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Henlius Reports First Patient Dosing in P-I Trial of HLX05-N (Biosimilar, Erbitux) in China 

Shots:  Henlius has dosed the first patient in China in the P-I HLX05-N (HLX05-N-mCRC102), a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)  The study will compare HLX05-N vs. US & EU sourced Erbitux in mCRC, evaluating PK similarity, efficacy, safety, and immunogenicity in combination with mFOLFOX6 CT  HLX05-N is Henlius' cetuximab biosimilar candidate, developed under global biosimilar guidelines, with analytical and non-clinical studies demonstrating high…

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Biocytogen Collaborates with Whitehawk Therapeutics to Develop Bispecific ADC

Shots: Biocytogen has entered into a global collaboration with Whitehawk Therapeutics to develop bispecific antibody-drug conjugates (BsADCs) Biocytogen will provide ~5 bispecific antibodies from its RenLite platform & Whitehawk will evaluate these in combination with its ADC linker-payload technologies, with Whitehawk holding the option to advance resulting BsADC candidates Biocytogen will receive an upfront payment,…

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Key Biosimilars Events of June 2026 

Shots:  June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC),  and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology,  ophthalmology,  oncology, osteoporosis, and reproductive medicine.  Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.  Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.  Celltrion Seeks…

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Orion Pharma Expands Partnership with Shilpa Medicare for Nivolumab Biosimilar in the EU 

Shots:  Orion Pharma has entered into an agreement with Shilpa Biologicals to co-develop and supply IV nivolumab biosimilar across Europe  As per the deal, Orion will gain exclusive rights to register, market, distribute & sell the nivolumab biosimilar across the EU, while Shilpa Biologicals will lead product development, exclusively manufacture & supply the product, and receive development &…

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Sanyou Biopharmaceutical and Baiyunshan Xihe Partner on AI-Driven Radiopharmaceutical Development

Shots: Sanyou & Baiyunshan Xihe have entered into a strategic collaboration to co-develop novel radiopharmaceuticals & radiodiagnostic products by combining AI-driven drug discovery with nuclear medicine expertise As per the deal, Sanyou Bio will contribute its AI-STAL libraries & AI-Drug Accelerator platform for target molecule discovery, while Baiyunshan Xihe will lead radionuclide production, radiolabeling, preclinical…

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Novartis to Acquire Myricx Bio for ~$1.5B

Shots: Novartis has entered into an agreement to acquire Myricx Bio, strengthening Novartis’ oncology pipeline & advancing next-generation targeted drug conjugates with novel payload mechanisms Myricx is developing ADCs, using NMT inhibitor (NMTi) payloads designed to disrupt key cancer cell processes, with preclinical data showing broad activity across solid tumors, incl. TOPO-1-resistant models As per…

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Ipsen to Acquire Kartos Therapeutics for ~$1.75B

Shots: Ipsen has entered into a definitive merger agreement to acquire Kartos Therapeutics, incl. its asset, navtemadlin, expanding its hemato-oncology late-stage pipeline As per the deal, Ipsen will acquire Kartos Therapeutics through a fully-owned subsidiary for $450M upfront & ~$1.3B in milestones, incl. a significant regulatory approval milestone & sales-based milestones; closing is expected by…

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Antares Therapeutics Inks ~$1.9B Deal with Novartis for Undruggable Oncology Targets

Shots: Antares Therapeutics has entered into a strategic collaboration with Novartis to discover, develop & commercialize small molecule therapies against undruggable oncology targets Antares will lead research & apply its discovery engine to a select number of historically undruggable targets until option exercise, while continuing to advance its wholly owned & partnered precision medicine pipeline…

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CXO Talks Podcast | The Road to Acquisition: Oncolytics’ CEO Jared Kelly on Clinical Data, IP & Pharma Partnerships

Shots: In an engaging conversation with PharmaShots CXO Talks, Jared Kelly, CEO & Director of Oncolytics Biotech, shared insights from his experience leading corporate strategy at Ambrx and contributing to its $2B acquisition by Johnson & Johnson, offering a practical perspective on what makes biotech companies attractive acquisition targets. Kelly explained why successful biotech acquisitions…

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