20210201-招银国际-Expect_rich_R_D_catalysts_11页_1mb

CMB International Securities | Equity Research | Company Update Summary

Core Content

I-Mab BioPharma (IMAB US) is a global biopharma company focused on the discovery, development, and commercialization of novel and highly differentiated biologics for immuno-oncology and autoimmune diseases. The company is progressing from a clinical stage biotech to a fully integrated global biopharmaceutical company with strong R&D capabilities, GMP manufacturing, and commercial potential.

Main Points

• Key R&D Catalysts in 2021E: I-Mab expects significant milestones in 2021, including data readouts from US Phase 1 trials for Uliedlimab (TJD5) and Lemzoparlimab (TJC4), and the potential for out-licensing deals.

• Uliedlimab (TJD5, anti-CD73 mAb):

  • Conducting parallel clinical trials in the US and China.
  • In the US, the Phase 1 trial in combination with Roche's atezolizumab is expected to release data in 1H21E.
  • In China, the Phase 1/2 trial with Junshi's toripalimab is ongoing.
  • Demonstrated superior safety and efficacy in preclinical studies, avoiding the "hook effect".
  • The company expects to achieve a significant out-licensing deal in 2021E, similar to its successful transaction with leMZoparlimab.

• Lemzoparlimab (TJC4, anti-CD47 mAb):

  • Conducting Phase 1 trials in the US and China.
  • In the US, the combination trial with Rituxan and Keytruda is in dose expansion for NHL and solid tumors.
  • In China, the Phase 1/2a monotherapy trial for r/r AML/MDS is expected to complete soon.
  • Received IND approval in Jan 2021 for a Phase 2 trial in combination with azacitidine in untreated AML/MDS.
  • Expected to achieve significant clinical synergies with AbbVie's Venclexta and other therapies.

• TJ202 (anti-CD38 mAb):

  • Expected to file BLA for 3L MM in 2H21E.
  • The company has raised the probability of success (PoS) for TJC4 and TJD5 due to the fast progress of these assets.

• Risks:

  • Delays in the R&D process.
  • Intense competition from peers.

Key Information

Financial Performance (YE 31 Dec)

Target Price and Performance

• Target Price: US$71.10 (Up/Downside +30.72%)
• Current Price: US$54.39
• 12-Month Price Performance: Not provided in detail, but the company's share performance has been strong.

Shareholding Structure

Upcoming Milestones and Catalysts

• Lemzoparlimab (TJC4):

  • China AML Phase 1 data readout: 1H 2021
  • NHL China trial start: Early 2021
  • US Solid tumor combo trial start: Early 2021
  • US Solid tumor combo data readout: 2021
  • 3L MM BLA submission: 2021
  • Combo with C4 IND: 2H 2021

• Uliedlimab (TJD5):

  • US Phase 1 combo trial data readout: 1H 2021
  • China combo trial start: Early 2021

• Corporate Milestones:

  • US R&D Center to open in San Diego: 2021
  • Commercial team ramp up: 2021

Clinical Development Plan for Lemzoparlimab

• Phase 1 Trial: Well tolerated with no DLT or hemolytic anemia observed.
• Monotherapy Efficacy: 33.3% ORR and 66.6% DCR in 30 mg/kg cohort.

Competitive Landscape

• CD47 Biological Therapies:

  • Hu5F9-G4 (Magrolimab): Phase 3 in 1L higher-risk MDS; Phase 1b in AML.
  • TTI-621: Phase 1.
  • TTI-662: Phase 1.
  • ALX148: Phase 1/2 in higher risk MDS.
  • AO-176: Phase 1/2 in r/r MM.
  • IMM01: Phase 1.
  • Lemzoparlimab (TJC4): Phase 1 (mono and combo PD-1 / CD20); Phase 2 in r/r AML/MDS.
  • HX009: Phase 1.
  • IMM0306: Phase 1.
  • IBI322: Phase 1.
  • AK117: Phase 1.
  • MIL95: Phase 1.
  • ZL-1201: Phase 1.
  • IMM2505: Pre-clinical.
  • JMT601: Pre-clinical.

• Long-Acting Growth Hormone Products:

  • Jintrolong: Approved in China (2014).
  • NNC0195-0092: Phase 3 by Novo Nordisk.
  • Lonapegsomatropin (ACP-001): Phase 3 by Visen Pharmaceuticals.
  • Eftansomatropin TJ101: Phase 3 by I-Mab.
  • Eftansomatropin GX-H9: Phase 3 by Genexine.
  • PEG-rhGH: Phase 2/3 by Anhui Anke.
  • Y-shaped pegylated somatropin: Phase 2/3 by Xiamen Amoytop.
  • Somatrogon: Phase 3 by OPKO/Pfizer.

Strategic Collaborations

• Global Strategic Partnership with AbbVie: Involves the development and commercialization of lemzoparlimab and two BsAb candidates in ex-Greater China regions.
• Collaboration with MorphoSys: For the development and commercialization of TJ210 (anti-C5aR1 mAb) in Greater China and South Korea.

Conclusion

I-Mab is a fast-growing biopharma company with a robust and diverse pipeline of drug candidates for immuno-oncology and autoimmune diseases. The company is leveraging its strong R&D and business development capabilities to advance its pipeline and secure significant out-licensing deals. The company is expected to deliver multiple milestones in 2021, including data readouts from key trials and the potential for BLA submissions. The DCF-based target price has been raised to US$71.10, reflecting the company's strong potential and fast progress. The company's strategic focus on a risk-balanced fast-to-market China strategy and a fast-to-PoC global strategy positions it well for future growth.