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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,…
3 days ago

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Celltrion
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Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases

Shots: The CHMP has recommended Celltrion's Steqeyma autoinjector (45mg/0.5mL & 90mg/1mL), a biosimilar version of Stelara (ustekinumab), for the treatment of pts with plaque psoriasis, psoriatic arthritis (PsA) & Crohn’s disease (CD) SteQeyma (CT-P43) is a human anti-IL-12 & IL-23 monoclonal antibody that is also available in SC formulation (45mg/0.5 mL or 90mg/1 mL in…
December 18, 2025

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NEWS

Harbour BioMed and BMS Collaborate in ~$1.1B Deal to Advance Next-Generation Multi-Specific Antibodies

Shots: Harbour BioMed has entered into a multi-year, global strategic collaboration & license agreement with BMS to discover & develop next-generation multi-specific antibodies leveraging the Harbour Mice platform As per the deal, Harbour BioMed & BMS will jointly identify & advance multi-specific antibody programs, with Harbour eligible for $90M in total payments, ~$1.03B in development & commercial…
December 17, 2025

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NEWS

Formycon Partners with Zydus to Commercialize FYB206 (Biosimilar, Keytruda) in the US and Canada

Shots: Formycon has entered into an exclusive licensing & supply agreement with Zydus Lifesciences Global FZE, UAE (Zydus' subsidiary) to commercialize Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the US & Canada As per the deal, Formycon will be responsible for development, registration, manufacturing & supply of the product, while Zydus Lifesciences…
December 10, 2025

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NEWS

Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Shots: Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…
December 8, 2025

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NEWS

Alexion (AstraZeneca) and Neurimmune Expand Alliance to Develop NI009 for AL Amyloidosis

Shots: Neurimmune has entered into an exclusive global collaboration & licensing deal with Alexion to develop NI009, a preclinical human mAb for the treatment of AL amyloidosis Alexion will obtain an exclusive global license to Neurimmune’s AL amyloidosis–targeting Abs, incl. NI009, with Neurimmune handling preclinical activities, early manufacturing & the FIH study, while Alexion will…
December 5, 2025

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NEWS

Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

Shots: Formycon has entered into an exclusive licensing & supply agreement with MS Pharma for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the MENA region As per the deal, Formycon will receive an upfront payment, potential development & regulatory milestones, & a significant share of regional gross profits, though…
December 4, 2025

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Celltrion
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The US FDA Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: The US FDA has approved Omlyclo, an interchangeable biosimilar version of Xolair (omalizumab), in PFS presentation (300mg/2ml, SC) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), & IgE-mediated food allergy Omlyclo previously received the US FDA approval in Mar 2025 for PFS injections at…
December 3, 2025

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Zoetis
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Zoetis’ Lenivia (Izenivetmab) Receives the EC Approval for Osteoarthritis Pain Relief in Dogs

Shots: The EC has approved Lenivia (Q3W) for the reduction of pain associated with osteoarthritis in dogs Lenivia showed increased mobility & decreased pain after a single administration in a 9mos. field study, along with favorable safety in dogs Lenivia, a monoclonal antibody targeting NGF, is designed to provide longer-lasting pain relief in osteoarthritis by…
November 27, 2025

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