Innovent Biologi - IVBIY STOCK NEWS

Innovent Biologics announced that its PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, received its second Fast Track Designation from the FDA for treating advanced squamous non-small cell lung cancer (sqNSCLC) that has progressed after anti-PD-(L)1 therapy and chemotherapy.

Clinical trial results presented at WCLC 2024 showed promising efficacy: the 3 mg/kg dose group (n=18) achieved 50.0% objective response rate (ORR) and 88.9% disease control rate (DCR). The 1/1.5 mg/kg group showed 5.5 months median progression-free survival (PFS) with 30.7% 12-month PFS rate. Notably, IBI363 demonstrated effectiveness in both PD-L1 low and high expression populations, with ORRs of 36.4% and 31.8% respectively.

Innovent Biologics and ASK Pharm announce NMPA approval of limertinib, their third-generation EGFR TKI drug for treating adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). This marks Innovent's 14th commercial product.

A Phase 2b pivotal study with 301 patients showed impressive results: 68.8% overall response rate, 92.4% disease control rate, and 11.0 months median progression-free survival. For patients with CNS lesions, the response rate was 65.9% with 10.6 months median PFS.

Additionally, limertinib met its primary endpoint in a Phase 3 trial comparing it to gefitinib for first-line NSCLC treatment. A separate NDA for first-line treatment in patients with specific EGFR mutations is under NMPA review.

Innovent Biologics presented at the 43rd Annual J.P. Morgan Healthcare Conference, highlighting 2025 as a pivotal year for business growth and global innovation. The company aims to achieve domestic product revenue of 20 billion RMB by 2027 through its expanding oncology portfolio and general biomedicine segment.

The company's innovation engine, Innovent Academy, has developed advanced technology platforms including ScFv engineering, T cell engager, and antibody platforms. They have progressed 8 ADC candidates into clinical trials with data from over 600 patients.

Key 2025 milestones include expected approvals for mazdutide for weight loss and type 2 diabetes, teprotumumab for thyroid eye disease, and picankibart for psoriasis. The company plans to submit NDAs or conduct registrational trials for seven drugs and initiate pivotal trials for seven innovative pipeline candidates.

Innovent Biologics (HKEX: 01801) has received Breakthrough Therapy Designation (BTD) from China's NMPA for IBI343, a TOPO1i anti-CLDN18.2 ADC, for treating CLDN18.2-positive advanced pancreatic cancer patients who progressed after prior treatment. The designation was based on Phase 1 study results showing promising efficacy: 23.3% confirmed overall objective response rate and 5.3 months median progression-free survival in 43 patients.

This marks IBI343's second BTD, following its May 2024 designation for gastric cancer treatment. The drug also received FDA Fast Track Designation in June 2024 for advanced pancreatic cancer. The first U.S. Phase 1 patient was dosed in December 2024. The company plans to initiate pivotal MRCT studies and explore combination therapy possibilities for pancreatic cancer and other solid tumors.

Innovent Biologics (HKEX: 01801), a global biopharmaceutical company, announces its participation in the 43rd Annual J.P. Morgan Healthcare Conference from January 13-16, 2025, in San Francisco. Dr. De-Chao Michael Yu, the company's Founder, Chairman and CEO, will deliver a presentation on January 16 at 8:30 a.m. PST, covering business updates, strategic priorities, and future outlook.

The conference, recognized as the industry's largest healthcare investment symposium, will host over 8,000 investors and representatives from 550 global healthcare companies. Dr. Yu will also participate in a panel discussion on 'China Biopharma Industry Global Expansion Strategy' on January 15 at 2:15 p.m. PST.

Innovent, which develops and commercializes medicines for oncology, cardiovascular, metabolic, autoimmune, ophthalmology, and other major diseases, will provide live audio webcasts and presentation slides through their website.

Innovent Biologics (HKEX: 01801) has received approval from China's NMPA for the second New Drug Application of DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor. This approval is for treating adult patients with locally advanced or metastatic ROS1-positive NSCLC.

The approval is based on the Phase 2 TRUST-I trial results, which showed impressive efficacy: 91% confirmed objective response rate in ROS1 TKI-naïve patients and 88% intracranial response rate. After a median follow-up of 23.5 months, the median duration of response and progression-free survival were not reached.

This follows DOVBLERON®'s first approval in December 2024 for previously treated ROS1-positive NSCLC patients. It becomes Innovent's 13th commercial product, strengthening their TKI franchise alongside RETSEMOV®, PEMAZYRE®, and DUPERT®.

Innovent Biologics has entered into an exclusive global license agreement with Roche for IBI3009, a novel DLL3-targeted antibody drug conjugate (ADC) candidate for treating advanced small cell lung cancer. IBI3009 has received IND approvals in Australia, China, and the U.S., with Phase 1 study initiation in December 2024.

IBI3009 targets DLL3, an antigen overexpressed in small-cell lung cancer and neuroendocrine tumors but with low expression in normal tissues. Developed using Innovent's proprietary topoisomerase 1 inhibitor platform, the drug has demonstrated promising anti-tumor activity in mouse models, particularly in chemo-resistant tumors.

Under the agreement, Roche gains exclusive global rights for development, manufacturing, and commercialization. Innovent will receive an $80 million upfront payment and is eligible for up to $1 billion in milestone payments plus tiered royalties on net sales.

Innovent Biologics (HKEX: 01801) has received NMPA approval for DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor, for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.

The approval is based on the Phase 2 TRUST-I trial results, which demonstrated significant therapeutic effects on brain lesions and efficacy in crizotinib-resistant patients. DOVBLERON® becomes Innovent's 13th commercial product, addressing a critical need as approximately 2.6% of NSCLC patients in China are ROS1-positive, with up to 55% developing brain metastases after initial treatment.

A second NDA for DOVBLERON® was accepted and granted Priority Review Designation in March 2024 for first-line treatment of ROS1-positive NSCLC patients.

Innovent Biologics and Eli Lilly have announced a Distribution and Promotion Agreement for Jaypirca® (pirtobrutinib) in Mainland China. Under the agreement, Innovent will handle importation, marketing, distribution, and promotion, while Lilly maintains responsibility for R&D and post-market medical affairs.

Jaypirca® is the first and only approved non-covalent BTK inhibitor, receiving FDA approval in January 2023 and NMPA approval in October 2024. It's indicated for adult patients with relapsed or refractory mantle cell lymphoma after at least two types of systemic therapy, including a BTK inhibitor.

The collaboration aims to leverage Innovent's established hematology oncology commercial team and Lilly's expertise in drug development to improve cancer patient outcomes in Mainland China.