By Fineline Cube 
China’s Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced a collaboration agreement with Merck KGaA (ETR: MRK), appointing the German company as the exclusive market promotion service provider for its recombinant human thyrotropin (rhTSH) for injection in mainland China (excluding Hong Kong, Macau, and Taiwan). Under the agreement, Zelgen Bio will receive an upfront payment of up to RMB 250 million (USD 35 million) and will pay Merck a double-digit percentage of net sales as a market promotion service fee.
Product Profile
The rhTSH, a biologics drug developed in-house by Zelgen Bio, has a structure identical to the amino acid sequence of endogenous human TSH. It rapidly elevates TSH levels without requiring patients to discontinue thyroid hormone therapy. By binding to the thyrotropin receptor (TSHR) on thyroid follicular cells or thyroid tumor tissue, it stimulates residual thyroid tissue and tumor tissue to enhance iodine uptake and thyroglobulin (Tg) secretion. This improves the sensitivity of postoperative recurrence monitoring and can be used as an adjunctive therapy for radioiodine ablation in differentiated thyroid cancer patients. Similar treatment regimens are widely adopted in the U.S. and European markets.
Regulatory Status
The drug’s Biologics License Application (BLA) was accepted for review by China’s National Medical Products Administration in June of last year and is currently awaiting regulatory approval.-Fineline Info & Tech