On May 22, 2026 Formosa Pharmaceuticals, Inc. reported that its abstract highlighting the differentiated binding profile and preclinical efficacy of TSY-310, a novel bispecific antibody-drug conjugate (ADC), has been selected for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago, Illinois. TSY-310 simultaneously targets EGFR and ROR1, two receptors frequently co-expressed in prevalent solid tumors. By leveraging a unique bispecific modality, TSY-310 optimizes target engagement and intracellular delivery, facilitating a potent bystander effect to address the challenges of tumor heterogeneity.

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Details

Title: TSY-310, A Novel Bispecific EGFR x ROR1 ADC, Exhibits Potent Antitumor Activity in Heterogeneous Breast Tumors Through Enhanced Internalization and Bystander Cytotoxicity
Session: Developmental Therapeutics: Molecularly Targeted Agents and Tumor Biology
Date & Time: May 30, 2026, 1:30 pm – 4:30 pm CT
Abstract Number: 3086
Poster Number: 223
Presenter: Dr. Kuo-Ming Yu, Ph.D., Director, CMC and Production

Highlights

Superior Selectivity: Bispecific binding, enhancing internalization specifically in tumor cells co-expressing EGFR and ROR1.
Enhanced Payload Delivery: Evidence of efficient lysosomal trafficking and the subsequent release of the cytotoxic payload.
Bystander Efficacy: Eradication of neighboring antigen-negative tumor cells, a critical factor in treating complex, heterogeneous tumor environments.

"Our participation at ASCO (Free ASCO Whitepaper) is an acknowledgement of the program’s potential as a worthy contributor to the future oncology treatment landscape," said Erick Co, President & CEO of Formosa Pharmaceuticals. "We are eager to place TSY-310 in the toolbox of oncologists and patients who face the evolving challenges with traditional single-target therapies."

Full abstract and presentation details will be available through ASCO (Free ASCO Whitepaper) and corporate websites in accordance with the meeting’s policies.

About TSY-310: TSY-310 is a next-generation bispecific ADC targeting EGFR and ROR1. By achieving high-affinity target recognition through an efficient, simplified protein architecture, TSY-310 aims to provide a durable, "best-in-class" therapeutic option for patients with advanced solid tumors, including Non-Small Cell Lung Cancer (NSCLC).

(Press release, Formosa Pharmaceuticals, MAY 22, 2026, View Source [SID1234665926])

On May 21, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that six abstracts from its clinical studies, selected for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, are now available on ASCO (Free ASCO Whitepaper)’s official website. Three of the six studies have been selected for rapid oral presentations, and three as poster presentations. These abstracts report data from ongoing studies evaluating the company’s three lead drug candidates, including BCR-ABL inhibitor olverembatinib(HQP1351); Bcl-2 inhibitor lisaftoclax (APG-2575); and MDM2-p53 inhibitor alrizomadlin (APG-115).

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This year’s ASCO (Free ASCO Whitepaper) Annual Meeting will take place in person at McCormick Place in Chicago, IL, and online, May 29 – June 2, 2026. The ASCO (Free ASCO Whitepaper) Annual Meeting showcases cutting-edge research in clinical oncology and advanced cancer therapies and is the world’s largest gathering in the clinical oncology community.

The key clinical results from Ascentage Pharma’s abstracts selected for the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting are as follows:

Rapid Oral Presentations

Olverembatinib (HQP1351) combined with blinatumomab in patients with lymphoid blast phase chronic myeloid leukemia (CML-LBP) or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL)

Abstract #: 6513

Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: May 30, 2026, 1:51 – 1:57 p.m., Central Time (May 31, 2026, 2:51 – 2:57 a.m., Beijing Time)

First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

Highlights:

● This multicenter, open-label phase Ib study evaluated the combination of olverembatinib and blinatumomab in patients with relapsed/refractory (R/R) Ph+ BCP-ALL or CML-LBP.

● Among five patients with measurable residual disease (MRD) positivity and no complete response (CR) at study entry, four achieved CR, and two achieved MRD negativity, with an overall manageable safety profile.

● This study provides initial clinical evidence supporting the feasibility of combining olverembatinib with immunotherapy in patients with CML-LBP and R/R Ph+ BCP-ALL in an international patient population.

Updated efficacy and safety of olverembatinib (HQP1351) as second-line therapy in patients with chronic-phase chronic myeloid leukemia (CP-CML)

Abstract #: 6510

Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: May 30, 2026, 1:21 – 1:27 p.m., Central Time (May 31, 2026, 2:21 – 2:27 a.m., Beijing Time)

First Author: Weiming Li, MD, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Highlights:

● This is a single-arm, multicenter, open-label study conducted in China, evaluating the efficacy and safety of olverembatinib as a second-line therapy in patients with CP-CML.

● Among 42 evaluable patients, at cycle 24, the complete cytogenetic response (CCyR) rate reached 91.3%, and the major molecular response (MMR) rate reached 60.9%. Among 32 patients who failed first-line second-generation TKIs, 81.3% achieved CCyR and 50% achieved MMR, with a favorable safety profile.

● Olverembatinib shows good tolerability and leads to high MMR and CCyR in patients with CP- CML without T315I mutation that is resistant/intolerant to first-line TKls.

Alrizomadlin (APG-115) alone or in combination with lisaftoclax (APG-2575) for the treatment of pediatric patients with relapsed/metastatic rhabdomyosarcoma (RMS) or other soft-tissue sarcomas (STSs)

Abstract #: 10012

Session Title: Pediatric Oncology II

Date and Time: May 30, 2026, 8:00 – 8:06a.m., Central Time (May 30, 2026, 9:00 -9:06 p.m., Beijing Time)

First Author: Yizhuo Zhang, MD, Department of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China

Highlights:

● This is a multicenter clinical trial conducted in China, evaluating the safety and preliminary efficacy of alrizomadlin (APG-115) as monotherapy or in combination with lisaftoclax (APG-2575) in heavily pretreated pediatric patients with neuroblastoma (NB), as well as relapsed/metastatic rhabdomyosarcoma (RMS), Ewing sarcoma (EWS), and other soft-tissue sarcomas (STSs).

● Results showed that no dose-limiting toxicities (DLT) were observed in either monotherapy or combination groups. Adverse events were mainly gastrointestinal and hematologic, with few serious adverse events, and no treatment-related deaths or discontinuations. In terms of clinical benefit, one patient with refractory RMS in the monotherapy group achieved CR; in the combination group, the objective response rate (ORR) was 30% and the disease control rate (DCR) was 80%.

● This regimen demonstrated a manageable safety profile and preliminary antitumor activity in pediatric solid tumors, warranting further investigation.

Poster Presentations

Updated clinical and translational results of olverembatinib (HQP1351) in patients with succinate dehydrogenase (SDH)-deficient tumors

Abstract #: 11539

Session Title: Sarcoma

Date and Time: June 1, 2026, 1:30 – 4:30 p.m., Central Time (June 2, 2026, 2:30 – 5:30 a.m., Beijing Time)

First Author: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China

Highlights:

● This study in SDH-deficient tumors evaluated the efficacy of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumors (GIST) and paraganglioma.

● Among 26 patients with SDH-deficient GIST, 6（23.1%）pts experienced PR as best response, with a median progression-free survival (PFS) of 25.7 months; among 6 patients with SDH-deficient paraganglioma, best responses were observed in 4 patients, with SD lasting≥4 cycles(CBR, 66.7%) and a median PFS of 8.25 months.

● This study, for the first time, revealed that olverembatinib inhibits fatty acid-promoted tumor cell migration by targeting the p38-CD36 pathway, providing a further insight on the mechanism of action of olverembatinib in SDH-deficient tumors.

A phase 3 study of olverembatinib (HQP1351) in patients with chronic-phase chronic myeloid leukemia: POLARIS-2 trial in progress

Abstract #: TPS6608

Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: June 1, 2026, 9:00 a.m. – 12:00 p.m., Central Time (June 1, 2026, 10:00 p.m. -Tuesday June 2, 2026, 1:00 a.m., Beijing Time)

First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

Highlights:

● This FDA and EMA-cleared, global Phase III registrational clinical trial (POLARIS-2) is evaluating olverembatinib in patients with chronic-phase CML

● The study includes two independent cohorts. In Part A, patients with chronic-phase CML who have received at least two prior TKIs are randomized in a 2:1 ratio to receive olverembatinib or bosutinib; Part B is a single-arm study evaluating olverembatinib in patients harboring the T315I mutation. The primary endpoint for both parts is the MMR rate at or by 24 weeks.

A global multicenter, open-label, randomized, phase 3 registrational study of lisaftoclax (APG-2575) in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): GLORA trial in progress

Abstract #: TPS7101

Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: June 1, 2026, 9:00 a.m. – 12:00 p.m., Central Time (June 1, 2026, 10:00 p.m. -Tuesday June 2, 2026, 1:00 a.m., Beijing Time)

First Author: Matthew Steven Davids, MD, Dana-Farber Cancer Institute

Highlights:

● GLORA is a global, multicenter, open-label phase 3 registrational study.

● The aim of the study is to evaluate the efficacy and safety of lisaftoclax in combination with a BTK inhibitor in patients with CLL/SLL. Eligible patients have CLL/SLL and, after 12 months of BTKi monotherapy, have achieved neither complete response (CR) nor progressive disease (PD). The study plans to enroll approximately 440 patients across 126 centers in 18 countries and is currently enrolling.

(Press release, Ascentage Pharma, MAY 21, 2026, View Source [SID1234666007])

On May 21, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that members of Revolution Medicines’ senior management team will host a webcast on Sunday, May 31 at 7:00 pm ET to discuss positive results from the Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) following presentation of the data during the Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, MAY 21, 2026, View Source [SID1234665996])

On May 21, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting taking place from May 29 to June 2, 2026 in Chicago, USA.

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Results from the pivotal Phase II registration study of savolitinib in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China will be presented during a rapid oral session. The study met its primary endpoint of objective response rate ("ORR") per RECIST 1.1, as assessed by the Independent Review Committee ("IRC"). As of the data cut-off of October 8, 2025, the IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included the IRC-assessed disease control rate (DCR) of 63.1%, median time to response (TTR) of 1.4 months, median duration of response (DoR) of 9.7 (95%CI: 3.7, 18.5) months, and median progression-free survival (PFS) of 4.0 (95%CI: 2.6, 5.0) months, respectively. The data supported the New Drug Application (NDA) submission to the China National Medical Products Administration (NMPA), which was accepted and granted priority review in December 2025.

Additionally, further analyses of the fruquintinib’s FRESCO, FRESCO-2, FRUSICA-1 and FRUSICA-2 studies, as well as investigator-initiated studies of fruquintinib and surufatinib spanning across a diverse range of potential tumor indications will be presented.

Details of the presentations, including links to available abstracts, are as follows:

Abstract title Presenter / Lead Author Presentation details
SPONSORED STUDIES
A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas Zhi Peng, Beijing, China 4011
Rapid Oral Abstract Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Monday, June 1, 2026 1:15 PM CDT
Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2 Elena Elez, Barcelona, Spain 3555
Poster Session: Gastrointestinal Cancer – Colorectal and Anal
Efficacy of fruquintinib plus sintilimab versus axitinib or everolimus by scores of IMDC risk factors and PD-L1 expression at baseline in previously treated advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study Kaiwei Yang, Beijing, China 4531
Poster Session: Genitourinary Cancer
– Kidney and Bladder
Efficacy with fruquintinib plus sintilimab versus axitinib or everolimus in advanced renal cell carcinoma: A post-hoc analysis from FRUSICA-2 trial by baseline tumor burden Yuanyuan Qu, Shanghai, China 4533
Poster Session: Genitourinary Cancer
– Kidney and Bladder
Association of Palmar-plantar erythrodysesthesia syndrome (PPES), hypothyroidism and clinical outcome in previously treated endometrial cancer (EMC) with pMMR status: A subgroup analysis of FRUSICA-1 Xiaotian Han, Shanghai, China e17612
Publication Only: Gynecologic Cancer

INVESTIGATOR-INITIATED STUDIES
Efficacy and safety of fruquintinib combined with chemotherapy versus bevacizumab combined with chemotherapy as second-line treatment for metastatic colorectal cancer: A prospective, multicenter, randomized controlled trial Jianmin Xu, Shanghai, China LBA3563
Poster Session: Gastrointestinal Cancer – Colorectal and Anal
CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer Yue Liu, Hangzhou, China TPS3680
Poster Session: Gastrointestinal Cancer – Colorectal and Anal
Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF-080/QUINTIS trial Joseph Tintelnot, Hamburg, Germany TPS3684
Poster Session: Gastrointestinal Cancer – Colorectal and Anal
A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety Chang Wang, Changchun, China 2631
Poster Session: Developmental Therapeutics – Immunotherapy
Fruquintinib plus FOLFIRI or mFOLFOX6 as second-line therapy for patients with RAS-mutant metastatic colorectal cancer (mCRC): A phase II, multicenter, open-label study Yun Xu, Shanghai, China 3528
Poster Session: Gastrointestinal Cancer – Colorectal and Anal
A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC) Wenhua Li, Shanghai, China 3534
Poster Session: Gastrointestinal Cancer – Colorectal and Anal
A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases Mengzhou Guo, Shanghai, China 3552
Poster Session: Gastrointestinal Cancer – Colorectal and Anal
Biomarker-driven assessment of immunochemotherapy with or without fruquintinib as first-line treatment for advanced gastric/GEJ adenocarcinoma: Initial clinical results and subgroup analysis from the MGC-FLORA study Xiaodong Zhu, Shanghai, China 4063
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial) Hao Wen, Shanghai, China 5579
Poster Session: Gynecologic Cancer
Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, phase II study Wangjun Liao, Guangzhou, China e15539
Publication Only: Gastrointestinal Cancer – Colorectal and Anal
Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study Yifu He/Jiayu Niu, Hefei, China e15560
Publication Only: Gastrointestinal Cancer – Colorectal and Anal
Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer Qian Li, Nanning, China e15571
Publication Only: Gastrointestinal Cancer – Colorectal and Anal
Chidamide combined with serplulimab and regorafenib or fruquintinib as third-line therapy for advanced colorectal cancer (C-ooperate/SCOG-C001): A single-arm, exploratory, multicenter, phase 2 trial Wei Li, Suzhou, China e15583
Publication Only: Gastrointestinal Cancer – Colorectal and Anal
Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States Vasu Bansal, Kansas City, US e15713
Publication Only: Gastrointestinal Cancer – Colorectal and Anal
Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase Ib/II study (FUNCTION) Beibei Chen, Zhengzhou, China e16033
Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study Yanhong Gu, Nanjing, China e16070
Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Xuetao Shi/Jingtao Zhong, Jinan, China 4136
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Surufatinib plus KN046 and chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma: Updated results and biomarker analysis from a phase 1b/2 trial Wenquan Wang, Shanghai, China 4198
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: Update of a prospective single center, single-arm phase II clinical trial Huijuan Yang, Shanghai, China 5586
Poster Session: Gynecologic Cancer
Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study Bei Xu, Shanghai, China 8119
Poster Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study Fuxiang Zhou, Wuhan, China e16172
Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study Shasha Fan, Changsha, China e16222
Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Osimertinib plus savolitinib in osimertinib-resistant non-small-cell lung cancer with low level gene copy number MET: A multi-center, open-label, and phase 2 study Xiang Han, Qingdao, China e20079
Publication Only: Lung Cancer –
Non-Small Cell Local-Regional/
Small Cell/Other Thoracic Cancers

(Press release, Hutchison China MediTech, MAY 21, 2026, View Source [SID1234665995])

On May 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 new drug application (NDA) for toripalimab in combination with disitamab vedotin for patients with HER2-expressing (which is defined as achieving a score of 1+, 2+ or 3+ in HER2 immunohistochemistry test), locally advanced or metastatic urothelial carcinoma (UC) was approved by the National Medical Products Administration (NMPA). Disitimab vedotin is an antibody drug conjugate independently developed by RemeGen Co., Ltd. With this latest approval, toripalimab injection now has 13 approved indications in the Chinese Mainland.

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UC is among the top ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising. According to the latest data from the National Cancer Center, in 2022, the number of new cases of UC in China reached 92,900, and the number of deaths exceeded 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs.

In 2021, toripalimab injection was approved for the second-line and above treatment of advanced UC, becoming the first immunotherapy drug approved for non-selective population-based indications of advanced UC in China.

The approval of this new indication is based on results from the RC48-C016 study (NCT05302284). The study is a multi-center, randomized, open-label and controlled phase 3 clinical trial which evaluated the efficacy and safety of toripalimab in combination with disitamab vedotin versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2 (human epidermal growth factor receptor 2)-expressing (which is defined as HER2 IHC 1+, 2+ or 3+) locally advanced or metastatic UC. The study was conducted in 74 clinical centers across China with Professor Jun GUO from Beijing Cancer Hospital and Professor Aiping ZHOU from the Cancer Hospital of the Chinese Academy of Medical Sciences as the principal investigators.

In October 2025, the study results of RC48-C016 were published in The New England Journal of Medicine (NEJM), and shared in an oral presentation at the Presidential Symposium of the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting (#LBA7).

The results were positive for both primary endpoints, progression free survival ("PFS", assessed by blinded independent review) and overall survival ("OS"). Compared with traditional chemotherapy, toripalimab in combination with disitamab vedotin for the first-line treatment of HER2-expressing advanced UC more than doubled the median PFS [13.1 months vs. 6.5 months, hazard ratio (HR)=0.36, 95%CI: 0.28-0.46; p<0.0001], as well as the median OS (31.5 months vs. 16.9 months, HR=0.54, 95%CI: 0.41-0.73; p<0.0001). The objective response rate (ORR) greatly increased (76.1% vs. 50.2%) and the medium duration of response (DoR) almost tripled in comparison (14.6 months vs. 5.6 months). The combination therapy group also demonstrated significant improvements in safety compared to the chemotherapy group.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, "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. In urologic oncology immunotherapy, toripalimab continues to be a driving force and this approval deepens its impact across the immunotherapy landscape. We are immensely proud to partner with RemeGen. Together, we were able to combine two locally-developed innovations to create a powerful synergistic treatment that significantly improves both PFS and OS. Moving forward, Junshi Biosciences will expand on our Immuno-Oncology (I-O) 2.0 strategy, pursuing the next generation of combination therapies and novel target drugs to fulfill our commitment to enduring innovation, ensuring China’s innovation benefits global patients."

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 more than 40 countries and regions including the United States, the European Union, India, the United Kingdom, Australia and Singapore, and is also under review for marketing in various countries and regions worldwide.

(Press release, Shanghai Junshi Bioscience, MAY 21, 2026, View Source [SID1234665994])