CASI Pharma makes first commercial launch with Evomela

US-based, China-focused CASI Pharmaceuticals Inc., trumpeted the launch in China of its first commercial product. The launch of Evomela (melphalan for injection) follows approval from the National Medical Products Administration (NMPA) in December 2018, for use as high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplant in patients with multiple myeloma (MM), and as a palliative treatment for MM patients unable to take oral therapy.

Melphalan is a chemotherapy drug that belongs to the class of nitrogen mustard alkylating agents. The oral formulation of the drug was first brought to China by GlaxoSmithKline in 2001. CASI’s injectable formulation is the only form of melphalan suitable for use in the high-dose conditioning indication in pre-transplant therapy, and the firm states that currently it is the only company with a mephalan product commercially available on the market.

MM affects around 27,800 people in China each year, and around 16,900 cases are eligible for auto-hematopoietic stem cell transplantation each year. However, currently only around 800 patients go on to perform the procedure. Evomela is set to be distributed by China Resources Guokang Pharmaceuticals Co., Ltd, (CRGK) under a March 2019 deal. CASI acquired the drug as one of a three-drug licensing agreement signed with Spectrum Pharmaceuticals Inc., now owned by US-based Acrotech Biopharma LLC, in September 2014. Also part of that deal was Marqibo (a liposome formulation of vincristine sulfate), which is currently at the Phase III trial stage for Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in China.


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U.S.-based, China focused CASI Pharmaceuticals Inc., (Nasdaq.CASI) announced the signing of an exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd, (CRGK), focused on Evomela (melphalan hydrocholoride).
U.S.-based, China market-focused CASI Pharmaceuticals (NASDAQ: CASI) announced receipt of National Medical Products Administration (NMPA) approval for Marqibo (a liposome formulation of vincristine sulfate) to enter a registrational clinical trial in China. CASI licensed Greater China development rights to Marquibo from U.S. firm Spectrum Pharmaceuticals signed in September 2014, and reported by GBI.
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