Hengrui Pharma Showcases Global Impact at the 2025 ASCO: 72 Study Results Highlight Chinese Cancer Innovation

On June 5, 2025 Hengrui Pharma reported a strong international presence, featuring 15 innovative drugs and 72 research outcomes at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting successfully concluded in Chicago on June 3 (local time) (Press release, Hengrui Pharmaceuticals, JUN 5, 2025, View Source [SID1234653747]). These included 4 oral presentations, 5 rapid oral presentations, 27 poster presentations, and 36 online publications. Multiple groundbreaking research advances has elicited widespread discussion among global experts.

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In the field of breast cancer, results from 19 studies evaluating the company’s innovative drugs—pyrotinib, dalpiciclib, camrelizumab, apatinib, adebrelimab, Trastuzumab rezetecan (SHR-A1811), and SHR-2017, either in combination with each other or with chemotherapies, were presented at ASCO (Free ASCO Whitepaper) 2025. Notably, 7 studies involving pyrotinib and 6 studies involving dalpiciclib were selected, with both agents consistently demonstrating promising efficacy, reinforcing their established roles in breast cancer treatment. Furthermore, studies evaluating SHR-A1811 and adebrelimab were selected for rapid oral presentations, attracting considerable attention from the industry.

In the field of gastrointestinal cancers, drugs such as camrelizumab, apatinib, adebrelimab, and SHR-8068 were featured in a total of 30 accepted studies. Notably, camrelizumab was included in 21 of these studies, demonstrating its broad therapeutic profile and potential while reinforcing its position as a key focus at ASCO (Free ASCO Whitepaper). This further solidifies the achievements of China-developed PD-1 inhibitors on the global stage. Additionally, adebrelimab, which has achieved significant breakthroughs in lung cancer in recent years, is actively expanding into new indications. At this year’s ASCO (Free ASCO Whitepaper), five related studies exploring adebrelimab’s efficacy in indications such as hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA) , and pancreatic cancer were presented. The ongoing emergence of cutting-edge research on both established and emerging agents holds promise for improving clinical outcomes for patients with gastrointestinal tumors.

Across a wide range of disease areas—including lung cancer, gynecologic cancers, lymphoma, bladder cancer, head and neck cancer, melanoma, sarcoma, nasopharyngeal carcinoma, chordoma, salivary gland cancer, thymic cancer, desmoid tumors, and salivary duct carcinoma—Hengrui Pharma’s innovative oncology portfolio (camrelizumab, apatinib, adebrelimab, pyrotinib, dalpiciclib, fluzoparib, famitinib, SHR-A1811, SHR-1501, SHR-1701, SHR-1826, SHR-A1912, and SHR-A2102) was featured in 22 research presentations at ASCO (Free ASCO Whitepaper) 2025. These comprised 4 oral presentations, 2 rapid oral presentations, 12 poster presentations, and 4 online publications, collectively demonstrating the company’s robust R&D capabilities. Additionally, one online publication highlighted ondansetron oral soluble film, underscoring its favorable efficacy in preventing and treating chemotherapy-induced nausea and vomiting (CINV).

For 15 consecutive years, Hengrui Pharma has consistently presented its cutting-edge research at the ASCO (Free ASCO Whitepaper) Annual Meeting, highlighting the company’s global leadership in oncology drug research and development while showcasing China’s robust pharmaceutical innovation capabilities to the international academic community. The inclusion of 70 Hengrui-sponsored studies at this year’s meeting reflects the strong foundation laid by the company’s portfolio of 23 marketed innovative drugs and a robust pipeline of over 90 candidates currently in development. Looking ahead, Hengrui will remain committed to its patient-centric approach, striving to develop advanced therapeutics that support the "Healthy China" initiative and enhance clinical outcomes for patients globally.

Hengrui Pharma Showcases Global Impact at the 2025 ASCO: 72 Study Results Highlight Chinese Cancer Innovation

On June 5, 2025 Hengrui Pharma reported a strong international presence, featuring 15 innovative drugs and 72 research outcomes at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting successfully concluded in Chicago on June 3 (local time) (Press release, Hengrui Pharmaceuticals, JUN 5, 2025, View Source [SID1234653747]). These included 4 oral presentations, 5 rapid oral presentations, 27 poster presentations, and 36 online publications. Multiple groundbreaking research advances has elicited widespread discussion among global experts.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In the field of breast cancer, results from 19 studies evaluating the company’s innovative drugs—pyrotinib, dalpiciclib, camrelizumab, apatinib, adebrelimab, Trastuzumab rezetecan (SHR-A1811), and SHR-2017, either in combination with each other or with chemotherapies, were presented at ASCO (Free ASCO Whitepaper) 2025. Notably, 7 studies involving pyrotinib and 6 studies involving dalpiciclib were selected, with both agents consistently demonstrating promising efficacy, reinforcing their established roles in breast cancer treatment. Furthermore, studies evaluating SHR-A1811 and adebrelimab were selected for rapid oral presentations, attracting considerable attention from the industry.

In the field of gastrointestinal cancers, drugs such as camrelizumab, apatinib, adebrelimab, and SHR-8068 were featured in a total of 30 accepted studies. Notably, camrelizumab was included in 21 of these studies, demonstrating its broad therapeutic profile and potential while reinforcing its position as a key focus at ASCO (Free ASCO Whitepaper). This further solidifies the achievements of China-developed PD-1 inhibitors on the global stage. Additionally, adebrelimab, which has achieved significant breakthroughs in lung cancer in recent years, is actively expanding into new indications. At this year’s ASCO (Free ASCO Whitepaper), five related studies exploring adebrelimab’s efficacy in indications such as hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA) , and pancreatic cancer were presented. The ongoing emergence of cutting-edge research on both established and emerging agents holds promise for improving clinical outcomes for patients with gastrointestinal tumors.

Across a wide range of disease areas—including lung cancer, gynecologic cancers, lymphoma, bladder cancer, head and neck cancer, melanoma, sarcoma, nasopharyngeal carcinoma, chordoma, salivary gland cancer, thymic cancer, desmoid tumors, and salivary duct carcinoma—Hengrui Pharma’s innovative oncology portfolio (camrelizumab, apatinib, adebrelimab, pyrotinib, dalpiciclib, fluzoparib, famitinib, SHR-A1811, SHR-1501, SHR-1701, SHR-1826, SHR-A1912, and SHR-A2102) was featured in 22 research presentations at ASCO (Free ASCO Whitepaper) 2025. These comprised 4 oral presentations, 2 rapid oral presentations, 12 poster presentations, and 4 online publications, collectively demonstrating the company’s robust R&D capabilities. Additionally, one online publication highlighted ondansetron oral soluble film, underscoring its favorable efficacy in preventing and treating chemotherapy-induced nausea and vomiting (CINV).

For 15 consecutive years, Hengrui Pharma has consistently presented its cutting-edge research at the ASCO (Free ASCO Whitepaper) Annual Meeting, highlighting the company’s global leadership in oncology drug research and development while showcasing China’s robust pharmaceutical innovation capabilities to the international academic community. The inclusion of 70 Hengrui-sponsored studies at this year’s meeting reflects the strong foundation laid by the company’s portfolio of 23 marketed innovative drugs and a robust pipeline of over 90 candidates currently in development. Looking ahead, Hengrui will remain committed to its patient-centric approach, striving to develop advanced therapeutics that support the "Healthy China" initiative and enhance clinical outcomes for patients globally.

Hoth Therapeutics to Spotlight HT-001 in Investor-Focused KOL Event Addressing Breakthrough Combating Cancer Treatment Skin Toxicities

On June 5, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company pioneering breakthrough therapies to improve the lives of patients, reported a Key Opinion Leader (KOL) event showcasing HT-001, its novel topical therapeutic, designed to treat debilitating skin toxicities caused by EGFR inhibitor cancer therapies (Press release, Hoth Therapeutics, JUN 5, 2025, View Source [SID1234653746]).

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These common treatment-limiting side effects—such as rash and inflammation—often force patients to reduce or stop potentially life-saving cancer therapy. HT-001 offers a targeted solution aimed at protecting patients’ quality of life and ensuring continued access to their critical oncology treatments.

The overall chemotherapy drug market was valued at USD 10.87 billion in 2024 and is expected to reach USD 18.35 billion by 2031. A significant portion of this market will involve patients who experience skin toxicities.*
Supportive care needs: The rise in chemotherapy treatments naturally drives demand for supportive care drugs to manage side effects, including skin rashes.*
Unmet needs: While supportive care drugs exist, chemotherapy-induced skin rash, particularly conditions like Acral erythema (hand-foot syndrome), can be severe and debilitating, highlighting the potential for novel or improved treatment options.*
Robb Knie, CEO of Hoth Therapeutics, remarked "HT-001 Presents the first of its kind treatment for cancer patients suffering with skin toxicities associated with EGFR therapies. We are excited to present the groundbreaking case study and interim Phase 2a results. We believe our data highlights HT-001’s strong safety profile and the potential for it to set a new standard of care in this underserved area."

The upcoming event will feature expert commentary from leading derm-oncology and dermatology specialists Jonathan Hale Zippin M.D., Ph.D. and Adam Friedman, M.D., F.A.A.D., who will highlight the urgent clinical need and the promising role of HT-001 in cancer care, including the preliminary data results showing safety and efficacy in the open-label cohort of the ongoing clinical trial for HT-001. Investors will gain an inside look at how HT-001 could reshape the treatment landscape for cancer-related dermatologic side effects and become a prophylactic treatment option used by oncologists prescribing EGFR inhibitors to patients.

In tandem with clinical momentum, Hoth recently received a USPTO Filing Receipt for a new patent application covering HT-001’s unique formulation—further reinforcing its expanding intellectual property portfolio and strategic market protection for this asset.

Key Highlights:

Addressing an unmet need with HT-001
Strong IP strategy underway, expanding protection around HT-001
Compelling mechanism of action to treat EGFR-inhibitor-induced toxicities
Near-term clinical and development milestones to be discussed at the KOL event
The KOL event will also provide an update on Hoth’s pipeline progress, IP strategy, and Phase 2 trial that is underway.

Investors, media, and potential partners along with healthcare professionals are invited to attend this event, information on how to join will be released as we near the event date, June 24, 2025, at 3:30PM EST.

*=View Source,in%20increased%20demand%20for%20chemotherapy.

QureBio Ltd. Completes Nearly CNY 100 Million Series C1 Financing Led by Efung Capital, accelerating clinical progress in global competition for core pipelines

On June 5, 2025 Qure Biotechnology (Shanghai) Co., Ltd. (QureBio) reported that it has completed a Series C1 financing round. The financing raised nearly CNY 100 million (approximately USD 14 million) and was led exclusively by Efung Capital (Press release, QureBio, JUN 5, 2025, View Source [SID1234653745]). This infusion of capital will be used to accelerate QureBio’s clinical trials and advance its pipeline of novel antibody therapeutics.

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Therapeutic Focus and Technology Platforms

QureBio specializes in developing bispecific and multispecific antibody and protein therapeutics to address unmet medical needs in cancer, autoimmune diseases, and inflammatory disorders. The company has established a suite of proprietary technology platforms – including its I2T platform and its T-cell engager and NK-cell engager platforms – which form the foundation for its pipeline of novel drug candidates. Using these platforms, QureBio has built a robust pipeline of therapeutics aimed at previously intractable diseases.

Pipeline Highlights

Key pipeline developments include:

Q-1802 (Claudin18.2/PD-L1 bispecific antibody): Received regulatory clearance to initiate clinical trials in both China and the United States in March 2021. Phase II patient enrollment is nearly complete, and preparations are underway for Phase III clinical trials in China.
Q-1801 (SIRPα/PD-L1 bispecific antibody): Obtained clinical trial approvals in China and the US, and is poised to begin clinical studies.
PD-1 Antibody-Cytokine Fusion Candidate: An innovative fusion protein with dual functions as a PD-1 checkpoint inhibitor and a cytokine modulator, demonstrating a favorable therapeutic window. This candidate targets an area where similar approaches by larger biopharmaceutical companies have faced setbacks, and QureBio is seeking partners to accelerate its global development.
Strategic Partnerships and Industry Recognition

QureBio’s proprietary antibody engineering technology has garnered broad industry recognition. Leveraging its platform capabilities, the company has established collaborations with leading biotechnology and pharmaceutical firms – including BRL Medicine, BioMap, Hengrui Pharma, and Precision Scientific – to co-develop novel therapies. These partnerships underscore QureBio’s status as an emerging leader in innovative biopharmaceuticals.

Highlights in Oral Presentation of Mabwell’s 9MW2821 at 2025 ASCO

On June 5, 2025 Mabwell reported advancement at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago, USA, from May 30 to June 3, the results of the Phase Ib/II clinical study of 9MW2821 in combination with Toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUC) were presented by Prof. Xinan Sheng, Chief Physician of the Department of Urologic Oncology, Beijing Cancer Hospital, on behalf of the research team, with key highlights as below (Press release, Mabwell Biotech, JUN 5, 2025, View Source [SID1234653744]):

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Oral Presentation

Background:

Urothelial carcinoma (UC) is a common malignant tumor worldwide. Global cancer statistics released in 2024 showed that bladder cancer is the ninth most commonly diagnosed cancer in the world, with about 614,000 new cases and 220,000 deaths annually. The burden and morbidity of bladder cancer is significantly higher in men than in women. It is the sixth most common cancer and the ninth leading cause of cancer death in men [1].

9MW2821 (Bulumtatug Fuvedotin, BFv) is a next-generation Nectin-4 targeting antibody-drug conjugate. Previous study of BFv has shown promising efficacy in la/mUC patients who progressed on/after platinum-based chemotherapy and immune checkpoint inhibitors [2]. A pivotal phase 3 study of BFv is ongoing in China (NCT06196736, CTR20234024).

Toripalimab is a novel recombinant humanized anti-PD-1 monoclonal antibody that has been approved in multiple countries including China and the USA.

It is the first time to report in detail on the efficacy and safety of 9MW2821 in combination with Toripalimab in patients with la/mUC.

Method:

This is a phase Ib/II, open-label, multicenter study of BFv and Toripalimab in la/mUC in China. Every 21 days per cycle, patients received BFv (1.0 or 1.25mg/kg, on day 1 and 8) and Toripalimab (240mg, on day 1). Treatment until disease progression or unacceptable toxicity.

Results:

As of Apr. 30, 2025, 52 patients with la/mUC were enrolled. Among the 40 assessable patients (treatment-naive for la/mUC) with the median age of 67, 70% of patients were male, 72.5% had an Eastern Cooperative Oncology Group (ECOG) score of 1, 55% with tumor primary site at upper urinary tract, 15% had liver metastases, 82.5% were Nectin-4 positive and 20% were PD-L1 positive.

The Objective Response Rate (ORR) was 87.5% (95% CI: 73.2, 95.8), confirmed ORR was 80%, complete response (CR) rate was 12.5%, Disease Control Rate (DCR) was 92.5% (95% CI: 79.6, 98.4). 97.5% of assessable patients had tumor reduction, 57.5% of assessable patients had tumor reduction of 50% above.

The ORR in selected subgroups was consistent with results in overall population. Different subgroups of treatment-naive patients could benefit from BFv and Toripalimab regardless of primary tumor site, liver metastasis, expression of Nectin-4 and PD-L1. The ORR was 100% (24/24) in patients older than 65, 94.44% (17/18) in patients with tumor primary site at lower urinary tract, 83.33% (5/6) in patients with liver metastasis, 100% (7/7) in nectin-4 negative patients, and 100% (8/8) in PD-L1 positive patients.

As of April 30, 2025, 45% (18/40) of subjects experienced disease progression or death, with a median progression-free survival (mPFS) of 12.5 months (95% CI: 6.47-NA), and a median duration of response (mDoR) that has not been reached. Median follow-up time was 10.8 months, thus mPFS and mDoR was not mature.

The incidence rate of treatment-related adverse events (TRAE) was 98.1%, and most of the TRAEs were grade 1-2. The incidence rate of TRAEs ≥grade 3 was 42.3%, mainly characterized by neutrophil counts decreased (11.5%), alanine aminotransferase increased (5.8%), and white blood cell decreased (5.8%). The incidence rate of serious TRAEs was 28.8%, and no TRAEs leading to death occurred. BFv and Toripalimab showed well-tolerated safety profile. No new safety signals of BFv or Toripalimab were observed in this study.

Conclusion:

BFv combined with Toripalimab has demonstrated encouraging efficacy and manageable safety profile in la/mUC. Patients with advanced age, liver metastases and negative expression of Nectin-4 also achieved considerable response in this study, suggesting that BFv in combination with Toripalimab may provide a new treatment option for patients with advanced UC who are intolerant of or potentially have a poor prognosis with platinum-based chemotherapy. A pivotal phase 3 study of BFv combined with Toripalimab vs platinum-based chemotherapy is ongoing in China (NCT06592326, CTR20242828).

About 9MW2821

9MW2821 is a novel Nectin-4 targeting ADC, which achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process of Mabwell. It stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. And it’s the first Nectin-4 targeting ADC to disclose clinical efficacy data in cervical, esophageal, and breast cancers. 3 Phase III pivotal clinical trials are ongoing. Its monotherapy and combination therapy with Toripalimab for UC have been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. It has also been granted Fast Track Designations (FTD) for 3 indications and Orphan Drug Designation (ODD) for 1 indication by the U.S. Food and Drug Administration (FDA).