on 26 november 2021, alphamab oncology (stock code: 9966.hk)，3d medicines (beijing) co., ltd. (3dmed), and simcere pharmaceutical group limited (simcere) jointly announced that envafolimab (kn035), the world's first single-domain pd-l1 antibody formulated for subcutaneous injection (sc) co-developed by the three companies, has received marketing authorization from the chinese national medical products administration (nmpa). the approved indication for envafolimab is for adult patients with microsatellite instability-high (msi-h) or mismatch repair deficient (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.
currently, all marketed pd-1 and pd-l1 antibody drugs are marketed as intravenous injectable (iv) in china and globally. the average time for administration is 0.5-2 hours.
as the world's first sc pd-l1 antibody, envafolimab can be administered within 30 seconds—significantly shortening treatment time, while sparing the patients from various adverse reactions arising from intravenous infusion. it provides an alternative treatment option for the cancer patients who are intolerant to iv injection and have otherwise no accessibility to immunotherapy. the nature of sc injection make it possible to be administered in community hospitals or even at home, therefore reserving healthcare resources in china and promoting the implementation of hierarchical diagnosis and treatment policy.
a pivotal phaseⅱclinical study, led by professor lin shen from peking university cancer hospital and institute，has evaluated the efficacy and safety of envafolimab in patients with advanced dmmr/msi-h tumors. the updated clinical data presented at csco 2021 showed that the objective response rate (orr) of patients who received envafolimab as second or later-line treatment is 44.7%, including 12 (11.7%) cases of complete response (cr). the responses were durable, and the rates of durable response at 12 months in patients with advanced colorectal cancer (crc), advanced gastric cancer, other advanced solid tumors, and all patients were 89.3%, 100%, 100%, and 93.2%, respectively. the median progression-free survival (pfs) was 11.1 months, 12-month overall survival (os) rate was 73.6%. envafolimab was well tolerated in this study with no cases of immune-related pneumonitis, immune-related colitis, or immune-related nephritis reported.
dr. ting xu, chairman and ceo of alphamab oncology, commented, “since discovering envafolimab, we have been driven by the clinical needs of patients and the differentiated advantages to develop and launch the world’s first and only subcutaneously injected pd- l1 inhibitor with our partners, and continue to develop this product that has a global competitive advantage. we will continue committing to the mission of the company, to make cancer manageable and curable, leveraging the competitive advantages of our integrated proprietary biologics platforms, and keep on developing breakthrough next generation therapies for cancers, so that more patients can benefit from biotechnology progress."
dr. zhaolong gong, chairman and ceo of 3dmeds, added, “envafolimab is our first product reaching commercial stage codeveloped with partners and investigators. we have built a robust pipeline based on our belief that cancer is increasingly being managed as a chronic disease. the launch of envafolimab proves our capabilities from preclinical discovery, to ind and nda. through strategic cooperation with our partners, we will deliver the world’s first subcutaneous pd-l1 antibody to cancer patients, and help them live longer and better."
mr. jinsheng ren, chairman and ceo of simcere pharmaceutical, commented: "simcere's mission is ‘providing today’s patients with medicines of the future’, namely, new drugs with greater clinical significance, including better patient compliance. as the first subcutaneous pd-l1 antibody approved globally, envafolimab brings to the world a brand-new method of administrating pd-l1 antibody that has the potential of changing the game in immunotherapy. subcutaneous injection is safer and more convenient than traditional iv infusion, therefore providing a new therapy option to patients with better treatment experiences and quality of life. i wish to thank our partners and the dedicated clinical experts for their fruitful efforts. we will accelerate the commercialization of this innovative drug and make it available to patients sooner."
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.
