Innovent Biologics

165 articles with Innovent Biologics

• Innovent and Lilly Jointly Announce the Approval of TYVYT® (sintilimab injection) by China NMPA in Combination with Chemotherapy as First-line Treatment of Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

  6/27/2022

  Innovent Biologics, Inc. and Eli Lilly and Company, announced that the National Medical Products Administration of China has approved the supplemental New Drug Application for TYVYT® in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

• Innovent and Lilly Jointly Announce the Approval of TYVYT® (sintilimab injection) by China NMPA in Combination with Chemotherapy as First-Line Treatment for Esophageal Squamous Cell Carcinoma

  6/20/2022

  Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), and Eli Lilly and Company ("Lilly", NYSE: LLY) today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection).

• Innovent Announces the NMPA Acceptance of the New Drug Application for Tafolecimab Injection (anti-PCSK-9 antibody)

  6/14/2022

  Innovent Biologics, Inc. announced that the China's National Medical Products Administration has formally accepted the New Drug Application for tafolecimab injection for the treatment of primary hypercholesterolemia and mixed dyslipidemia.

• Innovent and Etana Jointly Announce the Approval of Bevagen® (Bevacizumab Biosimilar) by the Indonesian Food and Drugs Authority (BPOM)

  6/14/2022

  Innovent Biologics, Inc. and PT Etana Biotechnologies Indonesia, jointly announced that the Indonesian Food and Drugs Authority has approved Bevagen®, a recombinant humanized anti-VEGF monoclonal antibody drug, for five indications including metastatic colorectal cancer, locally recurrent or metastatic triple negative breast cancer, advanced, metastatic, or recurrent non-small cell lung cancer, epithelial ovarian, fallopian tube, and primary peritoneal cancer, and cervical cancer.

• IASO Bio and Innovent Present Updated Data of BCMA CAR-T Cell Therapy (Equecabtagene Autoleucel) at EHA 2022

  6/13/2022

  IASO Biotherapeutics and Innovent Biologics, Inc. jointly announced that the updated data from phase 1/2 study of Equecabtagene Autoleucel, a fully-human anti-B cell maturation antigen chimeric antigen receptor T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma, was presented in the form of an oral presentation at the 27th European Hematology Association Annual Meeting in Vienna on June 9-12, 2022.

• Innovent Releases Results of High-dose Cohorts in Phase 1 Clinical Study of Mazdutide (IBI362) in Chinese Adults with Overweight or Obesity at ENDO 2022

  6/13/2022

  Innovent Biologics, Inc. announces that the results of high-dose cohorts in a phase 1 clinical trial of mazdutide, a glucagon-like petide-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity are presented as an on-demand poster at ENDO 2022.

• Innovent and IASO Bio Present Updated Data of BCMA CAR-T Cell Therapy (Equecabtagene Autoleucel) at EHA 2022

  6/13/2022

  Innovent Biologics, Inc. and IASO Biotherapeutics jointly announced that the updated data from phase 1/2 study of Equecabtagene Autoleucel, a fully-human anti-B cell maturation antigen chimeric antigen receptor T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma, was presented in the form of an oral presentation at the 27th European Hematology Association Annual Meeting in Vienna on June 9-12, 2022.

• Innovent Announces Phase 2 study of Mazdutide（IBI362） in Chinese Participants with Overweight or Obesity Met Primary and All Key Secondary Endpoints

  6/7/2022

  Innovent Biologics, Inc. (Innovent) (HKEX: 01801), announces that the primary and all key secondary endpoints were met in a randomized, double-blind, placebo-controlled phase 2 study of mazdutide (R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) dual agonist, in Chinese participants with overweight or obesity.

• AnHeart Therapeutics and Innovent Biologics Present Updated Phase 2 Efficacy and Safety Data of Taletrectinib (ROS1 Inhibitor) at ASCO 2022

  6/6/2022

  AnHeart Therapeutics (“AnHeart”), and Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), jointly announced today updated efficacy and safety data from the Phase 2 TRUST clinical trial of taletrectinib in patients with ROS1-positive non-small cell lung cancer (NSCLC), at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

• Innovent Presents Clinical Data of Phase I Study for IBI351 (KRAS G12C Inhibitor) as Monotherapy for Solid Tumors at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

  6/6/2022

  Innovent Biologics, Inc. presented the preliminary data of IBI351 from dose escalation portion of a phase I clinical trial at the 2022 American Society of Clinical Oncology Annual Meeting.

• Innovent and IASO Bio Jointly Announce the NMPA Acceptance of the New Drug Application for Equecabtagene Autoleucel for the Treatment of Relapsed and/or Refractory Multiple Myeloma

  6/6/2022

  Innovent Biologics, Inc. and IASO Biotherapeutics jointly announced that the China National Medical Products Administration has formally accepted the New Drug Application for Equecabtagene Autoleucel, a fully human anti-B cell maturation antigen chimeric antigen receptor T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma.

• Innovent and AnHeart Jointly Present Updated Phase 2 Efficacy and Safety Data of Taletrectinib (ROS1-TKI) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

  6/6/2022

   Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), and AnHeart Therapeutics ("AnHeart"), today jointly announced updated efficacy and safety data from the Phase 2 TRUST clinical trial of taletrectinib in patients with ROS1-positive non-small cell lung cancer (NSCLC), at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

• Innovent Appoints Mr. Gary Zieziula as Independent Non-executive Director

  6/1/2022

  Innovent Biologics, Inc. announced the appointment of Mr. Gary Zieziula as an independent non-executive director of the board of directors and a member of the audit committee of the Board and the strategy committee of the Board.

• Innovent Receives NMPA Breakthrough Designation for IBI310, the Anti-CTLA-4 Monoclonal Antibody, Combined with Sintilimab in Advanced Cervical Cancer Treatment

  4/13/2022

  Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI310 in combination with sintilimab for the treatment of patients with recurrent or metastatic cervical cancer.

• Innovent Release Phase 1 Results of IBI322 (anti-PD-L1/CD47 bispecific antibody) in patients with advanced solid tumors at AACR Annual Meeting 2022

  4/11/2022

  Innovent Biologics, Inc. announced that the results of the Phase I study for IBI322 in patients with advanced solid tumors were presented at the American Association for Cancer Research Annual Meeting 2022.

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  Clinical Catch-Up: COVID-19, AAN, ACC

  4/11/2022

  It was a very busy week for clinical trial news, in part because of presentations coming out of the American Academy of Neurology (AAN) meeting. Here’s a look.

• Innovent Announces the Approval of Pemazyre® (pemigatinib) by the NMPA for the Treatment of Adults with Locally Advanced or Metastatic Cholangiocarcinoma

  4/6/2022

  Innovent Biologics, Inc.  announced that the National Medical Products Administration (NMPA) has approved Pemazyre.

• Innovent Releases Results of a Phase 3 Clinical Study of IBI306 (PCSK-9 inhibitor) in Chinese Patients with Heterozygous Familial Hypercholesterolemia at the American College of Cardiology Annual Congress 2022

  4/4/2022

  Innovent Biologics, Inc. announces that the results of a phase 3 clinical trial of recombinant full-human anti-PCSK-9 monoclonal antibody in Chinese patients with heterozygous familial hypercholesterolemia have been accepted as an abstract presented at the American College of Cardiology Annual Congress 2022.

• Innovent Announces First Patient Dosing of Claudin18.2/CD3 Bispecific Antibody IBI389 in Phase 1a/1b Clinical Trial for Advanced Solid Tumor

  3/29/2022

  Innovent Biologics, Inc. announced the first patient dosing for its proprietary recombinant bispecific antibody targeting Claudin18.2 and CD3 in a Phase I clinical trial for the treatment of advanced malignancies.

• Innovent Announced 2021 Annual Results

  3/29/2022

  Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases announced 2021 annual results including its major achievements and progress.