Henlius HLX43: Analysis of One of the World's Only Two PD-L1 ADC Drugs

The mention of “Tianfu Communication” in your question is a typo. HLX43 is a product of , not Tianfu Communication (300394.SZ, an optical communication company). Below is a detailed analysis of HLX43:

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HLX43 is Henlius’s independently developed

with the following key statuses [0]:

• Second globally and first in China
  to enter the clinical phase PD-L1 ADC drug
• Completed the
  first Phase 2 clinical trial dosing
  for solid tumors
• R&D code HLX43, developed by Henlius Biotech

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HLX43 uses ADC technology to conjugate PD-L1 antibody with cytotoxic drugs, achieving:

• Dual mechanism of action
  : Both blocking PD-1/PD-L1 immune checkpoints and directly killing tumor cells
• Higher targeting
  : Precisely delivering chemotherapy drugs to tumor tissues, reducing systemic side effects

• PD-L1 high-expression tumors
  : May have higher efficacy for PD-L1 positive patients
• Immunotherapy-resistant patients
  : Provides new options for patients resistant to PD-1/PD-L1 monoclonal antibodies
• Combination therapy potential
  : Can be used with chemotherapy or other immunotherapies

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According to the latest market data [0]:

Indicator	Value
Market Cap	30.98 Billion HKD
Current Share Price	57.00 HKD
52-Week Price Range	15.20 - 92.00 HKD
P/E Ratio	33.93x
ROE	25.67%
YTD Growth	+142.55%

• H1 2025 revenue: 1.54 Billion USD, with steady year-on-year growth
• Net Profit Margin: 14.22%, good profitability
• Cumulative share price increase over the past 3 years: 345.31%

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The PD-1/PD-L1 market is one of the largest oncology drug markets globally. Keytruda (Merck) had global sales exceeding 25 Billion USD in 2024. If HLX43 is successfully launched, it will face:

1. Merck Keytruda’s first-mover advantage and brand recognition
2. Fierce competition from approved PD-1/PD-L1 drugs
3. R&D progress of other PD-L1 ADCs

1. Efficacy advantage of ADC technology over monoclonal antibodies
2. Localization advantage in the Chinese market
3. Exploration space for combination therapy regimens

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1. Clinical Trial Risk
   : Phase 2 clinical data has not been fully disclosed; efficacy and safety need further verification
2. Regulatory Approval Uncertainty
   : Requires Phase 3 clinical trials and NMPA/FDA approval
3. Commercialization Capability
   : ADC drug production and commercialization require high technical thresholds
4. Intensified Market Competition
   : Many global pharmaceutical companies are布局 the PD-L1 ADC track

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As one of the world’s only two PD-L1 ADCs, HLX43 indeed has the potential to challenge Keytruda’s market position. Its innovative mechanism of action and differentiated positioning provide Henlius with a competitive edge. However, it will take time from clinical approval to commercial success; investors need to closely monitor subsequent clinical data disclosure and product approval progress.

• Detailed disclosure of HLX43 Phase 2 clinical data
• Initiation of Phase 3 clinical trials
• Regulatory approval progress

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[0] Jinling API - Henlius (2696.HK) Company Profile and Real-time Quotes

This analysis is based on public information and does not constitute investment advice. The stock market has risks; investment needs caution.