Qilu Pharmaceutical's Generic Ruxolitinib Phosphate Tablet Application Accepted by CDE; Originator Drug Generates $4.7B Annual Global Sales

(Source: MosaMedix Big Data)

On August 15, the CDE official website showed,Qilu Pharmaceutical Co., Ltd.The marketing application for Ruxolitinib Phosphate Tablets, filed under Category 4 of the chemical drug registration, has been accepted.Moxie Medical DatabaseShows that the drug's global sales exceeded $4.7 billion in 2024,Qilu PharmaceuticalWill participate in the competition to become the second Chinese-produced generic.

Ruxolitinib is a First-in-class JAK1/JAK2 inhibitor, developed byIncyteDeveloped and byNovartisCommercialized in collaboration for the treatment of intermediate- or high-risk myelofibrosis, graft-versus-host disease, and other conditions, it was first approved for marketing in the United States in November 2011.

Since its launch, Ruxolitinib has demonstrated impressive market performance with sales increasing year by year. Data from Mosentropy Medical shows that the global sales of Ruxolitinib reached nearly $4 billion in 2022, leading the JAK inhibitor sector. In 2023, it climbed to $4.314 billion, and in 2024, it reached $4.728 billion, showing steady growth momentum.

NovartisThe phosphate ruxolitinib tablets were approved for marketing in China through the priority review process in March 2017. After being included in the national medical insurance in 2019, its sales increased rapidly. In 2020, the sales revenue of this product successfully exceeded 200 million yuan in China's hospital market, growing to 553 million yuan in 2023; in 2024, it increased by 16.11% year-on-year to reach 642 million yuan, with the market performance continuing to improve.

To better protect market rights and interests,NovartisAndIncyteA patent barrier has been constructed for Ruxolitinib. Among them,Incyte CorporationThe patent US8722693B2 for the phosphate form of Ruxolitinib has been granted in multiple countries/regions, including China (Chinese counterpart patents CN101932582B, CN103524509B), with the expected expiration date in China being June 12, 2028.

Although the patent barrier remains unbroken, in the race for generic drug applications,ChengduYuandong BioOvertaking on the curve, Qilu Pharmaceutical Co., Ltd. was the first to secure the domestic first generic + first approval of Ruxolitinib Phosphate Tablets in China on November 21, 2024.

ExceptQilu PharmaceuticalIn addition, there is anotherZhengda Tianqing, Shandong New Era,Kelun Pharmaceutical, Chengdu Bright Pharmaceutical, Zhejiang Huahai Pharmaceutical, Hangzhou Zhongmei Huadong PharmaceuticalA total of 19 companies, including Qilu Pharmaceutical Co., Ltd., have submitted Class 4 generic drug applications, all of which are currently under review and approval. The intense competition for the second domestically produced product has begun.

In addition,NovartisA Phase IV clinical trial of Ruxolitinib Phosphate Tablets for Polycythemia Vera (PV) and Graft-Versus-Host Disease (GVHD) is currently being conducted in China.BeijingFuyuan PharmaceuticalThe bioequivalence (BE) test is currently underway.

It is worth noting that this is alreadyQilu PharmaceuticalThe second submission of the generic product's marketing application. The application submitted on April 22 was not approved, and the specific reasons have not been disclosed yet. Hopefully, this application will be successfully approved.

In terms of active pharmaceutical ingredients (APIs), 14 companies have completed the API registration for Ruxolitinib Phosphate, with 4 of them already upgraded to "A" status.Sichuan Qingmu PharmaceuticalIs the first generic drug approval companyChengdu Yuandong Biopharmaceutical's wholly-owned subsidiary.

Ruxolitinib Phosphate, as a benchmark product in the field of JAK inhibitors, has shown great potential in both the anti-tumor and dermatological treatment fields. With its market value continuously rising and clinical applications deepening, its importance will become increasingly prominent. It remains to be seen which company will become the second Chinese manufacturer to produce this drug.