爱美津制药有限公司今日宣布美国食品和药物管理局最终批准其青霉胺胶囊250mg的仿制药申请

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2019年5月8日

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Lyndhurst NJ, USA, May 8, 2019 — Amerigen Pharmaceuticals Limited (“Amerigen”) today announced that Amerigen’s Abbreviated New Drug Application (“ANDA”) for Penicillamine Capsules USP 250 mg has received final approval from the U.S. Food and Drug Administration. This is the first such ANDA to be approved as a generic equivalent to Bausch Heath’s Cuprimine®. The finished product is manufactured for Amerigen in the U.S. where it has already been launched by Amerigen’s affiliate, Amerigen Pharmaceuticals, Inc.

Penicillamine Capsules USP are indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.

John Lowry, Amerigen’s President and CEO, commented, “We are delighted to launch this first generic of Penicillamine Capsules. This is Amerigen’s ninth U.S. product launch and the fourth time we have brought a first generic to market, with important savings for the American healthcare system.”

美国新泽西州林德赫斯特2019年5月8日消息：爱美津制药有限公司（爱美津）今天宣布，爱美津的青霉胺胶囊250mg的仿制药申请已获得美国食品和药物管理局的最终批准。这是首个获批的与Bausch Heath公司的Cuprimine®等效的仿制药产品。该仿制药产品在美国生产，并已由爱美津的子公司爱美津制药股份有限公司于美国进行上市。

青霉胺胶囊可用于治疗威尔逊氏病胱氨酸尿症，以及对常规治疗无效的严重活动性类风湿关节炎患者。

爱美津的总裁兼首席执行官John Lowry评论说：“我们很高兴我们的青霉素胺胶囊的首仿产品上市。这是爱美津在美国上市的第九款产品，也是我们的第四款首仿产品，为美国医疗体系节省了大笔资金。”

关于爱美津 About Amerigen

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are potential first generics, challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.

爱美津制药致力于仿制药所涉及到的全部阶段的业务，是一家包括美国和中国多成员企业的集团公司。集团由爱美津制药控股。美国市场的注册和商业活动由位于新泽西州，林赫斯特的美国爱美津负责；集团的中国分公司，苏州爱美津制药有限公司，位于中国江苏省苏州市。爱美津制药集团目前在美国以及中国均有药品上市和销售，同时，我们拥有活跃的在研产品组，面向美国食品药品监督管理局（FDA）注册和已申报若干个仿制药品种（ANDA），并且计划开展向中国食品药品监督管理局（CFDA）注册和申报产品的工作。爱美津从事开发的口服制剂产品，是开发难度高，需要专门的技术，或生产要求高度严格管理控制，以及法规复杂，需要规避或挑战专利的仿制药。爱美津集团旗下公司或合作方开发和生产的所有产品，都满足高质量标准，包括美国FDA。