The latest healthcare and pharma news from Japan, including Shionogi’s COVID-19 pill, the Japanese parliament’s green light for emergency approvals of drugs and vaccines and Hitachi’s partnership with Invivoscribe.
Shionogi’s COVID-19 pill (Reuters)
The future of Shionogi & Co Ltd’s experimental treatment, S-217622, is still uncertain. The company recently announced promising findings, citing Phase-2b results from the Phase II/III clinical trial, saying that the pill “demonstrated rapid clearance of the infectious SARS-CoV-2 virus.” After the announcement, Shionogi’s shares climbed due in part to a report that the U.S. government is in talks to acquire supplies of the drug. They then sank after news that the drug could pose risks for pregnant women, based on preclinical data.
Japan’s pharma lobbies joined forces to urge reforms (Reuters)
Japan’s three major pharmaceutical lobbies recently came together to urge for reforms in the government’s drug-pricing system, saying that the country needs a more transparent and predictable price-setting mechanism to keep the market attractive for research-based companies.
“The policy environment in Japan has become increasingly unpredictable and challenging,” said James Feliciano, who heads the American lobby, PhRMA, in Japan. “The Japanese market is losing its attractiveness,” he claimed. According to data from PhRMA, biopharmaceutical investment has increased 33 percent globally between 2015 and 2020 and at the same time fallen 9 percent in Japan.
Parliament gives green light to emergency approval of drugs and vaccines (Japan Times)
After Japan’s lag in rolling out COVID-19 vaccines with respect to other developed countries, the Japanese parliament recently enacted a bill to speed up emergency approvals. The bill, which will amend the pharmaceuticals and medical devices law, was approved unanimously at a plenary session of the House of Councilors. Under the new system, regulatory approval may be granted to new drugs and vaccines before they complete clinical trials, if their safety is confirmed and their effectiveness can be estimated.
Takeda foresees bouncing back after yearlong profit drop (Reuters)
Takeda Pharmaceutical Co recently announced that despite tt its 12-month operating profit slide of 9.5 percent, it is foreseeing a rebound in the current year. The operating profit for the year that ended on March 31 came in at JPY 461 billion, compared with JPY 509.27 billion in the previous period while the company estimated the current fiscal year’s operating profit to touch JPY 520 billion.
Part of Takeda’s growth this year may be based on the domestically-produced COVID-19 vaccine, developed by Novavax Inc (NVAX.O), which was approved by Japanese regulators last month. Japan has agreed to purchase 150 million doses, the majority of the Japanese population has already been fully vaccinated. CEO Christophe Weber said that the uptake of the Novavax vaccine in Japan is “very difficult to predict.”
Since Takeda took over Shire in 2019, the company has been under pressure to reduce debt and build its drug pipeline.
Hitachi partners with Invivoscribe (BioSpectrum Asia)
Hitachi High-Tech Corporation, has entered a strategic partnership with Invivoscribe, Inc, a privately held California-based life science corporation, to accelerate the molecular diagnostics and precision medicine businesses of both companies by combining Invivoscribe’s technology, assay and bioinformatics development, global clinical testing, and international regulatory expertise with Hitachi High-Tech’s expertise in measurement and analysis systems technologies.
Kyowa Kirin consolidates its manufacturing capability with new API building (BioSpectrum Asia)
Kyowa Kirin is set to build a new active pharmaceutical ingredient (API) manufacturing facility (HB7 Building) at its Takasaki Plant that will be manufacture Active Pharmaceutical Ingredients (APIs) usin Kyowa Kirin’s unique antibody technology and protein engineering. It will be equipped with a GMP compliant manufacturing facility and pilot facility for investigational APIs in early phase development. This will enable a quicker supply of investigational APIs, and it is ultimately expected to facilitate a rapid start of early phase clinical trials. Construction is due to be completed in early 2024.
Fujitsu and RIKEN’s joint research on next-gen IT drug discovery technology (BioSpectrum Asia)
Fujitsu and RIKEN have launched a joint research project on next-generation IT drug discovery technology with the ultimate aim of accelerating digital transformation (DX) in drug discovery, which may dramatically reduce time and costs for new drug development. Based on this research, the two companies aim to develop a next-generation IT drug discovery technology by the end of fiscal 2026. Fujitsu and RIKEN anticipate that this technology will perform an analysis of the target protein and drug candidate molecule complex. It will also be able to predict large-scale structural changes of molecules with speed and accuracy, contributing to the development of middle-molecular drugs and large-molecular drugs.
