Qilu Pharmaceutical Enters High-Growth Diuretic Market with Bumetanide Injection Filing
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
According to the CDE official website, todayQilu Pharmaceutical(Hainan)Submitted Category 3 Generic Chemical DrugBumetanide Injection（Application No.: CYHS2303056）Marketing application accepted.This varietyThe market is highly promising, with a significant increase of 112% in 2022. To date, no companies in China have had their related products pass the evaluation, but nearly 10 companies have submitted applications for the marketing of generic drugs. Unfortunately, none have passed the consistency evaluation.QiluExpected to be the first to pass the evaluation.
BumetanideNi（Bumetanide）ByValidus PharmsDeveloped by the company, the trade name isBUMEX, a derivative of furosemide (Lasix), belongs to a new type of loop diuretic. It was approved for marketing by the FDA on February 28, 1983, and is recognized worldwide as one of the safest and most effective loop diuretics, mainly used for congestive heart failure, liver and kidney diseases.(Including Nephrotic Syndrome)Treatment for edema. This product has been marketed in approximately 20 countries worldwide, including the United States, France, Denmark, Japan, and China.Bumetanide InjectionIt was first approved for marketing in Japan in April 1976 under the trade name LUNETORON, with a specification of 1ml: 0.5mg. The original research bumetanide injection has not entered China.
Annual sales break through 100 million yuan, surge by 112%
According to the data statistics from Pharma Intelligence,Bumetanide InjectionIn 2021 salesBreakthrough of 100 Million Yuan, exceeding 100 million yuan, a year-on-year increase of 260%, in 2022BumetanideContinued growth, sales exceeded 200 million, a year-on-year increase of 112%, with huge market potential. Among this, injectable solutions are the main sales dosage form, accounting for over 70%. On the enterprise side,Guilin NanyaoOccupying the majority of the market share.
With the expansion of the market, more and moreGeneric EnterprisesStart laying out related products.According to the data statistics from PharmaCloud,Except this timeQilu PharmaceuticalEnterprise, andChengdu Yuandong Biopharmaceutical、Sichuan Meidakang Huakang Pharmaceutical Co., Ltd.、Zhongshan Wanhua Pharmaceutical, Chengdu HaitongPharmaceuticalsetc.9HomePharmaceutical companySubmittedBumetanide InjectionTheGenericMarketing Application, currently onlyGuilin NanyaoSubmittedBumetanide InjectionConsistency Evaluation Application.
Favorable competitive landscape
In addition,BumetanideThe approved dosage forms for marketing also include tablets and powder injections.Bumetanide InjectionOnly in ChinaWuhan Jiuan Pharmaceutical, Hubei Jinyao Pharmaceutical, etc.15 companiesEnterpriseObtain production approval.Bumetanide for Injection and Bumetanide TabletsThere are 11 and 7 companies respectively.The industry has obtained production approval.Currently,Bumetanide InjectionNone of the companies in China have passed the evaluation.
In view of the huge potential of the diuretic market in China andClothMetaniThe solid quality itself,QiluIf this generic drug can be successfully approved, it may be able to gain a share in the diuretic market and is also expected to become the first to pass the consistency evaluation.
2023 to PresentQiluHave been obtainedPazopanib Tablets, Olaparib Tablets, Injectable Octreotide Acetate Microspheres, Dolutegravir Sodium Tablets, Paliperidone Palmitate InjectionFive first-to-market generic drugs. In addition, apart from the recently submitted Bumetanide Injection, Qilu Pharmaceutical has 36 other varieties this year.(56 specifications)Submitted a generic drug marketing application, all are under review and approval.
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