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Alphamab Oncology and CSPC Achieved an Licensing Cooperation on Anti-HER2 Bispecific Antibody KN026 in Mainland China

August 24, 2021 09:09 Eastern Daylight Time

Suzhou, China, August 24, 2021 - Alphamab Oncology (stock code: 9966 HK) announced today that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab” or “the Company”), a wholly-owned subsidiary of Alphamab Oncology, signed a contract with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of the company's proprietary anti-HER2 bispecific antibody KN026 in Mainland China. The totaldeal size reaches 1 billion RMB, and the Company will receive a double-digit royalty based on sales revenue.


According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in mainland China (excluding Hong Kong, Macau and Taiwan), and bear the cost of all planed clinical trials in territory; In addition, JMT-Bio will devote joint efforts with Alphamab to develop more potential indications of KN026 single agent or combo treatment in other solid tumors . Alphamab Oncology will receive 150 million RMB upfront payment, with up to 850 million RMB development and sales milestone payments, and will receive a double-digit royalty based on sales revenue.


KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). It can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated equivalent efficacy compared with the combination of Trastuzumab and Pertuzumab and was superior to either single agent in HER2-positive tumor cell lines. Data from several clinical studies have shown that in patients with HER2-positive GC/GEJ or breast cancer, even after first-line or multi-line treatment, KN026 still demonstrated positive data, especially for patients with GC/GEJ.


About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.


KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.


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 bispecific 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.


About CSPC

CSPC Pharmaceutical Group Co., Ltd. (CSPC) is a nation-level innovative enterprise integrating R&D, production and sales of innovative drugs. The group owns assets totaling 50 billion RMB and 27,000 employees. CSPC has shaped the “Red Chip + A” financing pattern, with two subsidiaries listed on HKEX and A-shares respectively. The Hong Kong-Listed Company (01093.HK), with market value of 100 billion, is a constituent stock of the Hang Seng Index (HSI).


In 2020, CSPC invested nearly 3 billion RMB in R&D. Throughout the group, there are 2,000 employees specializing in R&D, more than 200 of which have doctor's degrees or international experience. Until now, CSPC has launched around 300 innovative drug projects, comprising of over 40 ongoing projects on innovative target macromolecule drugs, over 40 on innovative small molecule drugs, and over 20 on new preparations.


Between the 10 or more pharmaceutical production bases located in Hebei, Shanxi, Shandong, Jiangsu, Jiangxi, Tianjin and other regions, we sell products to more than 100 countries and regions around the world. Among them, 36 varieties have made over 100 million RMB in sales.


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.