Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)

Why It Matters

The clearances accelerate Henlius’ entry into high‑value immuno‑oncology markets, positioning the firm as a competitive biosimilar and ADC developer in China and abroad.

Key Takeaways

• NMPA approves HLX18 IND for Opdivo biosimilar.
• HLX17 and HLX13 enter Phase I dosing in China.
• HLX15‑SC gains dual IND clearance from NMPA and FDA.
• HLX43 advances to global Phase II/III NSCLC trial.
• Henlius expands biosimilar and ADC pipeline rapidly.

Pulse Analysis

China’s regulatory environment is becoming a launchpad for domestic biotech firms seeking to capture a share of the lucrative immuno‑oncology market. By securing NMPA IND approval for HLX18, Henlius not only mirrors the US FDA’s earlier clearance of the same candidate but also demonstrates its capability to navigate parallel regulatory pathways. This dual‑track strategy reduces time‑to‑market for a checkpoint inhibitor that competes directly with Merck’s Opdivo, potentially lowering treatment costs for Chinese hospitals and patients while expanding the company’s revenue base.

Beyond HLX18, Henlius is rapidly advancing a suite of biosimilars—HLX17 (a pembrolizumab analogue) and HLX13 (a ipilimumab analogue)—which have already entered Phase I trials with first patient dosing completed. The simultaneous IND clearance of HLX15‑SC, a subcutaneous daratumumab biosimilar, by both Chinese and American regulators underscores the firm’s growing credibility on a global stage. These developments diversify Henlius’ portfolio, mitigate reliance on a single product, and position it to meet rising demand for affordable monoclonal antibody therapies across multiple cancer indications.

The most differentiated asset, HLX43, is a PD‑L1‑targeting antibody‑drug conjugate that has shown promising early efficacy and manageable safety in solid tumours, including non‑small cell lung cancer. Its progression to a multinational Phase II/III trial for advanced squamous NSCLC signals Henlius’ ambition to move beyond biosimilars into innovative oncology therapeutics. Success could establish the company as a dual‑play player—offering cost‑effective biosimilars while pioneering next‑generation ADCs—thereby reshaping competitive dynamics in both domestic and international markets.