This week’s Immunology & Gastro-Dermatology update highlights regulatory approvals, reimbursement wins, emerging diagnostics, long-term efficacy readouts, comparative treatment evidence, workforce policy insights, and early clinical-stage innovation across autoimmune and inflammatory diseases.
In Today’s Newsletter
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🌏 Imfinzi approved in the US as first and only perioperative immunotherapy for patients with early gastric and gastroesophageal cancers [1] [US • 2 Dec 2025]
Context: AstraZeneca’s Imfinzi (durvalumab), combined with FLOT chemotherapy, has been approved in the US for early gastric and gastroesophageal junction cancers, based on MATTERHORN Phase III trial data.
Key point: The approval marks the first-ever immunotherapy for early gastric cancers, with data showing a 29% reduction in the risk of progression and a 22% reduction in the risk of death compared to chemotherapy alone.
Implication: This approval could significantly improve survival rates for patients with early gastric and GEJ cancers, establishing a new standard of care.
💊 GC Genome Publishes Blood-Based Colorectal Cancer Screening Study in AJG [2] [US • 2 Dec 2025]
Context: GC Genome’s study, utilizing its AI-based fragmentomics technology, demonstrates the potential for a blood-based colorectal cancer screening method with high sensitivity and specificity.
Key point: The test showed 90.4% sensitivity for CRC detection, and 94.7% specificity for individuals with normal colonoscopy, with robust results across various CRC stages.
Implication: This blood test could revolutionize colorectal cancer screening, offering a less invasive alternative to colonoscopy.
🧬 SKYRIZI® Receives Positive Reimbursement Recommendation by Canada’s Drug Agency for Ulcerative Colitis [3] [CA • 2 Dec 2025]
Context: AbbVie’s SKYRIZI (risankizumab) has received a positive reimbursement recommendation for ulcerative colitis from Canada’s Drug Agency, following successful Phase 3 clinical trials.
Key point: SKYRIZI is now recommended for reimbursement in patients with moderately to severely active UC who have had inadequate responses to conventional therapy or biologics.
Implication: This could improve access to an effective treatment for UC patients in Canada, with AbbVie working towards expanding availability.
🎯 Nemolizumab Provides Durable Efficacy, Favorable Safety for Atopic Dermatitis Through 2 Years [4] [Global • 2 Dec 2025]
Context: A study shows that nemolizumab provides long-term efficacy in improving skin lesions and pruritus in moderate-to-severe atopic dermatitis (AD) patients.
Key point: Patients treated with nemolizumab saw continuous improvement over 2 years, with an 88.2% EASI 75 response rate.
Implication: Nemolizumab could become a key treatment for AD, offering durable symptom relief with a well-tolerated safety profile.
☢️ Baricitinib, Ritlecitinib, Deuruxolitinib: Comparative Efficacy in Alopecia Areata [5] [Global • 2 Dec 2025]
Context: A Bayesian network meta-analysis compares the efficacy of oral JAK inhibitors for severe alopecia areata (AA), finding deuruxolitinib superior to others in promoting hair regrowth.
Key point: Deuruxolitinib 8 mg BID showed the highest efficacy for achieving clinically significant hair regrowth at week 24, compared to baricitinib and ritlecitinib.
Implication: These findings may guide future treatment choices for patients with severe AA, though safety concerns for JAK inhibitors persist.
🧠 British Society for Immunology Publishes New Report on Clinical Immunology and Allergy Workforce [6] [UK • 2 Dec 2025]
Context: The British Society for Immunology’s report highlights critical workforce shortages in clinical immunology and allergy services across the UK.
Key point: The report reveals that 15 services in the UK are operating with minimal staffing, and calls for urgent action to increase medical training posts and other healthcare staff.
Implication: Policymakers need to act quickly to address workforce gaps and ensure sustainable healthcare delivery in immunology and allergy specialties.
💉 Daewoong Pharmaceutical Launches Zeltopa Tablets as Low-Cost JAK Inhibitor for Autoimmune Diseases [7] [KR • 2 Dec 2025]
https://biz.chosun.com/en/en-science/2025/11/27/6SXMNPAP75AWBP2QAEVTIR3N7A/
Context: Daewoong Pharmaceutical has launched Zeltopa tablets, a low-cost JAK inhibitor for autoimmune diseases like rheumatoid arthritis and ulcerative colitis.
Key point: Zeltopa offers the same therapeutic efficacy as the original at a significantly lower price point, improving treatment access for patients.
Implication: This launch could reduce the financial burden for patients in the autoimmune disease market, providing a more affordable treatment option.
🔬 InnoCare Announces First Patient Dosed in Global Phase II Clinical Trial of Soficitinib for Prurigo Nodularis [8] [Global • 2 Dec 2025]
Context: InnoCare Pharma has dosed the first patient in a Phase II trial of Soficitinib (ICP-332), a TYK2 inhibitor, for the treatment of prurigo nodularis.
Key point: Soficitinib is aimed at treating inflammatory skin diseases by targeting the JAK-STAT signaling pathway, with a focus on reducing itching and inflammation.
Implication: Soficitinib could offer a promising new treatment for prurigo nodularis, expanding InnoCare’s portfolio in dermatology.
🤝 Galux and Celltrion Join Forces to Accelerate Next-Gen Autoimmune Drug Development [9] [KR • 2 Dec 2025]
https://www.koreabiomed.com/news/articleView.html?idxno=29825
Context: Galux and Celltrion have entered a strategic collaboration to co-develop AI-designed multi-specific antibodies for autoimmune diseases.
Key point: The collaboration combines Galux’s computational design platform with Celltrion’s biologics development expertise to accelerate the creation of next-generation autoimmune treatments.
Implication: The partnership could lead to innovative treatments for autoimmune diseases, revolutionizing the field with AI-driven antibody development.
Why it matters
- Imfinzi’s approval [1] as the first perioperative immunotherapy for gastric and GEJ cancers represents a landmark in cancer treatment, potentially offering longer survival for patients with early-stage disease.
- GC Genome’s colorectal cancer screening study [2] could significantly improve early cancer detection and reduce reliance on more invasive procedures like colonoscopy.
- SKYRIZI’s positive reimbursement recommendation [3] in Canada offers a new treatment option for UC patients, with the potential to improve quality of life for those with severe cases.
- Nemolizumab [4] offers long-term relief for atopic dermatitis patients, providing a new, durable treatment option for skin conditions.
- Baricitinib, Ritlecitinib, and Deuruxolitinib [5] results highlight deuruxolitinib as the most effective hair regrowth treatment for alopecia areata.
- The British Society for Immunology’s report [6] underscores the urgent need for workforce expansion in clinical immunology and allergy services in the UK, ensuring that patients continue to have access to specialized care.
- Daewoong Pharmaceutical’s launch of Zeltopa tablets [7] provides a low-cost alternative to Xeljanz, making JAK inhibitors more affordable for autoimmune disease patients.
- InnoCare’s Soficitinib trial [8] marks a step forward in prurigo nodularis treatment, addressing a serious skin condition with no effective therapies.
- Galux and Celltrion’s partnership [9] could accelerate the development of next-generation autoimmune drugs, introducing more innovative treatments to the market.
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FAQ
What is the significance of Imfinzi’s approval?
Imfinzi’s approval as the first perioperative immunotherapy for gastric and GEJ cancers could drastically improve survival rates for early-stage cancer patients and become a new standard of care [1].
What did GC Genome’s colorectal cancer screening study show?
GC Genome’s study demonstrated that its blood-based screening test has high sensitivity and specificity, offering a promising alternative to colonoscopy for detecting colorectal cancer at early stages [2].
How will SKYRIZI benefit UC patients in Canada?
SKYRIZI’s positive reimbursement recommendation gives UC patients in Canada access to a new treatment option that has been proven effective in clinical trials for severe cases [3].
How effective is Nemolizumab for atopic dermatitis?
Nemolizumab has shown durable efficacy in treating moderate-to-severe atopic dermatitis, with significant improvements in both skin lesions and itching over a two-year period [4].
Which JAK inhibitor is most effective for alopecia areata?
Deuruxolitinib was found to have the highest efficacy in promoting hair regrowth compared to other JAK inhibitors, making it the top choice for treating severe alopecia areata [5].
What does the British Society for Immunology report suggest?
The report calls for an urgent national review of the clinical immunology and allergy workforce in the UK to address staffing shortages and ensure sustainable service delivery [6].
What does Daewoong’s Zeltopa launch mean?
Daewoong’s Zeltopa tablets provide a cost-effective alternative to Xeljanz, making JAK inhibitors more affordable for patients with autoimmune diseases [7].
What is Soficitinib being developed for?
Soficitinib is being developed for the treatment of prurigo nodularis, a chronic skin disease causing intense itching and nodules, with promising results in Phase II trials [8].
What does the Galux-Celltrion partnership focus on?
The partnership aims to accelerate next-generation autoimmune treatments through the use of AI-designed multi-specific antibodies, opening new possibilities for autoimmune disease therapies [9].
Entities / Keywords
Imfinzi, AstraZeneca, gastric cancer, GEJ cancer, MATTERHORN.
GC Genome, colorectal cancer screening, AI-based fragmentomics.
SKYRIZI, AbbVie, ulcerative colitis, Canada.
Nemolizumab, atopic dermatitis, long-term efficacy.
Baricitinib, Ritlecitinib, Deuruxolitinib, alopecia areata.
British Society for Immunology, workforce report, clinical immunology.
Zeltopa, Daewoong Pharmaceutical, JAK inhibitor, autoimmune diseases.
Soficitinib, InnoCare Pharma, prurigo nodularis, TYK2 inhibitor.
Galux, Celltrion, AI-designed antibodies, autoimmune disease treatments.
References
- https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-as-first-and-only-perioperative-immunotherapy-for-patients-with-early-gastric-and-gastroesophageal-cancers.html
- https://www.kron4.com/business/press-releases/cision/20251127CN34458/gc-genome-publishes-blood-based-colorectal-cancer-screening-study-in-the-american-journal-of-gastroenterology/
- https://www.globenewswire.com/news-release/2025/11/28/3196206/0/en/SKYRIZI-risankizumab-Receives-Positive-Reimbursement-Recommendation-by-Canada-s-Drug-Agency-for-Ulcerative-Colitis-and-AbbVie-Concludes-Letter-of-Intent-with-the-pan-Canadian-Pharm.html
- https://www.dermatologyadvisor.com/news/nemolizumab-provides-durable-efficacy-favorable-safety-ad-through-2-years/
- https://www.dermatologytimes.com/view/baricitinib-ritlecitinib-deuruxolitinib-comparative-efficacy-in-aa
- https://www.immunology.org/news/british-society-immunology-publishes-new-report-clinical-immunology-and-allergy-workforce
- https://biz.chosun.com/en/en-science/2025/11/27/6SXMNPAP75AWBP2QAEVTIR3N7A/
- https://www.globenewswire.com/news-release/2025/11/28/3195971/0/en/InnoCare-Announces-First-Patient-Dosed-in-the-Global-Phase-II-Clinical-Trial-of-TYK2-Inhibitor-Soficitinib-for-Treatment-of-Prurigo-Nodularis.html
- https://www.koreabiomed.com/news/articleView.html?idxno=29825