceutical Curry Jun" a number of biological drugs attack, Xinda Adamo single resistance, Hengrui Karelli pearl single resistance, health yuan and then get heavy-weight inhalers, a number of innovative drugs ...

Read: Latest! Drug review dynamics at home and abroad! This week to see point 1. International drug dynamics 2. Xinda biological Adamo single anti-approved listing, is the third domestic 3.health yuan heavy-weight inhalant isopropyl bromide inhalation solution 4 imitation approved for listing 4. Hengrui Pharmaceutical Karelli pearl single anti-declaration listing and to be included in the priority review of 5. Multi-import innovative drugs China approved for listing this period (August 28 to September 4) international and domestic products approved for listing.
Internationally, Shishi Shiguibao Onureg was approved by the FDA for use in patients with acute myeloid leukemia; Noor and Nord Sogroya were approved by the FDA for adult treatment of growth hormone deficiency; Mylan/Parkon long-acting insulin glycelin was approved for listing in the U.S. FDA; and Roche HIV-1/HIV-2 qualitative test reagents were approved for listing by the FDA.
AstraZeneca Imfinzi's combination of etoposide and carpentry or cisplatin for first-line treatment of adults with broad-stage small cell lung cancer has been approved for market in the European Union; GSK's world's first BCMA targeted therapy Brenrep has been approved for the European market; and Gilead's "Gisser III" Epclusa has been approved by the European Union for the treatment of chronic hepatitis C pediatric patients aged 6 years and weighing 17 kg.
In China, a number of generic heavy varieties were approved, among them the healthy isopropyl bromide inhalation solution, Qilu pharmaceutical Malay acid afatini tablets, diazine pharmaceutical industry access to tymoamine capsules of concern; Biological Adamo monoantigen injections, AstraZeneur's Tigrello dispersal tablets, Sanofi's insulin glycogen injections, Novo Pharmaceuticals' Adolfate beta injections, etc., more dynamics are as follows: Domestic review and approval of new dynamics this week CDE There are 36 acceptance numbers (30 varieties) reported for production status updates, more dynamics are as follows: Xinda bioAdamu single resistance approved for listing, is the third domestic September 2, Thyda biorecombinant human anti-tumor necrotic cause-alpha (T) NF-alpha) monoclonal antibody drug Surisin ® (Adamo monoantigen injection, English trademark: SULINNO®) has been approved for market for the treatment of rheumatoid arthritis, strong scoliosis and psoriasis.
Adamu single resistance has been China's national major new drug creation special support, this time approved as the third domestic Adamo single resistance.
Adamu single antigen research drug (commodity name: Shumeile) developed by AbbVie, according to the world's best-selling drug sales data show that in 2019 Adamo single anti-global sales of 137.4 billion yuan, of which the original research accounted for 132 billion yuan.
Adamu single anti-ocgen global sales map According to pharmaceutical data show that up to now, including Xinda biological Adamo single anti-injection, a total of 3 domestic Adamo single anti-biosypolytic drugs were approved for the market, the remaining two are Baio Tegli and Haizheng Pharmaceutical AnJianning.
According to the data of pharmaceutical intelligence, the current domestic Adamo single anti-biological similar drugs in addition to Baiotai, Haizheng Pharmaceuticals, Xinda Biological three enterprises were approved for listing, Fuhong Hanxuan, United Creatures, Zhengda Tianqing this variety is also on the way to the market, and Fuhong Hanyu varieties have been included in the priority review sequence, approved for listing also refers to the day to wait.
present, the treatment cost of Adamo monoantigen injection is still beyond the affordability of many ordinary Chinese patients, resulting in a low use rate of Adamo monoantigen in China.
2019 to negotiate access to national health care to address patient pain points.
this time, the approval of ® is expected to benefit more patients and families, improve their quality of life.
health yuan heavy-weight inhalant isopropyl tobly bromide inhalation solution class 4 imitation was approved for listing recently, health yuan subsidiary Shenzhen Mrs. Pharmaceuticals isopropyl tobly bromide inhalation solution class 4 imitation was approved for listing.
isopropyl bromide as an anticholinel energy drug, which is used in therapy for acute asthma attacks in the form of inhaled beta-subject agitants.
isopropyl tobly bromide solution was first developed by Gringer Ingham, which was approved for listing in the UK in August 1986 and entered the Chinese market in 2004.
2019, sales of isopropyl bromide inhalants in China's public medical institutions exceeded 1 billion yuan, and Grigg Ingham's market share was more than 97%.
data show that up to now, a total of 6 domestic manufacturers (including health yuan and 1 import registration) declared, health yuan for the first in the country according to the new registration classification application and approved 4 classes of generic drugs manufacturers.
health yuan for many years continued in the field of respiratory layout, is the domestic potential respiratory inhalation agent leading enterprises.
Up to now, more than 20 products in the study, has been listed 4 items (isopropropyl bromide inhalation solution, Budinide mixed suspension solution, hydrochloric acid L-Salbutamol inhalation solution and compound isopropropyl bromide inhalation solution), of which Budinaid is the terminal of China's public medical institutions TOP1 inhalant varieties, inhaled compound isopropyl bromide ammonium solution, hydrochloric acid left salbutamol atomized inhalation solution for domestic imitation.
At present, health Yuanhai Pharmaceuticals' sulfate tebutalin inhalation solution 4 imitation listing applications in the review and approval, the variety in China's public medical institutions terminal sales of more than 1 billion, the leading enterprise is AstraZenecon.
Qilu Pharmaceuticals Malay acid afatini tablets were approved for listing Qilu Pharmaceuticals 4 classes of generic drug Malay acid afatini tablets were approved for the market, becoming the second pharmaceutical company after Haussen Pharmaceuticals approved for listing.
Afatini belongs to the second generation of EGFR-TKI, developed by Grigg Ingham.
was approved by the FDA in July 2013 and entered China in February 2017 for first-/second-line treatment of non-small cell lung cancer positive for EGFR mutations.
September 2018, Afadini negotiated access to the National Health Insurance Category B.
8 EGFR-TKI have been approved for listing in China, of which Giffeitini has been included in the volume procurement in China, Qilu Pharmaceuticals successfully won the bid.
Hausen Pharmaceuticals' Afatini has been the first to be approved for listing in China in June 2020, pharmaceutical data show that there are currently four new categories of domestic manufacturers to submit Afatini listing applications in the approval process, including Shi Pharmaceutical Group, Yangzijiang, Zhengda Tianqing, Collum Pharmaceuticals, Shandong Kongfu Pharmaceuticals and Jiangxi Shanxiang Pharmaceuticals.
the pharmaceutical industry obtained the approval of the market of tymoamine capsules recently, the two-python pharmaceutical company 100mg capsule specifications according to the new 4 categories to obtain drug registration approval, as if through a consistent evaluation.
Testimonamide is a new type of oral second-generation alkylation agent- mitrogine derivative, clinically used to treat newly diagnosed polymorphic glioblastoma and the recurrence or progression of polymorphic glioblastoma or mesozoic astroblastoma after routine treatment, for the first line of treatment of glioma.
currently only three domestic tymoamine capsules, including the original research, have been approved for listing.
pharmaceutical industry this time 100mg of tymoamine capsule approved for market will be more convenient for patients with 20mg specifications to take.
domestic review and approval, new acceptance of this week's CDE new report production acceptance number 16, a total of 12 varieties, of which Karelli pearl single resistance and Fumaric acid Vonora biopsy is of great concern, more dynamics see the table below: Hengrui medicine Karelli pearl single anti-declaration Listed and intended to be included in the priority review days ago, Hengrui Pharmaceutical Karelli Zhu single anti-listing application was accepted by CDE, and included in the proposed priority review varieties public list, for the past after receiving second-line and above chemotherapy disease progress or insufferable treatment of patients with advanced nasopharyngeal cancer.
injection with karelli pearl monoanti is humanized anti-PD-1 monoclonal antibody, currently there are 6 PD-1 monoclonal antibodies approved for market, see the table below.
, global sales of anti-PD-1 antibodies in 2019 were approximately $18.809 billion.
Henrui Pharmaceuticals has independently developed Kareliju single anti-lymphoma, advanced hepatocellular carcinoma, advanced esophageal squamous cancer and non-squamous non-small cell lung cancer since its listing in May 2019.
A phase II key clinical study (CAPTAIN study) of advanced nasopharyngeal cancer that failed chemotherapy after second-line and above chemotherapy began in August 2018, with the results to be presented orally at the upcoming ESMO Conference.
In addition, randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies of the first-line treatment of local recurrence or distant metastatic nasopharyngeal cancer in Karelliju single-anti-combined cisplatin and Gissinabin have reached the end of effectiveness, and will provide more treatment options for patients with nasopharyngeal cancer in China in the future.
Shandong New Era Pharmaceutical Fumaric Acid Vonora Biopics market application was accepted Recently, Shandong New Era Pharmaceuticals Fumaric Acid Vonora Tablets Market Application was accepted.
Fumaric acid vonola biopsy by blocking the K-channel of the H-plus, K-ATP enzyme, competitive blocking K-plus binding with the enzyme, can stay in the stomach wall cells for a long time, thus quickly inhibiting the secretion of stomach acid, with a new mechanism of action, is the first approved to enter the Chinese market potassium ion competitive acid blocker (P-CAB).
Fumaric acid vonola tablets were launched in Japan in February 2015 and their adaptations include reflowal esophagealitis, stomach ulcers, duobial ulcers, prevention of recurrence of stomach ulcers or duobious ulcers and the eradication of Helicobacter pyrethroids during treatment with low-dose aspirin or nonsteroidal anti-inflammatory drugs.
2019 sales of Fumaric Vonora tablets were $668 million, up 24.9% year-on-year, according to the company's Takeda Pharmaceuticals results report.
December 2019, Takeda Pharmaceutical Fumaric Acid Vonola was approved for sale in China, and Walker is now officially put into production at Takeda's Tianjin plant.
, according to the investigation, Takeda Fuma acid Vonora tablets in China's compound patents will expire in 2026, Shandong New Era Pharmaceuticals is currently the only company in accordance with the generic drug category 4 declaration.
data sources: pharmaceutical data, enterprise announcements and other network public data sources: pharmaceutical intelligence network, enterprise announcements and other network public information.