INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics and IASO Biotherapeutics announced promising results from a clinical study of IBI326, a fully human BCMA-targeting CAR T-cell therapy for relapsed/refractory multiple myeloma, published in Blood. The study showed a 100% overall response rate (ORR) among 18 patients, with 72% achieving complete response. The one-year progression-free survival (PFS) and overall survival (OS) rates were 58.3% and 75%, respectively. Notably, IBI326 exhibited a favorable safety profile despite some cases of cytokine release syndrome. This innovative therapy was granted breakthrough therapy designation by China's NMPA in February 2021.

Innovent Biologics and AnHeart Therapeutics announced an exclusive license agreement for the co-development and commercialization of taletrectinib, a next-generation TKI targeting ROS1 and NTRK, in Greater China. AnHeart will handle development until regulatory approval, receiving upfront payments, R&D fees, and potential milestone payments totaling USD189 million. Currently, taletrectinib is under three phase 2 studies for treating ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors. Innovent aims to enhance its oncology portfolio with this collaboration.

Innovent Biologics has successfully initiated a global Phase 3 clinical trial for pemigatinib (IBI375), designed to treat unresectable or metastatic cholangiocarcinoma in China. The trial evaluates pemigatinib against the standard treatment of gemcitabine plus cisplatin, targeting patients with FGFR2 rearrangement. Dr. Hui Zhou noted the urgent need for improved therapies given the poor prognosis associated with existing treatments. Previous studies showed pemigatinib provided satisfactory safety with promising efficacy signals, suggesting a potential benefit for targeted therapy in this challenging patient population.

Innovent Biologics and Eli Lilly announced that the U.S. FDA has accepted for review a Biologics License Application (BLA) for sintilimab injection combined with pemetrexed and platinum chemotherapy for first-line treatment of nonsquamous non-small cell lung cancer (NSCLC). This landmark application marks the first submission of sintilimab outside of China, following its regulatory approval in China earlier in 2021.

The FDA plans to decide by March 2022, with no review issues identified at this stage.

Innovent Biologics announces the presentation of multiple clinical data at the 2021 ASCO annual meeting, showcasing their developments in cancer treatment. Key studies include:

• Lung Cancer: Two-year follow-up on PD-1 blockade in NSCLC.
• Colorectal Cancer: Preliminary results of fruquintinib plus sintilimab.
• Advanced Malignancy: Safety study of pemigatinib.
• Solid Tumors: Dose-escalation study of IBI110 with sintilimab.

Innovent continues to innovate with promising clinical trials involving their key products.

Innovent Biologics announces the successful dosing of the first patient in a Phase 2 clinical trial for IBI302, a bispecific fusion protein targeting both VEGF and complement pathways for neovascular age-related macular degeneration (nAMD). The trial aims to evaluate the efficacy and safety of IBI302 in improving visual acuity and addressing retinal fibrosis. Preliminary Phase 1 results showed good safety and improvements in visual acuity and retinal thickness. By targeting both pathways, IBI302 aims to overcome limitations of current therapies for nAMD.

Innovent Biologics announced positive results from the Phase 3 ORIENT-3 study, comparing TYVYT® (sintilimab injection) to docetaxel for advanced squamous non-small cell lung cancer (sqNSCLC). The trial with 290 patients showed significant improvements in overall survival (11.79 months vs. 8.25 months, P=0.02489) and progression-free survival (4.30 months vs. 2.79 months, P<0.00001). The data were presented at the AACR Annual Meeting. This trial highlights the potential of TYVYT® as a critical therapy for sqNSCLC, where treatment options are limited, showcasing Innovent's commitment to patient care.

Innovent Biologics announced that the NMPA in China has granted Breakthrough Therapy Designation for Parsaclisib (IBI376) to treat relapsed/refractory follicular lymphoma. This designation is based on ongoing Phase 2 studies showcasing promising efficacy, with a 75% objective response rate and a 15.8-month median progression-free survival. Innovent, which has rights for Parsaclisib in Greater China, emphasizes its commitment to developing effective cancer therapies. The BTD status will facilitate faster review processes, advancing treatment accessibility for patients.

Innovent Biologics reported significant financial growth for 2020, achieving a total revenue of RMB 3,843.8 million, up 266.9% from RMB 1,047.5 million in 2019. The company's product revenue reached RMB 2,367.5 million, a 133.0% increase year-over-year. Innovent launched three new antibody drugs, augmenting its portfolio to four commercial products. The firm expanded its production capacity from 5,000L to 24,000L and raised approximately US$1.3 billion through share placements, with US$1.8 billion in cash on hand by February 2021.