Innovent Biologi Stock Price, News & Analysis

Innovent Biologics and Eli Lilly announced that HALPRYZA® (rituximab injection) has been approved by China's NMPA for treating non-Hodgkin's lymphoma and chronic lymphocytic leukemia. This marks Innovent's fourth monoclonal antibody approval, following TYVYT®, BYVASDA®, and SULINNO®. The drug will provide a more affordable treatment option for Chinese patients, enhancing healthcare access. With confirmed safety and efficacy in major clinical trials, HALPRYZA® aims to improve patient outcomes in a growing segment of hematological malignancies in China.

Innovent Biologics announced the expiration of the waiting period under the HSR Act, allowing its global collaboration with Eli Lilly for TYVYT® (sintilimab injection) to take effect. This milestone triggers a $200 million upfront payment. TYVYT® has received marketing approval in China for relapsed Hodgkin's lymphoma and is included in the NRDL. Innovent is actively engaged in over 20 clinical studies to assess TYVYT®'s efficacy in various cancers, bolstering its robust pipeline of oncology drugs.

Innovent Biologics, a leading biopharmaceutical company, will host a virtual R&D day on November 10, 2020, featuring two sessions: one in Mandarin from 8:00 AM to 12:00 PM and another in English from 9:00 PM to 1:00 AM (next day), both China/Singapore time. The event will cover the company's development, long-term vision, and an in-depth discussion on its R&D pipeline. Participants must register before November 8 to receive access details. Innovent is recognized for its innovative treatments, including three marketed products and a robust pipeline targeting major diseases.

Innovent Biologics announced that the ORIENT-32 Phase 3 trial of TYVYT® (sintilimab injection) combined with BYVASDA® (bevacizumab biosimilar injection) for treating advanced hepatocellular carcinoma met primary endpoints of progression-free survival (PFS) and overall survival (OS). This interim analysis showed significant improvements over sorafenib, with a safety profile consistent with prior studies. Innovent plans to discuss these results with the National Medical Products Administration in China to potentially advance treatment options for HCC patients.

Innovent Biologics and Eli Lilly presented biomarker results from the ORIENT-11 study at the ESMO Virtual Congress 2020. The trial evaluated TYVYT® (sintilimab injection) combined with ALIMTA® (pemetrexed) for first-line treatment of advanced nonsquamous non-small cell lung cancer (nsqNSCLC). Biomarker analysis indicated that the MHC-II pathway is linked to better progression-free survival (HR, 0.41; P=0.0041), suggesting its potential as a predictive marker. The Chinese NMPA has accepted a supplemental NDA for this combination therapy, indicating a significant step in cancer treatment advancements.

Innovent Biologics and Eli Lilly presented results from the ORIENT-12 study at the ESMO Virtual Congress 2020. This Phase 3 trial evaluated TYVYT® (sintilimab injection) combined with GEMZAR® and platinum chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sqNSCLC). The study enrolled 357 patients and showed a significant improvement in progression-free survival (PFS) with TYVYT® compared to placebo. The median PFS was 5.5 months for the treatment group versus 4.9 months for placebo, indicating a promising clinical outcome with no new safety signals reported.

Innovent and Eli Lilly announce the presentation of six clinical studies for TYVYT® (sintilimab injection) at the upcoming ESMO Virtual Congress 2020 from September 19-21. Key studies include Phase 3 trials for lung cancer and hepatocellular carcinoma, showing positive preliminary efficacy. Innovations include the combination of sintilimab with various chemotherapy agents, providing insights into patient selection and treatment outcomes. The collaboration between Innovent and Lilly emphasizes a strong partnership in advancing oncology treatments.

Innovent Biologics has received approval from China's National Medical Products Administration for SULINNO® (adalimumab injection), a biosimilar treatment aimed at rheumatoid arthritis, ankylosing spondylitis, and psoriasis. This marks Innovent's third monoclonal antibody approval, expanding its product range beyond oncology. With around 20 million patients in China suffering from these conditions, SULINNO® aims to offer a more affordable alternative to existing therapies, thus improving access and quality of life for patients.

Innovent Biologics has announced the completion of first healthy subject dosing in its Phase I clinical trial (CIBI112A101) for IBI112, a recombinant anti-interleukin 23p19 subunit antibody. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and tolerability of IBI112 in healthy Chinese subjects. IBI112 targets IL-23, playing a pivotal role in autoimmune diseases such as psoriasis and inflammatory bowel disease. Innovent aims to address significant unmet medical needs in these conditions, with promising preclinical data supporting the drug's efficacy and safety.