alphamab oncology announces four ind application approvals from nmpa cde-凯发88

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alphamab oncology announces four ind application approvals from nmpa cde

may 13, 2020 10:39 eastern daylight time

suzhou, china, may 12, 2020 - alphamab oncology (stock code: 9966 hk) announced today that jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab”), a wholly-owned subsidiary of the company, has received approvals for four ind applications for new therapies of kn046, a recombinant humanized pd-l1/ctla-4 bispecific antibody, and kn026, an anti-her2 bispecific antibody from the center for drug evaluation (cde) of national medical products administration (nmpa) of china.

dr. ting xu, founder, chairman and ceo of alphamab oncology commented, “kn046 and kn026 are the next-generation bispecific drugs for cancer treatment. both are expected to emerge as potential cornerstone for a range of cancer treatments. the approval of the four ind applications marks a new milestone for our continued efforts on expanding combo treatments. by leveraging strong internal research and development capabilities and proprietary platforms, we will keep focusing on developing our products, through combination with internal and external drug candidates.,we are striving to fully explore clinical potentialsand provide new treatment options for hard to treat cancer patient with the sense of urgency.”

evaluation of the effectiveness, safety and tolerance of kn046 in combination with kn026 for her2-positive or her2 expression solid tumors in phase ib clinical study (cxsl20000029/cxsl2000030)

kn046 and kn026 are two innovative bispecific antibodies developed by jangsu alphamab oncology. kn046 is the only anti-pd-l1/ctla-4 bispecific antibody drug in clinical development phase globally. in pre-clinical studies, kn026 has demonstrated potentially equivalent or superior efficacy compared with trastuzumab w/o combination with pertuzumab. both products have showed good safety, tolerability and initial effectiveness in monotherapy clinical trials. the clinical trials for the approved ind application will be conducted on her2-positive or her2 expression solid tumors, with indications including, but are not limited to her2-positive or her2 expression breast cancer, gastric cancer, esophageal cancer, colorectal cancer, pancreatic cancer, biliary tract cancer, ovarian cancer, urothelial cancer and lung cancer.

multicenter, open label, phase ib/ii clinical trials for ningetinib tosylate in combination with kn046 for the treatment of advanced hepatocellular carcinoma (cxsl2000023)

the approved ind application aims to conduct clinical trials on kn046 in combination with ningetinib tosylate for the treatment of solid tumors and blood tumors, including but not limited to the treatment of hepatocellular carcinoma (hcc). ningetinib tosylate (ct053) is a multi-target small molecule kinase inhibitor independently developed by sunshine lake pharma co., ltd. ("sunshine lake"), which can directly inhibit tumor growth, also indirectly inhibit the growth of tumor cells by blocking the formation of new blood vessels. jiangsu alphamab and sunshine lake have reached a cooperation agreement on kn046 and ct053 combination therapy in 2019.

phase ii clinical study to assess the effectiveness and safety of recombinant humanized anti-her2 bispecific antibodies (kn026) in monotherapy or combination therapy for her2 low expression or her2 positive recurrent/metastatic breast cancer (cxsl2000031)

kn026 is an anti-her2 bispecific antibody developed by alphamab oncology using the proprietary fc-based heterodimer bispecific platform technology called crib. previously, the ind of kn026 was approved by china nmpa and the us food and drug administration (fda) in 2018, and is currently undergoing multiple phase i/ii clinical trials in china, and phase i clinical trials in the united states for indications including her2-positive and low-expression breast cancer, gastric cancer, urothelial cancer and ovarian cancer. this ind application is approved to apply lyophilized dosage of kn026 for treatment of her2-positive or her2 expression solid tumors, including in combination with docetaxel as first-line treatment to metastatic recurrent her2-positive or her2 expression breast 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 highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into phase i – iii clinical development phases in china, us and japan.  

the company also has state-of-the-art manufacturing capability designed and built to meet nmpa and eu/fda’s cgmp standards.alphamab oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world. 

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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.