药品上市许可转让

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新华制药:成为腺苷钴胺胶囊上市许可持有人
news flash· 2025-06-27 09:00
Core Viewpoint - The company XinHua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the supplemental application of Adenosylcobalamin capsules, allowing the transfer of the marketing authorization holder [1] Group 1: Regulatory Approval - The approval notification allows the company to transfer the supplemental application without the need for board or shareholder meeting reviews, in accordance with the Shenzhen Stock Exchange listing rules and the company's articles of association [1] - The transaction does not constitute a related party transaction or a major asset restructuring as defined by the regulations [1] Group 2: Product Indications - Adenosylcobalamin capsules are primarily indicated for the treatment of megaloblastic anemia, nutritional anemia, anemia during pregnancy, multiple neuritis, radiculitis, trigeminal neuralgia, sciatica, and nerve paralysis [1] - The product can also be used as an adjunctive treatment for nutritional disorders and leukopenia caused by radiation and drugs [1]
湖南方盛制药股份有限公司关于受让药品上市许可的进展公告
Shang Hai Zheng Quan Bao· 2025-06-04 21:30
Group 1 - The company Hunan Fangsheng Pharmaceutical Co., Ltd. has acquired the ownership of 20 registered drug varieties from Kangyi Pharmaceutical Co., Ltd. in Hong Kong [1] - A joint venture company in Hong Kong is to be established with a registered capital of 20 million HKD, where the company will hold 35% initially [1] - The company plans to sign a new drug transfer agreement with Kangyi Pharmaceutical after the establishment of the joint venture [1] Group 2 - Due to regulatory issues regarding foreign investment, the company has adjusted its shareholding structure in the joint venture, increasing its stake from 35% to 50% and raising its investment from 7 million HKD to 10 million HKD [2] - The new shareholding structure includes other parties with varying stakes, ensuring compliance with investment regulations [2][3] - The joint venture will officially sign the investment cooperation agreement to clarify the rights and obligations of all parties involved [3] Group 3 - The adjustment in the shareholding structure of the joint venture is not expected to significantly impact the company's normal operations or financial results [3] - The transfer of drug licenses is still in process and is not affected by the changes in the joint venture [3]