Group 1 - The core point of the article is that Yuandong Biologics has received approval from the National Medical Products Administration for the drug registration certificate for Pirfenidone tablets [2] Group 2 - The announcement was made on the evening of September 5, indicating a significant regulatory milestone for the company [2] - The approval of the drug is expected to enhance the company's product portfolio and market presence [2] - This development may lead to potential revenue growth opportunities for Yuandong Biologics in the pharmaceutical market [2]

Group 1 - The company has received the drug registration certificate for Pirfenidone Tablets from the National Medical Products Administration, indicating compliance with drug registration requirements [1][2] - The drug is classified as a Class 4 chemical drug and is indicated for the treatment of partial seizures in adults and children aged 4 years and above [2] - The original developer of the drug is Eisai Europe Limited, which first launched it in the EU in July 2012, followed by approvals in the US and Japan [2] Group 2 - The sales amount for the original drug in 2024 is projected to be approximately 96.52 million yuan, reflecting a year-on-year growth of 39.74% [2] - The company has entered into a commercial cooperation agreement with Anhui Wanbang Pharmaceutical Technology Co., Ltd., where Wanbang will handle sales and promotion of the drug [2] - The company is responsible for the production and supply of the drug and will share in the profits from sales after the drug is launched [2]

智通财经APP讯，苑东生物(688513.SH)发布公告，公司于近日收到国家药品监督管理局(简称"国家药监 局")核准签发的吡仑帕奈片《药品注册证书》。 吡仑帕奈片主要活性成份为吡仑帕奈，属于国家《麻醉药品和精神药品管理条例》规定的第二类精神药 品，适应症为用于成人和4岁及以上儿童癫痫部分性发作患者(伴有或不伴有继发全面性发作)的治疗。 ...