Qilu Pharmaceutical Achieves Major Milestone with First-to-File Approval of $2.3B Apalutamide and Dapoxetine Tablets
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On December 3, according to the NMPA official website, Qilu Pharmaceutical(Including Subsidiaries)SubmittedDapoxetine Hydrochloride TabletsAndApalutamide TabletsTwo Class 4 generic drugs have been approved for production and are considered to have passed the evaluation, includingApalutamide TabletsApart from the original research, no pharmaceutical companies in China have been approved yet. This time, Qilu Pharmaceutical has been successfully approved, becoming the first generic drug manufacturer of this variety in China.
Screenshot source:NMPA OfficialNet
Over $2.3 Billion Heavyweight Prostate Drug: Three Major Star Pharmaceutical Companies in Fierce Competition
Apalutamide（apalutamide）It was developed by the University of California and exclusively licensed to Aragon Pharmaceuticals in 2009. In 2013, Aragon was acquired by Johnson & Johnson, and Janssen, a subsidiary of Johnson & Johnson, took over the drug's development, market launch, and production. The product is primarily used to treat non-metastatic castration-resistant prostate cancer and is the world’s first approved drug for this indication. According to the Moselle Pharma database, in 2023,Apalutamide TabletsGlobal sales exceeded $2.3 billion, a year-on-year increase of 26.9%, making it a "blockbuster prostate drug."
ApalutamideAfter being included in the medical insurance system, it quickly entered a period of rapid sales growth, showing a strong growth trend in domestic market sales. According to the Moselle Pharma database, in 2023Apalutamide TabletsSales in the Chinese hospital market exceeded 400 million yuan, with a year-on-year increase of 91.8%.
Screenshot source:Moxie Pharma (formerly Yaoke Rongyun)National Hospital Sales Database
PreviouslyApalutamide TabletsApart from the original research, no pharmaceutical company in China has been approved yet. This time, Qilu Pharmaceutical Co., Ltd. has been successfully approved, becoming the first to launch a domestically produced generic and pass the evaluation in China. In the field of generic drugs,Apalutamide TabletsThe competition is particularly fierce, with three major star pharmaceutical companies—Nanjing Zhengda Tianqing Pharmaceutical, Sichuan Kelun Pharmaceutical, and Chengdu Yuandong Biopharmaceutical—having submitted applications for the registration of generic drugs under Category 4.
Screenshot source:Moxie Pharma (formerly Yaorong Cloud)China Drug Evaluation Database
A Major Product in Men's Health Soars 47.65%, Qilu Expands its Strong Portfolio in the Billion-Dollar Market
DapoxetineIt is an efficient selective serotonin reuptake inhibitor, mainly used in clinical practice for the treatment of premature ejaculation (PE) in males aged 18 to 64. With its significant clinical benefits, low safety risks, and rapid onset of action, dapoxetine has become the first-line treatment drug recommended in the Guidelines for Diagnosis and Treatment of Premature Ejaculation both in China and internationally. According to the MoreHealth pharmaceutical database,Dapoxetine Hydrochloride TabletsIn 2023, the sales revenue in the Chinese hospital market exceeded 30 million, with a year-on-year increase of 47.65%. In the field of genitourinary system and sex hormone drugs(Chemical drugs or biologics)In the field, the sales revenue of the Chinese hospital market in 2023 exceeded 18.4 billion yuan. In the billion-dollar market, Qilu Pharmaceutical has added a new powerful product.
Screenshot source:Moxie Pharma (formerly Yaoke Rongyun)National Hospital Sales Database
As of now,Dapoxetine Hydrochloride TabletsThirty pharmaceutical companies, including Qilu Pharmaceutical, Guangzhou Baiyunshan Pharmaceutical, and Sichuan Kelun Pharmaceutical, have been approved and passed the evaluation. Among them, Shandong Huabai Kaisheng Biotechnology was the first company to pass the evaluation for this product and has also been included in the third batch of centralized procurement.
Screenshot source:Moxie Pharma (formerly Yaorong Cloud)Summary Database of Evaluated Drugs
From 2024 to present, Qilu Pharmaceutical(Including Subsidiaries)There isPomalidomide Capsules, Dasatinib Tablets, Riociguat Tablets, Crisaborole OintmentThirty-two varieties, including nine that were the first to pass the evaluation, have been approved and passed the quality consistency evaluation.Riociguat Tablets, Metformin Empagliflozin Tablets (Ⅵ), Emtricitabine Rilpivirine Tenofovir Alafenamide Tablets, Sodium Patisiran Soft Capsules, Bendamustine Hydrochloride Concentrated Solution for Injection, Eltrombopag Ethanolamine Tablets, Apalutamide TabletsSeven first-to-market varieties.
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