First Patient Completed Dose Administration in Phase III Registrational Clinical Study of Kelun-Biotech SKB264 for the Treatment of Second-line and Above HR+/HER2- Breast Cancer

First Patient Completed Dose Administration in Phase III Registrational Clinical Study of Kelun-Biotech SKB264 for the Treatment of Second-line and Above HR+/HER2- Breast Cancer Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (otherwise known as Kelun-Biotech, stock code: 6990.HK) completed the first patient dose administration in China for its Phase III registrational study of the innovative TROP2 ADC product, SKB264 (also known as MK-2870) recently. This study, led by Professor Xu Binghe from the Cancer Hospital of Chinese Academy of Medical Sciences, is investigating the use of SKB264 for the treatment of second-line and above hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer.   SKB264 (MK-2870), which is jointly developed with MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA), is one of the core products of Kelun-Biotech and possesses independent intellectual property rights, is the first domestically produced TROP2-ADC to secure Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of HR+/HER2- breast cancer and has subsequently entered into Phase III registrational studies. Accordingly, Kelun-Biotech has carefully designed a comprehensive development plan for this core asset in China. Currently, SKB264 monotherapy is being investigated in Phase III registrational clinical studies for HR+/HER2- breast cancer patients in the second-line setting and beyond. Additionally, SKB264 in combination or uncombination with A167 (anti-PD-L1 monoclonal antibody) is undergoing Phase II investigational studies in first-line patients. In addition, SKB264 for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior systemic therapies, with at least 1 of those therapies targeting an advanced or metastatic stage, has been approved for in Priority Review by the CDE.   According to the latest data of the International Agency for Research on Cancer (IARC), 2.3 million new cases of breast cancer occurred worldwide in 2020, accounting for about 25% of female malignancies. Surpassing lung cancer for the first time, it is becoming the most common malignant tumor and poses a serious threat to the health of women worldwide. The annual number of new cases of female breast cancer in China (416,000) is far higher than that in other countries, ranking first in the world. Approximately 60% of breast cancer patients in China have tumors that express HR+/HER2-, and about 70%[1-2] with a higher proportion abroad. As SKB264 (MK-2870) progressively advances into the Phase III registrational clinical study for second-line and above HR+/HER2- breast cancer, and successfully administered the initial patient dosage, this provides an encouraging indication that SKB264 (MK-2870) is poised to benefit a larger population of HR+/HER2- breast cancer patients in the near future.   About SKB264 (MK-2870) SKB264 is an innovative TROP2-directed ADC which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with a DAR of 7.4 (novel topoisomerase I inhibitors)  [3] .    SKB264 has received 3 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC), locally advanced or metastatic EGFR-mutated non-small cell lung cancer which has failed EGFR-TKI therapy, and locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer which has received at least second-line systemic therapy. Based on preliminary clinical data, SKB264 is currently being evaluated in Phase Ⅱ and Phase Ⅲ clinical trials as either a single agent or combination therapy in multiple solid tumors. Domestic development: the Phase Ⅲ registrational clinical study of SKB264 monotherapy in patients with advanced or metastatic TNBC who have failed at least second-line therapy has arrived the primary endpoint and is expected to be the first domestic TROP2-ADC to be approved for marketing. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant EGFR-mutated NSCLC are rapidly advancing. Several Phase Ⅱ clinical studies in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are conducting smoothly. Developments abroad: Kelun-Biotech has granted MSD the exclusive rights to develop, manufacture, and commercialize SKB264 (MK-2870) in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). Currently, MSD has initiated a clinical study of MK-2870 EGFR-mutant NSCLC, and several other global multicenter registrational clinical studies are under preparation.   About Kelun-Biotech Kelun-Biotech（6990.HK）is a subsidiary of Kelun Pharmaceutical Holdings, which focuses on the R&D, manufacture, commercialization and international cooperation of biotechnology-derived pharmaceuticals and innovative small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug development and industrialization platform around the unmet clinical needs of the world and China, the Company is committed to becoming an internationally leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed, and 4 ADCs are in clinical trials (including 2 in the registrational Phase III or NDA filing stage), along with several projects in preclinical development. At present, the company has 33 innovative projects for the treatment of major diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 projects are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries including China, Europe, and the United States. To learn more, please visit https://kelun-biotech.com/  .   References: [1] 郑莹, 等. 中国癌症杂志, 2013(08):10-18. [2] DeSantis CE, et al. CA Cancer J Clin, 2016, 66(1):31-42. [3] Cheng Yezhe, et al. Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. Frontiers in Oncology, Vol 12, 2022.   Forward-Looking Statements This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.   It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.

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