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国药现代586万元收购乳果糖口服溶液上市许可 丰富慢病治疗产品线
Xin Lang Cai Jing· 2025-11-03 10:24
Core Viewpoint - Shanghai Modern Pharmaceutical Co., Ltd. announced the acquisition of the marketing authorization for Lactulose Oral Solution from Anhui Meilai Pharmaceutical Co., Ltd. for 5.86 million yuan, aimed at enriching its chronic disease treatment product line and aligning with its mid-to-long-term development strategy [1][2]. Transaction Overview - The transaction involves the complete marketing authorization rights for Lactulose Oral Solution (15ml:10g), including global production, sales, and intellectual property rights. Anhui Meilai is required to transfer all technical documentation and assist in the approval process for the change of the marketing authorization holder and production site [2]. - The transaction does not require approval from the company's board or shareholders and is not classified as a related party transaction [2]. Market Outlook for the Product - Lactulose is used primarily as an osmotic laxative for treating chronic functional constipation and has prebiotic effects that help regulate gut flora. The product is projected to achieve sales of 2.069 billion yuan in public medical institutions and retail markets by 2024, indicating significant market potential [3]. - The product specification (15ml:10g) received approval from the National Medical Products Administration on January 8, 2025, and is currently produced by Anhui Yongshengtang Pharmaceutical [3]. Parties Involved - **Transferor**: Anhui Meilai Pharmaceutical Co., Ltd., established in December 2021 with a registered capital of 25.3655 million yuan, engages in drug production, import/export, and technology transfer. The company has no affiliation with Shanghai Modern and is capable of fulfilling its contractual obligations [4]. - **Transferee**: Guoyao Group Zhijun (Shenzhen) Pingshan Pharmaceutical Co., Ltd., a core subsidiary of Shanghai Modern, established in July 1990 with a registered capital of 50 million yuan, possesses production capabilities for various dosage forms and has established industrial capabilities in anti-infection and digestive drugs [5]. Key Contract Terms - The transfer payment of 5.86 million yuan will be made in installments based on the progress of the contract. The transferee will hold product rights from the first payment date and can independently change the production site. The transferor must not produce or sell the product before the authorization change is completed and is liable for the authenticity and completeness of the technical documentation [6]. - Breach of contract terms stipulate that if the transferor causes process validation failures or data authenticity issues, the transferee can terminate the contract and demand a full refund and compensation for losses. Unauthorized sales by the transferor will incur penalties and liability for all direct and indirect losses [6]. Impact on Company Operations - The acquisition aligns with the company's strategy in the chronic disease sector and enhances its digestive drug pipeline, although it is not expected to significantly impact current operating performance. The company acknowledges that the approval processes for changing the marketing authorization holder and increasing production sites may take time and involve uncertainties [7]. - Following the completion of the transaction, the transferee will gain full industrial rights for Lactulose Oral Solution, and with its existing production capabilities, it is expected to quickly realize product commercialization. Analysts believe that if effectively integrated into the company's sales network, this product could become a new growth driver for the company [7].