Chinese Innovative Drugs Go Global with GLP-1 Dual-Agonists, rhTSH and More

　　【Pharmaceutical Network Industry DynamicsZelgen announced on the evening of June 5 that the company had signed a service agreement with Ares Trading S.A. (hereinafter referred to as "ATSA"), a Swiss subsidiary of Merck KGaA. According to the agreement, Zelgen agreed to authorize ATSA as the exclusive marketing service provider for recombinant human thyrotropin (rhTSH) for injection within China.
 

It is reported that the injectable recombinant human thyroid-stimulating hormone is a biological macromolecule drug independently developed by Zelgen. In June 2024, the company submitted the Biologics License Application (BLA) for this drug to the National Medical Products Administration (NMPA) and it was accepted. In August of the same year, the company received the drug registration verification notice issued by the Center for Drug Evaluation (CDE) of the NMPA. As of the date of the announcement, the clinical verification and the two-in-one inspection for the marketing evaluation of this product have been completed, and the evaluation work is currently proceeding in the normal process.
 

According to the agreement, under the premise of meeting relevant terms, Zelgen will receive a maximum authorization fee of 250 million yuan. Among this, within 30 working days from the effective date of the agreement, ATSA will pay the first advance payment of 50 million yuan to Zelgen; after the first indication of the recombinant human thyroid-stimulating hormone for injection is approved for marketing, ATSA will pay the second installment of 200 million yuan. In addition, Zelgen will also need to pay ATSA a market promotion service fee based on a double-digit percentage of net sales.
 

Recently, there has been continuous good news regarding the overseas expansion of innovative drugs produced in China. In addition to Zelgen, Hansoh Pharma recently announced that it has granted Regeneron Pharmaceuticals, Inc. (Regeneron) an exclusive overseas license for its investigational GLP-1/GIP dual receptor agonist HS-20094. HS-20094 is an investigational GLP-1/GIP dual receptor agonist that has successfully completed multiple Phase II clinical trials, showing positive efficacy and safety data. It is currently undergoing Phase III clinical trials in China. According to the agreement, Hansoh Pharma will receive an upfront payment of $80 million and is eligible to receive up to $1.93 billion in milestone payments based on the product's development, regulatory approval, and commercialization progress, as well as double-digit percentage royalties on future potential product sales.
 

Guojian Pharmaceutical announced on May 20 that the company, along with its affiliates 3SBio and Shenyang 3SBio Pharmaceutical Co., Ltd., has jointly granted Pfizer exclusive rights to develop, manufacture, and commercialize the licensed product, Project 707 (SSGJ-707), in the licensed territory (i.e., all countries and regions outside of China) and field (i.e., all therapeutic, diagnostic, and preventive indications for human and veterinary use). Pfizer retains the right to commercialize the licensed product in China by making additional payments. According to the agreement, Pfizer will pay a non-refundable and non-creditable upfront payment of $1.25 billion, up to $4.8 billion in development, regulatory approval, and sales milestone payments, as well as tiered royalties in the double-digit percentage based on net sales of the product in the licensed territory. The upfront payment for this licensing deal set a new record for the highest upfront payment for a domestically produced innovative drug going overseas.
 

Xinova and Astellas announced at the end of May that they had reached an exclusive licensing agreement for XNW27011. According to the terms of the agreement, Xinova will receive an upfront payment of $130 million and is eligible to receive near-term payments of up to $70 million, as well as milestone payments related to development, registration, and commercialization potentially reaching up to $1.34 billion.
 

In addition, on May 30, CSPC Pharmaceutical Group announced on the Hong Kong Stock Exchange that the group is currently in discussions with several independent third parties regarding three potential transactions. These transactions involve licensing and cooperation in the development, production, and commercialization of certain products from the group (including Epidermal Growth Factor Receptor Antibody-Drug Conjugates and other drugs developed through the group's technology platform). For each potential transaction, the potential upfront payments, potential development milestone payments, and potential commercialization milestone payments that may be payable to the group could total approximately US$5 billion. One of the three potential transactions is currently in its later stages.
 

Currently, domestically produced innovative drugs are opening the door to the global market with solid strength, showcasing the speed and power of "Chinese innovation" on the international pharmaceutical stage. The future holds even more promise for their new journey of development.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.