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Seagen, RemeGen Ink $2.6B License Agreement for Anti-HER2 Drug Disitamab Vedotin

NEW YORK – Seagen and Chinese pharma company RemeGen entered into an exclusive worldwide license agreement worth up to $2.6 billion to develop and commercialize RemeGen's anti-HER2 drug disitamab vedotin.

Seagen will pay RemeGen $200 million upfront for exclusive rights to disitamab vedotin for global development and commercialization, outside of RemeGen’s territory in Asia, excluding Japan and Singapore. RemeGen is also eligible to receive up to $2.4 billion in potential development, regulatory, and commercialization milestone payments across several indications. RemeGen will also receive high-single-digit to mid-teen percentage royalty payments from sales of disitamab vedotin in Seagen's territory.

Under the agreement, Seagen will lead global development of disitamab vedotin, while RemeGen will fund and oversee clinical trials and regulatory submissions in its territory. 

In June, RemeGen received conditional approval in China for disitamab vedotin as a treatment for HER2-expressing locally advanced or metastatic gastric cancer patients who have received two lines of prior chemotherapy. The company also has several ongoing clinical trials of the drug. It is conducting two registrational Phase III studies in China in HER2-expressing urothelial cancer and HER2-low breast cancer and has earlier-stage studies in China for HER2-low urothelial cancer, HER2-positive biliary cancer, and HER2-positive non-small cell lung cancer.

RemeGen also has earlier-stage global studies of disitamab vedotin in HER2-expressing urothelial cancer and HER2-low breast cancer. Last year, the company began a Phase II study in the US in HER2-positive patients with metastatic or unresectable urothelial cancer.

"Disitamab vedotin has demonstrated robust antitumor activity in multiple advanced cancers where no effective therapy is available," RemeGen CEO Jianmin Fang said in a statement. "Seagen is a well-known global biotechnology company recognized for its capabilities in the field of oncology and [antibody drug conjugate] therapies. We are delighted to partner with Seagen to maximize the potential of disitamab vedotin and to make it available to patients worldwide. We believe this license agreement highlights the global potential of disitamab vedotin in the ADC arena and is a major milestone for us as we begin the journey to transform from a domestic to a global biopharmaceutical company."

Earlier this year, Seagen received approval in the UK and Europe for another anti-HER2 agent. Its drug tucatinib (Tukysa) in combination with trastuzumab (Genentech's Herceptin) and chemotherapy was approved for previously treated, HER2-positive, locally advanced or metastatic breast cancer.