Wired News – CASI Pharma Purchased abbreviated new drug applications Portfolio from Sandoz
LONDON, UK / ACCESSWIRE / January 30, 2018 / Active-Investors.com has just released a free research report on CASI Pharmaceuticals, Inc. (NASDAQ: CASI). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=CASI as the Company's latest news hit the wire. On January 26, 2018, the Company declared that it has acquired a portfolio of abbreviated new drug applications (ANDAs) from Sandoz Inc. The portfolio includes 25 ANDAs approved by the US Food and Drug Administration (FDA), one ANDA that FDA tentatively approved, and three ANDAs that are pending FDA approval. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, CASI Pharmaceuticals most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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Acquisition Likely to Enhance CASI Pharma's Strategic Focus to Commercialize Quality Drug Candidates in China
The Company intends to select and commercialize certain products from the portfolio that have unique market opportunity and cost-effective manufacturing in China and/or in the US. The acquisition will enhance CASI Pharma's strategic focus to build a robust pipeline. The Company will transfer a select subset of products from the portfolio to lower cost manufacturing facilities in China and contemplates submitting CBE-30 supplement or Prior Approval Supplement (PAS) to the approved/pending ANDAs as soon as possible.
The acquired application also includes entecavir, an antiviral medication used in the treatment of hepatitis B viral infection (HBV), which in China accounts for more than half of the estimated 700,000 HBV-related deaths worldwide each year. CASI Pharma also intends to develop and market on its own priority products from the portfolio and may partner the remaining US ANDA assets to strategic partners.
CASI Pharma to Launch Certain Products Acquired from Sandoz's Portfolio in China
Ken Ren, Ph.D., Chief Executive Officer of CASI Pharma, stated that with FDA-approved ANDA status and the high-quality standards of Sandoz, the Company anticipates leveraging the Chinese FDA's (CFDA) more recent regulations to accept western pharmaceutical and clinical data for rapid entry into China's market while being competitive in the marketplace. Ken added that this is an exciting and unprecedented time in the CFDA regulatory landscape, against a backdrop of soaring demand in China for high quality import pharmaceuticals. The Company is confident in its ability to launch certain products in China that it has acquired from the Sandoz portfolio, along with its launch of EVOMELA®, MARQIBO®, and ZEVALIN® all of which are in various stages of CFDA review.
About FDA-Approved Abbreviated New Drug Application
ANDA contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
About CASI Pharmaceuticals, Inc.
Founded in 1991, CASI Pharma is a biopharmaceutical company focused on the acquisition, development, and commercialization of quality pharmaceuticals and innovative therapeutics addressing CANCER and other unmet medical needs for the global market, with a focus on greater China and the US. The Company is headquartered in Rockville, Maryland.
About Sandoz Inc.
Established in 1886 and based in Holzkirchen, Bavaria, Sandoz (formerly known as Geneva Pharmaceuticals Technology Corporation) is a global leader in generic pharmaceuticals and biosimilars. The Company is a subsidiary of Novartis Group.
Stock Performance Snapshot
January 29, 2018 - At Monday's closing bell, CASI Pharmaceuticals' stock climbed 6.46%, ending the trading session at $4.12.
Volume traded for the day: 525.61 thousand shares, which was above the 3-month average volume of 489.53 thousand shares.
Stock performance in the last month – up 29.15%; previous three-month period – up 100.00%; past twelve-month period – up 188.11%; and year-to-date - up 26.77%
After yesterday's close, CASI Pharmaceuticals' market cap was at $268.05 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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