on december 2, a sunny, warm and joyful day, the cold-chain truck loaded with envafolimab, the world’s first subcutaneously injected pd-l1 antibody, left alphamab oncology, carrying the hope of "innovative medicine for a better life", is about to go to the whole country and put them into the battle on the front line of anti-tumor. this is the first shipment of envafolimab, co-developed by alphamab oncology (stock code: 9966.hk), 3dmed and simcere (02096.hk), following its approval in china on november 25 2021, and start a new era of 30-second dosing for making cancer manageable and curable.
envafolimab is a single domain fc fusion pd-l1 antibody invented by alphamab oncology. in the development, considering the pain of multiple treatments and long-time administration for tumor patients, and the clinical needs of patients with venous atrophy or intravenous infusion intolerance, alphamab oncology has taken a new approach to discover antibody candidates, making breakthroughs in stability, high concentration and engineering, and successfully developed subcutaneously injected pd-l1 inhibitors.
with the innovation of subcutaneous injection, envafolimab has made an impressive mark in the history of china's biopharmaceutical research and development. it is the world's first and only subcutaneously injected pd-l1 antibody approved for marketing, the world's first single-domain antibody approved for the treatment of cancer, the first self-discovered camel-derived nanobody in china, and the first domestic pd-l1 antibody approved for marketing in china. compared with other pd-(l)1 antibodies, it has differentiated advantages such as stability at room temperature, small single injection volume, convenient administration process, less injection site restriction, and good safety. it is of great value to reduce the occupation of medical resources, to make cancer manageable and curable, and improve the quality of life of patients.
it took 10 years from r&d to the approval of envafolimab, and 7 days to deliver the first commercial product shipment. every time we overcome difficulties, it comes from alphamab oncology 's unremitting pursuit to provide patients with high-quality, affordable and innovative drugs with significant clinical value. we look forward to fully exploring its clinical value and innovative advantages with our partners, so that more patients can see the hope of curing tumors and experience the beauty of life.
envafolimab is manufactured at alphamab oncology, and the company has state-of-the-art manufacturing capabilities designed and built to meet nmpa and eu/fda’s cgmp standards, so that it can provide innovative biological medicines with good safety, efficacy and affordable for cancer patients.
about envafolimab（kn035）
envafolimab is a single domain fc fusion pd-l1 antibody independently invented by alphamab oncology，and co-developed with 3d (beijing) medicines since 2016. on march 30, 2020, alphamab oncology, 3dmed, and simcere reached a strategic cooperation, whereby alphamab oncology is responsible for production and quality control, and 3dmed is responsible for the clinical development in oncology field, and simcere is responsible for the exclusive commercial promotion of products in mainland china.
based on its unique design that allows rapid subcutaneous injection, it has advantages of improved safety, convenience in drug administration, and treatment compliance. patients do not require an intravenous infusion which lowers medical costs. at present, envafolimab is being studied in clinical trials in multiple tumor types in china, the united states and japan, including registration/phase iii clinical trials in multiple indications. envafolimab obtained orphan drug designation from the us fda for the treatment of advanced biliary tract cancer and soft tissue sarcoma. in november 2021, envafolimab obtained the market approval by the chinese national medical products administration for the treatment of msi-h or dmmr advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options.
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.
