on december 6 2021, alphamab oncology (stock code: 9966.hk), 3d medicines (beijing) co., ltd. (3dmed), and simcere pharmaceutical group limited (simcere) jointly announced that the press conference was held in beijing for the launch of the world's first subcutaneously injected pd-l1 antibody envafolimab, which has received marketing authorization from the chinese national medical products administration (nmpa), providing a new treatment option for cancer patients in china.
professor shen lin from peking university cancer hospital and professor jianming xu from the first medical center of pla general hospital communicated with the journalists on the clinical value, unique differentiation advantages and future application prospects of envafolimab. dr. feng wang, vice president of simcere hosted the press conference. dr. ting chen, senior director of manufacturing of alphamab oncology, fang xia, secretary of the board of directors of 3d medicines, and jianxue lu, vice president of simcere, as corporate representatives, answered reporters’ questions and introduced the research and development process of this chinese original innovative drug and its commercial plan.
domestic anti-tumor antibody, reached a number of "first" achievements
from the perspective of patient needs, the developers and clinical investigators of envafolimab have made siganificant innovations in both molecular and clinical design, and reached a number of "firsts": the world's first subcutaneously injected pd-l1 antibody, the first immunotherapy product for a pan-tumor indication in china and the first domestic pd-l1 antibody drug.
professor shen lin, the principal investigator of envafolimab commented: “the immune system is very active under the skin, so subcutaneous administration is logical for immunotherapy. however, the change from intravenous to subcutaneous administration is a completely different development strategy, not a simple change of the dosage form. in addition, envafolimab is also the first pan-tumor immunotherapy drug in china, and there is no precedent for the development of envafolimab in the msi-h/dmmr indication, which requires researchers to explore by themselves. this is a real innovation in china.
we are pleased to see that chinese innovative drug research and development has made great progress in recent years. in the past, new drug development in europe and the us mainly focused on the highly prevalent diseases in the west. domestic companies could understand chinese patients better and make better communication with chinese clinical experts, developing new drugs more suitable for chinese patients. we believe that china's innovative drugs will further flourish in the future, benefiting patients both in china and the world.”
subcutaneous injection, allowing patients to receive treatment in community clinics
the unique molecular structure design of envafolimab provides the possibility of its formation by subcutaneous injection, and the dosage is only one-eighth of that of similar intravenous drugs. on the safety and convenience of envafolimab, professor jianming xu, who is the principal investigator of the phase i clinical study, commented: “in terms of the mechanism of action, pd-l1 antibody has relatively fewer immune-related adverse reactions. the results from phase i clinical study has built our confidence in the follow-up clinical development. with low dosage, it has advantages in safety and improved convenience.
patients who received immunotherapy often need long-term medication for up to two years. during this period, patients need to travel to and from the hospital repeatedly for inpatient infusions, which is difficult under the impact of the pandemic, especially for patients in off-site locations. envafolimab is expected to be administered in community clinics and even promoted for home treatment in the future, demonstrating its convenience. it can also be combined with other drugs in the future to further expand new indications.”
china's first pan-tumor immunotherapy with promising application
the phase ii clinical trial of envafolimab is the first pan-tumor clinical study in china for patients with msi-h/dmmr advanced solid tumors. the updated data presented at the 2021 csco annual meeting showed that the objective response rate (orr) in the treatment of ≥second-line patients was 44.7%, including 12 (11.7%) cases of complete response (cr).
professor lin shen said: “the study is a basket trial, i.e., a clinical trial design method for precision treatment. the successful launch of envafolimab has played an important role in demonstration. envafolimab achieved an orr of over 40% in msi-h patients with more than a dozen tumor types, including colorectal cancer, gastric cancer, endometrial cancer, prostate cancer, and bile duct cancer, confirming its efficacy is comparable to iv pd-(l)1 products, and most of the patients who benefited are still taking the drug and their os are expected to be improved. the updated data will be presented next year. although the percentage of msi-h, a biomarker, varies in different cancer types, such as only 1% - 2% in gastric cancer, gastric cancer incidence is high in china, and these patients can follow the results of this study and choose the appropriate drug.”
in addition to the marketed indication, several clinical studies of envafolimab is being conducted, such as another pan-tumor study in patients with tmb-h, and the study of envafolimab combined with anti-angiogenic drugs. for the expansion of the drug's indications, clinical experts said that dual immunotherapy exploration could be attempted with envafolimab to improve the efficacy, as well as in a broad range of indications for which immune checkpoint inhibitors have been approved.
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.
