China’s Minghui Pharmaceutical has licensed its late-stage thyroid eye disease candidate to ASKA Pharmaceutical for up to $440 million plus royalties, granting the Japanese drugmaker exclusive development and commercialization rights in its home country.
ASKA is paying $110 million upfront and the rest in milestones, as well as more than 30% on net sales in Japan, ASKA will add the subcutaneously administered IGF-1R targeting antibody MHB018A to its slate of thyroid medications.
The Japanses company has already secured a 96% share of the homegrown market, according to the company. Approved medicines in the biopharma's Japanese portfolio include the hepatic encephalopathy treatment Rifxima, the hypothyroidism therapy Thyroxin and the antihypertensive drug Candesartan.
Minghui will retain rights to MHB018A outside of Japan and maintain its global development strategy.
Patients with thyroid eye disease (TED), an autoimmune condition, experience inflammation around the eyes that can lead to vision loss in severe cases. In phase 1/2 study results released in June, MHB018A was well tolerated and reduced eye bulging known as proptosis by 81% in active TED at 12 weeks and 76% in chronic TED at 24 weeks.
U.S.-approved drugs for TED are all given intravenously, including Tepezza, which Amgen gained in its $27.8 billion acquisition of Horizon Therapeutics, and Viridian Therapeutics’ Lumvoa, which was approved in June. Both are IGF-1R inhibitors.
In Japan, where ASKA will be tasked with commercial rollout, only Tepezza is approved as of 2024. Kissei Pharmaceutical has exclusive rights to Lumvoa in Japan, though it has not yet reached approval.
Beyond MHB018A, subcutaneous IGF-1R inhibitors in development include a formulation of Tepezza, as well as Viridian’s elegrobart, both of which have demonstrated positive phase 3 results this year.
Minghui CEO Guoqing Cao, Ph.D., noted ASKA’s knowledge of the Japanese market and development pathway as reasons for the partnership.
“Japan is an important market for MHB018A, and ASKA brings deep expertise in endocrinology, clinical development, regulatory affairs and commercialization,” Cao said in the release.