2025-06-02-Jefferies-Akesobio（9926）_勘误-_HARMONi_中国数据可信度得到证明_11页_1mb

• 👑 Company: Akeso Inc. (9926 HK)

• Rating: Buy

• Price Target: HK$150 (target based on DCF valuation)

• Key Points on HARMONi Trial:

  • The HARMONi global trial demonstrated translatability of China phase 3 data to global populations, supporting out-licensing potential.
  • U.S. PFS HR is projected to be approximately 0.59 based on blended data alignment with China trial results.
  • Overall survival (OS) data showed <50% maturity, so continued evolution expected; filings will depend on further OS development.

• 📉 Risk Assessment:

  • Regulatory barriers aren't a major concern due to immature OS data (<50% maturity) and strong cross-border efficacy patterns.
  • Concerns over Daiichi Sankyo's HER3 setback are overstated as HARMONi's OS remain immature.

• 💊 Product Pipeline & Strategy:

  • Advancing AK112 (PD-1/VEGF bispecific) in chemo combos for sq-NSCLC and CRC; exploring ADC partnerships and in-house bispecific ADC development.
  • Noted as a potential M&A target due to recent price pullbacks and competitive valuation.
  • AK104 (PD-1/CTLA-4 bispecific, approved in China) commercialization success builds confidence for future sales.

• 🤔 Key Questions:

  • How does China data translatability impact out-licensing and global partnerships?
  • What are the risks of pipeline delay or regulatory hurdles affecting share price?

• 📈 Investment Thesis:

  • Up-side potential: Strong head-to-head data vs. Keytruda in NSCLC, GLobal expansion of AK112 by 2025, DCF-based PT of HK$150.
  • Down-side PT: HK$50, driven by pipeline failure or commercialization risks.

• ⚠️ Core Risks:

  • Pipeline delays, regulatory issues, ADC development hurdles, partner deal-breakdowns.

Summary: **Akeso inc. (9926 HK) receives "Buy" rating with a HK$150 price target, driven by translatability of China trial data to global populations. CEO'S study supports global efficacy and indicates PD-1/VEGF combo potential against Keytruda. The company has a promising pipeline with AK112 advancing in sq-NSCLC/CRC and ADC partnerships. Downside risks centred on pipeline failure or commercialization hurdles.