Toripalimab's New Class 2.2 Filing: Pioneering a Global First-in-Class Indication Eight Years Post-Launch

On July 10, 2026, China's Center for Drug Evaluation (CDE) announced that Shanghai Junshi Biosciences Co., Ltd. has filed a new clinical trial application for toripalimab injection (brand name: Tuoyi®), which has been accepted for review. The filing is classified as a Class 2.2 therapeutic biological product—a designation reserved for new indications that have not yet been approved anywhere in the world. In other words, Junshi is pushing toripalimab into a therapeutic territory that no PD-1 inhibitor has yet conquered globally.

The question many readers may ask: Toripalimab has been on the market for nearly eight years—why is it still being filed as a "new drug"?

Under China's Classification and Submission Requirements for Biological Product Registration, Class 2 therapeutic biological products are categorized as improved biologics. Class 2.2 specifically refers to products seeking approval for new indications that have not been approved domestically or internationally, and/or targeting new patient populations. This classification carries three significant implications.

First, it represents a genuine global first. The indication being sought has not been approved for any PD-1 or PD-L1 inhibitor anywhere in the world—a true first-in-class expansion. Second, it is driven by clinical value rather than mere formulation changes or manufacturing optimizations; the goal is to directly expand the treated population and address unmet clinical needs. Third, there is a policy advantage: improved new drugs approved under Class 2.2 are eligible for a four-year post-approval monitoring period, during which they enjoy market exclusivity protection.

As China's first domestically developed PD-1 monoclonal antibody to receive regulatory approval, toripalimab has never stopped expanding its indications since launch. This latest Class 2.2 filing reaffirms Junshi's strategy of deep, sustained investment in tumor immunotherapy.

Eight Years, Thirteen Indications

Toripalimab made history in December 2018 when China's National Medical Products Administration (NMPA) approved it for the treatment of unresectable or metastatic melanoma in patients who had failed prior systemic therapy. It was the first domestically developed PD-1 inhibitor to reach the Chinese market, ushering in a new era of homegrown tumor immunotherapy.

As of May 2026, toripalimab has been approved for 13 indications in China, making it one of the most comprehensively covered domestic PD-1 products on the market:

The thirteenth indication, approved in May 2026, carries particular milestone significance: it is the world's first approval of a PD-1 inhibitor combined with an antibody-drug conjugate (ADC) as first-line therapy for urothelial carcinoma. The approval covers the full population of patients with HER2 IHC 1+, 2+, and 3+ expression, marking the formal entry of immunotherapy into the era of "IO + ADC" combination treatment.

Notably, all twelve indications approved prior to 2026 have been included in China's National Reimbursement Drug List. Toripalimab is the only anti-PD-1 monoclonal antibody in the reimbursement catalog indicated for the treatment of melanoma, renal cell carcinoma, and triple-negative breast cancer, significantly improving patient access to these therapies.

Clinical Data Surges: Perioperative Treatment Becomes the New Battleground

Recent clinical data releases suggest that toripalimab's development focus is shifting from late-stage treatment toward perioperative therapy and precision combination regimens—likely the direction of this new Class 2.2 indication.

Lung Cancer Perioperative: Indication Set to Expand to Stage II–III. On May 26, 2026, Junshi Biosciences announced that the NEOTORCH Phase III study had reached its final analysis primary endpoint. The trial demonstrated that toripalimab combined with platinum-based doublet chemotherapy, used as perioperative treatment for patients with resectable Stage II–III non-small cell lung cancer, significantly improved event-free survival (EFS). Based on these results, Junshi plans to file a supplemental application with the NMPA in the near term to expand the perioperative indication from Stage III only to the full Stage II–III population, covering more early-stage lung cancer patients.

Gastric Cancer Perioperative: Three-Year Survival Rates Jump Significantly. In July 2026, the Journal of Clinical Oncology (JCO) published three-year survival data from a study of toripalimab combined with chemotherapy as perioperative treatment for locally advanced gastric cancer and gastroesophageal junction cancer. The results were striking: compared with chemotherapy alone, the toripalimab combination raised the three-year event-free survival rate from 32.5% to 50.3%, and the three-year overall survival rate from 48.8% to 64.6%. The survival benefit was consistent across most subgroups, including patients beyond the dMMR population. These data have effectively established immunotherapy as a standard-of-care option in the perioperative gastric cancer setting.

2026 ASCO: Challenging Conventional Wisdom. At the recently concluded 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, two toripalimab studies drew industry attention. One challenged the conventional belief that patients with EGFR or ALK mutations are not suitable candidates for immunotherapy, exploring combination immunotherapy approaches in this population. A second large-scale real-world study confirmed that toripalimab's perioperative regimen delivers robust efficacy across diverse patient populations.

Formulation Upgrade: Subcutaneous Injection on the Horizon. In March 2026, the CDE accepted a marketing application for toripalimab's subcutaneous formulation (JS001sc), covering all twelve indications already on the market. Compared with intravenous infusion, subcutaneous injection can reduce administration time from 30–60 minutes to just 3–5 minutes, substantially improving the patient experience and outpatient throughput efficiency. Approval is expected in 2027.

The Second Half of PD-1: From Price Wars to Clinical Value

Toripalimab's latest Class 2.2 filing reflects a broader shift in the PD-1 competitive landscape. The race has entered its second half.

After the wave of approvals and national reimbursement negotiations between 2018 and 2023, China's domestic PD-1 market has moved past the question of "whether there is a product" to "how good is the product." Pure price competition is a thing of the past. The competitive focus has shifted in four directions.

Among China's "Big Four" domestic PD-1 inhibitors—Hengrui's camrelizumab, BeiGene's tislelizumab, Innovent's sintilimab, and Junshi's toripalimab—all are accelerating new indication pipelines. But toripalimab, as the first Chinese PD-1 to reach the U.S. market, has taken a lead in perioperative treatment and IO + ADC combination strategies.

Innovation Never Stops

From the first domestic PD-1 approval in 2018 to the ongoing pursuit of global first-in-class indications, toripalimab's eight-year journey mirrors China's broader trajectory in tumor immunotherapy—from following, to running alongside, to leading in certain areas.

Many say PD-1 has become a "red ocean." But clinical need is never fully satisfied. For early-stage cancer patients, better perioperative regimens are needed to improve cure rates. For late-stage patients, more precise combination strategies are needed to extend survival and improve quality of life. For patients with rare tumor types, access to immunotherapy remains an unmet need.

The industry now watches to see whether this Class 2.2 clinical trial will deliver on its promise—and whether toripalimab can once again open a door that no PD-1 inhibitor has walked through before.

Sources: CDE official website, Junshi Biosciences announcements, NMPA official website, Journal of Clinical Oncology, 2026 ASCO Annual Meeting public materials. This article is for pharmaceutical industry information sharing purposes only and does not constitute medical advice. Please consult a physician for specific treatment plans.