Collaboration between Kelun-Biotech and Merck Sharp & Dohme on core product SKB264 (MK-2870) triggers relevant clinical milestone payments

Clinical trials in non-small cell lung cancer (NSCLC) and endometrial cancer (EC) conducted by Kelun-Biotech and Merck Sharp & Dohme for the core product of the collaboration, SKB264 (MK-2870), have triggered relevant clinical milestone payments totaling $75.0 million. The Company has received a portion of the payment from Merck Sharp & Dohme and expects to receive the balance in the near future.   Collaboration Update:   In May 2022, Kelun-Biotech granted Merck Sharp & Dohme exclusive rights to develop, manufacture and commercialize SKB264 (MK-2870) in all territories outside of Greater China.   Merck Sharp & Dohme announced that it has initiated three pivotal Phase 3 clinical trials evaluating SKB264 (MK-2870) as a monotherapy for the treatment of previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations or other genomic alterations, as a monotherapy for the treatment of endometrial cancer (EC) previously treated with platinum-containing chemotherapy and immunotherapy, and with pabopoetin. ), and in combination with pembrolizumab for metastatic NSCLC with programmed death ligand 1 (PD-L1) expression greater than or equal to 50%.   Based on written confirmation from Merck Sharp & Dohme, clinical trials in NSCLC and EC have triggered related clinical milestone payments totaling $75.0 million. The Company has received a portion of the payment from Merck Sharp & Dohme and expects to receive the balance in the near future.   About SKB264 (MK-2870, trade name: Jatelle)   SKB264 is a representative and innovative ADC targeting TROP2 developed by OptiDC, the internationally renowned ADC development platform of Kelun-Biotech. SKB264 consists of a humanized anti-TROP2 monoclonal antibody with high affinity and targeting properties, which is conjugated to the toxin small molecule T030 (topoisomerase I inhibitor) through the stability-optimized CL2A linker. T030 (topoisomerase I inhibitor) with an average drug-antibody ratio (DAR) of 7.4. The stability of SKB264 is enhanced in two ways, allowing more ADCs to reach tumor cells. On the one hand, the antibody end of the linker uses a methylsulfonylpyrimidine linker that irreversibly couples to the antibody, and on the other hand, T030 contains a methylsulfone structure that binds stably to the toxin end of the linker.SKB264's linker combines both extracellular pH-sensitive cleavage of the tumor cell and intracellular enzymatic cleavage of the tumor cell, which allows for the highly efficient release of the toxin's small molecules and the exertion of an antitumor effect.The activity of T030 is comparable to that of DXd and has a bystander effect. In summary, SKB264 has a triple antitumor effect: first, the pH-sensitive linker can be cleaved to release T030 in the acidic tumor microenvironment; second, SKB264 can be endocytosed into the tumor cell and then cleaved to release T030 by zymotics; finally, T030 can transcend the cell membrane to exert the bystander effect to kill the surrounding tumor cells. Finally, T030 can pass through the cell membrane and exert a “bystander effect” to kill the surrounding tumor cells. Good stability, high affinity antibody, high DAR value, high active toxin, triple anti-tumor effects become the cornerstone of SKB264's potent anti-tumor effect, which has also been initially confirmed in clinical studies.   About Kelun-Biotech:   Kelun-Biotech （ 6990.HK ） is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC?, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/ .

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