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Henlius Xuhui Facility Passes Colombian GMP Inspection for HANLIKANG


Shanghai, China, November 28, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) announces that recently, it has received the resolution of the Colombian National Food and Drug Surveillance Institute (the “INVIMA”) to grant it the GMP certification, pursuant to which the company’s manufacturing site Xuhui Facility has successfully passed the GMP inspection by the INVIMA for the related production lines of HANLIKANG and meets Colombian GMP standards. INVIMA certifies quality management system by adopting WHO standards and wins high recognition in South America. The GMP certification by Colombia, along with the GMP certification by Brazil, brings HANLIKANG a step further to South American countries.

Colombia is one of the largest countries in South America, with nearly 50 million population and thus ever-increasing medical needs. In 2019, the company reached a cooperation agreement with Colombian pharmaceutical company FARMA DE COLOMBIA to promote the commercialization of HANLIKANG in four South American countries including Colombia. HANLIKANG is the first China-developed biosimilar. It has been benefiting a wide patient population with differentiated strategies. Ever since its launch in 2019, it has been approved for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis, for which the originator rituximab has not been approved in China, making it the rituximab with the most approved indications in China. It has so far benefited nearly 220,000 Chinese patients.

The INVIMA GMP certification also confirms that the company’s manufacturing facility and supporting quality management system are in conformity with the highest quality standard, laying a solid foundation for its global footprint. The company’s two commercially operational sites – Xuhui Facility and Songjiang First Plant and the supporting quality management system have passed on-site inspections and audits conducted by the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), Pharmaceutical Inspection Co-operation Scheme (PIC/S) participating members Indonesia’s National Agency for Drug and Food Control (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), the EU Qualified Person, and multiple international business partners. With a total capacity of 48,000 Liters, the two sites work synergistically to reach the maximum operational scale and maintain stable supply in China, Europe and Latin America. The third facility - Songjiang Second Plant, when fully-operational, will add another 96,000 Liters, making the company's total capacity hit 144,000 Liters in 2026 to address the ever-increasing global market needs.

Apart from South America, Henlius has been actively collaborating with global partners such as Abbott, Eurofarma, Accord, Cipla, Elea, Jacobson and KGbio to help patients in the U.S., Canada, Europe, and other emerging markets. Staying true to its original aspirations, Henlius will redouble its efforts in bringing more high-quality products to patients worldwide.