RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
CASI Pharma (Nasdaq: CASI), a biopharmaceutical company dedicated to bringing quality pharmaceutical products to the Chinese and U.S. markets announced today that it has acquired a portfolio of 25 U.S. FDA-approved abbreviated new drug applications (ANDAs), one ANDA that FDA tentatively approved, and three ANDAs that are pending FDA approval. CASI 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 U.S.
Ken Ren, Ph.D., CASI’s Chief Executive Officer commented, “The acquisition of the Sandoz ANDAs enhances our strategic focus to build a robust pipeline and commercialize quality drug candidates in China, including entecavir, an antiviral medication used in the treatment of hepatitis B viral infection (“HBV”), which unfortunately in China accounts for more than half of the estimated 700,000 HBV-related deaths worldwide each year. With FDA-approved ANDA status and the high-quality standards of Sandoz, we anticipate 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.”
Dr. Ren continued, “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. We are confident in our ability to launch certain products that we acquired from the Sandoz portfolio in China, along with our launch of EVOMELA®, MARQIBO® and ZEVALIN® all of which are in various stages of CFDA review. We look forward to completing our Company’s transition from research and development to commercial.”
About CASI Pharmaceuticals, Inc.
CASI is a U.S. based, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of therapeutics addressing cancer and other unmet medical needs for the global market with a focus on commercialization in China. CASI’s product pipeline features (1) EVOMELA®, MARQIBO®, ZEVALIN®, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in various stages in the regulatory process for market approval in China, (2) an acquired portfolio of 25 FDA-approved ANDAs, 4 ANDAs that are pending FDA approval, from which CASI will prioritize a select subset of product registration and commercialization in China, (3) our proprietary drug candidate, ENMD-2076, currently in Phase 2 clinical development, and (4) proprietary early-stage candidates in preclinical development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com and in the Company’s filings with the U.S. Securities and Exchange Commission.
Source: Biospace
