Strong Domestic Competition Heats Up for Johnson & Johnson's $3B Blockbuster Cancer Drug Apalutamide
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On August 27, the CDE official website showed,Hainan Zhuotai PharmaceuticalAndShanghai Chuangnuo PharmaceuticalClass 4 chemical drugs for joint declarationApalutamide TabletsThe listing application has been accepted. In 2024, the drug's global sales reached nearly $3 billion, and it also broke the 700 million mark in China's hospital market. Currently, the fourth spot for domestically produced drugs is under intense competition.
Screenshot source: CDE official website
Apalutamide（apalutamide）Is a new generation of orally available androgen receptor（AR）Inhibitor, mainly used for the treatment of non-metastatic castration-resistant prostate cancer（nmCRPC）, is the world's first treatment drug specifically targeting this condition.
Screenshot source: Mesentech Global Drug R&D Database
The drug was initially developed by the University of California and licensed in 2009.AragonExclusive development; 2013AragonByJohnson & Johnson（Johnson）Acquisition, Johnson & Johnson SubsidiaryJanssen PharmaceuticalResponsibleApalutamideThe development, market launch, production, and sales were first approved by the FDA for the U.S. market in 2018.
According to the Mosentropy pharmaceutical database, in 2023ApalutamideGlobal sales exceed $2.3 billion, a year-on-year increase of 26.58%. In 2024, the market territory will further expand, with sales climbing to $2.999 billion, achieving a year-on-year growth of 25.96%.
Screenshot source: Mesentech Global Drug R&D Database
ApalutamideApproved for marketing in China in 2019, under the trade name "Ansenke"；New indications approved in 2020; successfully included in the Class B National Medical Insurance Catalog in 2021. With the support of medical insurance, its sales in China have experienced explosive growth, with nationwide in-hospital sales exceeding 730 million yuan in 2024, a year-on-year increase of 11.62%, and the market is expanding rapidly."
Screenshot source: Mosan Medicine National Hospital Sales (All-Terminal) Database
Prostate cancer, as a common malignant tumor in the male urinary and reproductive system, has seen a continuously rising global incidence rate. According to the World Health Organization（WHO）Data: In 2020, the number of new cases of prostate cancer in men worldwide reached 1.4143 million, accounting for 14.1% of all malignant tumors. In 2021, the number of prostate cancer patients in China was 627,600.
Screenshot source: Mosan Medicine Epidemiology Database
Currently, non-chemotherapy drugs for the treatment of CRPC in China mainly consist of anti-androgens.（AR）drugs as the core, and in the sales ranking of AR inhibitors in China's hospital and retail markets over the past three years,ApalutamideBoth rank first, demonstrating considerable market potential.
Screenshot source: Mosentropy Medicine National Hospital Sales (All-Terminal) Database
Screenshot source: Mosentropy Medicine Entity Pharmacy Sales Database
In the field of domestically produced generic drugs,Qilu PharmaceuticalIn December 2024, it was successfully obtained.Apalutamide TabletsThe first domestic generic + the first to pass the evaluation in China, from 2025 to present,Kelun PharmaceuticalAndYuandong BioHave also been successively approved.
Screenshot source: Mosentropy Medicine Consistency Evaluation Database
At this stage, there are 18 pharmaceutical companiesApalutamide TabletsThe marketing application is under review and approval, includingZhengda Tianqing、Chengdu Better Pharmaceutical Co., Ltd.、Huadong Medicine、Zhejiang Nuode Pharmaceutical、Jiangxi Kerui Pharmaceutical, etc. The competition for the fourth domestically produced product has entered a white-hot stage.
Screenshot source: Mosentropy China Drug Evaluation Database
ApalutamideThe rhythm of patent expiration is clear, core compound patents（ZL200780019654.7）Expires in 2027, Composition Patent（ZL201580066233.4）Expires in December 2035, and the original research is facing increasing pressure from the approaching patent cliff.
Source of screenshot: Mosentropy Global Marketed Drug Patent Database
Since 2025, a surge of generic drug applications from Chinese pharmaceutical companies has aimed to disrupt the market landscape. Original research enterprises have faced attacks from multiple parties, intensifying market competition. Currently, 19 companies have completed the API (Active Pharmaceutical Ingredient) registration for Apalutamide, with 7 already transitioning to "A" status.
Screenshot source: Mosentropy Pharmaceutical API Database
ApalutamideAs an important drug in the field of prostate cancer, with proven efficacy and medical insurance coverage, it has broad market prospects. As patent barriers gradually loosen and generic drug competition enters deeper waters, its market may undergo a reshaping of the landscape, bringing more treatment options and medication benefits to prostate cancer patients in China.
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