By Fineline Cube 
Shanghai‑based InnoCare Pharma (HKG: 9969, SHA: 688428) announced on September 8, 2025 that its Bruton’s tyrosine kinase (BTK) inhibitor Orelabrutinib—marketed in Singapore as Ino‑03—has received Health Sciences Authority (HSA) clearance for the treatment of adult patients with relapsed/refractory marginal zone lymphoma (R/R MZL).
This marks the drug’s second approved indication in Singapore; the first, granted in November 2022, covered relapsed/refractory mantle cell lymphoma (R/R MCL).
Drug Profile
- Mechanism – Highly selective BTK inhibition with minimal off‑target activity.
- Safety Advantage – Designed to reduce adverse events common to earlier BTK inhibitors.
- Therapeutic Scope – Approved in China for CLL/SLL, MCL, MZL, and first‑line CLL/SLL (April 2025).
Regulatory Milestone
- Singapore – HSA approval extends Orelabrutinib’s reach to a new lymphoma subtype, strengthening its market presence in the region.
- China – Orelabrutinib’s regulatory journey began in December 2020 (CLL/SLL & MCL) and has since expanded to MZL (April 2023) and first‑line CLL/SLL (April 2025).
Clinical Landscape
- R/R MZL – Limited approved options; Orelabrutinib offers a targeted alternative with a favorable safety profile.
- Competitive Edge – The drug’s selectivity differentiates it from other BTK inhibitors that carry higher toxicity risks.
Strategic Implications
- Market Expansion – The dual Singapore approvals position InnoCare to capture a broader patient base across the Asia‑Pacific.
- Pipeline Synergy – Success in MZL may accelerate development of Orelabrutinib in other hematologic malignancies and autoimmune indications.
- Investor Outlook – The approvals are expected to bolster InnoCare’s valuation by unlocking new revenue streams and enhancing its competitive moat.-Fineline Info & Tech