Junshi's Cancer Combo Doubles Survival, Sets New Treatment Standard

SHANGHAI, China – May 21, 2026 – China's National Medical Products Administration (NMPA) has approved a landmark combination therapy for urothelial carcinoma, a common and aggressive form of bladder cancer. The approval grants Junshi Biosciences the green light to market its anti-PD-1 drug, toripalimab, in combination with RemeGen's antibody-drug conjugate (ADC), disitamab vedotin, as a first-line treatment for patients with HER2-expressing locally advanced or metastatic disease.

The decision marks a pivotal moment for cancer care in China, offering a new and powerful alternative to traditional chemotherapy. The approval is based on staggering clinical data showing the combination more than doubled patient survival rates, heralding a new era for a patient population with significant unmet needs.

A New Standard of Care Emerges

The approval is supported by the remarkable results of the RC48-C016 study, a Phase 3 clinical trial whose findings were so significant they were published in The New England Journal of Medicine and featured at the prestigious Presidential Symposium of the 2025 European Society for Medical Oncology (ESMO) annual meeting. The study's outcomes represent a paradigm shift in treating this difficult cancer.

Patients receiving the toripalimab-disitamab vedotin combination demonstrated a median progression-free survival (PFS) of 13.1 months, a dramatic improvement over the 6.5 months seen in patients receiving standard platinum-based chemotherapy. Even more impressively, the median overall survival (OS) was extended to 31.5 months with the combination, compared to just 16.9 months for the chemotherapy arm.

"This is a significant breakthrough," one leading European oncologist commented on the study's findings. The expert, not involved in the study, noted that the combination represents a "potential new standard of care" for this patient population, highlighting that the benefits were consistent across various patient subgroups, including those ineligible for cisplatin, a common chemotherapy agent.

Urothelial carcinoma is a growing public health challenge globally, and particularly in China, where it is among the top ten most prevalent cancers. According to recent data, China saw over 92,900 new cases and more than 40,000 deaths from the disease in 2022 alone. For years, the prognosis for patients with advanced disease has been poor, underscoring the urgent need for more effective therapies. This new combination directly addresses that need, with an objective response rate of 76.1%, far surpassing the 50.2% achieved with chemotherapy.

The Science of Synergy: A Two-Pronged Attack

The success of the new regimen lies in the powerful synergy between its two components, which attack the cancer from different angles. It is a prime example of Junshi Biosciences' 'Immuno-Oncology (I-O) 2.0' strategy, which focuses on developing next-generation combination therapies.

Toripalimab is an anti-PD-1 monoclonal antibody. It works by blocking the PD-1 protein on immune cells, a mechanism that cancer cells often exploit to hide from the body's defenses. By inhibiting this interaction, toripalimab effectively takes the brakes off the immune system, allowing it to recognize and attack tumor cells.

Disitamab vedotin, developed by RemeGen, is a sophisticated antibody-drug conjugate (ADC), often described as a 'biological missile.' It consists of a monoclonal antibody that specifically targets the HER2 protein found on the surface of cancer cells. This antibody is linked to a potent cytotoxic agent, monomethyl auristatin E (MMAE). The ADC seeks out HER2-expressing cancer cells, binds to them, and is then internalized. Once inside, it releases its toxic payload, killing the cancer cell from within while minimizing damage to surrounding healthy tissue.

Together, the two drugs create a potent one-two punch. The ADC-driven cell death releases tumor antigens, which are like 'wanted posters' for the immune system. Toripalimab then ensures the immune system is fully activated to hunt down and destroy any other cancer cells bearing those antigens, creating a more durable and comprehensive anti-tumor response.

Notably, the treatment is approved for a broad group of patients whose tumors express HER2 at any level (IHC 1+, 2+, or 3+), a group that constitutes up to 70% of all urothelial carcinoma cases. This widens its applicability far beyond the narrow subset of patients with high HER2 overexpression.

A Testament to China's Biopharma Innovation

This approval is not just a clinical victory; it is a powerful symbol of China's rapidly ascending biopharmaceutical industry. The combination of two domestically developed, innovative drugs from two different Chinese companies—Junshi Biosciences and RemeGen—to create a therapy that outperforms the global standard of care underscores the country's growing prowess in drug discovery and development.

"The approval of toripalimab's 13th indication is a huge milestone for us all, and sheds light on the importance of our open collaboration R&D strategy," said Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, in a statement. "Together, we were able to combine two locally-developed innovations to create a powerful synergistic treatment."

For Junshi, this is the 13th approved indication for toripalimab in mainland China, cementing its status as a versatile and foundational immuno-oncology asset. The drug has already been included in China's National Reimbursement Drug List (NRDL) for its previous 12 indications, a critical step for ensuring broad patient access. Given the new combination's profound clinical benefit, it is widely expected to be considered for NRDL inclusion, which would make this life-extending treatment affordable for millions.

This success reinforces Junshi's "In China, For Global" mission. Toripalimab is already approved in over 40 countries, including the United States and the European Union, for other indications. The outstanding results in urothelial carcinoma will likely bolster its reputation on the world stage and could pave the way for future global approvals for this combination, positioning Chinese innovation at the forefront of the global fight against cancer.