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HENLIUS BIOTECH(2696.HK):LARGE POTENTIAL IN INNOVATIVE PIPELINES

招银国际证券有限公司2025-06-24
  HLX43, a global leading PD-L1 ADC targeting broad indications. As one
  of the most advanced PD-L1 ADCs globally, HLX43 has demonstrated encouraging and competitive early efficacy in clinical trials for IO-resistant NSCLC patients. Among heavily pre-treated patients (median of three prior lines), HLX43 2mg/kg monotherapy achieved an ORR of 38.1% and an mPFS of 5.4 months. Notably, HLX43 showed consistent anti-tumor activity across both squamous and non-squamous NSCLC subtypes (cORR of 33.3% in each), regardless of PD-L1 expression status or the presence of brain/liver metastases. In terms of safety, HLX43 was well tolerated with low hematologic toxicity, supporting its potential for future development in first- line settings and in combination regimens. HLX43 is currently undergoing multiple Ph2 trials across broad indications of NSCLC, HCC, ESCC, NPC, HNSCC, and others. We also see the potential of HLX43 in combo with serplulimab (PD-1) likely in front-line. HLX43 demonstrates promising potential for out-licensing opportunities.
  HLX22 is another potential blockbuster. We view HLX22 (HER2 mAb) to
  be a strong alternative for 1L HER2+ gastric cancer (GC). In a Ph2 trial, with a median follow-up of 20.3 months, HLX22 (15 mg/kg) + trastuzumab + chemo showed dramatically improved efficacy over the current standard of care (trastuzumab + chemo), with median PFS not reached vs 8.2 months in the control arm. The hazard ratio was 0.20 (0.06-0.45), representing an 80% reduction in the risk of disease progression. Henlius is advancing a global Ph3 MRCT in this indication.
  Serplulimab shows promising potential in MSS CRC. Serplulimab (PD-
  1) represents a compelling opportunity in first-line MSS colorectal cancer- a large and underserved population. In a Ph2 trial, serplulimab + chemo + bevacizumab demonstrated numerically longer PFS (16.8 vs 10.1 months; HR 0.66) and OS (23.5 vs 20.2 months; HR 0.79) vs chemo + bevacizumab, which suggests meaningful clinical benefits in this difficult-to-treat setting. A Ph3 trial of serplulimab is ongoing in China and other Asian markets.
  To capture global biosimilar opportunities through extensive
  partnerships. Backed by strong commercial performance of HANQUYOU (trastuzumab) and serplulimab, Henlius has transitioned into a profit- generating company. Leveraging its broad and growing network of global partnerships, Henlius is actively expanding its presence in the international biosimilar market. Notably, marketing authorization applications for HLX14 (denosumab) and HLX11 (pertuzumab) are currently under FDA review, positioning the company to unlock significant overseas revenue streams upon approval and launch. In addition, Henlius is advancing multiple biosimilar assets in development, offering further licensing potential.
  Maintain BUY. We see potential of Henlius to evolve from a profitable bio- similar-focused company into a leading innovator in biologics. We revise our TP to HK$61.98 (WACC 9.83%, terminal growth 3.0%) from HK$20.33, a TP we previously derived before Henlius’ potential privatization last year

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