China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG) alectinib, and Alphamab Oncology’s HER2-targeted bispecific antibody (BsAb) KN026 (anbenitamab) are set for priority reviews. This designation is a significant step that could expedite the availability of these drugs to patients in need.
LM-302: A First-in-Class ADC
LM-302, a first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, was licensed to US firm Turning Point for exclusive development and commercialization globally, except in Greater China and South Korea, in a USD 1 billion deal in October 2022. The priority review is for the treatment of CLDN18.2-positive locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has previously received second-line or higher systemic treatment.
Alectinib: Next-Generation ALK Inhibitor
Roche’s alectinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor approved in China in August 2018, is indicated for use as postoperative adjuvant therapy for ALK-positive non-small cell lung cancer (NSCLC) patients. This priority review could expand its use in the treatment landscape for NSCLC.
KN026: Novel HER2-Targeted BsAb
Alphamab Oncology’s KN026 is a novel HER2-targeted BsAb that has demonstrated good tolerability and safety, showing anti-tumor activities in HER2-positive breast cancer across multiple clinical studies. CSPC Pharmaceutical Group subsidiary Shanghai JMT Biotechnology Co., Ltd obtained exclusive rights to the drug in breast and gastric cancer as monotherapy and in combination with KN046 in a licensing deal in August 2021. The priority review status awarded this week is for HER2-positive locally advanced, recurrent, or metastatic gastric cancer, including gastric/esophageal junction adenocarcinoma, in patients failing first-line chemotherapy or trastuzumab combined with chemotherapy.-Fineline Info & Tech
