On February 9, 2026, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that ZL-1310 for injection, a novel DLL3-targeting antibody-drug conjugate (ADC), is planned to be granted Breakthrough Therapy Designation.
As a member of the Peking University Cancer Hospital Medical Consortium and a Beijing secondary modern oncology specialized hospital, Beijing South Region Oncology Hospital International Department leverages a robust multidisciplinary diagnosis and treatment platform to rapidly integrate such globally leading therapies into the treatment plans of international patients. If you or a loved one is facing the challenges of second-line or later treatment for small cell lung cancer, please carefully read the data below and contact us immediately.
Contact Beijing South Region Oncology Hospital International Department now:
- Phone: 400-880-3716
- WeChat ID: 17801183037
- Email ①: 100085_010@163.com
- Email ②: myimmnet@163.com
**Hard Data: Up to 86% Efficacy in Patients with Brain Metastases**
At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, global phase 1a/1b clinical study data for ZL-1310 were presented.
For previously treated patients (second-line treatment):
- Unconfirmed objective response rate (uORR) reached 67%, with a disease control rate (DCR) of 97%.
- In the optimal biological dose group (1.6 mg/kg): Objective response rate (ORR) soared to 79%, with a disease control rate (DCR) of 100%.
- This means: Nearly all 10 patients receiving this dose achieved tumor control, and nearly 8 patients experienced significant tumor shrinkage.
For the most challenging patients with brain metastases:
- Patients with baseline brain metastases: Objective response rate (ORR) was 68%.
- Patients who had never received cranial radiotherapy: Objective response rate (ORR) was as high as 86%!
This data is groundbreaking. Traditional chemotherapy drugs struggle to penetrate the blood-brain barrier, yet ZL-1310 demonstrates robust anti-tumor activity intracranially. For international patients concerned about the side effects of whole-brain radiotherapy, this represents a significant hope of “avoiding brain radiation.”
**Safety Profile:** In the <2.0 mg/kg dose group, the incidence of treatment-related adverse events (TRAEs) of grade 3 or higher was only 6%, with no treatment-related interstitial lung disease (ILD) or treatment discontinuation events reported.
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**III. Why Choose Beijing South Region Oncology Hospital International Department?**
For international patients, accessing new therapies is not just about “whether the drug is available,” but also a systematic process involving “who can use it, how to use it, and who manages the side effects.”
Beijing South Region Oncology Hospital International Department provides prospective assessments and full-cycle management for cutting-edge therapies such as ZL-1310 for eligible patients. Whether you are from Southeast Asia, the Middle East, Europe, or the Americas, we have a well-established international medical service process.
We offer comprehensive services ranging from pre-hospital consultations, multilingual translation, medical visa letters, to rehabilitation follow-ups. Strict adherence to the “one doctor, one patient, one room” policy ensures your privacy and dignity are fully respected, even in a foreign country.
Currently, ZL-1310 has been granted Orphan Drug Designation and Fast Track Designation by the U.S. FDA. Its planned inclusion in China’s Breakthrough Therapy Designation will significantly accelerate its accessibility in China.
Do not let language barriers, information gaps, or cumbersome procedures prevent you from accessing advanced treatments. Beijing South Region Oncology Hospital International Department has established a green channel for international patients.
Pick up the phone or contact us via WeChat or email to share your situation. Our medical consultants will provide a preliminary assessment within 24 hours.
- Phone (24-hour consultation): 400-880-3716
- WeChat (instant communication): 17801183037 (supports English and Chinese)
- Email (for medical records):
- 100085_010@163.com
- myimmnet@163.com
Post time: Feb-12-2026