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Henlius Entered into a Collaboration with Promega to Develop the Companion Diagnostic Kit for Henlius' Serplulimab MSI-H Solid Tumours Indication

Shanghai, China, 5th August, 2021 - Shanghai Henlius Biotech, Inc. (2696.HK) announced the Company has entered into a collaboration agreement with Shanghai Promega Biological Products Co., Ltd. (Promega) to jointly develop and commercialize a companion diagnostic kit for the innovative anti-PD-1 mAb serplulimab. Henlius’ serplulimab and Promega’s companion diagnostic will be available in China (excluding Hong Kong, Macau and Taiwan regions) to provide precise MSI screening and appropriate immune therapy for more patients with solid tumors. Recently, the New Drug Application (NDA) of serplulimab for the treatment of MSI-H solid tumours has been granted priority review by the National Medical Products Administration (NMPA).

Companion diagnostic contributing to the widely used in the treatment of MSI-H solid tumours of serplulimab

Defective mismatch repair (MMR) in a tumor cell can lead to an insertion or deletion mutation (INDEL) in microsatellites during DNA replication, and the accumulation of incorrect mutations usually causes MSI-H. MSI-H occurs in several cancer types, such as endometrial cancer, colorectal cancer, gastric cancer, renal cell carcinoma, ovarian cancer, etc. In China, there are more than 300,000 newly diagnosed MSI-H solid tumour patients each year, according to the incidence of different tumor types and that of MSI-H in solid tumours. Patients who suffer from this disease usually have higher response rates for immune checkpoint inhibitors. Thus, MSI-H is becoming a more and more important biomarker for the immunotherapy predictions of patients with solid tumours.

The diagnostic method being co-developed under the new agreement is multiplex polymerase chain reaction (PCR) by capillary electrophoresis, which is regarded as the "gold standard" of MSI testing in the industry with high accuracy and specificity. Promega has more than fifteen years of experience in MSI research, and its MSI assay has been applied to several clinical studies around the world. By detecting a tumor’s MSI status, if the patient is MSI-H positive and meets the treatment criteria, the corresponding immunotherapy can be carried out without screening tumor sites and pathological classification, which aligns with the advanced concept of precision medicine.

Clinical trials cover comprehensive cancer types with high incidence, all-around international layout benefits emerging markets

Henlius has adopted a differentiated "Combo+Global" strategy on serplulimab. Currently, serplulimab has been approved for clinical trials in China, the United States, the European Union and other countries and regions. Steady progress has been made in the clinical studies of 10 immuno-oncology therapies of serplulimab that cover lung cancer (LC), esophageal carcinoma (EC), hepatocellular carcinoma (HCC), gastric cancer (GC) and head and neck squamous cell carcinoma (HNSCC), etc.,  based on the clinical demand. What’s more, several global multi-centre Phase 3 trials have been conducted and have enrolled about 2000 patients in China, Turkey, Poland, Ukraine, Russia, etc., which shows confidence and recognition on the quality of the product in the international market. Apart from international trials of serplulimab, Henlius also actively seeks international cooperation opportunities, especially with patients in emerging markets. The company has reached a collaboration agreement with PT Kalbe Genexine Biologics (KG Bio), upon which KG Bio is granted exclusive rights to develop and commercialize serplulimab in relation to its first monotherapy and two combination therapies in 10 Southeast Asian countries.

Reference Notes

[1] Yang G, Zheng RY, Jin ZS. Correlations between microsatellite instability and the biological behaviour of tumours. J Cancer Res Clin Oncol. 2019 Dec;145(12):2891-2899.
[2] Michael J Overman, Ray McDermott, Joseph L Leach, et al. Nivolumab in patients with metastatic DNA mismatch repair deficient/microsatellite instability-high colorectal cancer (CheckMate 142): results of an open-label, multicenter, phase 2 study[J]. Lancet Oncology, 2017,18(9):1182-1191.
[3] Aurelien Marabelle, Dung T Le, Paolo A Asciert, et al. Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study[J]. J Clin Oncol, 2020, 38(1): 1-10.