Shionogi is hoping to demonstrate the efficacy of its oral COVID-19 candidate Xocova through an appropriate primary endpoint in its Phase III trial, while the Japanese firm is also eyeing global expansion for the drug should a world-first domestic approval be granted.

Zydus Cadila expects to launch its DNA COVID-19 vaccine in the first quarter of fiscal 2022 but it already has more advance purchase orders than it can produce. Meanwhile, the Indian firm is confident of saroglitazar being approved for primary biliary cholangitis in the US, with the NCE also poised to become the largest contributor to India sales in three to five years.

Japan’s regulators have approved a large batch of new products, including a novel antibody from Chugai, two world-first nods for the country’s second HIF-PH inhibitors and an asthma therapy, and the first Humira biosimilar in Japan – as well as five drugs from Novartis.

Zydus Cadila hopes to launch its version of Gilead’s remdesivir by end-July in India, even as earlier licensees Hetero Drugs and Cipla have just commercialized the antiviral. Plans for pegylated interferon alfa-2b to treat COVID-19 include a trial in Mexico and an IND in the US. Separately, desidustat is being considered for additional indications.