Recently, Changchun High & New Technology Industries Group Co., Ltd. issued an announcement stating that its subsidiary, Saizeng Medical, signed an exclusive licensing agreement with Yarrow Bioscience, Inc. for the GenSci098 injection project.

Under the agreement, Saizeng Medical expects to receive an upfront payment of US$120 million and near-term development milestone payments (including a non-refundable and non-deductible upfront payment of US$70 million and subsequent near-term development milestone payments of US$50 million), and will be entitled to receive up to US$1.365 billion in milestone payments, as well as sales royalties of more than 10% of net sales after subsequent product launches.

Yarrow will acquire the exclusive global rights to develop, manufacture, and commercialize GenSci098 injection outside of Greater China, for the research, development, and commercialization of GenSci098 injection for indications including thyroid-associated ophthalmopathy (TED) and diffuse toxic goiter (GD). Saizeng Medical will retain the rights to develop and commercialize GenSci098 injection in China.

The agreement is effective from the date of its entry into force until the expiry of the sales revenue sharing period (no less than 10 years after the first commercial sale in each country/region). Upon expiry, Yarrow shall acquire an indefinite, payable, irrevocable, and royalty-free right within the scope of the authorization.

Yarrow is a new biopharmaceutical company based in New York, founded and incubated by investment firm RTW. It focuses on discovering transformative and groundbreaking innovations in the biopharmaceutical and medical technologies. However, the company is not publicly traded and has not disclosed any other pipeline projects.

GenSci098 is a Class 1 biological novel drug independently developed by Jinsai Pharmaceutical. This drug is a humanized thyroid-stimulating hormone receptor (TSHR) antagonistic monoclonal antibody . It specifically binds to TSHR in the thyroid gland or retrobulbar tissue, blocking its binding to autoantibodies, thereby inhibiting the synthesis and release of thyroid hormones, inhibiting the proliferation of thyroid cells, and preventing the release of hyaluronic acid and inflammatory factors. This allows it to improve hyperthyroidism and also improves exophthalmos.

The thyroid-stimulating hormone receptor (TSHR) is a G protein-coupled receptor (GPCR) that controls thyroid cell metabolism. It has a wide range of functional effects in metabolism and various physiological processes, and its abnormal activation or dysregulation is associated with a variety of diseases.

For example, patients with Graves' disease (GD) produce autoantibodies that activate TSHR, leading to hyperthyroidism, and may also trigger Graves' ophthalmopathy (GO), causing swelling of the eye muscles.

Preclinical and early clinical data suggest that GenSci098 injection has the potential to be a novel treatment for Graves' disease (GD). Based on its unique target, GenSci098 has the potential to significantly reduce pathogenic irritant antibodies in GD patients, thereby treating the root cause of GD. Furthermore, it has the potential to significantly improve clinical outcomes, such as preventing thyroid-related tetany (TED) and reducing hyperthyroidism recurrence, while effectively controlling hyperthyroidism, thus altering the disease course.

Currently, GenSci098 is in Phase 1 clinical trials for the treatment of thyroid-associated ophthalmopathy (TED) and diffuse toxic goiter (Graves' disease, GD).

In addition, Orange Sail Pharmaceuticals' TSHR/IGF-1R bispecific antibody VBS-102 (preclinical stage) was licensed to US-based Ollin Biosciences for $440 million earlier this year. Ollin Biosciences, which completed a $100 million financing round for global development, also demonstrates the value and popularity of the TSHR track.

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