jiangsu alphamab’s new manufacturing facilities’ phase i production lines have received “drug production license”-凯发88

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jiangsu alphamab’s new manufacturing facilities’ phase i production lines have received “drug production license”

july 06, 2020 08:00 eastern daylight time

suzhou, july 6, 2020 - alphamab oncology (stock code: 9966 hk) announced that jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab” or “alphamab oncology”), a wholly-owned subsidiary of the company, the phase i 2x2,000l production lines of its new manufacturing facilities which has a designed total capacity over 30,000l and is located at no. 175 fangzhou road, suzhou industrial park, suzhou city, jiangsu province, has obtained “drug production license” by jiangsu provincial drug administration. this marks that the further improvement of the company's production capabilities, and further expansion of the scale of development.

the new biopharmaceutical manufacturing site of jiangsu alphamab has a designed total capacity over 30,000l and is located at no. 175 fangzhou road, suzhou industrial park, suzhou area of jiangsu pilot free trade zone, china. it is designed and constructed in accordance with cgmp standards with two 2000l cell culture production lines, 1 stainless steel buffer preparation system, and 1 purification line. these production lines are equipped with world-class equipment, meeting the regulatory requirements of nmpa, fda and ema for good manufacturing practice (gmp).

previously, jiangsu alphamab had obtained a drug production license to produce biological products in the older production lines of suzhou biomedical industry park. after this approval, the new facilities will produce humanized fc-based ctla-4 fusion protein, recombinant humanized anti-her2 bispecific antibody, recombinant humanized pd-l1/ctla-4 bispecific antibody drug substance. this additional manufacturing capacity would ensure stable supply of clinical drugs for international multiple centers clinical trials, accelerate the large commercial scale production process, and provide safe and efficacious innovative drugs to cancer patients.

about alphamab oncology

alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine in 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.

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.