Drug Curry Jun inhaling preparations is expected to break the monopoly of foreign enterprises! Section 7 PD-1 single anti-declaration listing; Collum first imitation is about to be approved, health dollar, and then Ding ...
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Last Update: 2020-07-30
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Source: Internet
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Author: User
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Read: The Latest! New Developments for the Week of Drug Review !---- . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2. Health meta-inhalation large variety Budinide was approved, respiratory pipeline quickly into maturity.. 3. Collum Pharmaceuticals' hydrochloric acid desation of the first model is about to be approved.4. Reding Pharmaceuticals introduces new drugs to report production.. Section 7 PD-1 is accepted for listing.the current issue (July 17-24) international and domestic drug approvals in an orderly manner.Internationally, the FDA approved the listing of innovative narcolepsy therapy, and AXA Pharmaceuticals Bcl-2 inhibitor APG-2575 and regenerative element IL-1 inhibitor rilonacept were also recognized by the FDA as orphan drugs.domestic attention is: Baiji Shenzhou PARP1/2 inhibitors, Astellas leukemia new drugs to be included in the priority review;in terms of approval, the current domestic attention in inhalation agents and paragraph 7 PD-1 declaration of listing, more dynamics are as follows: domestic review approval, new dynamics this week CDE has 59 acceptance numbers (40 varieties) reported production status updates, Among the high-profile is the approval of the health meta-inhalation agent and the imminent birth of The First Imitation of Colum, more dynamics as follows: Health Meta-Respiratory Major Variety approved health meta-inhalation with budenid mixed suspension approved for the treatment of bronchial asthma, and can replace or reduce oral steroids.this variety is the largest variety of inhalers, with sales of US$1.466 billion in 2019 and about RMB8 billion in domestic sales.at present, only astrazenectonos and Zhengda Tianqing were approved for listing.for many years, domestic respiratory drugs mainly imported, inhalation agents have a larger import replacement space.from the current domestic enterprise research and development layout, health elements in the leading position in inhalation preparations.health yuan 6 years of continuous layout in the field of respiratory medicine, is the domestic potential respiratory inhalation preparations leading enterprises.up to now, in the research products more than 20, has been listed 3 items (Budinide mixed suspension, hydrochloric acid l-salbutamol inhalation solution and compound isopropyl bromine inhalation solution), declared production of 4 items, clinical 3, approved clinical 1.9 of them in 2017 by the national "major new drug creation" science and technology major special high-end preparations support.2019 annual report shows: As of the end of 2019, the compound isopropyl bromine suction solution has been completed in 21 provinces and cities tender hanging network, L-salbutamol inhalation solution has completed 14 provinces of the tender hanging network, the company gradually entered the harvest period. Collon Pharmaceuticals- Hydrochloric Acid-Deacon will be developed by Bayer for the first imitation of deprecated dina, and is a selective inhibitor of da'afi and Sida, which, like Da'afi and Sida, is a selective inhibitor of dilatedsterase 5 (PDE-5) to address erectile dysfunction (ED) in men. was first approved in the European Union in March 2003 and imported into China in June 2004. at home, the ED market is best known for: Pfizer's Siddinaf (Wan Aike), Bayer's Valdinaf (Alida) and Lilly's Tadalafi (Healy), in recent years, with the approval of domestic generic drugs, the market share of the original research drug is gradually eroded, it is understood that in 2017 Baiyunshan Jingo has a tie with Pfizer. according to the drug intelligence data query, the current domestic layout of the land of land non-enterprises relatively few, and Qilu Pharmaceutical and Long San Pharmaceutical development of Thedina, is still in the clinical stage. domestic review approval and new acceptance this week CDE new report production acceptance number 22, a total of 17 varieties, of which re-Ding Pharmaceutical introduction of new drugs and 7 PD-1 attention, more dynamic see the table below: re-introduction of the variety of Ruptinib declared for listing received re-ding medicine submitted to Ripretinib new drug listing application, for the treatment of 3 kinds of gastrointestinal inhibitortreatment, including Imatini, patients with advanced gastroenteras. Ruptinib, an oral broad-spectrum KIT and PDGFR alpha inhibitor developed by Deciphera, is available in the U.S. on May 15, 2020 and is the only FDA-approved GIST four-line treatment drug recommended by NCCN guidelines. recently, the drug has been listed in Canada and Australia, with a product called Qinlock. June 2019, Reding Pharma obtained an exclusive license to develop and promote Ripretinib in Greater China (Chinese mainland, Hong Kong, Macau and Taiwan), and promoted Ripretinib's clinical development and registration in Greater China. currently, Deciphera plans to include the China Clinical Center in the ongoing Global Phase III INTRIGUE study to compare the efficacy of Ripretinib with Shoneib as a second-line treatment in patients with gastrointestinal mesomas. Section 7 PD-1! Jiahe Biogeno monovirus CDE has been accepted for the application of a new drug for the use of geptanolimab, a bioptic PD-1 antibody, for the treatment of peripheral T-cell lymphoma (PTCL). it is known that Jano singular resistance can selectively block dual ligands (PD-L1 and PD-L2), jiahe Bio has core intellectual property rights. , like other PD-1, Jiahe Bio is actively engaged in a number of clinical trials of Genomonoinata in China, involving cervical cancer, non-small cell lung cancer (NSCLC), rectal cancer and other indications. so far, the domestic market has a total of 8 PD-1/L1 single resistance listed, 3 PD-1 applications for listing have also been accepted, the details are as follows: data sources: pharmaceutical data, enterprise announcements and other network public data sources: pharmaceutical intelligence network, corporate announcements and other network public information.
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