Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Akeso’s gumokimab (AK111; SC, 17 doses per year, incl. loading) to treat mod. to sev. plaque psoriasis in adults based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 94.6% & PASI 100 reaching…

ByRidhi RastogiJune 12, 2026

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Takeda Reports P-III (LATITUDE Atlas) Trial Data on Zasocitinib for Plaque Psoriasis (PsO)

Shots: Takeda has reported topline P-III (LATITUDE Atlas) trial data assessing zasocitinib (TAK-279; 30mg, PO, QD) vs deucravacitinib (6mg, QD) in 606 adults with mod. to sev. PsO Trial showed that zasocitinib was superior to deucravacitinib in the 1EP, with improved PASI 100 response rates at Wk. 16, plus in all key 2EPs, incl. PASI 90…

ByRidhi RastogiJune 12, 2026

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Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

Shots: Samsung Bioepis has reported the launch of Ustekinumab BS 45 mg Syringe for SC Injection 「NIPRO」, a biosimilar version of Stelara, in Japan, marking the company’s first commercialized product in the country The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focused on developing &…

ByRidhi RastogiMay 20, 2026

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LEO Pharma’s Enstilar Receives the NMPA Approval for Plaque Psoriasis

Shots: The NMPA has approved Enstilar (calcipotriene/betamethasone dipropionate) for the treatment of adult patients with plaque psoriasis in China. Following NMPA approval, Enstilar is planned to launch in China later this year NMPA approval was backed by a P-III trial (n=604) in Chinese adults with plaque psoriasis, where QD Enstilar showed superior efficacy and met…

ByDipanshu DixitApril 17, 2026

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Takeda Presents P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis at AAD 2026

Shots: The 2 P-III (Latitude PsO 3001 & PsO 3002) trials assessed zasocitinib in 693 & 1108 adults with mod. to sev. PsO, with plans for NDA submission to FDA & other authorities starting Takeda’s FY’26 PsO 3001 showed 71.4% achieved sPGA 0/1 vs PBO (10.7%) & apremilast (32.1%), with 39.9% reaching sPGA…

ByRidhi RastogiMarch 30, 2026

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Eli Lilly Reports the P-IIIb (TOGETHER-PsO) Trial Data on Taltz + Zepbound for Adults with Psoriasis and Obesity or Overweight

Shots: Eli Lilly has reported P-IIIb (TOGETHER-PsO) trial data assessing Taltz (ixekizumab) + Zepbound (tirzepatide) vs Taltz alone in 274 adults with mod. to sev. plaque psoriasis & obesity/overweight with ≥1 additional weight-related comorbid condition At 36wks., the trial met its 1EP with 27.1% pts reaching PASI 100 & ≥10% weight loss compared to 5.8% pts. Trial…

ByRidhi RastogiFebruary 19, 2026

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Eli Lilly Reports P-IIIb (TOGETHER-PsA) Trial on Taltz + Zepbound for Psoriatic Arthritis and Obesity or Overweight

Shots: Eli Lilly has reported P-IIIb (TOGETHER-PsA) trial assessing concomitant Taltz (ixekizumab) & Zepbound (tirzepatide) vs Taltz alone in 271 adults with active PsA & obesity or overweight with ≥1 weight-related condition Trial met its 1EP, with 31.7% of pts achieving ACR50 & ≥10% weight loss at Wk. 36 vs 0.8%, & met a key…

ByRidhi RastogiJanuary 9, 2026

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Fresenius Kabi Launches an Additional Presentation of Otulfi (Biosimilar, Stelara)

Shots: Fresenius Kabi has launched Otulfi, an interchangeable biosimilar version of Stelara (ustekinumab), in a 45 mg/0.5 mL single-dose vial presentation for SC injection FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity of Otulfi vs Stelara among mod. to sev.…

ByRidhi RastogiJanuary 7, 2026

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Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan

Shots: Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026 It is also approved in Australia, Brazil, Canada,…

ByDipanshu DixitDecember 23, 2025

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Johnson & Johnson’s Tremfya (Guselkumab) Receives the EC Approval for Pediatric Plaque Psoriasis (PsO)

Shots: The EC has approved Tremfya (SC) for children (≥6yrs.) with mod. to sev. PsO, who are candidates for systemic therapy Approval was based on P-III (PROTOSTAR) trial in 120 pediatric pts, which met its co-1EPs of PASI 75 (~76% vs 20%) & IGA 0/1 (66% vs 16%) at 16wks., with ~40% vs 4% achieving IGA…

ByRidhi RastogiDecember 22, 2025

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Takeda Reports P-III (LATITUDE Atlas) Trial Data on Zasocitinib for Plaque Psoriasis (PsO)

Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

LEO Pharma’s Enstilar Receives the NMPA Approval for Plaque Psoriasis

Takeda Presents P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis at AAD 2026

Eli Lilly Reports the P-IIIb (TOGETHER-PsO) Trial Data on Taltz + Zepbound for Adults with Psoriasis and Obesity or Overweight

Eli Lilly Reports P-IIIb (TOGETHER-PsA) Trial on Taltz + Zepbound for Psoriatic Arthritis and Obesity or Overweight

Fresenius Kabi Launches an Additional Presentation of Otulfi (Biosimilar, Stelara)

Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan

Johnson & Johnson’s Tremfya (Guselkumab) Receives the EC Approval for Pediatric Plaque Psoriasis (PsO)

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