Remegen RC118 Phase I clinical study showed good safety and tolerability

On December 20, Remegen Biopharmaceutical (Yantai) Co.
, Ltd.
(688331.
SH/09995.
HK) announced that the Phase I clinical study of RC118 for injection in Australia and China is progressing smoothly, showing good safety and tolerability
.

RC118 for injection is an innovative antibody conjugate drug (ADC) independently developed by Remegen for the treatment of patients with locally advanced unresectable or metastatic malignant solid tumors
with positive expression of Claudin 18.
2 。 The product obtained the ethical license for phase I clinical trial issued by the Australian Human Research Ethics Committee in July 2021, and further obtained the phase I clinical trial approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration in September of the same year, and launched clinical studies in China and Australia at the end of the same year, mainly to explore its tolerability, safety and phase II recommended dose (RP2D)
in humans.

Preliminary clinical studies have shown that no dose-limiting toxic (DLT) events have been observed in clinical trials conducted in China and Australia throughout the climb, showing that RC118 is well tolerated in Chinese and Australians
.

It is worth mentioning that on December 8, Remegen announced that RC118 has been granted two orphan drug designations by the US Food and Drug Administration (FDA), with indications for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer
.
The orphan drug designation granted by the FDA applies to drugs and biologics for rare diseases with less than 200,000 patients in the United States each year, and the designated drugs have the opportunity to enjoy tax incentives in the United States, a 7-year market exclusivity period after marketing, and other incentive policies
.