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INSIGHTS+

Key Biosimilars Events of April 2026 

Shots:  Regulatory momentum stayed strong in April 2026, with key approvals including Poherdy (EC), Tuyory (EC), and multiple denosumab biosimilars in Canada, alongside NMPA IND clearances for Henlius’ HLX319 and HLX05-N and Mabwell’s Maiweijian sBLA acceptance.  Strategic activity expanded globally through Mochida–Qilu and Mabwell partnerships, while major M&A deals, Amneal–Kashiv and Sun Pharma–Organon, signaled growing biosimilar consolidation.  Pipelines and commercialization progressed with CuraTeQ’s P-III success for BP11 and Biocon’s US launch of Bosaya and Aukelso,…
May 5, 2026

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NEWS

Huahui Health and BeOne Medicines Partner for HH160 in a ~$2.02B Deal

Shots: Huahui Health has entered into a global exclusive option, license & collaboration agreement, granting BeOne an exclusive option for the development, manufacturing, & commercialization of HH160, a novel trispecific antibody in oncology immunotherapy As per the deal, Huahui will receive $20M upfront, $100M upon exercising the option, & ~$1.9B in development, regulatory & sales milestones, as well as tiered…
April 30, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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NEWS Uncategorized

Pheast Therapeutics Reports Early P-Ia Data for PHST001 at AACR 2026

Shots: Pheast Therapeutics presented initial P-Ia data for PHST001 at AACR Annual Meeting 2026, demonstrating target engagement, innate immune activation, and early clinical activity PHST001 (anti-CD24 macrophage checkpoint inhibitor) was generally well tolerated, across dose-escalation cohorts and early signals of clinical activity were observed incl. tumor shrinkage and disease stabilization Preclinical data showed enhanced tumor…
April 20, 2026

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Innate Pharma to Present P-II (MATISSE) Interim Data of IPH5201 in NSCLC at AACR 2026

Shots: Innate Pharma to present interim P-II (MATISSE) data (n=40) for IPH5201 at AACR Annual Meeting 2026, highlighting early efficacy in resectable NSCLC IPH5201 (anti-CD39) combined with durvalumab and chemotherapy showed promising pathological complete response (pCR) rates of 35.7% (PD-L1 ≥1%) and 50% (PD-L1 ≥50%) The study continues enrollment in PD-L1–positive pts., supporting further evaluation…
April 20, 2026

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EpiBiologics Reports First Patient Dosed in P-I Study of EPI-326 for EGFR-Driven Solid Tumors

Shots: EpiBiologics has dosed the first patient in a global P-I study evaluating EPI-326, a tissue-selective bispecific antibody targeting EGFR, in advanced solid tumors The first-in-human study will assess safety, tolerability, PK, and preliminary anti-tumor activity in pts with NSCLC and HNSCC, with potential expansion into colorectal cancer Preclinical data showed robust anti-tumor activity across…
April 20, 2026

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Piramal Pharma Solutions Partners with Ajinomoto Bio-Pharma Services to Advance ADC Development and Manufacturing

Shots: Piramal Pharma Solutions has entered into a strategic collaboration with Ajinomoto Bio-Pharma Services to support antibody-drug conjugate (ADC) development and manufacturing programs Under the agreement, Piramal will refer customers to Ajinomoto’s AJICAP platform for site-specific ADC conjugation, while Ajinomoto will direct clients to Piramal for CDMO manufacturing services across development and commercialization The collaboration…
April 17, 2026

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