Qilu Pharmaceutical Secures Third Domestic Denosumab Biosimilar, First-to-File on Complex Long-Acting Injectables, and $2B Antipsychotic
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On October 13, the NMPA released a new batch of drug approval certificates delivery information, with a large number of new drugs and generic drugs approved. Among them,Qilu PharmaceuticalHarvesting richly, not only capturing the 3rd domestically producedDenosumab InjectionBiosimilars, andLurasidone Hydrochloride TabletsAndPaliperidone Palmitate InjectionTwo generic drugs have been approved, the latter being the first domestically produced generic in China.So far this year, Qilu Pharmaceutical has had 27 drugs pass the consistency evaluation.Evaluation.
Screenshot source: NMPA official website
Denosumab Injection: The 3rd Biosimilar Produced in China
According to the introduction in the Qilu Pharmaceutical press release, denosumabUnique Pharmacokinetic and Pharmacodynamic PropertiesSupports a dosing regimen of once every six months, which can rapidly suppress bone turnover markers after administration, continuously reduce bone resorption, and is convenient to use with sustained effectiveness;The precise pharmacological mechanism enables denosumab to act on 100% of the bone without issues of bone matrix deposition., can be used for a long term.Studies have shown that denosumabCan be used continuously for more than ten years., and has good safety.
According to Amgen's 2022 annual report data,Denosumab's total sales reached $5.64 billion last year., including Prolia® for the treatment of osteoporosis(Prolia®, 60mg)Reaching 3.63 billion USD, a year-on-year increase of 12%. Another high-dose product, Xgeva®, is used for treating bone metastases from solid tumors and giant cell tumors of bone.(Xgeva®, 120mg)Sales exceeded $2 billion.
In China, AMG® and PROLIA® were approved for marketing in May 2019 and June 2020, respectively.Shandong Boan Biotechnology, Jiangsu Taikang BiotechnologyThe biosimilars have been successively approved. Currently, the Denosumab Injection has been successfully included in the 2022 National Medical Insurance Catalogue for severe osteoporosis in postmenopausal women and giant cell tumor of bone that cannot be surgically removed or where surgical removal may lead to serious functional impairment. According to the PharmaCloud database, the hospital sales revenue of Denosumab Injection reached 450 million yuan in 2022, increasing by 193% year-on-year, and its market is rapidly expanding.
Screenshot source: Pharma Intelligence China Hospital Sales Database
Notably, Qilu Pharmaceutical's denosumab injection has another marketing application with an acceptance number.CXSS2101023Still under review and approval. Based on the disclosed completion of Phase III clinical trials, its indications may possibly beBone Metastasis of Solid Tumors。
Lurasidone Hydrochloride Tablets: Anti-Psychotic Drug with Sales Exceeding 100 Million
The original research of Lurasidone isSumitomo PharmaThe brand name Loxada® is an atypical drug developed by Sumitomo Pharma.(Second Generation)Antipsychotic drugs, with global sales of this product exceeding 2 billion US dollars in 2021, are considered "blockbuster drugs."
In China, lurasidone tablets obtained marketing authorization from the National Medical Products Administration (NMPA) in January 2019 and officially launched in September of the same year. In March 2021, they were formally included in the National Reimbursement Drug List (NRDL). Data from PharmaYun shows that lurasidone's hospital sales revenue exceeded 100 million yuan in 2022, representing a year-on-year increase of 114%, with significant growth momentum.
Screenshot source:PharmCube National Hospital Sales Database
Currently, only lurasidone tablets have been approved for marketing in China. Apart from the original research company, seven enterprises ——Zhejiang Haiso(First)、Jiangsu Hengrui, Zhengda Tianqing, Yangtze River Pharmaceutical, Shijiazhuang No.4 Pharmaceutical, Zhejiang HuahaiAndDr. Reddy'sThe generic drug Lurasidone Hydrochloride Tablets has been approved and is deemed to have passed the evaluation. This time, Qilu Pharmaceutical Co., Ltd. is the 8th pharmaceutical company to pass the evaluation for this drug.
Among them,Zhejiang Hisun PharmaceuticalSecured the first generic. In the 7th batch of centralized procurement, Zhejiang Hisun Pharmaceutical, Yangtze River Pharmaceutical, Hansoh, and Zhengda Tianqing Pharmaceutical all won bids for Lurasidone Hydrochloride Tablets. This round of procurement has been gradually implemented since November 2022.
In addition, several pharmaceutical companies, including Jiangxi Simcere Pharmaceutical, Livzon Group, Changzhou Pharmaceutical Factory, Chongqing Yaoyou Pharmaceutical, and Cisen Pharmaceutical, have successively submitted marketing applications for Lurasidone Hydrochloride Tablets, all of which are currently under review and approval.
Paliperidone Palmitate Injection: China's First Monthly Dosing Long-Acting Microcrystal Formulation
This time, Qilu Pharmaceutical's Paliperidone Palmitate Injection has been approved for marketing, which is considered to have passed the consistency evaluation, becoming the product's...The First Generic Drug Manufacturer in China。It is reported that this is alsoChina's First Approved Monthly Long-Acting Microcrystal Formulation Produced in China。
Palmitate paliperidone is a prodrug of paliperidone, which forms a drug reservoir at the injection site after intramuscular injection for slow release of the drug. Palmitate paliperidone injection, as a new type of atypical antipsychotic long-acting microcrystalline drug, uses nanogrinding technology to precisely control the particle size distribution of the drug, overcoming the time lag barrier of drug release. It does not require oral medication supplementation and can be used for both acute and maintenance treatment of schizophrenia. Compared with traditional antipsychotic drugs, this productOnly requires administration once a month.。
So far this year, Qilu Pharmaceutical has had 27 drugs pass the consistency evaluation, among whichOlaparib Tablets, Injectable Octreotide Acetate Microspheres, Pazopanib Tablets, Dolutegravir Sodium Tablets, Probucol TabletsAndSodium Ertapenem for InjectionAll 6 products are the first to pass the evaluation. Overall, as of now, Qilu Pharmaceutical has a total of 140 products that have passed the consistency evaluation, of which 54 are the first in China.
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