Lonza and Engitix Announce License Agreement to Advance Targeted ADC Development

On July 21, 2026 Lonza, the world’s leading contract development and manufacturing organization (CDMO), and Engitix, a global leader in ECM-based drug discovery and development, reported a licensing agreement to advance the development of antibody-drug conjugates (ADCs) and deliver life-changing therapies for patients with chronic diseases.

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Under the agreement, Engitix will access Lonza’s ADC technology platform through a single-target license, including the use of SYNtecan E linker-payload and complementary GlycoConnect and HydraSpace. These technologies will support Engitix’s goal to develop and commercialize therapies. Lonza, through one of its affiliated companies, is eligible to receive upfront, clinical, regulatory, and commercial milestone payments, plus royalties on net sales of resulting products. Lonza is responsible for manufacturing components that are related to its proprietary technologies, and Engitix is responsible for the research, development, manufacturing, and commercialization of the ADCs.

Engitix has developed a proprietary human ECM platform that allows the study of disease biology directly in human tissue. This approach focuses on targets within the ECM itself, offering a differentiated pathway compared to traditional methods that focus on cell surface targets.

The collaboration enables Engitix to leverage Lonza’s established ADC technology platform to develop differentiated therapeutic candidates designed to selectively deliver potent payloads to tumor-selective targets identified through Engitix’s proprietary human ECM discovery platform.

Jan Vertommen, Vice President of Commercial Development, Advanced Synthesis, Lonza, commented: "We are pleased to collaborate with Engitix on this innovative program. By combining our ADC development and manufacturing expertise with Engitix’s unique ECM-based discovery platform, we aim to advance next-generation ADCs and unlock new possibilities in targeted therapies for patients."

Dr. Giuseppe Mazza, CEO and Co-Founder, Engitix, added: "At Engitix, we are committed to translating our unique understanding of the disease microenvironment into transformative therapies for patients with high unmet medical need. Licensing Lonza’s clinically validated conjugation and linker-payload technologies provides us with a powerful toolkit to develop next-generation ECM-targeted therapeutics with the potential for enhanced efficacy, reduced toxicity and improved therapeutic index."

The license agreement represents an important step in Engitix’s strategy to build a diversified pipeline of precision therapeutics addressing fibrosis, oncology, and other diseases driven by pathological tissue remodeling.

(Press release, Lonza, JUL 21, 2026, View Source [SID1234669356])

IMUNON Reports Positive Phase 2 MRD Clinical Data for IMNN-001, Demonstrating the Successful Overcoming of Historical IL-12 Safety Barriers in Frontline Ovarian Cancer

On July 21, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported new positive preliminary data from its ongoing Phase 2 minimal residual disease (MRD) translational clinical trial of IMNN-001, conducted in combination with standard of care neoadjuvant and adjuvant chemotherapy (N/ACT) plus bevacizumab, in women with newly diagnosed advanced ovarian cancer.

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This cutting-edge translational study is being conducted through the Break Through Cancer Targeting Minimal Residual Disease in Ovarian Cancer TeamLab, a multi-institutional collaboration accelerating research in ovarian cancer. The multi-site study is led by investigators at The University of Texas (UT) MD Anderson Cancer Center, which serves as the lead clinical site. Its objectives include understanding how chemo-immunotherapy with IMNN-001 impacts ovarian cancer’s "cold" tumor microenvironment and MRD after frontline treatment.

Nine patients in each of the control and experimental arms (total target accrual of 30 patients, 15 in each arm) have reached second-look laparoscopy (SLL), the study’s primary assessment point for surgical MRD. Compared to control, preliminary results show a deeper antitumor response, as demonstrated by a lower MRD-positive rate, in patients treated with IMNN-001 (44% vs. 67%), a higher rate of circulating tumor DNA (ctDNA) clearance (87.5% vs. 62.5%), and a numerically higher rate of patients achieving no evidence of disease (NED) following frontline therapy (100% vs. 56%).

"We are encouraged by these new data points from our MRD study, which continue to build the case for IMNN-001’s potential to make a meaningful difference for women with newly diagnosed advanced ovarian cancer," said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. "These findings, together with the consistent safety profile we’ve now observed across multiple studies, reinforce that we have overcome the historical safety and efficacy barriers associated with the development of a novel IL-12 immunotherapy and further bolster our confidence in IMNN-001 as we continue to advance our pivotal Phase 3 OVATION 3 trial."

"These new findings from the MRD study add an important layer of evidence to what we’ve observed with IMNN-001 to date," said study principal investigator, Amir Jazaeri, M.D., professor of Gynecologic Oncology and Reproductive Medicine at UT MD Anderson. "The reduction in residual disease and the encouraging ctDNA clearance we’re seeing, together with a consistent safety and tolerability profile, strongly support the continued investigation of IMNN-001’s role in the frontline treatment of ovarian cancer."

These new MRD findings build on results from the Company’s completed Phase 2 OVATION 2 study, in which IMNN-001 was associated with a 14.7-month increase in median overall survival compared to chemotherapy alone (45.1 vs. 30.4 months), and a 24.2-month increase among patients who also received PARP inhibitor maintenance therapy (65.6 vs. 41.4 months). The positive tolerability profile of IMNN-001 observed in prior studies has continued in the MRD study, including in combination with standard-of-care chemotherapy plus bevacizumab and in the maintenance setting, with no cytokine release syndrome, systemic toxicities, or serious immune-related adverse events observed to date. IMNN-001 is now being evaluated in the Company’s pivotal Phase 3 OVATION 3 trial, enrolling patients with newly diagnosed advanced ovarian cancer at clinical sites across the U.S.

Reinforcing previously published phase 2 data, new translational data from the MRD study also continue to support IMNN-001’s proposed mechanism of action. IMNN-001 induces robust expression of IL-12 in macrophages within the peritoneal fluid and tumor tissue, stimulating a cascade of anti-tumor cytokines, including interferon-gamma, and resulting in potent macrophage and T cell activation. These findings are consistent with a shift in the tumor immune microenvironment from "cold" to "hot," activating both innate and adaptive immune responses.

"We remain focused on generating a comprehensive body of evidence for IMNN-001 across our clinical program," added Dr. Lindborg. "The MRD study, together with our Phase 2 OVATION 2 results and the ongoing pivotal Phase 3 OVATION 3 trial, continues to build a consistent picture of IMNN-001’s benefit-risk profile in frontline ovarian cancer treatment."

About the Translational Phase 2 MRD Study

The Phase 2 MRD study (NCT05739981) is evaluating IMNN-001 in combination with standard-of-care neoadjuvant and adjuvant chemotherapy plus bevacizumab in women with newly diagnosed advanced ovarian cancer, conducted through the Break Through Cancer Targeting Minimal Residual Disease in Ovarian Cancer TeamLab. Patients in the experimental arm receive IMNN-001, administered intraperitoneally, in combination with N/ACT plus bevacizumab, followed by interval cytoreductive surgery and additional cycles of adjuvant chemotherapy plus IMNN-001. Patients then undergo second-look laparoscopy (SLL) to assess for minimal residual disease, followed by maintenance therapy assigned according to homologous recombination deficiency (HRD) status. The primary endpoint of the study is MRD-positive rate at SLL; the secondary endpoint is progression-free survival (PFS). The study also includes serial translational analyses of tumor tissue, circulating tumor DNA (ctDNA), microbiome, and intraperitoneal fluid, to further characterize IMNN-001’s impact on the tumor immune microenvironment.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity, acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, JUL 21, 2026, View Source [SID1234669355])

Nurix Therapeutics Announces HSR Clearance of Global Collaboration with Roche to Co-Develop and Co-Commercialize Potential Best-in-Class BTK Degrader Bexobrutideg Across Malignant Hematology, Immunology and Neurology

On July 21, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported the closing of its previously announced global collaboration agreement with Roche to co-develop and co-commercialize bexobrutideg, following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

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Summary of Business Terms
Under the terms of the agreement, Nurix will receive an upfront cash payment of $700 million and is eligible to receive development, regulatory and sales milestones for potential total payments of up to $2.3 billion. Development costs will be shared 40% by Nurix and 60% by Roche. The parties will equally split the profits and losses from U.S. commercialization. Nurix and Roche will co-commercialize bexobrutideg in the United States across all indications. Outside of the United States, Roche will be responsible for commercialization, with Nurix eligible to receive royalties ranging from the low- to high-teens. Nurix and Roche will jointly advance a broad clinical development program for bexobrutideg, including ongoing and planned studies in chronic lymphocytic leukemia (CLL), additional B-cell malignancies, multiple sclerosis (MS) and chronic spontaneous urticaria (CSU).

"This global collaboration marks a transformational moment for Nurix and the field of targeted protein degradation," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "With Roche as our partner, we are uniquely positioned to realize the full potential of bexobrutideg across oncology, immunology and neurology. Roche’s global development and commercial capabilities, combined with Nurix’s leadership in targeted protein degradation, provide the resources, expertise and shared commitment needed to rapidly advance bexobrutideg for patients who continue to face significant unmet medical needs. We are excited to begin this next chapter and to execute on what we believe is one of the most ambitious development programs ever undertaken for a degrader medicine."

About Bexobrutideg (NX-5948)
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.

​​​Bexobrutideg is currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed/refractory CLL, and in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed/refractory B-cell malignancies. Additional trials are planned, including the DAYBreak CLL-306 clinical trial (NCT07516093), a randomized Phase 3 trial comparing bexobrutideg to pirtobrutinib in patients with relapsed/refractory CLL, and the NX-5948-203 Phase 1/2 clinical trial (NCT07520006), assessing the combination of bexobrutideg with venetoclax with or without an anti-CD20 antibody in patients with relapsed/refractory CLL and treatment naïve CLL. A new tablet formulation of bexobrutideg is being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about these clinical trials can be found at clinicaltrials.gov.

(Press release, Nurix Therapeutics, JUL 21, 2026, View Source [SID1234669354])

Publication in Cancer Research Details Atebimetinib’s Broad, Durable Preclinical Activity and Favorable Tolerability Across RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition

On July 21, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported the publication of new findings in Cancer Research, a leading peer-reviewed journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), characterizing the differentiated mechanism and broad preclinical activity of atebimetinib.

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The article, "Dual-MEK Inhibitor Atebimetinib Displays Broad Activity in RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition and Resisting RAF-Bypass," (Kolitz et al., Cancer Research, doi.org/10.1158/0008-5472.CAN-25-4907) reports that atebimetinib demonstrated broad antitumor activity across RAS- and RAF-mutant models while resisting RAF-mediated bypass signaling, a key mechanism associated with resistance to other MEK inhibitors. Because the activity observed spanned a range of KRAS, NRAS, and BRAF alterations, the findings support the potential of atebimetinib to address RAS- and RAF-mutant cancers broadly — including the majority of RAS-mutant tumors that are not addressed by currently available mutation-selective inhibitors.

"Atebimetinib was deliberately designed to overcome the historical limitations of MEK inhibition, including the toxicity that comes with chronic MAPK pathway suppression, and the RAF-mediated pathway reactivation that has limited the durability of pathway suppression, particularly in RAS-mutant disease," said Brett Hall, Ph.D., Chief Scientific Officer of Immuneering. "The new findings noted in the Cancer Research article underscore the scientific basis for our Deep Cyclic Inhibitor technology and the broad, mutation-agnostic, durable activity we observed across RAS- and RAF-mutant models, reinforcing atebimetinib’s position as a differentiated, modern MEK inhibitor."

The article describes how atebimetinib combines a novel dual-MEK mechanism with a short half-life designed to achieve Deep Cyclic Inhibition (DCI) of the MAPK pathway. Unlike other MEK inhibitors that chronically suppress signaling and are prone to RAF-mediated bypass, atebimetinib was shown to produce profound but transient inhibition of MAPK signaling followed by recovery periods that allow normal tissue to rest between doses – an approach designed to improve tolerability while maintaining antitumor activity.

Key findings include:

Atebimetinib demonstrated potent inhibition of both pERK and pMEK across multiple KRAS-, NRAS-, and BRAF-mutant tumor models, including colorectal, lung, and melanoma models.
Whereas other MEK inhibitors reduced pERK but allowed pMEK to accumulate — the molecular signature of RAF-mediated pathway reactivation — atebimetinib reduced both pERK and pMEK, reflecting its resistance to CRAF-mediated bypass.
Atebimetinib’s short half-life enabled deep cyclic inhibition of the MAPK pathway, characterized by deep suppression during peak exposure followed by recovery toward physiologic baseline signaling between doses.
In multiple head-to-head in vivo studies, atebimetinib demonstrated greater depth and durability of tumor growth inhibition than the FDA-approved MEK inhibitor binimetinib across KRAS-, NRAS-, and BRAF-mutant tumor models while remaining well tolerated.
In the Colon-26 model, a syngeneic colon-carcinoma model widely used to study cancer cachexia, atebimetinib-treated animals maintained body weight near baseline (within approximately 5%) through roughly two weeks of dosing, while untreated control animals lost a median of more than 20% of body weight by approximately day 14. Across the in vivo models more broadly, atebimetinib-treated mice maintained body weight within a median of 3-5% over up to four weeks of chronic dosing.

Immuneering is currently recruiting patients in MAPKeeper 301 (NCT07562152), a global randomized Phase 3 pivotal trial evaluating atebimetinib plus mGnP versus standard-of-care gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer. In the second half of the year, the company expects to dose the first patient in a Phase 2 trial of atebimetinib plus Libtayo (cemiplimab) in patients with first-line RAS-mutant non-small cell lung cancer.

(Press release, Immuneering, JUL 21, 2026, View Source [SID1234669353])

Junshi Biosciences Announces Acceptance of the Supplemental Application for Toripalimab plus Chemotherapy as Perioperative Treatment for Resectable Stage Ⅱ-Ⅲ NSCLC

On July 21, 2026 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the supplemental application for toripalimab in combination with platinum-containing chemotherapy as perioperative treatment and subsequent monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage II-III non-small cell lung cancer (NSCLC) has been accepted by the National Medical Products Administration (NMPA). The supplemental application expands toripalimab’s indication from adult patients with resectable stage IIIA-IIIB NSCLC to adult patients with resectable stage II-III NSCLC.

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Lung cancer is a malignant tumor with the highest prevalence and mortality rate in the world. According to data released by the National Clinical Research Center for Cancer, in 2024, there were approximately 1.18 million new lung cancer cases and 0.74 million lung cancer deaths in China, accounting for 22.83% of all new cancer cases and 28.79% of all cancer deaths in the nation. Amongst these cases, 20%-25% were surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of the patients suffered from post-surgical recurrence and death. Radical surgery in combination with chemotherapy is one way to prevent recurrence, but chemotherapy, as preoperative neoadjuvant or postoperative adjuvant therapy, has limited clinical benefits and can only improve the 5-year survival rate by around 5%.

Immunotherapy, with PD-(L)1 inhibitors at the forefront, has been transforming the landscape of cancer treatment. It has long-term effects in terms of tumor control and/or elimination by relieving the immune suppression of tumor cells and reactivating the patients’ own immune cells to kill cancer. Many local and international lung cancer treatment guidelines recommend PD-(L)1 inhibitors as one of the standard perioperative treatments for resectable stage II-III NSCLC.

The supplemental application is principally based on NEOTORCH (NCT04158440), a randomized, double-blind, placebo-controlled phase 3 clinical study aiming to compare the efficacy and safety of toripalimab or placebo in combination with chemotherapy as perioperative treatment for resectable stage II/III NSCLC patients. Led by principal investigator Professor Shun LU of Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, the study enrolled a total of 501 patients with resectable stage II-III NSCLC. The primary endpoints are event-free survival (EFS) in patients with stage III and stage II-III disease as assessed by researchers, and major pathological response (MPR) rate in patients with stage III and stage II-III disease as assessed by the Blind Independent Pathology Review Committee (BIPR). The secondary endpoints include overall survival (OS), EFS as assessed by the Independent Review Committee (IRC), pathological complete remission rate (pCR rate), disease-free survival (DFS) and safety.

In January 2023, the EFS interim analysis of patients with resectable stage III NSCLC of NEOTORCH met the primary endpoint. The study results were presented through oral presentation at the April 2023 session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Session and the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. NEOTORCH was the world’s first phase 3 clinical study of an anti-PD-1 monoclonal antibody for NSCLC perioperative treatment (including neoadjuvant and adjuvant) with positive EFS results published in the Journal of the American Medical Association (JAMA) in January 2024.

The results showed that compared to perioperative chemotherapy alone, toripalimab in combination with chemotherapy as perioperative treatment led to a significant improvement in EFS (median EFS: not reached vs. 15.1 months, P<0.001), reduced risk of disease recurrence, progression events or death by 60% (HR=0.40, 95% CI: 0.28-0.57). Meanwhile, the OS in the toripalimab in combination with chemotherapy group showed a clear trend toward improved outcomes (HR=0.62, 95% CI: 0.38-1.00). Moreover, toripalimab in combination with chemotherapy as perioperative treatment increased the pCR rate to nearly 25-fold (pCR rate: 24.8% vs. 1.0%) and the MPR rate to nearly 6-fold (MPR rate: 48.5% vs. 8.4%).

In December 2023, based on the NEOTORCH interim analysis results, the supplemental new drug application for the new indication of toripalimab in combination with platinum-containing doublet chemotherapy for perioperative treatment of resectable stage IIIA-IIIB NSCLC patients was approved by the NMPA. It was the first domestically approved perioperative therapy for lung cancer in China, and the second worldwide.

In May 2026, the NEOTORCH finished the final analysis. The primary endpoints of EFS and MPR rate in the stage II-III population, as well as the MPR rate in the stage III population, met the pre-defined efficacy boundary.

In July 2026, the full results of a post hoc analysis of surgical outcomes from the NEOTORCH of toripalimab in combination with chemotherapy for perioperative treatment of resectable stage III NSCLC patients were officially published in JAMA Surgery, a leading international journal in the field of surgery. The analysis focused on stage III NSCLC patients who underwent surgery in the NEOTORCH and systematically evaluated the effects of toripalimab in combination with chemotherapy as perioperative treatment on surgical feasibility, complications, survival and other outcomes.

The results demonstrated that toripalimab in combination with chemotherapy significantly reduced the surgery cancellation rate (17.8% vs. 26.7%; p=0.03), thereby enabling more patients to undergo surgical resection without increasing perioperative risks or giving rise to any new safety signals. Among the 314 patients who completed surgery, compared with placebo in combination with chemotherapy, toripalimab in combination with chemotherapy effectively achieved higher rates of tumor downstaging and lymph node downstaging (tumor downstaging rate: 80.7% vs. 50.7%, lymph node downstaging rate: 67.5% vs. 48.6%), and improved the EFS benefit of the patients (HR=0.50, 95% CI: 0.33-0.74; p<0.001). Among the patients who achieved tumor downstaging or lymph node downstaging, toripalimab in combination with chemotherapy significantly improved EFS compared with placebo in combination with chemotherapy (HR=0.45 for both, p=0.002 and p=0.009).

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are twelve approved indications for toripalimab in the Chinese mainland:

unresectable or metastatic melanoma after failure of standard systemic therapy;

recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;

locally advanced or metastatic urothelial carcinoma (UC) that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;

in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;

in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);

in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);

in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;

in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);

in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);

in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);

in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients;

first-line treatment for unresectable or metastatic melanoma;

in combination with disitamab vedotin for the first-line treatment of HER2-expressing UC.

The first 12 indications have been included in the National Reimbursement Drug List (NRDL) (2025 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, RCC and TNBC. Toripalimab for the treatment of advanced NPC and ESCC was approved in Hong Kong SAR, China.

Internationally, toripalimab has been approved for marketing in nearly 50 countries and regions including the United States, the European Union, India, the United Kingdom, Australia, Singapore, Malaysia and South Africa, and is also under review for marketing in various countries and regions worldwide.

(Press release, Shanghai Junshi Bioscience, JUL 21, 2026, View Source [SID1234669352])