Bailitianheng iza-bren (EGFR×HER3 dual anti-ADC) was recognized as the 6th breakthrough treatment for CDE, and is used for platinum-resistant recurrent ovarian cancer, etc.
Recently, Baili Tianheng's innovative drug iza-bren (EGFR×HER3 dual anti-ADC) was awarded the 6th breakthrough treatment certification from the National Drug Review Center (CDE) of the National Drug Administration, with the indication of platinum-resistant recurrent ovarian cancer. This progress marks the further recognition of the drug's potential in the field of solid tumor treatment and also provides new therapeutic hope for patients with ovarian cancer.
1. The importance of breakthrough treatment identification
Breakthrough Therapy Determination (BTD) is a channel established by the China Drug Review Center to accelerate the research and development of innovative drugs with significant clinical advantages. Drugs that obtain BTD can enjoy priority during clinical trials and reviews, thereby benefiting patients more quickly. The indication approved by iza-bren this time is platinum-resistant recurrent ovarian cancer. This type of patient currently has limited treatment options, poor prognosis, and clinical needs need to be met urgently.
2. The mechanism of action and development of iza-bren
iza-bren is a bispecific antibody-conjugated drug (ADC) targeting EGFR and HER3. By blocking two signaling pathways simultaneously, it inhibits tumor growth and induces apoptosis. Its unique design is expected to overcome the drug resistance problem of single-target drugs. Here are the development milestones for iza-bren:
| time | progress |
|---|---|
| Q1 2021 | First time submitting a clinical trial application (IND) |
| Q3 2022 | Obtained the first breakthrough treatment certification (non-small cell lung cancer) |
| 2023 H1 | Initiate Phase II clinical trial of platinum-resistant ovarian cancer |
| June 2024 | Obtained the 6th BTD (platinum-resistant relapsed ovarian cancer) |
3. Current status of ovarian cancer treatment and the potential of iza-bren
Ovarian cancer is one of the common malignant tumors in gynecology, with about 70% of patients in advanced stages at the time of diagnosis. Platinum drugs are the first-line treatment option for ovarian cancer, but most patients will experience platinum resistance recurrence after treatment, resulting in treatment failure. The following is the current treatment status of platinum-resistant recurrent ovarian cancer:
| Treatment methods | Objective Remission Rate (ORR) | Median progression-free survival (mPFS) |
|---|---|---|
| Chemotherapy (such as gemcitabine) | 10-15% | 3-4 months |
| PARP inhibitor (Posterior line) | 20-30% | 4-6 months |
| Immune checkpoint inhibitors | <10% | 2-3 months |
In early clinical trials, iza-bren showed encouraging efficacy in patients with platinum-resistant ovarian cancer, with an ORR of 35% and a mPFS of 6.2 months, significantly better than existing therapies. If the subsequent trial data further verifies its efficacy, iza-bren is expected to become one of the standard treatment options for platinum-resistant recurrent ovarian cancer.
4. Industry and market reactions
The research and development progress of iza-bren has attracted widespread attention from the industry. At present, no ADC drugs targeting EGFR and HER3 have been approved worldwide, and Baili Tianheng is in a leading position in this field. Market analysis believes that if iza-bren is successfully listed, its peak sales are expected to exceed 5 billion yuan.
In addition, Bailitianheng is exploring the application of iza-bren in other solid tumors, including non-small cell lung cancer, head and neck cancer, etc. Here are the development status of other indications of iza-bren:
| Indications | Development stage | Expected milestones |
|---|---|---|
| Non-small cell lung cancer (EGFR mutation) | Phase III clinical | 2025 NDA Submission |
| Head and neck squamous carcinoma | Phase II clinical | Data read at the end of 2024 |
| Triple-negative breast cancer | Phase Ib/II clinical | 2025 H1 starts Phase III |
5. Summary and Outlook
iza-bren was awarded the 6th breakthrough treatment certification for CDE, which not only proves its therapeutic potential in platinum-resistant recurrent ovarian cancer, but also reflects the improvement of China's innovative drug research and development capabilities. As clinical trials advance, iza-bren is expected to provide new treatment options for more patients with solid tumors and promote the development of the dual-anti-ADC field.
In the future, Bailitianheng needs to further verify the long-term efficacy and safety of iza-bren, and explore the combined application with other therapies. The industry will also continue to pay attention to the development trends of this innovative drug, and look forward to it bringing clinical benefits to patients as soon as possible.
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