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01093 CSPC PHARMA
RTNominal up5.820 +0.010 (+0.172%)
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03/12/2020 11:37

CSPC Pharma (01093) antibody drug gets ODD from FDA

[ET Net News Agency, 3 December 2020] CSPC Pharmaceutical Group Limited (01093) said
the antibody drug NBL-015, independently developed by NovaRock Biotherapeutics Limited, a
subsidiary of the company in the United States, was granted orphan-drug designation by the
U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
NBL-015 is a fully human anti-Claudin-18.2 monoclonal antibody which has been protein
engineered to achieve optimized ADCC, CDC and ADCP effects. Preclinical in vitro cell
killing studies, animal pancreatic cancer elimination and safety studies have demonstrated
that NBL-015 has significant advantages over similar drugs in terms of low immunogenicity,
good safety, high affinity and high anti-tumour activity, providing a promising prospect
of becoming the best-in-class target therapy for the treatment of pancreatic cancer and
gastric cancer. (RC)

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