REMEGEN (09995) surged over 11%, with a gain of 11.02% at the time of writing to HKD 90.15, recording a turnover of HKD 577 million. According to the company's official social media account, it has released Phase I/II clinical trial data for its self-developed PD-1/VEGF bispecific antibody, RC148, both as a monotherapy for first-line treatment and in combination for second-line treatment of non-small cell lung cancer. The study data indicate that RC148, both as a monotherapy and in combination, demonstrated outstanding clinical efficacy and a manageable safety profile, achieving breakthroughs via two pathways. Previously, two of the company's innovative drugs covering four indications were successfully included in the 2025 National Reimbursement Drug List. Zhongtai Securities previously noted that REMEGEN is on an accelerated path to realizing its commercialization capabilities; through efficient operations and precise investments, the company is rapidly approaching its break-even point. Additionally, as of December 31, 2025, the CDE website indicated that a new indication for REMEGEN's drug disitamab vedotin was proposed for inclusion in the Breakthrough Therapy Designation program, for use in combination with trastuzumab and toripalimab as a first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma with high HER2 expression. Disitamab vedotin has previously been included in the Breakthrough Therapy Designation program three times; if this latest proposal passes the public notice period, it would mark the fourth Breakthrough Therapy designation for this drug.
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