Japan
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.
Several major Japanese firms, including Takeda, are planning layoffs at home and elsewhere as they make efforts to streamline their business and costs and cope with R&D and commercial challenges.
Results from the top Japanese pharma firms in the fiscal first quarter were marked mainly by strong global performances for mainstay products and significant currency effects due to the continued weakness of the yen, although forex concerns are rising. Eisai's Alzheimer's drug Leqembi also gained momentum, particularly in the US.
Otsuka Pharma’s acquisition of Jnana seems like a win for its pipeline, but the Japanese major faced a setback in a Delaware District Court where the judge’s opinion put challenger Lupin closer to a generic to its Jynarque (tolvaptan)
Despite initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges in gaining full approval in Japan, potentially providing learnings for other developers of regenerative medicines.
After expanding its local portfolio through acquisitions and partnerships, Chiesi is now aiming to build its presence in Japan's rare disease sector over the long term, helped by development of global products and possible new alliances.
The Japanese drug discovery bioventure builds on multiple alliances and an in-house platform to get away a successful IPO in Tokyo, which it will use to fund further pipeline and technology development.
If finally fully approved in its first indication, the HGF gene therapy could become a first-in-class therapy for PAD - but only after years of challenges in clinical trials.
SanBio’s lead cell therapy asset has been on a bumpy journey to its global-first approval and while a nod has now come in Japan in a high-need indication, a commercial launch is conditional on additional data to establish product equivalence and manufacturing consistency.
With no approved therapies globally for Stargardt's, competition in the indication is increasing in Japan, where Kubota Vision is seeking for conditional approval for emixustat, while Belite Bio’s contender tinlarebant has received Sakigake designation as a local Phase III program continues.
Academia-developed novel oral PAI-1 inhibitor in combination with Opdivo showed a strong response rate in PD-1 treated melanoma patients with certain disease characteristics and could represent a new breakthrough for a class with no clinical stage competitors.
The 15 July entry deadline for the Citeline Japan Awards 2024 in Tokyo is fast approaching, so here's a reminder to take a look at the categories and criteria and be sure you get those submissions in by this date. Sponsorship opportunities and tables are also available.
Korean bioventures join an inaugural matching event with Japanese pharma firms at Shonan iPark, amid rising hopes for further bilateral partnerships based on respective R&D capabilities.
The weak yen helped push up both global revenues and costs for major Japanese firms in the fiscal year ended 31 March, while good mainstay growth benefited Daiichi Sankyo and Astellas. Chugai meanwhile had a challenging start to its calendar financial year due to lower pandemic drug stockpiling.
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.
Astellas’ chief strategy officer, Adam Pearson, talks to Scrip about the company’s launch execution thrust for key therapies ahead of the loss of exclusivity for Xtandi and also deal-making appetite and choices, including the Iveric Bio buyout and walking away from the collaboration with Cartesian Therapeutics.
A pioneering approval filing for a therapeutic app by Shionogi is set to herald expansion of ADHD therapies beyond the pill in Japan, along with growth in the pediatric segment for the disorder.
The success of Enhertu led Daiichi Sankyo to raise its annual forecast for the fiscal year ending 31 March, while Eisai is readying for Leqembi’s steady US growth. Meanwhile, Astellas, Chugai and Shionogi balanced growth for some products with declines for others.
Additional studies have shown an ultra-high dose of mecobalamin safely decreased ALS progression in early-stage patients by 43%. Japan has spent decades studying the drug’s efficacy for the disease.
Setting a strategic focus on solid cancers with its enhanced PRIME CAR-T technology, Koji Tamada, CEO of Noile-Immune, shared the Japanese bioventure's collaboration strategies and views on the next generation of cell therapies.