bla submitted for kn035 (envafolimab)-凯发vip

english 中文简体 中文繁体

bla submitted for kn035 (envafolimab)-the world’s first subcutaneous pd-l1 antibody

november 16, 2020 20:55 eastern daylight time


november 16, 2020 - alphamab oncology (“jiangsu alphamab”,stock code: 9966.hk), 3d medicines inc. ("3dmed") jointly announced that the biologic license application (bla) of recombinant humanized pd-l1 single domain antibody (compound code: kn035, international nonproprietary name: envafolimab), has been submitted to the national medical products administration (nmpa). the applied indication is for the treatment of microsatellite instability-high (msi-h)/mismatch repair deficient (dmmr) advanced colorectal cancer, gastric cancer and other solid tumors that have failed the previous standard of care. simcere pharmaceutical group co., ltd. (“simcere) will be responsible for its commercialization and promotion in mainland china.


kn035 (envafolimab) is a single domain fc fusion pd-l1 antibody originally developed by alphamab oncology with a co-development formed with 3dmed, which is responsible for the clinical development in tumor indications. kn035 is the first single domain antibody for tumor immunotherapy and formulated with our proprietary technology for subcutaneous injection. kn035 (envafolimab) has obvious advantages in terms of safety, compliance and easy to use and cost reduction.


this application is based on kn035 monotherapy data from a pivotal phase ii trial(nct03667170) in advanced solid tumor patients with microsatellite instability-high (msi-h) / mismatch repair deficient (dmmr) . this was a single-arm open-label study with orr as primary endpoint according to blinded independent review committee (birc) evaluation.


a total of 103 patients were enrolled in the study. the birc confirmed objective response rate (orr) in all comers (n = 103) was 42.7%, and the orr in crc (n = 65) patients was 43.1%. the orr in gc patients (n = 18) was 44.4% and the orr in other solid tumors (n = 20) was 40.0%. the median duration of overall response (dor) assessed by birc in the overall population has not yet been reached and the 12-month dor rate was 92.2%. the median progression-free survival (pfs) was 11.1 months. the median overall survival (os) has not been reached and 12-month os rate was 74.6%. the incidence of grade 3 or 4 treatment related adverse events (traes) was 16%, and no trae resulted in death. the incidence of grade 3 or 4 immune related adverse event (irae) was 8%, and no immune-related pneumonia, colitis, nephritis, and neurotoxicity occurred. injection site reactions occurred in 9% of patients, all of which were grade 1 or 2.


dr. ting xu, founder, chairman and ceo of alphamab oncology, commented, “kn035 (envafolimab) is the first single domain antibody submitted for marketing authorization by alphamab oncology,and expected to become the world's first subcutaneous injectable pd-(l)1 inhibitor.  this application shows alphamab oncology's leading edge in differentiated innovation. we look forward to the approval of kn035; colloaborating with our partners, 3dmed and simcere, we plan to further develop kn035 in other major indications and rapidly penetrate the market, so as to benefit more patients. at the same time, we will continue to develop more safe, effective and globally competitive innovative drugs. "


john gong, ph.d., m.d., chairman and ceo of 3d medicines inc., commented, “after signing the collaboration agreement with alphamab oncology in february 2016, we have been rapidly pushing forward the global clinical development of envafolimab. since the first patient dosed in the u.s., nearly 1,000 patients have been recruited globally in our clinical trials, proving the safety and efficacy of envafolimab. with the concerted efforts of our partners, we have finally reached the historic moment of filing the new drug application for envafolimab. taking envafolimab as the starting point, we will intensify our efforts for the research and development of more innovative drugs, and strive to provide cancer patients in china and the world with more effective, more accessible, and more convenient options of next-generation immuno-oncology drugs, in ways to achieve our vision of ‘helping people with cancer live longer and better’."


ren jinsheng, board chairman and ceo of simcere said,” we are delighted to achieve such a milestone in the kn035 project with collaboration of alphamab oncology and 3d medicines. with distinctive characteristics and advantages such as subcutaneous injections, we believe it will truly benefit more patients and greatly improve compliance among them. furthermore, we have huge confidence that the strategic partnership will enable synergy in its commercialization in china and more indications being investigated, in efforts to provide more patients with medicines of the future.”


about kn035

kn035 (inn name: envafolimab) is a single domain fc fusion pd-l1 antibody independently invented by alphamab oncology. based on its unique design, it has advantages to improve safety, convenience in drug administration, and treatment compliance. it can be used for patients who are not suitable for intravenous infusion and lowers the occupancy of medical resource and cost. on march 30, 2020, alphamab oncology, 3dmed, and simcere reached a strategic cooperation. alphamab oncology is responsible for the 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. at present, kn035 (envafolimab) has been simultaneously conducting clinical trials for multiple tumor indications in china, the united states and japan, and multiple indications have entered registration/phase iii clinical trials. kn035 (envafolimab) has obtained the u.s. fda's orphan drug designation for advanced biliary tract cancer.


about alphamab oncology

alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. 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 pipeline includes eight anti-tumor drug candidates including mainly bi-specifics, and a covid-19 multifunctional antibody. four products have advanced into phase i-iii clinical trials in china, the united states, and japan.


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.

visit http://www.alphamabonc.com for more information.


about 3d medicines

3d medicines, inc. is a biopharmaceutical company at the stage of late clinical development and early commercialization. taking “help people with cancer live longer and better” as our concept, 3d medicines aims at the future long-term survival of tumor patients and focuses on the development of personalized next-generation immuno-oncology drugs, helping the tumor patients to live with prolonged survival time and a better quality of life. 3d medicines has established a pipeline with both innovative biological and small-molecule anti-tumor drugs, as well as a professional team capable of global development, registration and commercialization operation for new drugs.  

for more information, please visit www.3d-medicines.com


about simcere

simcere pharmaceutical group (stock code: 2096.hk) is rapidly transitioning to an innovation and r&d-driven pharmaceutical company, with a mission of “providing today’s patients with medicines of the future.” it has established a national key laboratory of translational medicine and innovative pharmaceuticals. simcere focuses on oncology (including cell therapy), central nervous system disease and autoimmune disease therapeutic areas, with a diversified product portfolio and industry-leading capabilities. its vigorous in-house r&d efforts and extensive r&d collaborations have made it a strategic cooperation partner with world leading pharmaceutical companies and biotechnology companies, in an effort to bring more global life science breakthroughs to china.

for more information, please visit: www.simcere.com


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.