Innovent Biologi - IVBIY STOCK NEWS

Innovent Biologics and HUTCHMED announce that their combination therapy of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has received conditional approval from China's NMPA for treating advanced endometrial cancer patients with pMMR tumors who failed prior systemic therapy.

The approval is based on the FRUSICA-1 study results, which showed significant efficacy with an IRC-assessed ORR of 35.6% and DCR of 88.5%. The median PFS reached 9.5 months and OS 21.3 months, with a rapid median time to tumor response of 1.6 months. This marks TYVYT®'s eighth approved indication, following priority review status and breakthrough therapy designation.

Innovent Biologics announces two significant updates to China's 2024 National Reimbursement Drug List (NRDL), effective January 1, 2025. SINTBILO® (tafolecimab injection), their first cardiovascular drug, is newly listed for treating adult primary hypercholesterolemia and mixed dyslipidemia. The anti-PCSK9 antibody reduces LDL-C by ~70% and Lp(a) by ~50%. Additionally, olverembatinib, their BCR-ABL inhibitor, has both renewed its existing indication and added a new one for chronic myeloid leukemia (CML) treatment. These NRDL inclusions aim to improve drug accessibility and affordability for Chinese patients.

Innovent Biologics announces the presentation of nearly 10 clinical data studies of its novel oncology molecules at ESMO Asia Congress 2024, scheduled for December 6-8 in Singapore. The highlight includes an oral presentation of updated Phase 1 results for their TOPO1i CLDN18.2 ADC (IBI343) in treating pancreatic cancer. The presentations encompass various cancer treatments, including studies on colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer. The data demonstrates encouraging efficacy and safety profiles, particularly for IBI343 in pancreatic cancer treatment, showcasing the company's progress in IO+ADC therapeutic development.

Innovent Biologics announces promising Phase 2 study results for picankibart, an anti-IL-23p19 antibody, in treating plaque psoriasis patients who previously showed inadequate response to other biologics. The study, involving 152 patients, demonstrated that 64.6% (42/65) of patients with prior inadequate response to IL-17 biologics achieved skin clearance or near clearance after 16 weeks of treatment. The primary endpoint was met with 48.2% (40/83) of patients achieving both sPGA score of 0 or 1 and BSA <3%. The treatment showed a favorable safety profile with no new safety signals identified. This marks the first clinical study in China evaluating a switch from other biologics to an IL-23p19-targeted drug.

Innovent Biologics (HKEX: 01801) announces that the primary endpoint of a Phase 2 clinical study for picankibart (IBI112), an anti-IL-23p19 antibody, in Chinese patients with moderately to severely active ulcerative colitis has been met. The study involved 150 subjects randomized to receive placebo, picankibart 200 mg, or 600 mg.

Key findings include:

• Significantly higher clinical remission rates in picankibart groups (20.0% for 200 mg, 14.0% for 600 mg) compared to placebo (2.0%)
• Higher clinical response rates in picankibart groups (54.0% for 200 mg, 68.0% for 600 mg) versus placebo (22.0%)
• Favorable safety profile with no new safety signals observed

The maintenance period is ongoing, with continued improvements in efficacy measures. Picankibart shows promise as a potential new treatment option for ulcerative colitis in China.

Innovent Biologics and ASK Pharm have announced a strategic collaboration for limertinib, a third-generation EGFR TKI for lung cancer treatment. Under the agreement, Innovent will obtain exclusive commercialization rights for limertinib in mainland China, receiving a fee based on net sales. ASK Pharm, as the MAH holder, will handle production and commercial supply, eligible for upfront, regulatory, and sales milestone payments.

Two NDAs for limertinib are under review by China's NMPA: one for EGFR T790M mutation-positive NSCLC after EGFR TKI therapy, and another for first-line treatment of EGFR exon 19 deletions or exon 21 L858R mutations in NSCLC. A Phase 3 trial comparing limertinib with gefitinib met its primary endpoint, with detailed data to be presented at future academic conferences.

Innovent Biologics announces the acceptance of a New Drug Application (NDA) by China's NMPA for picankibart, an anti-IL-23p19 antibody, for treating moderate to severe plaque psoriasis. Picankibart is the first IL-23p19 antibody to achieve over 80% PASI 90 after 16 weeks in a Phase 3 trial, offering the longest maintenance dosing interval (once every 12 weeks) in its class.

The NDA is based on positive results from the CLEAR-1 study, which met its primary and key secondary endpoints, showing significantly higher rates of skin lesion clearance and quality of life improvement compared to placebo. Picankibart demonstrated a favorable safety profile with no new safety signals.

As the first IL-23p19 antibody developed by a Chinese company to submit an NDA in China, picankibart shows best-in-class potential. Innovent aims to provide a safe and effective treatment option for Chinese psoriasis patients and continues to expand its portfolio in ophthalmology, autoimmune diseases, and cardiovascular and metabolic conditions.

Innovent Biologics (HKEX: 01801) presented clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, combined with bevacizumab in advanced colorectal cancer at the 2024 ESMO Congress. The Phase 1 study involved 35 subjects, showing promising anti-tumor efficacy with good tolerability. Key findings include:

- 21.9% overall response rate (ORR) and 65.6% disease control rate (DCR)
- Median duration of response: 8.1 months
- Median progression-free survival: 4.1 months
- Efficacy observed in patients with and without liver metastases, prior immunotherapy, and RAS mutations

The combination demonstrated potential in non-MSI-H/dMMR advanced colorectal cancer, a population typically less responsive to immunotherapy. Innovent is conducting further Phase 1/2 trials in China, the US, and Australia for various solid tumors.

Innovent Biologics presented clinical data on IBI354, a HER2 monoclonal antibody-camptothecin derivative conjugate, at the 2024 ESMO Congress. The Phase 1/2 study involved 368 participants with advanced solid tumors, including 178 with breast cancer, 92 with ovarian cancer, and 38 with colorectal cancer. Key findings:

1. Excellent safety profile with no DLT events up to 18mg dosage.
2. In platinum-resistant ovarian cancer, 40.2% ORR and 81.6% DCR.
3. In HER2-positive breast cancer, 67.8% ORR and 88.1% DCR.
4. In HER2-positive gastrointestinal malignancies, 57.1% ORR and 91.4% DCR.

IBI354 showed promising efficacy in multiple tumor types, including HER2-low expressions, with a favorable safety profile.