Qilu Pharmaceutical and CSPC Zhongrun's Pertuzumab Biosimilars Approved on Same Day, Targeting a RMB 3.5 Billion Market
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On December 23, according to the latest announcement on the NMPA official website,Qilu PharmaceuticalAndCHIATAI TIANQINGSubmitted as Class 3.3Pertuzumab InjectionBiosimilar Approved for Marketing on the Same Day, This ProductIt is a monoclonal antibody drug targeting the HER2 receptor, and the original product has been approved in China for the treatment of breast cancer.
Screenshot source:NMPA OfficialNetwork
PertuzumabThe original research was developed by Roche. This variety is a drug targeting the HER2 receptor, which prevents HER2 from binding to other HER receptors on the cell surface by combining with HER2.(EGFR/HER1, HER3, and HER4), thereby slowing down the growth of the tumor.PertuzumabIt was first approved for marketing by the FDA in 2012 and then received its first approval in China in 2018. From 2019 to 2022, it was included in the national medical insurance negotiation directory. After being covered by medical insurance, its market growth was promoted. According to the Moxen Pharma database,Pertuzumab InjectionIn 2023, sales in hospitals nationwide (all terminals) exceeded 3.5 billion yuan, with a year-on-year increase of 13.34%.
Screenshot source:Moxie Pharma (formerly Yaoke Rongyun)China Hospital Sales (All Terminals) Database
Previously, in ChinaPertuzumabThe market was exclusively dominated by Roche. However, with the entry of Qilu Pharmaceutical and Chia Tai Tianqing, this pattern has been completely disrupted. In January 2023, Qilu Pharmaceutical took the lead in submitting.Pertuzumab Injection(3.3 Class New Drug) Marketing Application; In the same May, Chia Tai Tianqing Nanjing Shunxin Pharmaceutical also followed suit.Moreover, at the 2023 SABCS, the Phase III study of CHIATAI TIANQING's pertuzumab biosimilar was selected for a poster presentation. This study is a multicenter, double-blind, parallel-controlled trial comparing the pertuzumab biosimilar.The efficacy and safety of biosimilar and originator drugs in treating HER2-positive breast cancer were comparable, according to the results.The approval of Qilu Pharmaceutical and Chia Tai Tianqing on the same day not only demonstrates their strength in the biopharmaceutical field but also successfully secures a first-mover advantage in the market.
Screenshot source:MaxEntropy Pharma (formerly Yaoke Rongyun) China Drug Approval Database
However, the market competition has not subsided as a result. Currently, seven companies have invested inPertuzumabThe Development of Biosimilars: Qilu Pharmaceutical and Chia Tai Tianqing Take the Lead. Meanwhile, Henlius and Hisun Pharmaceuticals Have Submitted Marketing Applications for Related Products, While CSPC and Sl Pharm Are Actively Advancing Their Similar Products into Phase III Clinical Trials. In the Future, With More Companies Entering the Market and Products Being Launched, Competition in the Pertuzumab Market Will Become Increasingly Intense.
Screenshot source:Moxie Medicine (formerly Yaorong Cloud) China Clinical Trial Database
Qilu Pharmaceutical and CHIATAI TIANQING have achieved much more in the biopharmaceutical field. Since this year, Qilu Pharmaceutical has successfully obtained clinical trial approvals for eight Class 1 new drugs, six of which are Class 1 new therapeutic biological products.Aipalolitovorelimab InjectionOne of them. Meanwhile, CHIATAI TIANQING has also obtained clinical trial approvals for three new therapeutic biologics.Beimousuab InjectionThese achievements not only demonstrate the innovation capabilities of the two companies in the biopharmaceutical field but also lay a solid foundation for their future development.
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