INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics, Inc. (HKEX: 01801) and Xuanzhu Biopharma announce a clinical trial collaboration and supply agreement for the combination therapies of TYVYT® (sintilimab injection) with KM-501 for advanced solid tumors in China.

Innovent Biologics, Inc. (HKEX: 01801) and Sanegene Bio USA Inc. have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Innovent also obtains an exclusive option to license in the future development, manufacturing, and commercialization rights of SGB-3908. Both parties will leverage their respective strengths to accelerate the development and ensure the commercial success of this innovative siRNA drug candidate.

Innovent Biologics, Inc. (HKEX: 01801) and AnHeart Therapeutics announced that the Center for Drug Evaluation of China's National Medical Products Administration has granted Priority Review Designation for the New Drug Application of taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have been previously treated with ROS1 TKIs.

Innovent Biologics, Inc. (Innovent) (HKEX: 01801) announces the publication of Phase 2 clinical trial results for mazdutide, a GLP-1R/GCGR dual agonist, in Chinese patients with overweight or obesity in Nature Communications. The results show significant weight loss and multiple cardiovascular and metabolic benefits, with ongoing Phase 3 trials in progress.

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.