injections has begun, it has only been seen so far that CDE has issued a draft for comment on December 22, 2017, and official documents have not been issued.However, this does not prevent a group of powerful and far-sighted enterprises in China from promptly submitting applications for consistency assessment of injection varieties.
Up to now, there have been 122 acceptance numbers for the consistency evaluation of injections undertaken by CDE, but only one variety of azithromycin for injection of Puli Pharmaceutical has passed the consistency evaluation.From the point of view of the "Catalogue of Listed Drugs in China", although there are several other types of injections listed, they all belong to "approved generic drugs according to the new registration category of chemical drugs" or "innovative drugs".
Obviously, for the consistency evaluation of injections, the review and approval criteria for the stock of old varieties are not yet clear, but if according to the new category 4 registration application, it is a clear way to obtain the qualification to use the "pass the conformity assessment" logo.
The following is a large variety of injections - Shugan Sodium Glucose Injection.
Shugengu Sodium Structural Formula
Shugengu Sodium is a γ-cyclodextrin that can form complexes with rocuronium or vecuronium, thereby reversing the neuromuscular blocking effects of rocuronium and vecuronium, and is the world's first selective relaxant antagonist for reversing neuromuscular blockers.In clinical surgical anesthesia, Shugan Sodium Injection can help patients with general anesthesia to accurately and quickly reverse the deep and moderate muscle relaxation (hereinafter referred to as muscle relaxation) status, promote the patient's ability to resume spontaneous breathing and limb mobility, and help improve the patient's Postoperative outcome.
Shugan Sodium Glucose was developed by Merck and listed in the European Union in September 2008, listed in the United States in December 2015, and listed in China in April 2017.2017 global sales 7.$04 billion, sales in the first three quarters of 2018 6.$6.1 billion, close to becoming a blockbuster variety.
Such a large variety naturally attracts the favor of domestic companies.On November 28th, only one and a half years after the original research was listed on the domestic market, Kelun Pharmaceutical announced that it was the first to submit a generic listing application for Shugan Sodium Glucose Injection and was accepted by the State Drug Administration.In addition to Kelun, there are only Hengrui and Hebei Zhiheng Pharmaceuticals, and the competitive landscape is relatively good.
Interestingly, on the evening of December 3, Buchang Pharmaceutical Co., Ltd., the main Chinese medicine variety, issued a technology development cooperation announcement. Its subsidiaries Tonghua Guhong and Jilin Buchang signed commissioned technology development contracts with two domestic CRO companies.The contract frame structure of the two cooperatives is very similar, involving two of the most important varieties of concern — voriconazole for injection (200 mg) and Shugan Sodium Glucose Injection (2 ml: 200 mg).
In the project of Shugan Sodium Glucose Injection (2ml: 200mg), Jilin Step will pay 15 million yuan to this CRO company, and the ultimate goal is to obtain the drug approval number.The services included in the cost are: 1 all pharmaceutical research costs; 2 package compatibility research costs; 3 the original research drug/reference preparation purchase costs required for the study; 4 local irritant allergic hemolytic test costs.
Moreover, for such a expenditure of 15 million yuan, the Jilin step is an "imperative" attitude, because the contract made the following agreement: The total amount of the contract is the contract price, and Party B must ensure that the project is consistent with the quality and efficacy of the original research drug...Until the approval number is obtained; in case of inconsistency, Party B is responsible for continuing the study until it is consistent.
Injectable generic drugs generally do not involve BE clinical trials when conducting conformity assessments, and the costs are mainly focused on pharmaceutical CMC research.For the above terms of the contract, it can only be explained that the psychological bottom line of Jilin Buchang is to spend 15 million yuan to get a new type 4 injection approval such as Shugan Sodium Glucose Injection.There's no way to put more...
After all, Kelun Pharmaceutical's R & D investment in the Shugan Sodium Glucose Injection project was only 7.36 million yuan...