"Drug Curry Jun" a number of heavy varieties were approved! Cenegermin eye drops, Hengrui inhalation with heptafluorane, Xinlitai hydrochloric acid Paroxetine intestinal soluble slow release tablets...

Guide: Up-to-date! Domestic and foreign drug review dynamics! This week' look at 1. International Drug Dynamics 2. The first neurotrophic cornealitis drug is about to be approved.
3. Henri inhalation with heptofluorocarbons was approved for market, the anaesthetic product line further expanded.
4. Anti-thrombosis drugs, anti-bacterial drug imitation competition intensified, the original research market is urgent! This issue (August 7 to August 14) has been approved for international and domestic products.
Internationally, the FDA approved Roche's gene Tektronit's Evrysdi (risdiplam) for the treatment of infants and adults over 2 months of age with spinal muscular dystrophy (SMA); The -130 injection was approved by the FDA; the Trevena injection opioid osterant Olinvyk was approved by the FDA; and Novartis omazoma monotherapy was approved by the European Union for extended adaptive disorders to aid in the treatment of chronic sinusitis associated with nasal.
in China, a number of imitation, imported products approved for listing, more dynamics as follows: domestic review and approval, new dynamics this week CDE has 52 acceptance numbers (33 varieties) reported to the production status update, of which Cnegermin eye drops, inhalation with seven Fluane, hydrochloric acid Paroxetine intestinal slow release tablets and other heavy varieties update the approval status, more dynamic as follows: the first neurotrophic cornealitis drug is about to be approved recently, Cenegermin eye drops market application into the administrative approval stage, is expected to be approved in the near future.
A recombinant protein of human neurogrowth factor developed for Domp? for Domp? for the treatment of neurotrophic keratitis (NK), which was recognized as an orphan drug by the European Union in December 2015, approved in the European Union in July 2017 and approved in the United States in August 2018, is the first neurotrophic keratitis treatment drug approved by the FDA.
in China, Cenegermin eye drops were included in the First ClinicalLy UrgentLy Needed Overseas Drug in August 2018, and in June 2019, Domp? Farmaceutici submitted an application for the drug to be marketed in China.
NK is a rare disability, degenerative ophthalmological disease, which causes corneal epitome cell damage and loss of corneal sensitivity, in more severe cases can cause corneal ulcers, cornea melting and perforation, seriously affecting the patient's visual ability, and even lead to blindness.
, the treatment of neurotrophic cornealitis is very complex, and no products have been approved for direct treatment of nerve damage.
Hengrui inhalation with heptofluorocarbons approved for market, anesthesia product line further expanded Hengrui Pharmaceuticals with a new class 4 generic drug declaration of inhalation of heptofluorocarbons approved for the market, the product is a halogen inhalation general anaesthetic, clinically suitable for adult and pediatric patients in-hospital surgery and outpatient surgery induction and maintenance of general anaesthetic.
data show that inhalation of heptanyl chlorane in 2019 domestic sample hospital sales of 633 million yuan, Hengrui City accounted for a relatively large.
2019 - Inhalation of Hepyfluorocarbon Sales Enterprise Analysis (TOP10) Because of the addictive and dependence of narcotic drugs in China is highly regulated, Hengrui has been involved in the narcotics industry since 2004 and has become one of the major manufacturers of targeted narcotic drugs in China.
anesthetics are now The second largest core business of Hengrui, including heptoplufluorane (inhalation anesthesia), right methostatin (sedative), ammonium acupressure (muscle pine), but also bhutofranolino (analgesics).
of these, heptofluorocarbons are the company's old narcotic drugs, which began selling domestically in 2004 and were approved for marketing in the United States by the FDA in 2015.
Hengrui Pharmaceutical Inhalation with heptanyl chlorane not only submitted a consistent evaluation supplementary application, but also reported production in a new classification, this approval, is conducive to the consolidation of market position.
hydrochloric acid Paroxetine intestinal lysolative slow release tablets are about to be approved, GSK antidepressant exclusive market is expected to end recently, Xinlitai hydrochloric acid Paroxetine intestinal soluble slow release tablets 4 types of imitation market application has entered the "in the approval" stage, the first imitation is about to be approved.
paroxetine is an SSRI drug used to treat depression, panic disorder, obsessive-compulsive attitudes and behaviors, post-traumatic emergency disorders and systemic anxiety disorders.
Hydrochloric acid Paroxetine intestinal soluble resoluble release tablets is one of the new slow release agents in the 2017 health insurance negotiation varieties, after entering the national health insurance, product sales quickly released, GlaxoSmithKline is the only domestic market sales of hydrochloric acid Paroxetine intestinal soluble slow release tablets manufacturers.
, according to the four categories of imitation declaration listed enterprises have Xinlitai and Shanghai Xuantai, the current Xinlitai progress is the fastest, Shanghai Xuantai is still in the review and approval.
once Xinlitai's products are approved for production, GSK antidepressant exclusive market is expected to end.
domestic review approval and new acceptance this week CDE new report production acceptance number 16, a total of 12 varieties, of which Devashaban tablets, hydrochloric acid Moxisa star drops eye drops have attracted much attention, more dynamics see the table below: A Devashaban tablets were accepted, anti-thrombosis drug competition is fierce, drug intelligence data show that Ruiyang Pharmaceuticals, China Pharmaceutical Group Zhijun (Shenzhen) Pingshan Pharmaceuticals Devashaban tablets to copy 4 categories submitted for listing applications to be accepted.
Devashaban tablets for an oral direct suppression of Xa factor anticoagulants, up to now, the domestic has been Zhengtianqing Pharmaceutical Group, Shi Pharmaceutical Group, Yangzijiang Pharmaceutical Group and Nanjing Zhengtianqing 4 pharmaceutical enterprises to imitate 4 categories approved, as through consistent evaluation.
addition, there are Qilu Pharmaceuticals, Guangdong Dongsan Pharmaceuticals, Zhejiang Huahai Pharmaceuticals and other 28 pharmaceutical companies to copy 4 categories to submit listing applications in the review and approval.
although there is only one Bayer production company on sale in China, fierce competition is coming.
Wuhan Noan Pharmaceuticals into the hydrochloric acid Moxisa star eye drops first imitation battle! August 12, Wuhan Noan Pharmaceuticals hydrochloric acid Moxisa star eye drops 4 imitation of the listing application was awarded.
the product will enter the Chinese market in 2018 and the national health insurance catalog in 2019.
At present, in addition to Wuhan Noan Pharmaceuticals, there are Qilu, Koren, Yangzijiang and other 10 pharmaceutical companies in the four types of imitation listing applications are in the review and approval, the first imitation of the dispute is extremely fierce.
data sources: pharmaceutical data, enterprise announcements and other network open data sources: drug intelligence network, enterprise announcements and other network open information.