Innovent Biologi Stock Price, News & Analysis

Innovent Biologics has received NMPA approval for SYCUME® (teprotumumab N01), China's first and world's second IGF-1R antibody drug for treating thyroid eye disease (TED). This breakthrough ends a 70-year period without new TED treatments in China.

TED, an autoimmune disorder affecting orbital health, has an annual incidence of 16 per 100,000 in women and 2.9 per 100,000 in men. The Phase 3 RESTORE-1 study demonstrated that 85.8% of patients achieved ≥2 mm proptosis reduction at Week 24 with SYCUME® treatment.

SYCUME® offers advantages including a liquid injection formation, improved stability, and better patient compliance. This approval provides a more accessible treatment option compared to the existing IGF-1R antibody treatment available overseas, which costs approximately 3 million RMB per course.

Innovent Biologics (IVBIY) has initiated a pivotal study of IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, comparing it head-to-head with pembrolizumab in melanoma patients. The first patient has been dosed in this registrational trial for treating unresectable locally advanced or metastatic mucosal or acral melanoma in treatment-naive patients.

Early clinical trials of IBI363 showed promising results:

• 61.5% overall objective response rate (ORR)
• 84.6% disease control rate (DCR)
• Sustained tumor responses and long-term benefits observed

The safety profile has been manageable, with common treatment-related adverse events including arthralgia, anemia, thyroid dysfunction, and rash. The study's primary endpoint is progression-free survival (PFS), assessed by an Independent Radiology Review Committee using RECIST v1.1 criteria.

Innovent Biologics announces that its ipilimumab injection (IBI310) has received NDA acceptance and Priority Review designation from China's NMPA. The application is for combination use with sintilimab as neoadjuvant treatment for resectable MSI-H/dMMR colon cancer, marking China's first domestic CTLA-4 inhibitor NDA.

The approval is based on the Phase 3 NeoShot trial results, which met its primary endpoint. In the per-protocol population (n=101), the combination therapy showed significantly higher pathological complete response rates (80.0% vs 47.7%, p=0.0007) compared to sintilimab alone. All patients achieved R0 resection, with no disease recurrence at 5.65 months median follow-up.

The treatment could increase R0 resection rates, achieve pathological complete response, and potentially reduce the need for adjuvant chemotherapy without increasing safety risks or surgery delays.

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®.