Skip to content Skip to footer

Henlius Reports First Patient Dosing in P-I Trial of HLX05-N (Biosimilar, Erbitux) in China 

Shots:  Henlius has dosed the first patient in China in the P-I HLX05-N (HLX05-N-mCRC102), a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)  The study will compare HLX05-N vs. US & EU sourced Erbitux in mCRC, evaluating PK similarity, efficacy, safety, and immunogenicity in combination with mFOLFOX6 CT  HLX05-N is Henlius' cetuximab biosimilar candidate, developed under global biosimilar guidelines, with analytical and non-clinical studies demonstrating high…

Read more

Henlius Receives NMPA IND Clearance for HLX05-N (Biosimilar, Erbitux)

Shots: The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC) HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditions Cetuximab is an anti-EGFR monoclonal…

Read more

Top 20 Oncology Companies of 2025 

Shots:  ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care  In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…

Read more