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復星醫藥:海外監管公告 - 關於許可產品獲藥品註冊批准的公告

FOSUN PHARMA: Overseas Regulatory Announcement - Announcement in Relation to the Approval for Drug Registration of a Licensed Product

HKEX ·  Nov 27 18:03

Summary by Futu AI

2024年11月27日,复星医药宣布其控股子公司上海夏星原药获得国家药监局批准,注射用A型肉毒毒素用于治疗成人头部肌张力障碍的新适应症。该产品此前已在美国获得FDA批准,用于改善成人眉间纹等症状。公司自2018年起与Revance Therapeutics, Inc.合作,获得该产品在中国内地、香港及澳门的独家进口、使用及商业化权利。截至2024年10月,复星医药在该产品的研发投入累计约为人民币4.87亿元。根据IQVIA数据,2023年全球注射用A型肉毒毒素的销售额约为24.6亿美元。此次新适应症的批准,预计将进一步提升该产品在中国市场的竞争力和销售潜力。
2024年11月27日,复星医药宣布其控股子公司上海夏星原药获得国家药监局批准,注射用A型肉毒毒素用于治疗成人头部肌张力障碍的新适应症。该产品此前已在美国获得FDA批准,用于改善成人眉间纹等症状。公司自2018年起与Revance Therapeutics, Inc.合作,获得该产品在中国内地、香港及澳门的独家进口、使用及商业化权利。截至2024年10月,复星医药在该产品的研发投入累计约为人民币4.87亿元。根据IQVIA数据,2023年全球注射用A型肉毒毒素的销售额约为24.6亿美元。此次新适应症的批准,预计将进一步提升该产品在中国市场的竞争力和销售潜力。
On November 27, 2024, Fosun Pharmaceutical announced that its holding subsidiary Shanghai Xiastar Pharmaceutical has received approval from the National Medical Products Administration for injectable type A botulinum toxin to treat a new indication of adult focal dystonia. The product was previously approved by the FDA in the United States for improving symptoms such as glabellar lines in adults. Since 2018, the company has partnered with Revance Therapeutics, Inc. to obtain exclusive rights for the import, use, and commercialization of the product in mainland China, Hong Kong, and Macau. As of October 2024, Fosun Pharmaceutical has invested approximately 487 million RMB in the research and development of this product. According to IQVIA data, the global sales of injectable type A botulinum toxin were about 2.46 billion USD in 2023. The approval of this new indication is expected to further enhance the competitiveness and sales potential of the product in the Chinese market.
On November 27, 2024, Fosun Pharmaceutical announced that its holding subsidiary Shanghai Xiastar Pharmaceutical has received approval from the National Medical Products Administration for injectable type A botulinum toxin to treat a new indication of adult focal dystonia. The product was previously approved by the FDA in the United States for improving symptoms such as glabellar lines in adults. Since 2018, the company has partnered with Revance Therapeutics, Inc. to obtain exclusive rights for the import, use, and commercialization of the product in mainland China, Hong Kong, and Macau. As of October 2024, Fosun Pharmaceutical has invested approximately 487 million RMB in the research and development of this product. According to IQVIA data, the global sales of injectable type A botulinum toxin were about 2.46 billion USD in 2023. The approval of this new indication is expected to further enhance the competitiveness and sales potential of the product in the Chinese market.

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