- 5 days ago
- 9 min read
Table of Content: |
Introduction
For families facing a cancer diagnosis after standard treatment has failed, two words carry enormous weight: what's next?
Increasingly, the answer leads to China.
Over the past decade, China's oncology sector has undergone a structural transformation. Regulatory reform through the National Medical Products Administration (NMPA), growing domestic biotech investment, and high patient volumes across specialized hospital networks have pushed several cutting-edge treatments from clinical research into conditional or full commercial approval — sometimes years ahead of Western regulatory timelines.
For international patients, especially South East Asian patients with relapsed lymphoma, refractory multiple myeloma, HER2-positive cancers, MSI-H solid tumors, or chronic lymphocytic leukemia, this gap matters enormously. Therapies that remain locked inside Phase 2 trials in the United States or Europe may already be commercially accessible in China.
This article covers seven advanced therapies in China that are either conditionally approved or fully approved by the NMPA — and what international patients need to know before pursuing any of them.
Why China Has Become Important for Advanced Therapies
The field of oncology in China has changed dramatically over the past decade. Regulatory reform, high patient volumes, domestic biotech investment, and specialized hospital networks have all helped Chinese centers move several advanced therapies from clinical research into approved or near-approved use.
Reviews of China’s advanced therapy sector note that the National Medical Products Administration (NMPA) has used expedited pathways such as priority review to support innovative cell and gene therapy.
Key disease areas where China's advanced therapy access now leads the West include:
Relapsed or refractory B-cell lymphoma (CD19 CAR-T)
Relapsed or refractory multiple myeloma (BCMA CAR-T)
HER2-expressing urothelial, gastric, and breast cancers (antibody-drug conjugates)
Recurrent cervical and gastric cancers (PD-1/CTLA-4 bispecific antibodies)
MSI-H/dMMR advanced solid tumors (subcutaneous checkpoint inhibitors)
CLL/SLL after BTK inhibitor exposure (next-generation BCL-2 inhibitors)
This is not a claim that every patient should travel to China. It is an evidence-based observation that for specific diagnoses, specific biomarker profiles, and specific treatment histories, China may offer the most advanced accessible option in the world.
7 Advanced Therapies in China That Are Still in Phase 2 Trials in the West
1. Relmacabtagene Autoleucel: CD19 CAR-T for Relapsed Lymphoma
Relmacabtagene autoleucel (also known as relma-cel or Carteyva) is an autologous CD19 CAR-T therapy. In this treatment model, a patient’s own T cells are collected, engineered to recognize CD19-positive cancer cells, expanded, and infused back into the body.
China’s NMPA approved relma-cel in 2021 for adults with relapsed or refractory large B-cell lymphoma after two or more systemic treatment lines. JW Therapeutics described this therapy as the first CAR-T product approved as a Category 1 biologics product in China.
The therapy has since become indicated in more conditions, including follicular lymphoma and mantle cell lymphoma, which makes it one of the more established domestic CAR-T examples in China. For international patients, candidacy depends on lymphoma subtype, CD19 expression status, prior treatment lines, organ function, and infection risk. CAR-T is not suitable for everyone — and a physician-led case review is essential before any referral is considered.
2. Equecabtagene Autoleucel: BCMA CAR-T for Multiple Myeloma
Equecabtagene autoleucel (marketed in China as Fucaso) is a BCMA-targeted CAR-T drug for relapsed or refractory multiple myeloma. BCMA is a major target in modern myeloma treatment because it is strongly expressed on malignant plasma cells.
China’s NMPA conditionally approved equecabtagene autoleucel in June 2023 for adults with relapsed or refractory multiple myeloma after at least three treatment lines have been exhausted, including a proteasome inhibitor and an immunomodulatory agent.
We understand the importance of this decision because multiple myeloma patients may exhaust standard drug classes over time. Once relapse follows exposure to proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy, cellular therapy can become a major discussion point.
However, BCMA CAR-T is not an outpatient infusion. Patients need careful evaluation for cytopenias, kidney function, infection risk, disease tempo, bridging therapy needs, and post-infusion monitoring for cytokine release syndrome and neurotoxicity.
3. Zevorcabtagene Autoleucel: Another BCMA CAR-T Option for Myeloma
Zevorcabtagene autoleucel (also called zevor-cel) is another fully human BCMA-targeted CAR-T product. China approved it in 2024 for adults with relapsed or refractory multiple myeloma after at least three prior therapy lines.
A North American LUMMICAR study was designed as a phase 1b/2 trial for relapsed or refractory multiple myeloma. The study showed how the same therapy can be commercially available in China, whereas Western access remains tied to clinical trials.
For patients who want to compare multiple myeloma options in China, the practical question is whether the treating center has the right product access, manufacturing pathway, inpatient monitoring team, ICU support, infection control process, and follow-up plan.
4. Disitamab Vedotin: A HER2-Targeted Antibody-Drug Conjugate
Disitamab vedotin (also known as RC48) is an antibody-drug conjugate. In other words, it combines an antibody that targets HER2 with a cancer-killing payload. The goal is to deliver chemotherapy-like activity more directly to cancer cells that express HER2.
Disitamab vedotin was initially conditionally approved in China for HER2-positive advanced urothelial cancer. Other HER2-expressing tumors can also benefit from this treatment, including gastric and breast cancers.
In the West, this drug is included in a phase 2 clinical trial in advanced urothelial cancer. The UK Health Research Authority describes a phase 2 study of disitamab vedotin for HER2-expressing advanced urothelial carcinoma.
This therapy is mostly relevant for patients whose tumor has HER2 expression, but who do not fit standard HER2 treatment categories in their home country. However, and before any referral is made, pathology review and HER2 testing are indispensable. A weak, old, or incomplete biomarker report may not be enough to make an informed decision.
5. Cadonilimab: A PD-1/CTLA-4 Bispecific Antibody for Cervical Cancer
Cadonilimab is a bispecific antibody that targets PD-1 and CTLA-4. These immune checkpoints are familiar in oncology. However, cadonilimab combines both targets in one antibody structure. China approved cadonilimab for recurrent or metastatic cervical cancer in 2022. Later on, the approval was expanded to include first-line cervical cancer therapeutic combinations.
This is very intriguing because dual checkpoint blockade may help activate immune response more broadly than single-target PD-1 or PD-L1 therapy. The trade-off is that immune-related toxicity must be taken seriously. Possible side effects include colitis, hepatitis, endocrinopathies, pneumonitis, and skin reactions.
For medical tourism, this is where physician-led advisory reviews become vital. A patient who already had severe autoimmune toxicity from immunotherapy may not be an ideal candidate. Another patient with cervical cancer, good performance status, and limited treatment options may deserve a detailed expert review.
6. Envafolimab: The First Subcutaneous PD-L1 Inhibitor Approved in China
Envafolimab is a subcutaneous PD-L1 inhibitor. Unlike most checkpoint inhibitors, which are given by intravenous infusion, envafolimab was developed as an injection under the skin.
It received approval in China for previously treated MSI-H or dMMR advanced solid tumors (based on pivotal phase 2 data).
MSI-H and dMMR tumors can respond well to immune checkpoint blockade. These biomarkers may appear in colorectal cancer, gastric cancer, endometrial cancer, and other solid tumors. However, many patients do not know whether their tumor has been tested properly.
For ChinaCureLink, this is a common situation where a second opinion may become necessary. For instance, an assessment of whether the patient needs another pathology review, MSI testing, mismatch repair immunohistochemistry, next-generation sequencing, and tumor mutational burden review all come into question.
7. Lisaftoclax: A Next-Generation BCL-2 Inhibitor for CLL/SLL
Lisaftoclax is an oral BCL-2 inhibitor. BCL-2 helps cancer cells avoid apoptosis (i.e., programmed cell death), so blocking it can help restore apoptosis in certain blood cancers.
China approved lisaftoclax in July 2025 for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who had received at least one systemic therapy before that included a BTK inhibitor.
In the West, the treatment has included phase 1b/2 CLL/SLL studies, and the therapy has also moved into broader global development.
For patients, the main issue is sequencing. CLL/SLL treatment depends on previous exposure to BTK inhibitors, TP53 status, del(17p), IGHV status, infection history, kidney function, tumor lysis risk, and current disease burden. A BCL-2 inhibitor may be valuable, but it must be introduced with a careful dose plan and tumor lysis prevention strategy.
Summary: Advanced Therapies in China
Therapy | Type | Main access in China | Disease area |
Relmacabtagene autoleucel | CD19 CAR-T | Approved in China. | Lymphoma. |
Equecabtagene autoleucel | BCMA CAR-T | Conditionally approved in China. | Multiple myeloma. |
Zevorcabtagene autoleucel | BCMA CAR-T | Approved in China. | Multiple myeloma. |
Disitamab vedotin | HER2 antibody-drug conjugate | Approved in China. | Urothelial, gastric, and breast cancers. |
Cadonilimab | PD-1/CTLA-4 bispecific antibody | Approved in China. | Cervical and gastric cancers. |
Envafolimab | Subcutaneous PD-L1 antibody | Approved in China. | MSI-H/dMMR solid tumors. |
Lisaftoclax | BCL-2 inhibitor | Approved in China. | CLL/SLL. |
The Most Important Question: Does This Therapy Make Sense for My Patient?
Access to an innovative therapy in China is not the same as suitability for a specific patient.
Each of the seven therapies above requires a detailed review of:
Diagnosis and histology — the precise subtype of the disease
Biomarker profile — HER2 expression, MSI/dMMR status, CD19/BCMA expression, TP53 status, and others depending on the therapy
Treatment history — how many prior lines, what agents, what responses
Organ function — renal function, hepatic function, cardiac status, pulmonary reserve
Performance status and fitness — ability to tolerate intensive therapy
Goals of care — curative intent vs. disease control vs. quality of life
A therapy that is transformative for one patient may be inappropriate or even dangerous for another. This is why access to advanced therapies in China must always begin with a physician-led clinical review — not a website search, not a forum recommendation, and not a travel booking.
How ChinaCureLink Helps Patients Navigate Advanced Therapies in China
Who Should Consider Advanced Therapies in China?
Advanced therapies in China may be worth exploring if any of the following apply:
Standard first-line or second-line treatment has failed or is no longer appropriate
A clinical trial at home has closed, has eligibility restrictions, or has a long waitlist
Biomarker testing suggests a target that is not yet commercially addressed in the patient's home country
The patient has been told there are no more standard options
A second opinion has identified a therapy class that is approved in China but not yet locally available
Important Considerations Before Traveling for Advanced Therapies in China
Pursuing treatment internationally carries real logistical, financial, and medical complexity. Before any patient considers traveling to China, the following should be clearly established:
Medical suitability. A physician must confirm the patient is fit for travel, fit for the specific therapy, and that the expected benefit outweighs the risks — including the risks of distance from home healthcare systems.
Biomarker confirmation. All required biomarkers should be validated through current testing, not assumed from prior results. Some biomarkers change over time or between treatment lines.
Continuity of care. A plan must exist for what happens when the patient returns home. Who will manage follow-up? Who will handle toxicities if they emerge after return?
Cost clarity. Advanced therapies in China involve real costs — therapy costs, hospitalization, monitoring, and travel. These must be understood upfront, with no ambiguity.
Communication and translation. Language barriers are real. Families need translator support throughout the process, from medical consultations to hospital discharge instructions.
ChinaCureLink addresses all of these considerations as part of its structured case support process.
Conclusion
Advanced therapies in China may provide innovative options for some patients who have exhausted standard care. China’s oncology sector continues to expand across CAR-T therapy, ADCs, and bispecific antibodies.
The safest path is to confirm whether the new drug fits the patient’s diagnosis, biomarkers, previous treatments, and general well-being.
ChinaCureLink helps families assess advanced therapies in China with clarity, caution, and confidence.
About ChinaCurelink
ChinaCurelink helps patients across Southeast Asia — including Indonesia, Malaysia, the Philippines, Vietnam, and Thailand — access the best cancer treatment at China's top hospitals, without the delays, language barriers, and administrative confusion that typically come with seeking care abroad.
We connect patients directly with China's top 5 cancer hospitals, ensuring that from the first case submission through to treatment and follow-up, every step is guided, translated, and coordinated by a team that understands both the medical and cultural needs of Southeast Asian patients.
ChinaCurelink is proudly affiliated with Medebound HEALTH— an international medical concierge company headquartered in New York, specialized in securing premium second opinions from top US hospitals and specialists. With over 10 years of experience and more than 3,000 patients served worldwide, Medebound HEALTH is recognized as one of the leading patient access services across North America and the Asia Pacific, Medebound HEALTH brings the same standard of expert care coordination to every patient we serve.
This article is for informational purposes only and does not constitute medical advice. All treatment decisions should be made in consultation with a qualified oncologist who has reviewed your complete medical history and current diagnostic information.
Comments