Merck Secures Exclusive Commercialization Rights in China for Zelgen's Recombinant Human TSH with Up to RMB 250 Million Deal

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PharmaCircleLearned: Recently, another new drug's China rights partnership.

Suzhou Zelgen Biopharmaceuticals Co., Ltd. (hereinafter referred to as "the Company") signed a Service Agreement (hereinafter referred to as "the Agreement") with Ares Trading S.A. (hereinafter referred to as "ATSA"), a Swiss subsidiary of Merck KGaA, on June 5, 2025. The Company agrees to authorize ATSA as the exclusive marketing service provider for recombinant human thyroid-stimulating hormone for injection (hereinafter referred to as "the Product") within the territory of the People's Republic of China (for the purpose of this Agreement, excluding the Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan region).

Under the terms of the agreement, the company will receive a total authorized amount of up to RMB 250 million, of which Ares Trading S.A. (ATSA) will pay the company the first installment of RMB 50 million within 30 working days from the effective date of the agreement, and the second payment of RMB 200 million after the approval of the first indication for the target product. The company will pay ATSA a market promotion service fee based on a double-digit percentage of net sales as stipulated in the agreement. Recombinant Human Thyrotropin for Injection is a large-molecule biologic drug independently developed by the company, classified as a therapeutic biologic product, and is currently in the application phase for drug registration and market launch.

In June 2024, the company submitted a Biologics License Application (BLA) for recombinant human thyrotropin for injection to the National Medical Products Administration (NMPA), which was accepted. In August 2024, the company received a drug registration inspection notice issued by the Center for Drug Evaluation (CDE) of the NMPA. As of the date of this announcement, the marketing evaluation of recombinant human thyrotropin for injection has completed clinical inspection and the two-in-one inspection, with the evaluation process proceeding normally.

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