Hengrui Pharmaceuticals (01276) rose more than 5% in the afternoon session. As of the time of writing, the stock was up 5.19%, trading at HKD 74.95, with a turnover of HKD 55.6871 million.
The company announced that its self-developed Claudin18.2 (CLDN18.2)-targeting Antibody-Drug Conjugate (ADC), SHR-A1904 for injection, has been officially included in the National Medical Products Administration's Center for Drug Evaluation list of breakthrough therapy varieties.
This drug is intended for the treatment of CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have previously received at least one line of systemic therapy.
According to the announcement, the inclusion in the breakthrough therapy program is based on the drug's potential clinical value for this specific indication.
The Center for Drug Evaluation will prioritize the allocation of review resources for this drug and strengthen R&D guidance to accelerate its clinical development and market approval process.
Gastric cancer is a highly prevalent malignant tumor in China; in 2020, new cases and deaths in the country accounted for approximately 44% and 48.6% of the global totals, respectively, indicating a significant unmet clinical need.
The CLDN18.2 target is highly expressed in various gastrointestinal tumors and is currently one of the hot targets in oncology drug development, with no similar ADC product approved for marketing globally.
