INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics and Eli Lilly announced that China's NMPA approved TYVYT® (sintilimab injection) combined with chemotherapy for advanced gastric cancer. This marks TYVYT®'s sixth NMPA indication and is significant as it is the first domestic PD-1 inhibitor approved for this type of cancer. The approval is based on the Phase III ORIENT-16 trial, which showed a 34% reduction in risk of death and a median overall survival improvement of 5.5 months. This development enhances Innovent's portfolio, addressing a critical need for effective gastric cancer treatments in China.

Innovent Biologics and Eli Lilly announced the approval of TYVYT® (sintilimab injection) by China's NMPA for first-line treatment of unresectable esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy. This marks the fifth approved indication for TYVYT® in China. The approval was based on the ORIENT-15 Phase 3 trial, which showed a significant overall survival improvement (16.7 months vs. 12.5 months) compared to placebo. The safety profile remained consistent with previous data, further solidifying TYVYT®'s position in cancer treatment.

Innovent Biologics and PT Etana Biotechnologies Indonesia announced the approval of Bevagen®, a bevacizumab biosimilar, by the Indonesian Food and Drugs Authority (BPOM) on June 13, 2022. This approval allows for five cancer treatment indications, including colorectal and breast cancer. Bevagen® will be the first Chinese antibody drug produced in Southeast Asia. The collaboration aims to leverage Etana's local market expertise to enhance patient access to affordable cancer treatments. Innovent's portfolio includes 32 assets, with several approved in China, showcasing its commitment to global market expansion.

Innovent Biologics announced that China's NMPA has accepted the New Drug Application (NDA) for tafolecimab injection, aimed at treating primary hypercholesterolemia and mixed dyslipidemia. This marks a significant advancement in the availability of PCSK-9 monoclonal antibodies in China. The NDA is based on three successful phase 3 trials (CREDIT-1, CREDIT-2, CREDIT-4), demonstrating up to a 65% reduction in LDL-C levels. Tafolecimab is expected to be the first recombinant fully human anti-PCSK-9 monoclonal antibody launched in China, potentially enhancing treatment options for patients with dyslipidemia.

IASO Biotherapeutics and Innovent Biologics presented updated data from the Phase 1/2 study of Equecabtagene Autoleucel, a CAR T-cell therapy for relapsed/refractory multiple myeloma, at the 27th EHA Annual Meeting on June 9-12, 2022. The study involved 79 patients, showing an overall response rate (ORR) of 94.9% and a complete response rate of 68.4%. The therapy exhibited manageable safety profiles, with 94.9% experiencing cytokine release syndrome (CRS), mostly mild. Key findings reveal potential for Equecabtagene Autoleucel as a breakthrough treatment for hard-to-treat patients.

Innovent Biologics has presented favorable results from high-dose cohorts of a Phase 1 clinical trial for mazdutide (IBI362), a dual agonist targeting GLP-1 and glucagon receptors, at ENDO 2022. The trial, involving 60 participants, indicated a weight reduction of 9.5% to 11.7% after 12-16 weeks of treatment. No serious adverse events were reported, highlighting a strong safety profile. The study supports mazdutide's potential as an effective anti-obesity treatment in China, where obesity rates exceed 100 million, and aims for Phase 3 trials in the latter half of 2022.

Innovent Biologics and IASO Biotherapeutics announced updated results from a Phase 1/2 study of Equecabtagene Autoleucel, a CAR T-cell therapy targeting relapsed/refractory multiple myeloma. Presented at the EHA Annual Meeting on June 12, 2022, the data from 79 patients showed an overall response rate (ORR) of 94.9%, with 68.4% achieving complete responses. Safety was manageable, with 94.9% experiencing cytokine release syndrome. The therapy exhibited prolonged persistence and low immunogenicity, suggesting significant potential as a treatment option for this challenging cancer.

Innovent Biologics announced positive results from a Phase 2 study of mazdutide (IBI362), a dual agonist for treating overweight and obesity in Chinese participants. The study met all primary and key secondary endpoints, with participants achieving a mean weight loss of up to 12.6% compared to placebo. Efficacy was dose-dependent, demonstrating significant reductions in body mass index and other metabolic parameters. The treatment was well tolerated, with only mild and transient side effects. The company is preparing to advance to Phase 3 trials following these encouraging results.

Innovent and AnHeart presented updated data on taletrectinib at ASCO 2022, highlighting its efficacy for ROS1-positive non-small cell lung cancer (NSCLC). In 67 TKI-naïve patients, the confirmed objective response rate (cORR) was 92.5%, while in 38 crizotinib-pretreated patients, it was 50%. Patients with brain metastasis showed a 91.7% intracranial cORR. Taletrectinib demonstrated good tolerability with few neurological adverse events, confirming its potential as a next-generation ROS1 inhibitor. Ongoing trials aim to further explore its capabilities against resistant mutations.