Qilu Pharma's Ruxolitinib Phosphate Tablet NDA Accepted, Racing for Second Domestic Generic of $4.7B JAK Inhibitor
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On August 15, the CDE official website showed,Qilu Pharmaceutical Co., Ltd.Class 4 chemical drug registration applicationRuxolitinib Phosphate TabletsThe listing application has been accepted. According to the MaxEntropy Pharma database, the drug's global sales exceeded $47 billion in 2024.Qilu PharmaceuticalWill participate in the competition to become the second domestically produced generic.
Screenshot source: CDE official website
RuxolitinibIt 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.
Source of screenshot: Mosentropy Global Drug R&D Database
Since its listing,RuxolitinibThe market performance has been impressive, with sales increasing year by year. Data from Mosentropy Pharmaceuticals shows that the global sales of Ruxolitinib reached nearly 4 billion US dollars in 2022, leading the JAK inhibitor track. It increased to 4.314 billion US dollars in 2023 and reached 4.728 billion US dollars in 2024, showing a steady growth momentum.
Screenshot source: Mosentropy Global Drug R&D Database
NovartisCompany'sRuxolitinib Phosphate Tablets, which was 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 quickly climbed. In 2020, the sales revenue of this product successfully broke through the 200 million yuan mark in China's hospital market, increasing 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.
Screenshot source: Mosentropy Medicine National Hospital (All-Terminal) Sales Database
To better protect market rights and interests,NovartisAndIncyteForRuxolitinibBuilt patent barriers. Among them,IncyteApplied by the companyRuxolitinib PhosphateThe salt-type patent US8722693B2 has been granted authorization in China and other countries/regions.(Chinese counterpart patents CN101932582B, CN103524509B)The expected expiration date of the domestic patent is June 12, 2028.
Screenshot source: Mosentropy Global Drug Launch Patent Database
Although the patent barrier remains unbroken, in the race for generic drug applications,Chengdu Yuandong BiopharmaceuticalOvertaking on the Curve, Qilu Pharmaceutical Co., Ltd. Secures Victory First on November 21, 2024Ruxolitinib Phosphate TabletsFirst domestic generic + first to pass the evaluation in China.
Screenshot source: Mosentropy China Drug Evaluation Database
ExceptQilu PharmaceuticalIn addition, there is anotherZhengda Tianqing、Shandong New Era、Kelun Pharmaceutical、Chengdu Better 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 fierce competition for the second domestically produced product has begun.
Screenshot source: Mosan Medical China Drug Evaluation Database
In addition,NovartisCurrently underway in ChinaRuxolitinib Phosphate TabletsPolycythemia（PV）Graft-versus-host disease（GVHD）Phase Ⅳ clinical trial.Beijing Fuyuan MedicineBioequivalence（BE）The trial is ongoing.
Screenshot source: Mosan Medical China Clinical Trial Database
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. We look forward to the smooth approval of this application.
Screenshot source: Mosentropy Medicine China Drug Evaluation Database
In terms of active pharmaceutical ingredients (APIs), 14 companies have currently completedRuxolitinib PhosphateThe filing of active pharmaceutical ingredients (APIs), four of which have been converted to "A".Sichuan Qingmu PharmaceuticalIs the first generic drug approval companyChengdu Yuandong BiopharmaceuticalWholly-owned subsidiary.
Screenshot source: Mosentropy Pharmaceutical API Database
Ruxolitinib PhosphateAs a benchmark product in the field of JAK inhibitors, it has shown great potential in both anti-tumor and dermatological treatment areas. 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.
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