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Innovent Biologics’ IBI363 Granted Breakthrough Therapy Designation for Melanoma
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug IBI363. The designation is for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma…
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Innovent Biologics Doses First Patient with IBI354 in HeriCare-Ovarian01 Study
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China-based Innovent Biologics, Inc. (HKG: 1801) has administered the first dose of its antibody-drug conjugate (ADC) IBI354 to a subject in the HeriCare-Ovarian01 study. This Phase III trial is a randomized, controlled, multicenter study designed to evaluate the safety and efficacy of IBI354 compared to chemotherapy in patients with HER2-expressing…
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HutchMed and Innovent Announce Positive Results for Fruquintinib and Sintilimab in Renal Cell Carcinoma Trial
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Chinese companies HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) jointly announced positive results from the Phase II/III FRUSICA-2 study. The trial evaluated the combination of fruquintinib and sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China, with…
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Innovent Biologics’ Sycume Approved by China’s NMPA for Thyroid Eye Disease
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China-based Innovent Biologics Inc. (HKG: 1801) announced that its New Drug Application (NDA) for Sycume (teprotumumab), a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has been approved by China’s National Medical Products Administration (NMPA). This approval marks Sycume as China’s first and the world’s second approved IGF-1R antibody drug,…
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Ascentage Pharma’s Olverembatinib Receives Third BTD in China for Ph+ ALL Treatment
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China-based Ascentage Pharma (HKG: 6855) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has awarded Breakthrough Therapy Designation (BTD) to its olverembatinib, a novel BCR-ABL1 tyrosine kinase inhibitor (TKI). The designation is for the drug’s use in combination with low-intensity chemotherapy as…
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Innovent Biologics Doses First Patient in IBI363 Melanoma Study vs Keytruda
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China-based Innovent Biologics, Inc. (HKG: 1801) announced the first patient dosing in the pivotal regulatory study for its IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein. The trial compares IBI363 monotherapy with Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not…
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Innovent Biologics’ Ipilimumab NDA Accepted by CDE with Priority Review for Colon Cancer
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), has accepted the New Drug Application (NDA) for ipilimumab, an anti-CTLA-4 monoclonal antibody (mAb), and granted it Priority Review designation. The application covers the drug’s use in combination with sintilimab as…
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Innovent Biologics’ IBI363 Receives FDA Fast-Track Designation for sqNSCLC
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received another fast-track designation from the US Food and Drug Administration (FDA) for its IBI363. The PD-1/IL-2α bispecific antibody fusion protein, previously granted fast-track status for melanoma, has now been awarded the designation for the treatment of unresectable, locally advanced,…
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Innovent Biologics Posts Strong Q4 Sales, Eyes 2025 Product Launches
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China-based Innovent Biologics Inc. (HKG: 1801) reported product sales of over RMB 2 billion (USD 274 million) in Q4 2024, up 25% year-on-year (YOY). For the full year, sales reached RMB 8.2 billion (USD 1.1 billion), marking a 40% increase YOY. The strong performance was driven by continued robust market…
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Innovent’s Limertinib Wins NMPA Approval for NSCLC Treatment
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that it has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its limertinib. This third-generation EGFR TKI has been approved for use in adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer…
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Innovent’s IBI343 Receives Breakthrough Therapy Designation for Pancreatic Cancer
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China-based biopharma Innovent Biologics, Inc. (HKG: 1801) has announced receiving another Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its IBI343. The latest designation was granted for the TOPO1i anti-CLDN18.2 antibody drug conjugate (ADC) as monotherapy for the treatment…
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Innovent Biologics’ Taletrectinib Gains NMPA Approval for ROS1 Positive NSCLC
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving an additional marketing approval from the National Medical Products Administration (NMPA) for its drug taletrectinib. This second-generation ROS1 tyrosine kinase inhibitor is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer…
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Innovent Biologics Strikes Licensing Deal with Roche for IBI3009 ADC
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced a significant licensing agreement with Swiss pharmaceutical giant Roche (SWX: ROG). The agreement grants Roche global exclusive development, manufacturing, and commercialization rights to Innovent’s IBI3009, a DLL3-targeted antibody drug conjugate (ADC) that is anticipated to offer new treatment options for patients with…
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Innovent Biologics Partners with Suzhou ForLong to Explore Sintilimab and FL115 Combination in Solid Tumors
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced a clinical study and supply agreement with Suzhou ForLong Biotechnology Co., Ltd, a collaboration aimed at exploring the potential of Innovent’s sintilimab combined with ForLong’s FL115 in treating advanced solid tumors. Sintilimab and FL115: A Promising Combination for Cancer TreatmentSintilimab, a PD-1…
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Nuvation Bio’s Taletrectinib NDA for ROS1+ NSCLC Receives FDA Priority Review
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US-based Nuvation Bio Inc. (NYSE: NUVB) has announced that the New Drug Application (NDA) for its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), taletrectinib, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The filing seeks approval for taletrectinib to treat advanced…
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Innovent Biologics’ Taletrectinib Wins NMPA Approval for ROS1+ NSCLC Treatment
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its taletrectinib, a second-generation ROS1 tyrosine kinase inhibitor. The drug is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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Innovent Biologics Partners with Eli Lilly for Distribution of Jaypirca in China
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China-based Innovent Biologics, Inc. (HKG: 1801) has entered into a significant distribution and promotion agreement with US pharmaceutical giant Eli Lilly and Company (NYSE: LLY). The agreement pertains to Lilly’s non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib). Financial details of the agreement have not been disclosed. Under the terms,…
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Innovent Biologics Initiates Phase I Trial for IBI3009 in Small Cell Lung Cancer and Neuroendocrine Tumors
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On December 13, 2024, Innovent Biologics, Inc. (HKG: 1801) registered a Phase I clinical trial for IBI3009 on the drug clinical trial registration and information public platform. The trial will investigate the efficacy of IBI3009 in treating small cell lung cancer (SCLC) and other neuroendocrine tumors. Exploring Biomarkers and Efficacy…
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Innovent Biologics’ IBI343 Shows Promising Results in Phase I Study for Pancreatic Cancer at ESMO Asia
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China-based biopharmaceutical company Innovent Biologics, Inc. (HKG: 1801) presented updated data from the Phase I study of its IBI343, an innovative anti-CLDN18.2 antibody drug conjugate (ADC), for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) during an oral presentation at the ESMO Asia Congress 2024. Updated Data Highlights Efficacy and…
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HutchMed and Innovent Biologics’ Fruzaqla-Tyvyt Combo Gets NMPA Conditional Approval for Endometrial Cancer
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Chinese firms HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) have jointly announced that they have received conditional approval from the National Medical Products Administration (NMPA) for the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab). This treatment is intended for patients with advanced endometrial cancer…
