China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the receipt of two Good Manufacturing Practice (GMP) certificates from Brazil’s National Health Surveillance Agency (ANVISA). This certification confirms that Henlius’ biologics manufacturing plant located in the Xuhui district of Shanghai has successfully passed GMP inspections for its biosimilars, Hanlikang (HLX01) and Hanquyou (HLX02).
Details on Hanlikang and Hanquyou
Hanlikang, a biosimilar version of Roche’s MabThera (rituximab), was first approved in China in February 2019 and has received indication approvals for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA). It competes globally with the originator MabThera, as well as Teva’s Truxima and Pfizer’s Ruxience.
Hanquyou, a biosimilar version of Roche’s Herceptin (trastuzumab), was developed in-house by Henlius in accordance with both Chinese and EU biosimilar guidelines. The drug earned market approvals in the EU and China within weeks of each other in July and August 2020. Henlius has also established licensing agreements with Cipla, Accord US, and Abbott in 2018, 2021, and 2022, granting these companies rights to Hanquyou in Australia, North America, and Brazil, respectively.
Market Context and Competitive Landscape
The originator Herceptin, along with Amgen’s Kanjinti and Pfizer’s Trazimera, are also available in the global market, highlighting the competitive landscape for biosimilars. The recent GMP certification from ANVISA positions Henlius to expand its reach in the Brazilian market, further solidifying its commitment to high-quality manufacturing standards.-Fineline Info & Tech
