Samsung Bioepis Reports MHLW Approval of its Ustekinumab Biosimilar

Shots: The MHLW has granted marketing approval to Ustekinumab BS IV infusion 130mg 「NIPRO」, a biosimilar version of Stelara (ustekinumab), for induction therapy in mod. to sev. active Crohn’s disease when other treatments are ineffective Additionally, the MHLW approved Ustekinumab BS SC Injection 45mg Syringes 「NIPRO」in Dec 2025, which was then launched in May 2026 The biosimilar…

ByRidhi Rastogi2 days ago

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BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

Shots: The MHLW has approved Orladeyo (berotralstat) for prophylactic therapy in pediatric pts (2 to <12 yrs.) with hereditary angioedema (HAE) Approval was based on interim APeX-P trial results in pediatric pts with HAE, which showed early & sustained reductions in monthly attack rates; published in the Annals of Allergy, Asthma & Immunology BioCryst plans to launch…

ByRidhi RastogiAugust 26, 2026

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Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Shots: The MHLW has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO) & RadiantLight randomized…

ByRidhi RastogiAugust 24, 2026

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The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Shots: The MHLW has approved Sarclisa (isatuximab; SC) + SoC for MM, while regulatory filing for the CirCLIQ on-body injector (OBI), based on the enFuse platform & submitted by Enable Injections, is under review; filing for both OBI & SC manual injection is under FDA review Approval was based on the P-III (IRAKLIA) study in R/R…

ByRidhi RastogiJune 19, 2026

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Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R DLBCL

Shots: The MHLW has approved Minjuvi (tafasitamab) + Lenalidomide for the treatment of adult pts. with r/r diffuse large B-cell lymphoma (DLBCL) Approval was based on the international P-II (L-MIND) trial, & a Japanese P-Ib/II (J-MIND) trial (Group 6) assessing Minjuvi + lenalidomide in pts with r/r DLBCL who are not eligible for autologous stem…

ByRidhi RastogiJune 19, 2026

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Oncolys BioPharma Reports MHLW Approval of Telomelysin for Esophageal Cancer

Shots: The Japanese MHLW has granted full marketing approval to Telomelysin Injection (suratadenoturev/OBP-301) for the treatment of esophageal cancer pts ineligible for curative resection or CT, based on a Japanese pivotal trial conducted at 17 sites Approval triggered a milestone payment to Oncolys under its deal with FUJIFILM Toyama Chemical, which granted FUJIFILM commercialization rights…

ByRidhi RastogiJune 10, 2026

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GSK Receives MHLW Approval for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The Japanese MHLW has approved GSK's Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for RSV disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing Arexvy in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429), which showed a non-inferior immune response in individuals (18-49yrs.) who are at increased…

ByRidhi RastogiMay 19, 2026

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MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

Shots: MEDIPOST has reported the P-III trial data assessing Cartistem (n=59) vs hyaluronic acid (n=61) in 130 knee osteoarthritis pts over a 52wk. follow-up period across 13 Japanese sites Trial met both co-1EPs of WOMAC knee pain & function scores, and ICRS cartilage repair grading. Improvements were also observed across all 2EPs, incl. VAS pain…

ByRidhi RastogiMay 15, 2026

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Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Shots: The Japanese MHLW has approved Dupixent to treat adults with mod. to sev.bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks. Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks. 4 to 6 if disease control was…

ByRidhi RastogiMarch 25, 2026

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Cytiva and Yoshindo Collaborate to Strengthen Domestic Biosimilar Manufacturing through their FlexFactory Contract in Japan

Shots: Cytiva and Yoshindo sign a FlexFactory contract to support the establishment of domestic biosimilar drug substance manufacturing in Japan. The investment is partly supported by Japan’s MHLW Yoshindo plans to supply biosimilars from its Toyama plant starting in 2028, supporting a stable and affordable biologics supply in Japan Cytiva’s FlexFactory platform uses modular bioprocessing technologies to support faster transition from facility design to GMP…

ByDipanshu DixitMarch 23, 2026

Samsung Bioepis Reports MHLW Approval of its Ustekinumab Biosimilar

BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R DLBCL

Oncolys BioPharma Reports MHLW Approval of Telomelysin for Esophageal Cancer

GSK Receives MHLW Approval for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Cytiva and Yoshindo Collaborate to Strengthen Domestic Biosimilar Manufacturing through their FlexFactory Contract in Japan

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