This week, Alphamab Oncology’s JSKN003 injection became the first Chinese bispecific antibody ADC declared for clinical use. The news review of this week is from August 15 to 19, covering a total of 24 pieces of information on drug review, R&D, and business.
Drug Review
NMPA – Marketing
[Approval]
1. On August 15, Roche China announced that a new indication for its targeted anti-cancer drug, entretinib, had been officially approved by the NMPA. It is for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Entratinib became the first ROS1 inhibitor with clear central nervous system (CNS) efficacy approved in China.
[Application]
2. On August 17, the CDE accepted Kyowa Kirin's marketing application for evocalcet tablets. It is for the treatment of the secondary hyperparathyroidism of chronic kidney disease. Evocalcet, a next-generation oral calcium-sensitive receptor agonist (calcimimetics), was first approved for marketing in Japan in March 2018.
3. On August 18, the CDE official website revealed that Daiichi Sankyo's marketing application for Trastuzumab deruxtecan, an ADC drug, had been formally accepted by the CDE. It is for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior systemic therapy in the metastatic disease stage, or who have relapsed during or within 6 months after the completion of the adjuvant chemotherapy.
4. On August 18, the CDE official website revealed that Boehringer Ingelheim's marketing application for a new indication for Jardiance tablets was accepted. The expected indication is reducing the risk of cardiovascular death in patients with type 2 diabetes and cardiovascular diseases. Jardiance is an oral once-daily, highly selective sodium-glucose co-transporter 2 (SGLT2) inhibitor.
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