Nomura: Kelun Biotech (6990.HK) First Global Phase III Trial Meets Primary Endpoints Ahead of Schedule
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Key Views
- The early achievement of primary endpoints in this global Phase III trial validates the therapeutic candidate's clinical profile and de-risks the registration pathway.
- Kelun Biotech intends to submit an NDA in the second half of 2026 based on the trial results.
- Nomura views this milestone as a meaningful value inflection point that could accelerate the product's commercialization timeline.
- The report maintains a Buy rating on the stock, with the target price unchanged.
Outlook
The NDA submission planned for the second half of 2026 represents the next key regulatory catalyst. No additional validation milestones or specific time windows were disclosed beyond the NDA filing plan.
Recommended Securities
- Kelun Biotech (6990.HK): Buy rating maintained; target price unchanged. Rationale: successful Phase III readout and favorable product commercialization prospects.
Key Risks
Potential regulatory approval delays and intensifying competitive dynamics remain the principal downside risks.