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NEWS

Zydus Lifesciences Launches Tishtha (Biosimilar, Opdivo) in India 

    Shots:  Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the India  Tishtha will be available in 100 mg and 40 mg strengths  Nivolumab is a mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma   Ref: Zydus  | Image: Zydus |  Press Release  Related News: Shanghai Henlius Receives the US FDA…
January 22, 2026

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Akesobio
NEWS

Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis

Shots: The Chinese NMPA has accepted the sNDA of gumokimab for the treatment of active ankylosing spondylitis (AS) sNDA was backed by the P-III (AK111-303) trial in AS, which met all efficacy endpoints, with 1EP (ASAS20 response rate) showing consistent improvements across subgroups, along with 2EP (ASAS40 response rate) & gumokimab delivering rapid symptom relief…
January 20, 2026

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J&J
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Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

Shots: J&J has reported the topline P-IIb (JASMINE) trial data assessing Imaavy (nipocalimab) vs PBO in 228 adults with SLE, along with the initiation of the P-III program Trial met its 1EP with higher SRI-4 composite response at Wk. 24, plus achieved secondary & exploratory endpoints, incl. those indicating the potential of nipocalimab for steroid sparing;…
January 7, 2026

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NEWS

GSK Reports the NMPA Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The Chinese NMPA has approved Nucala as an add-on maintenance treatment of adults with inadequately controlled COPD characterised by eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA filing is under review MATINEE assessed Nucala (100mg, SC, Q4W) vs PBO in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…
January 5, 2026

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Hutchmed
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HUTCHMED Initiates P-III Trial of Surufatinib + Camrelizumab + CT for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Shots: HUTCHMED has initiated P-III portion of P-II/III trial of the combination of surufatinib, camrelizumab, nab-paclitaxel & gemcitabine (S+C+AG) as the 1L treatment of metastatic PDAC in China, with the first patient receiving the dose on Dec 30, 2025 Trial will evaluate the combination against nab-paclitaxel + gemcitabine in ~400 PDAC adults who have not…
January 5, 2026

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Elanco
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Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis

Shots: The USDA has granted Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis, expected to launch in H1’26 Befrena (mAb) is an anti-IL31 injection for dogs, treats allergic and atopic dermatitis every 6–8 wks. In September, the FDA approved changes to Zenrelia (ilunocitinib tablets) US label, eliminating the fatal vaccine-induced disease risk, Elanco announced Ref:…
January 1, 2026

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NEWS

Windward Bio Secures Exclusive Rights to WIN027 from Qyuns Therapeutics in a ~$700M Deal

Shots: Windward Bio via its affiliate, LE2025 Therapeutics, has entered into a licensing agreement with Qyuns to develop & commercialize WIN027 (QX027N; anti-TSLPxIL-13 bsAb) As per the deal, Windward will obtain exclusive rights to develop, manufacture, & commercialize WIN027 outside of China, with Qyuns receiving an upfront payment, equity, & development, regulatory, & commercial milestones,…
December 24, 2025

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NEWS

Amneal Pharmaceuticals and mAbxience’s Boncresa and Oziltus (Biosimilar, Prolia and Xgeva) Receive the US FDA’s Approval 

 Shots:  The US FDA has approved Boncresa (denosumab-mobz), a biosimilar version of Prolia, and Oziltus (denosumab-mobz), a biosimilar version of Xgeva  Denosumab is an mAb that reduces bone resorption and is used in oncology and osteoporosis indications   Under the Amneal and mAbxience collaboration, mAbxience manages development and manufacturing, and Amneal has exclusive US commercialization rights  Ref: Amneal Pharmaceuticals| Image: Amneal Pharmaceuticals and mAbxience | Press Release Related News:- Kashiv BioSciences and Amneal…
December 22, 2025

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