Xinhua Finance, Nanjing, September 15 (Reporter Zhu Cheng) Recently, the official website of the National Medical Products Administration showed that the injectable degarelix acetate (trademark name: Qinglishu) independently developed by China Biopharmaceutical 's core enterprise, Zhengda Tianqing Pharmaceutical Group, has been approved for marketing for prostate cancer patients who need androgen deprivation therapy.
　　Zhengda Tianqing's degarelix acetate has been approved in the EU market, becoming the world's first generic drug, and has also received provisional approval in the US. During the domestic review process, Zhengda Tianqing also launched a patent challenge, successfully invalidating two core claims of the original drug. This product also became the first drug to receive a 12-month exclusivity period since the implementation of my country's early resolution mechanism for pharmaceutical patent disputes.
　　The early resolution mechanism for drug patent disputes, also known as the drug patent linkage system, is a mechanism to balance the development of innovative drugs.A set of rules and regulations governing the relationship between the interests of pharmaceutical companies and generic drug companies aims to protect pharmaceutical innovation while encouraging and promoting the early listing of generic drugs, so that patients can use cheaper generic drugs as soon as possible and promote orderly and healthy competition in the industry. In 2023 and 2024, Zhengda Tianqing filed invalidation declarations for two core patents of degarelix acetate registered in the Chinese listed drug patent information registration platform, and obtained the Beijing Intellectual Property Office.The court supported the case and the patent challenge was successful.
　　Relevant responsible persons of Zhengda Tianqing Company said that through the "first generic + patent challenge" model, the launch of new drugs will break the market monopoly of original research products in China, promote market competition, and greatly reduce the burden on patients.

https://finance.eastmoney.com/a/202509153514033831.html