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On March 18, The wholly-owned subsidiary of Li's large pharmaceutical company, Zhaoke Pharmaceuticals, obtained the approval of the State Drug Administration for listing according to the new 4-category declaration of qurals and needles, as if passed by consistency evaluation.
is a protocycline analogue developed by United Therapeutics that can directly stretch the lungs and systemic arterial blood vessels through intravenous and subcutaneous injections, and inhibit platelet aggregation, thereby treating pulmonary hypertension.
the drug was approved by the FDA in May 2002 for the treatment of pulmonary hypertension, a product called Remodulin.
July 2010, Li's Large Pharmaceuticals entered into an exclusive agreement with United Therapeutics to acquire Remodulin's exclusive distribution agency and pricing license in China.
Li's Large Pharmaceuticals is responsible for handling the required bridging tests and purchasing Remodulin from United Therapeutics at the agreed transfer pricing.
September 2011, the State Drug Administration CDE accepted Qu's application for listing.
April 2013, Qu-Ji-Neil was approved for import in China, the product is named Remodurin.
the second quarter of 2014, Remodurin officially listed in China for sale.
it is worth mentioning that RimoDurin in China's pricing is expensive, 20ml: 200mg maximum specification bid price of 99900 yuan / branch, is China's smallest packaging unit of the highest price of drugs, 20mg:20mg minimum specification of the winning price is also as high as 9825 yuan / branch.
source: Pharmaceutical Rubik's Cube PharmaGo winning database Domestic only Li's large pharmaceutical agent Qu-Front Neal injection original research products listed for sale, there is no generic drug production, so qurandal Neal injection seisizer is also included in the country's first list of encouraging generic drugs.
therefore, The generic application for the generic listing of the drug was submitted by MegaPharma in December 2018 and was given priority review by CDE in June 2019 on the grounds of "rare disease drug use" and approved in March 2020.
because The Company has only submitted a number of acceptances, it is not clear what the specifications of the approved generic drug are.
interesting, according to the FDA's official website, the four specifications of the drug approval number signed by Neal injection sinfyr were expired in 2019-05-02, and no new re-registration application was submitted by the enterprise.
considering that domestic generics have been approved, it is not excluded that Li's large pharmaceutical company and United Therapeutics have reached an agreement in advance on the development of registration strategy.
Source: National Drug Administration Source: PharmaGo Listed Drug Bank, Pharmaceutical Rubik's Cube, has also developed Tyvaso, a regeneron inhalant type product, and Orenitram, a slow-release tablet product, due to Remodulin's infusion site pain and injection response.
remodulin and Orenitram had sales of $587 million and $225 million, respectively, in 2019.
Source: Pharmaceutical Rubik's Next Pharma And United Therapeutics also jointly filed a clinical application for a precipitator-diethanolamine release tablet in 2012 and is currently in the clinical stage and has not yet submitted a listing application.
for the already listed domestic imitation version of the front of the Front-of-China Neil injection after the approval, hope that the price can also have greater concessions.
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