INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics announced that the NMPA of China has accepted its supplemental New Drug Application for sintilimab combined with chemotherapy for the first-line treatment of advanced gastric cancer. This decision is based on interim results from the Phase 3 ORIENT-16 trial, demonstrating a significant improvement in overall survival compared to chemotherapy alone. The trial involved 650 patients and met its primary endpoints. Sintilimab is already approved for various cancer treatments in China and aims to address critical treatment gaps in advanced gastric cancer.

Innovent Biologics and NeoCura Bio-Medical Technology have entered a strategic collaboration to study the combination therapy of sintilimab and the neoantigen vaccine NEO_PLIN2101 in cancer patients in China. The partnership aims to assess safety, pharmacokinetics, and preliminary efficacy, advancing the clinical development of combination immunotherapy for solid tumors. Innovent boasts a robust pipeline with five approved drugs and plans to launch over ten more in the next few years. This collaboration is expected to improve cancer treatment outcomes and enhance the therapeutic efficacy of sintilimab.

Innovent Biologics announced that the sintilimab ORIENT-31 study achieved its primary endpoint of progression-free survival (PFS) in patients with EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) after prior EGFR TKI treatment. This Phase 3 study is the first to show significant PFS improvement using sintilimab with BYVASDA® (bevacizumab biosimilar) plus chemotherapy compared to standard chemotherapy. The safety profile was consistent with previous studies, and detailed results will be presented at a medical meeting.

Innovent Biologics, a biopharmaceutical company, announced the successful dosing of the first patient in a Phase I/II clinical study of IBI351, a KRAS G12C inhibitor, for advanced solid tumors in China. This open-label study aims to evaluate the safety, pharmacokinetics, and efficacy of IBI351 in patients with the KRAS G12C mutation. The medication addresses a significant unmet medical need, as current treatments for this mutation are limited. Innovent collaborates with GenFleet Therapeutics for development and commercialization in China.

Innovent Biologics presented preliminary results from the Phase Ia study of IBI315, a first-in-class anti-Her2/PD-1 bispecific antibody, at the 2021 CSCO Annual Meeting. Conducted through May 25, 2021, 27 patients received varying doses, with no dose-limiting toxicities observed. The objective response rate was 20% among 15 patients who completed assessments. The study showed promise in safety and efficacy, paving the way for a planned Phase Ib trial to further investigate IBI315's applications in treating Her2 positive tumors.

Innovent Biologics has formed a strategic collaboration with UNION therapeutics to develop orismilast in China. UNION grants Innovent exclusive rights for research, development, and commercialization, receiving an upfront payment of USD 20 million and potential milestone payments of up to USD 247 million. Orismilast targets atopic dermatitis and psoriasis, addressing significant unmet clinical needs in a market with 50 million patients in China. The collaboration strengthens Innovent's position in autoimmune therapies, marking a key addition to its robust pipeline.

Innovent Biologics and AnHeart Therapeutics presented interim clinical data for taletrectinib (AB-106), a next-generation ROS1/NTRK inhibitor, at the CSCO 2021 Annual Meeting. The Phase 2 trial (TRUST) evaluated its efficacy in ROS1-positive non-small cell lung cancer (NSCLC). In treatment-naïve patients, the objective response rate (ORR) was 90.5%, while in pre-treated patients, the ORR was 43.8%. Taletrectinib showed good safety profiles, primarily causing mild gastrointestinal adverse effects. This promising data could provide hope for patients with limited treatment options in China.

Innovent Biologics has successfully dosed the first patient in a Phase 2 clinical trial for IBI112, an anti-interleukin 23 monoclonal antibody, aimed at treating moderate-to-severe plaque psoriasis. This trial, the first of its kind for domestic IL-23p19 inhibitors in China, seeks to evaluate the efficacy and safety of IBI112. With approximately 6 million psoriasis patients in China, the trial represents a significant advancement for patients seeking effective treatment options. The promising Phase 1 results highlight IBI112's safety profile and its potential for improved treatment adherence.

Innovent Biologics announced that the NMPA of China has accepted the supplemental New Drug Application for Sintilimab in combination with chemotherapy for treating esophageal squamous cell carcinoma (ESCC). This application is based on positive interim results from the Phase 3 ORIENT-15 clinical trial, which showed significant overall survival improvement. Esophageal cancer remains a major health concern in China, with Sintilimab representing a potential new treatment option. Innovent aims to expedite the review process for this regimen to address the urgent clinical need in ESCC patients.