nmpa grants priority review to the bla for envafolimab(kn035)-凯发vip

english 中文简体 中文繁体

nmpa grants priority review to the bla for envafolimab(kn035)

janurary 19, 2021 08:00 eastern daylight time

january 19 2021- alphamab oncology (stock code: 9966.hk) announced that, the recombinant humanized pd-l1 single-domain antibody envafolimab (project code: kn035) was granted priority review by the center for drug evaluation (cde) of the national medical products administration (nmpa). the envafolimab bla is accepted for the treatment of microsatellite instability-high (msi-h) advanced colorectal cancer, gastric cancer / mismatch repair deficient (dmmr) advanced solid tumors that have failed previous standard of care.


with the development of immunotherapy and combination therapy, many cancers are expected to become "chronic diseases" in the future, which can be controlled or even cured. the demand for less invasive application of medicine, eg. subc formulation of biologicsfor cancer patients is increasing. as the world's first subcutaneous pd-(l)1 inhibitor, envafolimab has shown good safety and efficacy in multiple clinical trials with >1000 patient enrolled. in addition, compared with other pd-(l)1 antibodies on the market or currently under development, envafolimab also has the advantages of stability at room temperature, small single injection volume, fast administration process, and fewer injection site restrictions. it could be an innovative treatment option for cancer patients and improve their quality of life.


priority review is a procedure established to encourage r&d of new drugs and accelerate the review and approval of new drugs with obvious clinical value and urgent clinical needs. according to the new "drug registration rules" ("drr") (samr order no.27) and working procedures for priority review and approval of drug marketing authorization (interim) (no. 82 of 2020) implemented on july 1, and july 7, 2020, respectively, once granted priority review, the regulatory authority will prioritize the review process and resource for applications with expected shorter review timelines.


about envafolimab (kn035)

envafolimab (inn name: kn035) 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. patients don’t need intravenous drip and the occupancy of medical resource and cost will be lower. 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, envafolimab (kn035) 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. envafolimab (kn035) has obtained the u.s. fda's orphan drug designation for advanced biliary tract cancer. the national medical products administration (nmpa) officially accepted the biologic license application (bla) for envafolimab (kn035) and granted priority review.


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 highly differentiated in-house pipeline includes eight tumor monoclonal antibodies and bispecific antibodies and a covid-19 multifunctional antibody. four products have advanced into phase i-iii clinical trials or pre-marketing stage in china, the united states, japan and australia. the bla for envafolimab (kn035) has been accepted and granted priority review by the national medical products administration (nmpa).


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 an 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 clinical-stage biopharmaceutical company with a mission to help people with cancer live longer and better. envisioning a future when cancer is managed as a chronic disease, 3d medicines focuses on the development of differentiated next-generation immuno-oncology drugs, helping cancer patients live with prolonged survival time and a better quality of life. 3d medicines has established a pipeline with both next-generation biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.

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.