INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics announced positive interim results from the Phase 3 ORIENT-15 study, presented at ESMO 2021, validating sintilimab's efficacy when combined with chemotherapy for esophageal squamous cell carcinoma (ESCC). The study achieved all endpoints: a median overall survival (mOS) of 16.7 months versus 12.5 months for the placebo group, and a median progression-free survival (mPFS) of 7.2 months versus 5.7 months. Sintilimab's safety profile was consistent with earlier studies. The company has submitted an application to the NMPA in China to secure first-line treatment approval for ESCC.

Innovent Biologics announced results from a Phase 2 study of pemigatinib in advanced cholangiocarcinoma patients at the ESMO Congress 2021. The study enrolled 34 subjects, revealing a 50% objective response rate (ORR) among 30 efficacy-evaluable participants. With a median follow-up of 5.13 months, the disease control rate was 100%. Safety analysis indicated that all subjects experienced treatment-related adverse events, with hyperphosphatemia (73.5%) as the most common. The New Drug Application for pemigatinib is under review in China, following approval in Taiwan.

Innovent Biologics has initiated a phase 2 clinical trial for IBI362, a dual agonist targeting GLP-1R and GCGR, for treating type 2 diabetes in China. The trial (NCT04965506) aims to assess IBI362's efficacy and safety compared to placebo and dulaglutide, focusing on HbA1c level changes over 20 weeks. Preliminary phase Ib results show a favorable safety profile and promising preliminary efficacy. IBI362 is licensed from Eli Lilly and may offer enhanced weight loss and metabolic benefits, appealing in a market where diabetes prevalence is 11.6% among adults in China.

Innovent Biologics and GenFleet Therapeutics have entered into an exclusive license agreement for the development and commercialization of GenFleet's KRAS G12C candidate, GFH925, in China and beyond. GFH925 has received Investigational New Drug approval in China and shows potential as a best-in-class treatment. Innovent will oversee clinical development in China and can pursue global commercialization. GenFleet will receive a $22 million upfront payment, with additional potential milestone payments totaling $290 million tied to development and sales success.

Innovent Biologics reported impressive interim results for the first half of 2021, achieving total revenue of RMB1,941.8 million, up 97.3% year-over-year driven by a doubling of product revenue to RMB1,854.6 million. The firm expanded its commercial portfolio from four to five products, thanks to the approval of PEMAZYRE® in Taiwan. Continuously growing revenue from TYVYT® and new products contributed significantly to their success. Innovent's pipeline now boasts 25 high-value assets, with six in pivotal trials, marking a strong trajectory for future growth.

Innovent Biologics announced the publication of phase 1b study results for IBI362, a dual agonist targeting GLP-1R and GCGR, in the journal EClinicalMedicine. This milestone is significant as it marks the first phase 1 clinical study from China in the metabolism field published in a Lancet journal. The study demonstrated substantial weight loss and multiple metabolic benefits, including improvements in blood pressure, lipids, and liver enzymes. IBI362 showed a favorable safety profile with no serious adverse events, suggesting potential as a novel treatment for obesity and type 2 diabetes.

Innovent Biologics announced on Aug. 15, 2021, that its sintilimab Phase 3 ORIENT-16 study achieved its primary endpoint, demonstrating significant improvement in overall survival for patients with advanced gastric cancer when combined with chemotherapy. This study is notable as it is the first Phase 3 trial in China showing an anti-PD-1 antibody's effectiveness in this setting. Innovent plans to file a supplemental new drug application based on the results, which are expected to provide a new treatment option for a patient population with limited options.

Innovent Biologics announced the successful meeting of the primary endpoint in the phase 3 CREDIT-2 study of IBI306, a recombinant human anti-PCSK-9 monoclonal antibody designed for treating heterozygous familial hypercholesterolemia in Chinese patients. After 12 weeks of treatment, participants exhibited a significant reduction in low-density lipoprotein cholesterol (LDL-C) levels compared to the placebo group, with a favorable safety profile. This pivotal study provides valuable evidence for the efficacy of IBI306, marking a critical step towards its registration and potential market entry.

Innovent Biologics has established a Scientific Advisory Board (SAB) to enhance its research and clinical pipelines, aiding in its mission to benefit patients globally. The SAB consists of three prominent scientists: Dr. Lewis L. Lanier, Dr. Lawrence Fong, and Dr. Carlos Garcia-Echeverria. This initiative seeks to advance Innovent's innovative biopharmaceuticals across cancer, autoimmune, and metabolic diseases. The company, listed on the Hong Kong Stock Exchange, has a robust pipeline with 25 assets and 5 approved products.