NMPA Accepts Toripalimab Perioperative NSCLC sNDA

Key Takeaways

• NMPA accepted Junshi's sNDA for perioperative toripalimab in resectable stage II-III NSCLC (announced July 21, 2026).
• Stage IIIA-IIIB perioperative use was already approved in December 2023—the first domestic perioperative lung-cancer immunotherapy in China, per Junshi.
• NEOTORCH (NCT04158440; n=501) previously showed EFS HR 0.40 and pCR 24.8% vs 1.0% in stage III analyses.
• Final May 2026 analysis met EFS and MPR endpoints in the broader stage II-III population.

Toripalimab perioperative sNDA at a glance

Field	Detail
Drug	Toripalimab + platinum chemotherapy (perioperative); monotherapy adjuvant
Company	Shanghai Junshi Biosciences (HKEX: 1877; SSE: 688180)
Regulator	China NMPA
Action	Supplemental application accepted (July 21, 2026 announcement)
Sought population	Adult resectable stage II-III NSCLC
Prior China label	Resectable stage IIIA-IIIB perioperative use (approved Dec 2023)
Pivotal trial	NEOTORCH (NCT04158440)

What filing did NMPA accept?

Junshi said the NMPA accepted a supplemental application for toripalimab combined with platinum-containing chemotherapy as perioperative treatment, followed by toripalimab monotherapy as adjuvant therapy, for adults with resectable stage II-III NSCLC. That expands the previously approved stage IIIA-IIIB perioperative indication.

Details: Junshi's July 21 GlobeNewswire acceptance release.

What is the China lung-cancer backdrop?

Junshi cited National Clinical Research Center for Cancer figures of about 1.18 million new lung-cancer cases and 0.74 million deaths in China in 2024. Roughly 20%–25% of cases are resectable at diagnosis, yet 30%–55% of patients still recur or die after radical surgery. Perioperative chemotherapy alone improves 5-year survival by about 5%, the company said.

What did NEOTORCH previously deliver?

NEOTORCH is a randomized, double-blind, placebo-controlled Phase 3 study of perioperative toripalimab versus placebo with chemotherapy in resectable stage II/III NSCLC (n=501). Primary endpoints include researcher-assessed EFS and BIPR-assessed MPR in stage III and stage II-III populations.

• Stage III interim: median EFS not reached vs 15.1 months; HR 0.40 (95% CI 0.28–0.57)
• OS trend: HR 0.62 (95% CI 0.38–1.00)
• pCR 24.8% vs 1.0%; MPR 48.5% vs 8.4%

Registration: ClinicalTrials.gov NCT04158440 (NEOTORCH). Results were published in JAMA (via JAMA Network) in January 2024, per Junshi.

What changed in the 2026 final analysis?

Junshi said the May 2026 final analysis met primary EFS and MPR endpoints in the stage II-III population and MPR in stage III. July 2026 post hoc surgical-outcome analyses were also flagged. Those datasets underpin the stage II-III supplemental dossier now under NMPA review.

What remains uncertain?

Acceptance is not approval. Exact stage II subgroup hazard ratios, surgical morbidity, and immune-related AE rates for the expanded population will matter for labeling. Timing of an NMPA decision and any NRDL implications were not disclosed.

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Frequently Asked Questions

Primary Sources

1. GlobeNewswire: Junshi — toripalimab perioperative NSCLC sNDA acceptance — July 21, 2026
2. ClinicalTrials.gov: NEOTORCH (NCT04158440)
3. JAMA Network (NEOTORCH publication venue cited by Junshi)
4. HKEX news (Junshi HKEX: 1877 disclosures portal)