Tags : HLX02

Henlius Signs an Exclusive License Agreement with Accord for HLX02

Shots:   Henlius to receives $27M up front, ~$13M regulatory milestones, $25M commercial milestones for every $500M of cumulative net sales, and is eligible to receive royalty up to 50% profit of HLX02. If the cumulative net sales of HLX02 reaches $3B, Henlius to receive ~$150M as commercial milestones Accord to get an exclusive license to […]Read More

Henlius Present P-III Data of HLX02 (biosimilar, trastuzumab) at ESMO

Shots: The P-III HLX02-BC01 study involves assessing HLX02 vs EU-sourced trastuzumab in combination with docetaxel in a 3wks. cycle for up to 1yr. in patients in a ratio (1:1) with HER2-positive recurrent/ mBC, prior not treated with systemic treatment   Results:  Per ITT set, ORRwk24 (71.3% vs 71.4%); Per PP set, ORRwk24 (74.2% vs 73.2%); […]Read More

Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab

Shots: On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac Henlius followed the NMPA and EMA’s biosimilar guidelines and has taken multiple head-to-head comparisons b/w HLX02 and the reference, […]Read More

Henlius and Accord Receive CHMP’s Positive Opinion for its HLX02

Shots: The EMA’s CHMP has granted a positive opinion, recommending marketing authorization for HLX02 to treat HER2+ early breast cancer, HER2+ metastatic breast cancer & previously untreated HER2+ metastatic adenocarcinoma of the stomach or gastro-esophageal junction EC will now review the CHMP’s positive opinion, with the expected regulatory decision in next 2-3mos. Once approved, a […]Read More

Henlius HLX02 (Trastuzumab for Injection) Receives EU GMP Certificates

Shots: Henlius has received two EU GMP certificate for drug substance (DS) line and drug product (DP) line for HLX02 (trastuzumab biosimilar) and has become the first EU certified site to self-develop an Ab drug depicting the company has commercial-scale manufacturing facility and quality management as per EU standards The EU GMP inspection is recognized […]Read More

Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02

Shots: The acceptance follows P-III study demonstrating bio-similarity data between HLX02 and reference product trastuzumab sourced from EU in 649 patients with HER2+ m-breast cancer and P-I study resulting equivalence in PK & safety studies b/w HLX02 and reference trastuzumab sourced from both EU and China In Jun’18, Henlius granted exclusive commercialization rights of HLX02 […]Read More