the 2021' china healthcare summit of entrepreneurs, scientists and investors (referred to as "chsesi") organized by the china pharmaceutical enterprise association, china medicinal biotech association, and general office of the central committee of chinese peasants and workers democratic party, is held from december 21 to 23 online and announced the 2021 top 100 chinese pharmaceutical innovative enterprises list. alphamab oncology was listed for the third consecutive year.
in order to deeply analyze the innovation capability and sustainability of china's pharmaceutical industry, healthcare executive started from may 2019, through model building, data collection and sorting, from the status quo of pharmaceutical innovation, with enterprises as the main body and based on hard data, through the three dimensions of innovation foundation, innovation process and innovation results, with the number of authorized patents, total number of patent citations, the number of clinical trials and the number of innovative drugs approved and marketed as the basis for evaluation, selected the "top 100 chinese pharmaceutical innovation enterprises" representing china's pharmaceutical innovation strength. this year is the third year that chsesi has released the list. alphamab oncology has been selected as one of the top 100 three times, demonstrating the company's outstanding innovation and sustainable development capabilities.
as a leading innovative biopharmaceutical company in china, under the leadership of dr.ting xu, alphamab oncology has created several unique and competitive technology platforms, such as a heterodimeric bispecific antibody platform, a charge repulsion induced antibody mixture(crsm) platform, and a site-specific conjugation platform, and built a biopharmaceutical industrialization base that meets international standards. the company has a fully integrated platform from early research and development of innovative drugs, clinical research and development to large-scale commercial production capabilities. its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a covid-19 bispecific antibody: 3 products have been granted four orphan drug designations by the us fda; 3 products have entered phase iii or pivotal clinical trials; 4 products are being investigated in more than 30 clinical studies worldwide.
on november 24 2021, the company’s first commercial product, envafolimab, received marketing authorization from the chinese national medical products administration(nmpa), creating a number of firsts: the world’s first subcutaneously administered pd-l1 inhibitor, china’s first and only immunotherapy drug with cross-tumor indications, and china’s first approved domestic pd-l1. it is an important step towards the ultimate realization of the company's mission, to make cancer manageable and curable.
currently, relying on the advantages of its proprietary technology platforms, the company continues to empower the expansion of its product pipeline and explore next-generation breakthrough anti-tumor therapies, such as the investigational pd-l1/ox40 bispecific antibody kn052, anti-her2 paratopes bispecific adc candidate jskn003. in the coming years, the company will continue to move forward at a rate of 2 to 3 inds per year, and strive to provide more innovative treatment options for cancer patients around the world, delivering hope.
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. in november 2021, envafolimab received marketing authorization from the chinese national medical products administration (nmpa) for the treatment of previously treated msi-h/dmmr advanced solid tumors.
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.
