Fierce Pharma Asia—Hengrui’s FDA reprimands; Sanofi’s India site expansion; Aslan’s downfall

Fierce Pharma July 19, 2024
Angus Liu

A 10-page Form 483 has detailed the shortfalls at Hengrui Pharma’s PD-1 plant behind a recent FDA rejection. Sanofi is investing heavily to expand its global capacity center in India. Singapore biotech Aslan Pharma is winding down. And more.

1. Behind Hengrui’s surprise FDA rejection: Scathing Form 483 lists litany of shortfalls at PD-1 drug plant

The Form 483 that led to the FDA’s rejection of Jiangsu Hengrui Pharma and Elevar Therapeutics’ PD-1 inhibitor camrelizumab included 10 observations issued to Hengrui’s subsidiary, Suzhou Suncadia Biopharmaceuticals. In addition, the FDA has upgraded a prior eight-observation Form 483 into a warning letter for Hengrui’s small-molecule facility in Lianyungang, China.

2. Sanofi to more than double its workforce at Hyderabad site with $437M...

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