INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics, Inc. (HKEX: 01801) announces the inclusion of TYVYT® and BYVASDA® in the National Reimbursement Drug List (2023 Version) for the treatment of various cancers, expanding their coverage to benefit a broader range of patients. TYVYT® is the first and only PD-1 inhibitor approved for the treatment of EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer post EGFR-TKI therapy, while BYVASDA® is the only bevacizumab approved for the same indication. This update aligns with Innovent's mission of developing affordable high-quality biopharmaceuticals and supports the 'Healthy China 2030' strategy.

Innovent Biologics, Inc. (HKEX: 01801) expands licensing deal with Synaffix B.V., a Lonza company (SIX:LONN), to develop new ADC candidates using Synaffix's ADC technology, including GlycoConnect®, HydraSpace®, and toxSYN® linker-payloads. Innovent will focus on research, development, manufacturing, and commercialization of new ADC candidates. Synaffix will receive upfront payment, potential milestone payments, and royalties on commercial sales for each licensed target. Dr. Kaijie He, Vice President of Cancer Biology and ADC research at Innovent, expressed excitement about the expanded collaboration, while Peter van de Sande, Head of Synaffix, praised Innovent's R&D expertise and clinical development capabilities.

Innovent Biologics, Inc. (HKEX: 01801) announced the interim analysis results of ORIENT-16, the Phase 3 study evaluating sintilimab in combination with chemotherapy for the first-line treatment of advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The study has met its primary endpoint at the prespecified interim analysis, showing that sintilimab in combination with chemotherapy significantly prolongs overall survival in the first line treatment for overall population of gastric cancer. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies, and no additional safety signals were identified for the combination of sintilimab and chemotherapy in GC patients. Based on the study results, sintilimab in combination with chemotherapy was approved by the National Medical Products Administration (NMPA) of China as first-line treatment for G/GEJ in June 2022, and was included in the national reimbursement drug list (NRDL), becoming the first and only immunotherapy for gastric cancer covered by NRDL in China.

Innovent Biologics, Inc. (HKEX: 01801) presents updated clinical data of IBI351 (KRAS G12C inhibitor) monotherapy in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) at the European Society for Medical Oncology Asia Congress (ESMO Asia) 2023. The data from a registrational Phase II study of IBI351 for NSCLC is accepted as a LBA (Late-breaking abstracts) program. The New Drug Application (NDA) for IBI351 monotherapy treating NSCLC was recently accepted by China's National Medical Products Administration (NMPA) and granted Priority Review Designation.

Innovent Biologics, Inc. (Innovent) (HKEX: 01801) has been upgraded to 'A' according to MSCI's latest ESG rating, reflecting the capital market's recognition of Innovent's continued progress in ESG governance and sustainability, as well as of its long-term investment value. Innovent's performance in ESG and sustainable development stood out above the industry average level, with a robust product pipeline and a healthy business model.

Innovent Biologics, Inc. (01801:HKEX) announces the acceptance of the New Drug Application (NDA) for IBI351, a KRAS G12C inhibitor, by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The NDA has been granted Priority Review designation for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. The NDA is based on the results from a single-arm registrational Phase 2 clinical study (NCT05005234) and will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia Congress 2023.

Innovent Biologics, Inc. (01801) and AnHeart Therapeutics announce the acceptance of the New Drug Application (NDA) for taletrectinib by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Taletrectinib is a next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. The NDA acceptance is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients. Results from an interim analysis of the TRUST-I trial were presented at the European Lung Cancer Congress (ELCC) 2023.

Innovent Biologics, Inc. (HKEX: 01801) has announced the full results from a Phase 2 clinical trial of mazdutide (IBI362), a GLP-1R and GCGR dual agonist, in Chinese patients with type 2 diabetes. The trial demonstrated robust efficacy in glycemic control and weight reduction, along with multiple cardiometabolic benefits and a favorable safety profile. Mazdutide significantly reduced HbA1c levels, fasting plasma glucose, and body weight, offering a potential novel treatment option for T2D patients. The Phase 3 studies of mazdutide in Chinese T2D patients are currently underway.

Innovent Biologics presents latest data of two ophthalmic bispecific antibodies at the AAO 2023 Annual Meeting. Phase 2 study of IBI302 for neovascular age-related macular degeneration (nAMD) showed noninferior BCVA gains compared to aflibercept. Preliminary signal observed for IBI302 in preventing macular atrophy and fibrosis occurrence. Phase 1 study of IBI324 for diabetic macular edema (DME) demonstrated safety and efficacy. Both drugs showed robust efficacy with no new safety risk signals.