政府新闻
君实生物：JS125药物临床试验申请获批准 2024-09-26
Shares of Junshi Biosciences gained after the European Union approved the Chinese drugmaker’s monoclonal antibody cancer treatment, which generates most of the company’s revenue.
The European Commission, the EU's executive branch, has approved Junshi Bio's first-line innovative cancer drug Toripalimab, known commercially in Europe as Loqtorzi, to treat patients with advanced nasopharyngeal carcinoma and squamous cell carcinoma in conjunction with other specific drugs, the Shanghai-based firm said in an exchange filing late on Tuesday.
Toripalimab will become Europe's first drug to treat nasopharyngeal carcinoma and will also be Europe's only first-line treatment for advanced or metastatic squamous cell carcinoma, Junshi Bio noted. The approval is valid in all 27 EU member countries, as well as Iceland, Norway, and Liechtenstein, it added.
Toripalimab, China's first anti-PD-1 monoclonal antibody treatment approved for sale, has had more than 40 clinical studies for 15 indications worldwide, with 10 indications approved in the Chinese mainland.
An advanced nasopharyngeal carcinoma therapy combining Toripalimab and other specific drugs was approved by the US Food and Drug Administration for sale last October, becoming that US' first and only such approved treatment to date and also the first FDA-approved innovative biological drug independently researched, developed, and made by a Chinese firm, Junshi Bio noted.
Toripalimab's China sales reached CNY671 million (USD95.6 million) in the six months ended June 30, accounting for 85 percent of the company’s total revenue, according to its most recent earnings report. The firm had spent CNY5.8 billion (USD826.6 million) to develop and commercialize the drug as of the end of June, laying out CNY214 million in the first half.
Source: Yicai Global
