kn035 (envafolimab) bla accepted by the national medical products administration-凯发88

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kn035 (envafolimab) bla accepted by the national medical products administration

december 22, 2020 08:00 eastern daylight time

december 22, 2020 - alphamab oncology (stock code: announced that, the biologic license application (bla) for the recombinant humanized pd-l1 single domain antibody (compound code: kn035, international nonproprietary name: envafolimab) which codeveloped with 3d medicines inc. ("3dmed") and simcere pharmaceutical group co., ltd. ("simcere") has been accepted by the national medical products administration (nmpa) on december 17. the applied indication is for the treatment of microsatellite instability-high (msi-h)/mismatch repair deficient (dmmr) advanced colorectal cancer, gastric cancer and other advanced solid tumors that have failed previous standard of care. kn035 (envafolimab) is the first bla submitted by alphamab oncology,expected to become the world's first subcutaneous pd-(l)1 inhibitor, and to solve unmet clinical needs.

microsatellite instability-high (msi-h) is widely presented in multiple solid tumors. in solid tumors such as gastric cancer (gc), colorectal cancer (crc), biliary tract cancer, prostate cancer and endometrial cancer, the incidence of msi-h is relatively high. many clinical studies have proved that microsatellite instability (msi-h)/ mismatch repair deficient (dmmr) is an important predictive biomarker for tumor immunotherapy, and these patients are more likely to benefit from treatment with immune checkpoint inhibitors such as pd-l1. kn035 (envafolimab) is expected to become the first pd-( l )1 antibody approved by nmpa for msi-h/dmmr solid tumors in 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 multiple tumor indications. clinical results show good safety and efficacy. this bla is based on a pivotal phaseⅱclinical trial that evaluates kn035 (envafolimab) as a monotherapy for the treatment of microsatellite instability (msi-h)/ mismatch repair deficient (dmmr) advanced solid tumors. a total of 103 chinese patients with advanced msi-h/dmmr solid tumors who failed first-line or above systemic treatment were enrolled. the objective response rate (orr) assessed and confirmed by the blinded independent review committee (birc) in the overall population, colorectal cancer (crc), gastric cancer (gc) and other cancer patients was 42.7%, 43.1%, 44.4%, and 40.0% respectively.

the primary investigator of the envafolimab clinical trial, professor lin shen from beijing cancer hospital commented “subcutaneous envafolimab has demonstrated long-lasting efficacy and good safety in pivotal clinical trial. it can bring a new, safe, effective and convenient treatment option for patients with msi-h/dmmr advanced solid tumors who have failed at least first-line standard treatment in the past. we are looking forward to the launch of envafolimab and the clinical benefits of patients.”

dr. ting xu, founder, chairman and ceo of alphamab oncology, commented, “kn035 is the world's first subcutaneous pd-l1 inhibitor. after approval, it will fill the gaps for relevant indications immunotherapy in china. thanks to the support of the researchers and patients participating in the clinical trials, partners and all employees for their work, we look forward to the early approval of kn035 for marketing, benefiting more patients and their families. alphamab oncology will take this as the cornerstone, continue to develop cutting-edge tumor immunotherapy, and use our innovative products to lighten the life of patients and their families around the world.”

john gong, m.d., ph.d., chairman and ceo of 3d medicines inc., commented, “the acceptance of nda filling for envafolimab (kn035) by the national medical products administration (nmpa) is a significant milestone in the history of our company, proving our capabilities in clinical development and regulatory registration. we will work closely with our partners to bring envafolimab to the market as early as possible. we believe the differentiated advantages of envafolimab will provide better treatment options for cancer patients in china.”

ren jinsheng, board chairman and ceo of simcere commented, “simcere has a portfolio of innovative drugs and first-to-market products in the field of tumor treatment. we look forward to envafolimab with unique and differentiated advantages to bring better treatment options to clinical trials and patients. at the same time, with the support of relevant policies for accelerating review and approval, we are confident in working with strategic partners and clinical research institutions to accelerate the clinical development and commercialization of this innovative product, so as to work together to allow patients to use more effective drugs as soon as possible.

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. 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, 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. on december 17, 2020, the national medical products administration (nmpa) officially accepted the biologic license application (bla) of kn035 (envafolimab).

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, japan and australia.

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.

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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.

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about simcere

simcere pharmaceutical group(stock code: 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.

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