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  • HLB¡¤Jiangsu "FDA, facility issues not related to efficacy"
  • by Son, Hyung-Min | translator Kang, Shin-Kook | May 24, 2024 05:48am
Received a CRL for Rivoceranib plus camrelizumab¡¦issue was found during the monitoring of the pant
Not related to clinical results¡¦will retry for approval after seeking cooperation and supplementation
 ¡ã (from the left) Chief Technology Officer (CTO) Han Yong-hae of HLB Group, Vice President Frank Jiang of Jiangsu Hengrui Pharmaceuticals, CEO Jung Se-ho of Elevar Therapeutics, and Vice President Jang Sung-hoon of Elevar Therapeutics.

"It appears that there are no issues related to the efficacy of Rivoceranib plus camrelizumab therapy. However, we were pointed out of the manufacturing facility during the monitoring of Jiangsu Hengrui Pharmaceuticals. We do not need an additional clinical trial. By closely cooperating with the U.S. FDA, we will introduce a novel drug to patients with liver cancer."

HLB group and Jiangsu Hengrui Pharmaceuticals hosted a press conference on May 23rd at Sofitel Ambassador Seoul Hotel and stated this regarding the FDA¡¯s rejection of approval for their novel candidate drug, Rivoceranib plus camrelizumab, for the treatment of liver cancer.

The press conference was attended by Chief Technology Officer (CTO) Han Y
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