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Innovent will grant Spero Therapeutics exclusive rights to develop, research, manufacture, & commercialize SP001 worldwide, excl. Greater China, where Innovent will retain the rights
In return, Innovent will receive an upfront payment & development, regulatory & commercial milestone payments, representing the total deal value of ~$1.1B, plus Innovent will also receive tiered royalties on…
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Polpharma has granted Teva exclusive rights to commercialize both IV & SC formulations of Polpharma’s proposed biosimilar to Ocrevus (ocrelizumab) for multiple sclerosis, upon regulatory approval
As per the deal, Polpharma will lead biosimilar development & manufacturing, while Teva will oversee regulatory filings & commercialization across the US, EU, Brazil, Canada, Australia, New Zealand,…
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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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Tozorakimab reinforced its potential as a first-in-class COPD biologic with a third positive Phase III trial (MIRANDA), complementing OBERON and TITANIA and strengthening AstraZeneca’s regulatory package while validating IL-33 as a critical therapeutic pathway in COPD.
The MIRANDA trial demonstrated efficacy across one of the broadest COPD populations studied for a biologic, including former and current smokers, patients across…
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Tozorakimab demonstrated a potential first-in-class advantage in COPD, becoming the first IL-33 biologic to achieve positive outcomes across three pivotal Phase III trials (OBERON, TITANIA, and MIRANDA), highlighting the clinical relevance of targeting both reduced and oxidized forms of IL-33 to reduce exacerbations in a broad patient population.
The LUNA Phase III programme enrolled the most comprehensive…
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Part B of P-II (APEX) trial assessed high, medium, or low-dose zumilokibart vs PBO in 346 pts, where mid & high-doses met the 1EP at 16wks., with 61.6% pts on high dose, 65.9% on mid-dose & 50.5% on low dose achieved EASI-75 vs 23.4% on PBO
At Wk. 16, mid-dose also met key 2EP…
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The US FDA has approved Sanofi's Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D
Approval was supported by 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in…
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Akeso has reported the P-II (COMPASSION-26) trial results assessing cadonilimab + CT as the 1L treatment of advanced pancreatic ductal adenocarcinoma (PDAC)
As of Oct 20, 2025 (mFU of >2yrs.), trial showed robust & durable survival benefits, with mPFS of 11.1mos. & mOS of >23mos., showing 12 & 24mos. OS rate of 91.7% &…
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The EC has approved Enflonsia (clesrovimab) to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk infants
The Phase 2b/3 CLEVER trial (N=3,614) evaluated in infants entering their first RSV season. Enflonsia reduced RSV-associated medically attended LRIs…
Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis
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Apogee has reported maintenance data from Part A of the P-II (APEX) trial assessing zumilokibart (APG777; 360mg at Q3M or Q6M) in pts with mod. to sev. atopic dermatitis
Trial showed 75% (Q3M) & 85% (Q6M) of Wk. 16 zumilokibart-responders maintained EASI-75, while 86% (Q3M) & 78% (Q6M) sustained vIGA 0/1, with continued deepening…

