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From China With Discount? BeiGene Moves Towards First Global PD-1 Green Light

But Price, Competition Looming Hurdles Amid US Filing

 
• By Brian Yang

Already priced domestically at a deep discount to counterpart PD-1s in the US, Beigene's tislelizumab could potentially get the first global approval for a China-originated drug in this class, as the immuno-oncology sector as a whole continues to come under pressure in China.

Beigene Suzhou Opening
BEIGENE AT THE OPENING OF ITS SUZHOU FACTORY IN 2017 • Source: Scrip

Years ago, when the US Food and Drug Administration's director of Oncology Excellence Richard Pazdur told a Chinese audience that he would welcome the latest immuno-oncology therapy from China to the US market, many wondered what it would take to accomplish that.

On 13 September, BeiGene, Ltd., on behalf of its global partner Novartis AG, filed a US NDA for its PD-1 inhibitor tislelizumab for second-line esophageal squamous cell carcinoma (ESCC) after prior systemic therapy

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