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        Alphamab Oncology and Raygene Pharmaceutical Announced Partnership to Develop Combination Therapy of Bispecific Antibody KN046 and Small Molecule Drug RG001

        September 28, 2021 08:28 Eastern Daylight Time

        Suzhou, September 28,2021 - Alphamab Oncology (stock code: 9966.HK) announced, the company has entered a partnership agreement with Hangzhou Raygene Pharmaceutical Co., Ltd (Raygene Pharmaceutical) to jointly develop the combination therapy of the PD-L1/CTLA-4 bispecific antibody KN046 and the small molecule drug RG001 for the posterior line treatment of advanced HCC and liver metastasis CRC.

         

        Liver cancer and colorectal cancer are the common types of gastrointestinal cancers. According to the latest global cancer burden data released by the World Health Organization in 2020, liver cancer is the sixth most common cancer worldwide, and the third leading cause of cancer-related death globally. Over 50% of new cases and deaths occurred in China. Colorectal cancer is the third most common cancer worldwide and the second most common tumor in China. 83% of colorectal cancer patients in China were at a middle or advanced stage when diagnosed, and 44% of them had liver/lung metastasis.

         

        KN046 is a bispecific antibody independently developed by Alphamab Oncology, which simultaneously targets PD-L1 and CTLA-4 immune checkpoints and could effectively activate T cells and enhance immune anti-tumor ability. The Phase II clinical data of KN046 combined with Lenvatinib in the first-line treatment of HCC were published at the ESMO 2021. KN046 in combination with Lenvatinib in first line HCC achieved 57% and 76% ORR and 95% and 95% DCR by RECISCT 1.1 and imRECIST, respectively. Based on the results from this study, a global phase III clinical study of KN046 in combination with Lenvatinib for the first line treatment of hepatocellular carcinoma is justified and currently in the planning phase.

         

        RG001 (TATE) is a proprietary anti-tumor small molecule drug licensed in from abroad by Ruizhen Pharmaceutical. It could be acted as prodrug and transformed to cytotoxic metabolites in hypoxic tumor cell, and resulted in tumor cells killed. According to pre-study, it could achieve a synergistical effects to enhance anti-cancer capacity when combined with other immune checkpoint inhibitors.

         

        According to the agreement, Alphamab Oncology and Raygene Pharmaceutical will conduct clinical trials evaluating safety and efficacy of KN046 plus RG001 or in sequential combination for the posterior line treatment of advanced HCC, CRC liver metastasis and other indications jointly decided by both parties, and to bring new options to patients who have progressed after receiving chemotherapy, small molecule targeted therapy or PD-1 therapy.

         

        About KN046

        KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a different mechanism CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg(suppress tumor immunity) clearing function.

         

        There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, TNBC, ESCC, HCC and pancreatic cancer in Australia and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab has received FDA clearance to enter phase Ⅱ trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA's orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.

         

        About Alphamab Oncology

        Alphamab Oncology is focusing on innovation, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.

         

        Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).

         

        The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA’s cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.

         

        Alphamab Oncology Forward-Looking Statements

        This press release contains statements related to our future business and financial performance and future events or developments involving Alphamab Oncology that may constitute forward-looking statements. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. We may also make forward-looking statements in other reports, in presentations, in material delivered to shareholders and in press releases. In addition, our representatives may from time to time make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Alphamab Oncology’s management and business operation, many of which are difficult to predict and generally beyond Alphamab Oncology’s control. These are subject to a number of risks and uncertainties, including but not limited to, uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Alphamab Oncology's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding and Alphamab Oncology’s disclosures. Should one or more of these risks or uncertainties materialize or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. Other than as required by applicable law, Alphamab Oncology undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.