Earnings, deals and disclosures from Japan's listed pharma & healthcare companies, in English.
A slower-than-expected arrival of generic rivals for two of its drugs, plus a weaker yen, is pushing Otsuka Holdings' first-half net profit to ¥215bn, 68% above the guidance it issued in February.
FunPep's FPP004X hit its safety and antibody-response targets in a Phase 1 trial, with titers rising in 97 to 100 percent of subjects, but an exposure-chamber test found no symptom improvement over placebo, and the split result now goes to option-holder Shionogi for discussion on what comes next.
Overseas shipments to majority owner Roche and royalty income from a licensed itch drug pushed Chugai's core profit up 23% in the first half, even as Japan's drug-price cuts dented older cancer medicines at home.
Hemlibra shipments to majority owner Roche and a sharp jump in Nemluvio exports to Galderma drove Chugai's core operating profit up 21% in the first half, while Japan's price controls kept domestic growth modest and management left its full-year guidance exactly where it stood in January.
Chuikyo, Japan's insurance-pricing panel, set a ¥53.2mn reimbursement price for ReHeart, Cuorips's iPS cell-derived cardiac tissue sheet for severe heart failure, but sales cannot begin until the official listing takes effect on September 1.
FDA feedback let AnGes skip a required pre-application meeting and start a staged BLA filing for its HGF gene therapy targeting severe leg ischemia in PAD patients, a procedural green light rather than any read on approval chances.
JCR Pharmaceuticals will file for Japanese approval of givinostat, already sold for Duchenne muscular dystrophy in the US, EU and UK, using foreign trial data instead of a fresh domestic pivotal study, with a 2027 launch in view after talks with Japan's drug regulator.
Daito Pharmaceutical is folding into a new joint venture to absorb Kyorin's generic drug business while telling lawmakers that three straight years of annual price cuts have made its dominant Parkinson's disease tablet impossible to produce at a profit.
Eisai and Biogen can now sell a weekly, 15-second self-injection as the starting treatment for early Alzheimer's disease, not just the maintenance dose already approved last year.
The move: Towa plans to buy Tanabe Pharma Factory outright, start transferring 35 manufacturing and marketing approvals from April 2027 onward and use the added capacity to target 24bn tablets by 2030 and more than 30bn by 2036.
Positive phase 3 data move the IgA nephropathy treatment beyond its earlier proteinuria-based accelerated approval, while leaving Otsuka's outlook for the year ending December 2026 unchanged.
The Tokyo Growth-listed company delivered 906,000 new shares in the first month of a June 5 warrant issue, while rights linked to 13,876,000 shares remained unexercised at month-end.
Shareholders approved NPT's TOKYO PRO Market delisting application, putting July 29 as the last planned trading day before depository handling ends and brokers stop accepting related requests after delisting.
The CHMP said Tavneos’ benefits had not been shown to outweigh its risks after a review linked to phase III data-integrity concerns, leaving Kissei to assess Japan’s response and any earnings effect.
The June 26 appointment took effect immediately and leaves Sugii running the Prescription Kampo Medicine Company, with Tsumura saying it wants a stronger management structure and faster decisions.
BrightPath Bio says Tokuhiro Nakamura stepped down on June 25 for personal reasons, and that the departure does not take it below the director numbers required by law and its articles of incorporation.
Revenue rose to ¥201.68bn and pretax profit rebounded to ¥14.27bn in the year to March, but profit attributable to owners of parent slipped to ¥10.44bn and EPS eased to ¥90.39. That leaves a familiar generics-market tension: operations improved before tax, shareholders saw less of it at the bottom line.
The US registration covers Gyre shares issued in the Cullgen buyout, not fresh fundraising, and parent GNI says its effective interest stands at about 70 per cent with no material effect expected on consolidated results.
Sales rose to ¥9.91bn and ordinary income turned positive at ¥256.4mn, while net income reached ¥227.2mn. Operating cash flow was still negative at ¥486.9mn, even as the annual dividend rose to ¥3.50 a share.
The 29th option series can be exercised only if Helios wins domestic approval for HLCM051 in ARDS and records at least ¥1.5bn of revenue in any year through 2032. Full exercise would equal 9.0% of shares outstanding, while the same-day 28th, 29th and 30th series together reach 14.0% dilution.
Revenue rose to ¥2,139,245,000,000 in the year to March 2026 from ¥1,912,323,000,000 a year earlier, while profit before tax jumped to ¥376,587,000,000 and net profit attributable to owners of parent to ¥291,535,000,000. ROE reached 17.4%, and a separate internal control report said financial-reporting controls were effective as of March 31.
The three months to April 30 produced no revenue and an ¥836 million net loss, yet AKUGO was added to Japan's reimbursement list in May at ¥72 million and commercial sales began. SanBio also said it agreed Phase 3 trial design with the FDA for traumatic brain injury, though the company did not disclose early sales volume or hospital uptake.
CellSource turned a softer top line into a better interim profit picture. Consolidated revenue for the six months to April slipped 2.5% to JPY 1,775m, but SG&A fell 8.5% and operating profit climbed to JPY 125m from JPY 17m, even as combined blood- and adipose-derived processing cases edged down to 10,114 from 10,303. Management still kept its full-year forecast for a JPY 170m operating loss, saying the year remains one of strategic investment rather than tidy recovery.
GNI plans to buy all of Ayumi Pharmaceutical Holdings for ¥44.776 billion and make it a wholly owned unit, arguing the deal adds a steadier Japanese earnings base plus an established sales network in rheumatology, orthopedics and fever-and-pain drugs. Ayumi reported revenue of ¥38.543 billion and operating profit of ¥6.206 billion in the year to March 2026, giving GNI a domestic commercial platform rather than just another pipeline promise. The financing is the real tell. GNI will pay ¥18.005 billion in cash and settle ¥26.771 billion through a contribution in kind, issuing 9,974,291 new shares to the sellers, while also lining up ¥20 billion of borrowing from Mizuho Bank and SBI Shinsei Bank. Management says the deal should close between June 30 and September 30, but existing holders face 17.89% share dilution and BCP is expected to emerge as the largest shareholder.