INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics announced that the first participant has been dosed in the phase 3 clinical trial (GLORY-1) for mazdutide (IBI362), a dual agonist targeting GLP-1 and glucagon receptors, aimed at treating obesity in Chinese adults. The trial will enroll 600 subjects, assessing weight loss efficacy over 48 weeks. Previous phase 2 results showed a mean weight loss of 11.57%. Given China's rising obesity rates, mazdutide's potential for significant health improvements is crucial. Successful outcomes may lead to a new treatment option for obesity, promising better metabolic health for patients.

Innovent Biologics presented updated results from the Phase Ia trial of IBI351 (GFH925), a KRAS^G12C inhibitor, at the 2022 CSCO Annual Meeting. The trial included 67 patients with advanced solid tumors, predominantly non-small cell lung cancer (NSCLC). Key findings showed a 50.9% overall response rate (ORR) and 92.7% disease control rate (DCR) for evaluable NSCLC patients. No dose-limiting toxicities (DLTs) were reported, and treatment was well tolerated. A registrational trial is ongoing, aiming to further investigate IBI351's potential.

Innovent Biologics announced the results of a phase 3 clinical study (CREDIT-1) for tafolecimab (IBI306), a PCSK9 monoclonal antibody, in Chinese patients with non-familial hypercholesterolemia. The study enrolled 618 subjects and demonstrated significant reductions in LDL-C levels: -65.0% for 450 mg Q4W and -57.3% for 600 mg Q6W compared to placebo (both P < 0.0001). Tafolecimab had a favorable safety profile similar to other PCSK9 inhibitors. The drug's New Drug Application is under review in China, potentially leading to it being the first approved locally-developed PCSK9 inhibitor in the country.

Innovent Biologics has initiated a Phase I clinical trial for its anti-Claudin18.2 monoclonal antibody-drug conjugate, IBI343, marking a significant milestone as the first ADC candidate from Innovent's pipeline to enter clinical evaluation. The trial, taking place in Australia, aims to assess the safety and preliminary efficacy of IBI343 in patients with advanced solid tumors. Claudin 18.2 represents a promising target for treating gastric and pancreatic cancers, addressing a substantial unmet medical need given the limitations of current therapies.

Innovent Biologics has published results from a Phase 1b study of mazdutide (IBI362) for treating overweight or obesity in Chinese participants. The study demonstrated favorable tolerability and significant weight loss, with reductions of 9.5% and 11.7% in body weight for 10 mg and 9 mg cohorts, respectively. There were no serious adverse events reported. Ongoing clinical studies aim to further investigate mazdutide's efficacy as an innovative anti-obesity treatment, with Phase III studies recently initiated. This positions mazdutide as a potential alternative to bariatric surgery.

Innovent Biologics announced the approval of selpercatinib by China's NMPA for treating RET-driven cancers, including non-small cell lung cancer (NSCLC) and thyroid cancers. Selpercatinib, a RET kinase inhibitor, was co-developed with Eli Lilly and offers an 84.1% overall response rate (ORR) and 20.2 months of median duration of response for NSCLC patients. This approval enhances Innovent's oncology portfolio and positions the company to capitalize on a growing market. The approval marks a significant step for patients in China, providing new treatment options for those with limited choices.

Innovent Biologics has announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for CYRAMZA® (ramucirumab) for the treatment of hepatocellular carcinoma (HCC) in patients with an alpha fetoprotein level of ≥400 ng/mL previously treated with sorafenib. This approval is based on the positive results from the REACH-2 study, demonstrating improved overall survival and progression-free survival rates. This approval enhances Innovent's oncology portfolio and positions it to provide integrated patient solutions in China.

Innovent Biologics announced positive second interim analysis results from the Phase 3 ORIENT-31 study, evaluating sintilimab plus chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) who failed prior EGFR-TKI therapy. The study showed median progression-free survival (PFS) of 7.2 months for the combination therapy compared to 4.3 months for chemotherapy alone. Key secondary endpoints, including objective response rate, also improved. This trial marks a significant advancement in treatment options for this patient population.

Innovent Biologics announced the successful dosing of the first participant in a phase 2 clinical trial for mazdutide, a dual agonist for GLP-1 and GCGR, targeting obesity in Chinese adults. This randomized study aims to assess the safety and efficacy of a 9 mg dose of mazdutide, following positive results in lower doses that demonstrated significant body weight loss and metabolic benefits. The trial will enroll 80 participants over 24 weeks. The drug has shown best-in-class potential, with earlier studies indicating over 11.5% body weight reduction.