On September 14, HENGRUI PHARMA rose 3.2% in regular trading, trading at HK$45.16/share, with turnover of approximately HK$86.20 million. The gain was driven by a recent announcement that the company's subsidiary drug was included in China's breakthrough therapy designation list.

According to filings dated September 11, subsidiary Suzhou Shengdia Biopharmaceutical's ruzaltatug rezetecan injection was included in the National Medical Products Administration's breakthrough therapy program. The drug is an antibody-drug conjugate (ADC) targeting HER3, indicated for combination with bevacizumab to treat EGFR-mutant locally advanced or metastatic non-squamous non-small cell lung cancer. Notably, no HER3-targeting ADC for NSCLC has been approved globally, highlighting the drug's first-in-class potential. Cumulative R&D investment in the project stands at approximately RMB 355 million. The breakthrough therapy designation is expected to accelerate the regulatory review process.

The designation adds to a series of recent pipeline milestones, including NMPA acceptance of marketing applications for oral GLP-1 receptor agonist HRS-7535 tablets and anti-IL-13 antibody SHR-1819 for atopic dermatitis, as well as domestic manufacturing approval for oteseconazole capsules.

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