$2.6 Billion PARP Inhibitor Battle Heats Up: Qilu’s First-to-File Generic Faces Competition as Kelun Becomes Second Domestic Manufacturer
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Recently, according to the announcement on the NMPA official website,Hunan Kelun PharmaceuticalSubmitted Category 4 Generic Chemical DrugOlaparib TabletsApproved for marketing and deemed to have passed the evaluation. According to statistics from PharmaCloud, in May 2023Qilu PharmaceuticalSecuring the first generic version of this variety, this time,Kelun PharmaceuticalThe second domestically produced.
Screenshot source: NMPA official website
Olaparib Tablets（Olaparib）Developed by AstraZeneca, a global leading pharmaceutical company, it is an oral poly ADP-ribose polymerase（PARP）Inhibitor. It is specifically used to treat serious diseases such as epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. This innovative drug was first approved in the United States in 2017, followed by import approval from the Chinese government in 2018. More importantly, in 2019, Olaparib tablets were officially included in the National Medical Insurance Drug List.
The World's First PARP Inhibitor, Racking Up $2.6 Billion in Sales in 2022
OlaparibIs the world's first approved oral poly ADP-ribose polymerase（PARP）Inhibitors, by inhibiting PARP enzyme activity and preventing PARP from dissociating with DNA, synergize with DNA damage repair dysfunction to kill tumor cells. Original research byAstraZenecaAndMerck MSDCo-developed, with the trade name Lynparza.
December 19, 2014OlaparibApproved by the FDA for the treatment of ovarian cancer.As of now,OlaparibHas successively obtained indications for ovarian cancer, breast cancer, castration-resistant prostate cancer, pancreatic cancer, fallopian tube cancer, and peritoneal cancer.Since its listing,OlaparibSales increase year by year.AstraZeneca's 2022 financial report shows,OlaparibTotal sales for the year have reached 2.638 billion US dollars.
Screenshot source:PharmCube Global Drug Development Database
In China,OlaparibIt was first approved for marketing by the NMPA in August 2018 for the treatment of ovarian malignancies, and subsequently received approvals for other indications such as peritoneal or retroperitoneal tumors, malignant fallopian tube tumors, and prostate cancer.2019OlaparibThrough negotiation, the price was reduced by 61.8% to enter the Class B medical insurance directory. After several new indications were approved and further medical insurance negotiations, the current scope of medical insurance use has been expanded to 3 items:
Carrying germline or somatic BRCA mutations(gBRCAm or sBRCAm)Maintenance treatment for adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response after first-line platinum-based chemotherapy; Maintenance treatment for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response to platinum-based chemotherapy; Carrying germline or somatic BRCA mutations(gBRCAm or sBRCAm)And previous treatment(including a novel endocrine drug)Adult patients with metastatic castration-resistant prostate cancer who have failed treatment.
Screenshot source: PharmaCloud China Hospital Sales Database
According to the PharmaCloud database,Olaparib Tablets202In-hospital sales broke through the 1 billion yuan mark in 2 years, increasing by 18.5% year-on-year, with a clear market growth trend.
Eight pharmaceutical companies are in the layout, and Hunan Kelun Pharmaceutical Co., Ltd. has become the second Chinese-produced manufacturer.
According to the data statistics from PharmaCloud, currentlyOlaparib TabletsEight companies including Jiangsu Litai'er Pharmaceutical, Nanjing Fangshenghe Pharmaceutical, CSPC Ouyi Pharmaceutical, Jiangxi Shanxiang Pharmaceutical, and Sino-American Huadong PharmaceuticalFiled a generic drug marketing application, among which Qilu Pharmaceutical was the first to gain approval and secure the first generic. This time, Hunan Kelun Pharmaceutical Co., Ltd. is the second company to obtain this variety.
Source of screenshot:PharmCube China Drug Evaluation Database
In addition to the varieties approved this time,At present, Kelun Pharmaceutical Co., Ltd.There isPalbociclib Capsules, Lactulose Oral Solution, Ipratropium Bromide Nebulizer Solution, Levofloxacin Sodium Chloride Injectionetc. 32 typesThe variety has been approved and passed the evaluation.
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