Shanghai, China, October 11, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) announces that recently, PT Kalbio Global Medika, the subsidiary of Henlius' partner PT Kalbe Genexine Biologics（KGbio), has received the close-out letter of GMP inspection issued by the Indonesian Food and Drug Authority (Indonesian: Badan Pengawas Obat and Makanan, the“BPOM”), one of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) participating members, indicating that its Xuhui Facility passes the BPOM’s GMP inspection for the drug substance (DS) and drug product (DP) production lines, related labs and storage areas of its anti-PD-1 mAb HANSIZHUANG (serplulimab). It is the first time that the production lines for HANSIZHUANG have passed GMP inspection conducted by overseas authorities. The successful inspection by the BPOM, as well as the previous certification by China and the EU GMP, confirms that the company’s manufacturing facility and supporting quality management system are in conformity with the highest quality standards, bringing Henlius a step further to going global with high-quality products such as HANSIZHUANG.
Putting quality at the core, Henlius has been scaling up production capacity with Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. It has been putting in place a quality management system in accordance with the highest quality standards. The system covers the entire product continuum ranging from research and development to material management, product manufacturing, quality control, product supply management and product post-marketing surveillance. Its commercial production facilities and supporting quality management system have passed nearly 100 on-site inspections and audits conducted by the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the EU Qualified Person, and multiple international business partners. Notably, the inspected Xuhui Facility has a capacity of 24,000 liters. The site and its supporting quality management system have been certificated by the EU GMP in 2020, making it the first China- and EU-certified GMP site to manufacture self-developed antibody drug in China. Xuhui Facility and Songjiang First Plant, also with a capacity of 24,000 liters, hit a total capacity of 48,000 liters and 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 of capacity, making the total capacity hit 144,000 liters in 2026 to address the ever-increasing global market needs.
HANSIZHUANG is the company’s first innovative product and it was approved by the NMPA in China in March 2022. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC). It is the world's first anti-PD-1 mAb for the first-line treatment of SCLC. The marketing application of the first-line treatment for ES-SCLC is under review by the EMA. Henlius has been amplifying its reach by joining hands with more global partners such as KGbio and Fosun Pharma to speed up the regulatory progress of HANSIZHUANG in countries and regions such as ASEAN, MENA and the United States, a rosy outlook for benefiting more patients in the United States, Europe and emerging markets.
Previously, Henlius reached a collaboration agreement with KGbio in 2019, upon which KGbio is granted exclusive rights to develop and commercialise HANSIZHUANG in relation to its first monotherapy and two combination therapies in 10 ASEAN countries. In 2023, the cooperation has been expanded to MENA, covering a total of 22 emerging market countries. The BPOM inspection success stands a major step in bringing HANSIZHUANG to Indonesian market. Henlius will continue to support its partner KGbio in navigating the launch process of HANSIZHUANG in more emerging market countries. Staying true to the original aspirations of “affordable innovation and reliable quality”, Henlius will keep upholding high quality standards along the product life cycle and driving broader accessibility to high-quality medicines around the globe.
PIC/S is a co-operative arrangement between regulatory authorities in the field of GMP of medicinal products for human or veterinary use. It comprises more than 50 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia) and signs co-operation agreement with the international organisations such as the EMA, the ICH and the WHO. PIC/S aims at harmonising inspection procedures worldwide, developing common standards in the field of GMP and thus increasing mutual confidence between authorities. The PIC/S GMP guide has been the global standard in the field of GMP.
HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 4 indications are approved for marketing in China, 1 marketing application is under review in the EU, and more than 10 clinical trials are ongoing across the world.
HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC). The marketing application of the first-line treatment for ES-SCLC is under review by the EMA. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial approvals in China, the U.S., the EU and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine and the British Journal of Cancer, respectively. Furthermore, HASIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.