Hengrui Pharma's independently developed global first anti-PD-L1/TGF-βRII bispecific antibody fusion protein approved for marketing

Recently, according to information from Hengrui Pharma, its independently developed Class 1 innovative immunotherapy drug,  Retlirafusp alfa Injection (brand name: Aizeli®), has been approved for marketing by the National Medical Products Administration (NMPA). It is also the world's first approved anti-PD-L1/TGF-βRII bispecific antibody fusion protein.

The drug is approved for use in combination with fluorouracil and platinum-based drugs as a first-line treatment for locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma that has been assessed as PD-L1 positive (CPS ≥ 1) through fully validated testing.

It is reported that gastric cancer is a highly prevalent malignant tumor globally, with its incidence and mortality rates both ranking fifth among all cancer types. The number of gastric cancer patients in China is exceptionally large. Data shows that in 2022, there were over 350,000 new cases of gastric cancer and more than 260,000 deaths in China, with both its incidence and mortality rates ranking third among all malignant tumors in China.