Henlius HLX02 (Trastuzumab for Injection) Receives EU GMP Certificates
Henlius Reports the NMPA’s Acceptance of IND for HLX14 (biosimilar, denosumab)
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 by nearly 30 EU Member States also the inspection results may also be shared with other countries signed MRAs with the EU including the US and Canada
- HLX02 (biosimail, trastuzumab) is a developed biosimilar that has passed the EU GMP inspection in China, targeted for HER2+ve early-stage BC , HER2+ve mBC and HER2+ve mGC and showed no clinically meaningful differences terms of efficacy and safety in patients with recurrent or metastatic HER2+ breast cancer vs originator trastuzumab, also under review by the EMA for MAA. Additionally, has been evaluated in P-III trial vs originator in Mainland China, Ukraine, Poland, and the Philippines
Click here to read full press release/ article | Ref: Henlius | Image: Behance