20260903-招银国际-维立志博-B-09887.HK-Eyes_on_LBL-024_readouts_at_WCLC_ESMO_5页_1mb

LeadsBio (9887 HK) Summary

Core Content

LeadsBio is a clinical-stage biotechnology company with a focus on immunotherapy (IO) and has demonstrated a strong business development track record. The company has out-licensed two of its assets, LBL-051 and LBL-047, to global partners in 2024 and 2025 respectively. In the first half of 2026 (1H26), LeadsBio reported revenue of RMB36 million, primarily from a milestone payment of US$5 million from Dianthus related to LBL-047. Management expects revenue in the second half of 2026 (2H26) to exceed US$35 million, largely driven by the partnership with Oblenio on LBL-051.

The company remains well-capitalized, with RMB1.24 billion in cash at the end of 1H26, which is sufficient to fund operations through 2029 without the need for additional financing. The key value driver for the company is LBL-024, a registrational-stage 4-1BB-targeted asset with the potential to become a next-generation IO therapy with broad pan-tumor applicability. LBL-024 is the first globally developed 4-1BB-targeted candidate to reach the registrational stage, and its dual targeting of PD-L1 and 4-1BB may offer stronger immune activation and more durable responses compared to conventional checkpoint inhibitors.

Key Assets and Clinical Development

• LBL-024:

  • Dual targeting of PD-L1 and 4-1BB.
  • Expected to be the next-generation IO backbone with broad applicability.
  • Entered NDA stage, with NMPA accepting the NDA for 3L+ EP-NEC in August 2026 based on a pivotal Phase 2 study.
  • Approval expected in 1H27.
  • Phase 3 study in first-line EP-NEC is planned to start shortly.
  • Additional PFS and OS data from the Phase 1b/2 study in 1L EP-NEC are expected at ESMO in October.
  • The asset is also being evaluated in multiple indications, including NSCLC and BTC, with these becoming key registrational opportunities.
  • In first-line NSCLC, management reported an ORR of 77.4% in sq-NSCLC and 51.7% in nsq-NSCLC at 3.6 months of follow-up, with further updates expected at WCLC in September.
  • Discussions with China CDE for a Phase 3 study in 1L sq-NSCLC are in the final stage.
  • In first-line BTC, a Phase 3 study is under planning, with IND submission targeted for 1H27.

• LBL-034:

  • Targeting GPRC5D and CD3.
  • Data will be updated at the upcoming ESMO conference.
  • BD activities for LBL-024 and LBL-034 are ongoing.

Financial Overview

• Revenue (RMB mn):

  • FY24A: 0
  • FY25A: 177
  • FY26E: 322 (up 81.8% YoY)
  • FY27E: 157 (down 51.3% YoY)
  • FY28E: 389 (up 147.6% YoY)

• Adjusted Net Profit (RMB mn):

  • FY24A: -301.2
  • FY25A: -211.4
  • FY26E: -150.8
  • FY27E: -378.7
  • FY28E: -269.0

• R&D Expenses (RMB mn):

  • FY24A: -186
  • FY25A: -289
  • FY26E: -382
  • FY27E: -420
  • FY28E: -389

• Cash and Equivalents (RMB mn):

  • 1H26: 1,395
  • Expected to grow to RMB1,912 by end of FY28E.

• DCF Valuation:

  • Target Price: HK$100.50 (unchanged)
  • Terminal Growth Rate: 4.0%
  • WACC: 9.06%
  • Equity Beta: 0.9
  • Risk-Free Rate: 3.0%
  • Market Risk Premium: 10.0%

Upcoming Catalysts

• WCLC and ESMO Readouts:

  • Expected updates on LBL-024 data in NSCLC and BTC.
  • PFS and OS data from Phase 1b/2 study in 1L EP-NEC expected at ESMO.
  • LBL-034 data will also be presented at ESMO.

• Market Outlook:

  • CMBIGM maintains a BUY rating.
  • The company's upcoming data readouts are seen as key catalysts for re-rating.

Shareholder and Market Information

• Market Cap (HK$ mn): 13,315.8
• Average 3-Month Total Return (HK$ mn): 118.5
• 52-Week High/Low (HK$): 93.95 / 48.40
• Total Issued Shares (mn): 198.9
• Current Price (HK$): 66.95
• Up/Downside: 50.1%

Shareholding Structure

• Nanjing Lizhi: 6.3%
• Kang Xiaoqiang: 4.0%

Risk Factors

• Risks:
  • Increasing competition in the next-generation IO space.
  • Uncertainty around clinical data for large indications.

Analyst Disclosures

• The research analyst certifies that the views expressed reflect their personal opinions and that there is no direct or indirect compensation tied to the report.
• No trading in the stock covered in the report was done within 30 days prior to the report's issue.
• No trading is planned within 3 business days after the report's issue.
• The analyst does not serve as an officer of any Hong Kong-listed companies covered in the report.
• No financial interests in the companies covered in the report.

CMBIGM Ratings

• BUY: Potential return of over 15% over the next 12 months.
• OUTPERFORM: Industry expected to outperform the relevant broad market benchmark over the next 12 months.
• MARKET-PERFORM: Industry expected to perform in-line with the relevant broad market benchmark.
• UNDERPERFORM: Industry expected to underperform the relevant broad market benchmark.
• SELL: Potential loss of over 10% over the next 12 months.

Valuation Metrics

• P/B (Book Value per Share):

  • FY25A: 7.9
  • FY26E: 10.2
  • FY27E: 15.5
  • FY28E: 24.4

• P/E (Earnings Per Share):

  • Not applicable for FY24A and FY25A.
  • FY26E and onwards: Not specified.

Summary of Financial Projections

Conclusion

LeadsBio is a promising clinical-stage biotech company with strong business development and a robust pipeline of IO assets. LBL-024 is positioned as a key differentiator with potential for broad pan-tumor application. The company is well-capitalized, with sufficient cash reserves to fund operations through 2029. Upcoming data readouts at WCLC and ESMO are expected to provide important insights and drive valuation. CMBIGM maintains a BUY rating with an unchanged target price of HK$100.50.