On the evening of June 5th, Suzhou Zejing Biopharmaceutical Co., Ltd. (hereinafter referred to as "Zejing Pharmaceutical") issued a heavyweight announcement that the company had signed a service agreement with Ares Trading S.A. (hereinafter referred to as "ATSA"), a Swiss subsidiary of Merck KGaA in Germany, on the same day. According to the agreement, Zejing Pharmaceutical agrees to authorize ATSA as the exclusive marketing service provider for recombinant human thyroid stimulating hormone (rhTSH) for injection in China.



It is understood that recombinant human thyroid stimulating hormone for injection is a biomacromolecule drug independently developed by Zejing Pharmaceutical, which belongs to therapeutic biological products.



Yu Fenghui, a specially invited researcher at the China Financial Think Tank, told Securities Daily reporters that this cooperation not only injects strong impetus into the commercialization process of Zejing Pharmaceutical's products, but also raises market attention to the future development of thyroid cancer treatment.



According to the agreement, Zejing Pharmaceutical will receive an authorization fee of up to 250 million yuan, provided that the relevant terms are met. Within 30 working days from the effective date of the agreement, ATSA will make the first advance payment of 50 million yuan to Zejing Pharmaceutical; After the first indication of recombinant human thyroid stimulating hormone for injection is approved for market, ATSA will pay a second payment of 200 million yuan.



In addition, Zejing Pharmaceutical also needs to pay a marketing service fee to ATSA based on a double-digit percentage of net sales. Yu Fenghui believes that this cooperation model not only ensures that Zejing Pharmaceutical receives financial support in the early stage, but also deeply binds the interests of both parties to the future market performance of the product



During the interview, the reporter learned that thyroid stimulating hormone plays an irreplaceable and crucial role in the treatment process of thyroid cancer. It can stimulate the activity of thyroid cells and significantly increase the absorption of radioactive iodine, which not only helps to carry out more accurate whole-body scanning detection of radioactive iodine, but also enhances the killing effect on residual thyroid cancer cells. At present, many thyroid cancer patients in China mainly rely on traditional "thyroid hormone withdrawal therapy" to increase their levels of thyroid stimulating hormone in the body. However, this treatment method has drawbacks, as patients are prone to hypothyroidism symptoms after discontinuing medication, and also face the risk of tumor proliferation.



The injection of recombinant human thyroid stimulating hormone by Zejing Pharmaceutical brings a new solution to this dilemma. In June 2024, the company submitted a biological product marketing authorization application (BLA) for the product to the National Medical Products Administration (NMPA) and was accepted. In August of the same year, the company received a drug registration verification notice issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. As of the disclosure date of the announcement, the market review of the product has completed clinical verification and two in one examination, and the review work is in the normal process.



According to the announcement, if the above-mentioned products can be successfully approved for market and commercialized in the authorized area, it is expected to have a positive impact on the current and future business performance of Zejing Pharmaceutical. It should be noted that this transaction does not constitute a related party transaction, nor does it constitute a major asset restructuring as stipulated in the Measures for the Administration of Major Asset Restructuring of Listed Companies. This transaction does not require submission to the board of directors or shareholders' meeting for review. There is uncertainty about whether the product can be successfully approved for market launch and whether its commercial promotion after launch can meet expectations, and there is also a certain degree of uncertainty in the amount of market promotion service fees agreed upon in the agreement.



For Zejing Pharmaceutical, leveraging the commercial network and marketing capabilities of Merck, the German company behind ATSA, can accelerate the product commercialization process, convert research and development achievements into market revenue more quickly, and enhance the company's market position in the field of cancer treatment. At the same time, the authorized funds obtained can also provide financial support for the company's subsequent research and development, promoting the continuous advancement of innovative drug development pipelines. ”Bai Wenxi, Chairman of Zhonghe Kunlun (Beijing) Asset Management Co., Ltd., told Securities Daily reporters that this cooperation is an important measure for Merck, a German company, to deepen its layout in the Chinese market. Through cooperation with local innovative pharmaceutical enterprises, ATSA can quickly acquire innovative products, further enrich its product line in China, and achieve deep integration with local innovation forces.



Overall, the cooperation between Zejing Pharmaceutical and ATSA is a win-win strategic choice, not only providing better treatment options for thyroid cancer patients, but also laying a solid foundation for the long-term development of both parties in the pharmaceutical market. With the advancement of the marketing process of recombinant human thyroid stimulating hormone for injection, its impact on the market landscape deserves continuous attention. ”Bai Wenxi added that