JUNSHI BIO (01877) surged more than 4%, reaching HK$25 by the time of writing, with a trading volume of HK$34.83 million. The rise follows the company's announcement on December 14 that the U.S. Food and Drug Administration (FDA) has approved the clinical trial application for JS212, an EGFR/HER3 bispecific antibody-drug conjugate targeting advanced solid tumors.
Earlier in January 2025, JS212's clinical trial application was accepted by China's National Medical Products Administration (NMPA) and subsequently approved in March 2025. As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors.
Additionally, the NMPA approved a multi-cohort combination therapy clinical trial application for JS212 in November 2025, with related studies expected to commence soon.
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