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Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab)
Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults
Yesintek was previously approved as…
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InnoCare has reported a P-III trial assessing the efficacy, safety & tolerability of fadeucravacitinib (ICP-488) vs PBO in pts with moderate-to-severe plaque psoriasis
Trial met its 1EP with statistically significant & clinically meaningful improvement, while also achieving multiple 2EPs, demonstrating consistent efficacy across measures; data to be presented & published in the future
Fadeucravacitinib…
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Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks.
Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…
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The US FDA has approved Lipfendra (20mg, PO) as an adjunct to lifestyle intervention to reduce LDL-C in adults with hypercholesterolemia, incl. HeFH, based on 2 P-III trials (CORALreef Lipids & CORALreef HeFH) assessing it vs PBO
At Wk. 24 in Lipids trial, Lipfendra reduced LDL-C by 57% vs a 3% increase from…
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Junshi Biosciences has entered into a license agreement with Fosun Wanbang Pharma Group for roconkibart in the Greater China region, incl. Mainland China, Hong Kong SAR, Macao SAR, & Taiwan
Companies will cooperate on the development, registration, manufacturing & commercialization of roconkibart, an anti-IL-17A mAb, which showed 91% reached PASI 90 at wk. 16…
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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…
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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…
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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 &…
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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…
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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…

