REMEGEN (09995) rose nearly 8% in the afternoon session. As of the time of writing, the stock was up 7.67%, trading at HKD 79.3, with a turnover of HKD 405 million.

On the news front, as of December 31, 2025, the CDE (Center for Drug Evaluation) website indicated that the new indication for REMEGEN's Vdisituzumab is proposed to be included in the Breakthrough Therapy category.

The proposed use is in combination with trastuzumab and toripalimab for the first-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma with high HER2 expression.

Vdisituzumab has previously been included in the Breakthrough Therapy program three times. If this application passes the public notice period, it will become the drug's fourth Breakthrough Therapy designation.

Notably, according to the company's official WeChat account, REMEGEN announced Phase I/II clinical study data for its self-developed PD-1/VEGF bispecific antibody, RC148, as a monotherapy for first-line treatment and in combination regimens for second-line treatment of non-small cell lung cancer.

The study data revealed that both the RC148 monotherapy and the combination regimens demonstrated outstanding clinical efficacy and a manageable safety profile, achieving breakthroughs via dual pathways.