RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Priority Review (China), Breakthrough Therapy (China), Accelerated assessment (United States), Conditional marketing approval (China)

Structure/Sequence

Molecular FormulaC29H35ClFN7O3

InChIKeyBTMKEDDEMKKSEF-QGZVFWFLSA-N

CAS Registry2370013-12-8

Clinical Trials associated with Sunvozertinib

NCT07182682

/ Not yet recruitingPhase 3

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Anti-Tumor Efficacy and Safety of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery (WU-KONG16)

To assess the efficacy and safety of sunvozertinib versus placebo as adjuvant therapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) or P-loop and αC-helix compression (PACC) mutations, who have had radical surgery, regardless of adjuvant chemotherapy.

Start Date01 Oct 2025

Sponsor / Collaborator

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

NCT07079475

/ Not yet recruitingPhase 1/2

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)

This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment

Start Date01 Aug 2025

Sponsor / Collaborator

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

NCT06864624

/ RecruitingPhase 2IIT

Sunvozertinib as Neoadjuvant and Adjuvant Therapy in Stage II-IIIB Non-small-cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutation: a Single-arm, Phase 2 Study (WU-KONG20)

This is a single-arm, phase 2 study to investigate the efficacy and safety of sunvozertinib as neoadjuvant and adjuvant treatment for stage II-IIIB non-small-cell lung cancer patients with EGFR exon20 insertion mutation.

Start Date18 Feb 2025

Sponsor / Collaborator

Tangdu Hospital

[+1]

100 Clinical Results associated with Sunvozertinib

100 Translational Medicine associated with Sunvozertinib

100 Patents (Medical) associated with Sunvozertinib

Literatures (Medical) associated with Sunvozertinib

01 Oct 2025·CANCER LETTERS

Efficacy and safety of sunvozertinib monotherapy as first-line treatment in NSCLC patients with EGFR exon 20 insertion mutations: A phase 2, single-center trial

Article

Author: Lang, Hongli ; Gao, Xiaoxing ; Zhao, Jing ; Zhong, Wei ; Chen, Minjiang ; Yip, Chingwan ; Wang, Mengzhao ; Xu, Yan ; Wang, Mei ; Liu, Xiaoyan

Currently, no chemotherapy-free therapy is approved for the first-line treatment of non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (exon20ins). Sunvozertinib is an oral EGFR tyrosine kinase inhibitor, which has been approved in China for ≥ second-line EGFR exon20ins NSCLC. We conducted a multi-group phase 2 study of sunvozertinib, WU-KONG15 (NCT05559645), to explore its antitumor efficacy in treatment-naïve EGFR exon20ins NSCLC (Group 4). Sunvozertinib was administered at 200 mg once daily (QD). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), duration of response (DoR), overall survival (OS), and safety. Exploratory endpoints included circulating tumor DNA (ctDNA) biomarkers. As of January 15, 2025, 26 treatment-naïve patients with EGFR exon20ins NSCLC were enrolled and included in the efficacy analysis set. The median PFS was 10.1 months (95 % CI: 6.2, 13.9), with confirmed ORR of 73.1 % (95 % CI: 52.2, 88.4) and median DoR of 10.5 months (95 % CI: 7.2, 21.2). The estimated median OS was 23.1 months (95 % CI: 13.1, NE). A total of 99 patients were included in the safety analysis set. The median relative dose intensity was 98.2 %. The incidence of Grade ≥3 treatment-related adverse events was 35.4 %, including blood creatine phosphokinase increased (10.1 %), diarrhoea (8.1 %) and anaemia (8.1 %). Negativity of plasma EGFR exon20ins ctDNA correlated with better tumor response. In conclusion, sunvozertinib monotherapy demonstrated significant and durable antitumor efficacy and was well-tolerated in treatment-naïve patients with EGFR exon20ins NSCLC, suggesting its potential as a favorable first-line treatment option.

12 Sep 2025·Med

Current paradigm of EGFR^ins20 in non-small cell lung cancer: A long way forward.

Review

Author: Shrestha, Sagun ; Salgia, Ravi ; Reyes, Amanda ; Pisick, Evan ; Nguyen, Danny ; Arias-Romero, Javier ; Cadman, Karla ; Miyamura, Beatriz Viesser ; Malhotra, Jyoti ; Fricke, Jeremy ; Mambetsariev, Isa

EGFR^ins20 alterations are detected in 5% to 12% of the EGFR mutated subgroup in advanced non-small cell lung cancer. Historically, these alterations have been correlated with worse prognosis among the common EGFR mutation subtypes, which largely respond only to chemotherapy. The availability of new targeted therapies with EGFR^ins20 activity has transformed the precision medicine landscape for patients, with improved outcomes and survival. Previous clinical trials evaluating EGFR holistic targeted therapies, such as erlotinib, gefitinib, and osimertinib, in EGFR^ins20 patients have all failed, requiring a realignment of EGFR^ins20 therapeutic drug development. New clinical trial data on EGFR^ins20-specific targeted therapies have led to US Food and Drug Administration (FDA) approval of amivantamab-vmjw and accelerated FDA approval of sunvozertinib, with more clinical trial drugs currently under investigation. Next-generation sequencing (NGS) testing, including liquid biopsy, should be prioritized to differentiate patients with this subtype and consider the individual EGFR^ins20 variants that may respond differently to available therapeutics.

09 Sep 2025·JOURNAL OF CLINICAL ONCOLOGY

Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B).

Article

Author: Di Noia, Vincenzo ; Felip, Enriqueta ; Shim, Byoung-Yong ; Yang, James Chih-Hsin ; Bosch-Barrera, Joaquim ; Joaquin, Andres Barba ; Carcereny, Enric ; Parra, Hector Soto ; Hinojal, Gonzalo Fernández ; Tiseo, Marcello ; Lee, Dae Ho ; Le, Xiuning ; Bazhenova, Lyudmila ; Mazieres, Julien ; Cobo Dols, Manuel Angel ; Memmott, Regan M ; Fan, Yun ; Streich, Guillermo ; Yang, Tsung-Ying ; D'Arcangelo, Manolo ; Sun, Meili ; Brungs, Daniel ; Pellini, Bruna ; Liu, Geoffrey ; Jaime, Jesus Corral ; Antonuzzo, Lorenzo ; de Castro Carpeno, Javier ; Luo, Yung-Hung ; Li, Xingya ; Jänne, Pasi A ; Greillier, Laurent ; Hu, Ying ; Hong, Qunying ; Doucet, Ludovic ; Wang, Mengzhao ; Huang, Dingzhi ; Lv, Dongqing ; Rodriguez, Luis Paz-Ares ; Fang, Jian ; Planchard, David ; John, Thomas ; Ghiringhelli, François ; Zalcman, Gerard ; Kim, Yu Jung ; Han, Ji-Youn ; Shum, Elaine ; Bearz, Alessandra ; Zheng, Li

PURPOSE:

WU-KONG1B (ClinicalTrials.gov identifier: NCT03974022) is a multinational phase II, dose-randomized study to assess the antitumor efficacy of sunvozertinib in pretreated patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).

METHODS:

Eligible patients with advanced-stage EGFR exon20ins NSCLC were randomly assigned by 1:1 ratio to receive sunvozertinib 200 mg or 300 mg once daily (200 and 300 mg-rand cohorts). After predefined interim analysis, additional patients were enrolled and treated with the 300 mg dose once daily. The primary end point was blinded independent review committee (IRC)-assessed confirmed objective response rate (cORR), and the key secondary end point was duration of response (DoR).

RESULTS:

Among 85, 89, and 107 efficacy-evaluable patients in 200 mg-rand, 300 mg-rand, and 300 mg-all (including randomly assigned and nonrandomized patients) cohorts, the cORRs were 45.9% (97.5% CI, 33.6% to 58.5%), 47.2% (97.5% CI, 35.1% to 59.5%), and 45.8% (97.5% CI, 34.8% to 57.0%), respectively, per IRC assessment. The predefined null hypothesis was rejected with statistical significance (P < .0001). Comparing 300 and 200 mg-rand cohorts, higher cORRs were observed in patients with baseline brain metastasis (52.4% v 28.6%) and previous amivantamab treatment (41.7% v 25%), as well as longer DoR (13.8 v 11.1 months). At 200 and 300 mg once daily, the most common treatment-related adverse events with grade ≥3 included diarrhea (2.2% v 18%), blood creatine phosphokinase increased (6.6% v 12.6%), and anemia (4.4% v 6.3%).

CONCLUSION:

Sunvozertinib is efficacious at both 200 and 300 mg once daily in treating platinum-pretreated patients with advanced EGFR exon20ins NSCLC. The treatment-related adverse events of sunvozertinib were consistent with an EGFR tyrosine kinase inhibitor, with a more favorable safety profile at 200 mg than 300 mg once daily.

News (Medical) associated with Sunvozertinib

09 Sep 2025

·www.prnewswire.com

Dizal Showcases Robust Portfolio of Lung Cancer Studies at 2025 WCLC

SHANGHAI, Sept. 9, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced the presentation of new findings on its leading assets, ZEGFROVY® (sunvozertinib) and golidocitinib, in non-small cell lung cancer (NSCLC) at the 2025 World Conference on Lung Cancer (WCLC), held September 6–9 in Barcelona, Spain. ZEGFROVY: Targeting EGFR exon20ins and a wide spectrum of EGFR mutations The latest data from the multinational pivotal WU-KONG1 Part B (WU-KONG1B) study for ZEGFROVY were presented in an oral session at the conference and simultaneously published in the Journal of Clinical Oncology. Based on results from WU-KONG1B, ZEGFROVY received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2025 as the only targeted oral therapy for NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). ZEGFROVY demonstrated a favorable benefit/risk profile in patients with platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The study showed robust and durable antitumor activity with a manageable safety profile. (#MA08.01). In addition to the oral presentation, multiple studies of ZEGFROVY were presented at the WCLC, highlighting its potential across a broad range of NSCLC patients, including those with EGFR exon20ins across all lines of therapy, uncommon EGFR and HER2 mutations, EGFR-sensitive mutation and co-mutations, and EGFR mutations resistant to EGFR TKIs. Both monotherapy and combination regimens were evaluated. In EGFR exon20ins NSCLC, ZEGFROVY demonstrated promising antitumor efficacy and a tolerable safety profile across first- and second- line, as well as adjuvant and neoadjuvant treatment settings. ZEGFROVY combined with anlotinib achieved an objective response rate (ORR) of over 80% and a disease control rate (DCR) of 100% in treatment-naïve EGFR exon20ins NSCLC (#P3.12.43). In previously treated patients, ZEGFROVY combined with bevacizumab achieved a DCR of 100%, with target tumor lesion shrinkage observed in 85.7% of patients. With a median follow-up of 15.2 months, the median duration of response (DoR) was 19.1 months, and three patients (3/14) remained in response at the data cut-off (#P2.10.13). Real-world cases supported the potential of ZEGFROVY in early- and advanced- stage NSCLC patients with EGFR exon20ins. As a neoadjuvant therapy, ZEGFROVY showed encouraging clinical benefit, with all 3 patients achieving an obvious partial response (PR) before surgery. (#EP.07.49). In the adjuvant setting, ZEGFROVY showed sustained efficacy and tolerable safety profiles, helping patients successfully pass the 1-year after surgery, a peak period for disease recurrence (#EP.07.55). In the first-line maintenance setting, ZEGFROVY showed sustained efficacy and safety in lung adenocarcinoma patients who were intolerant to immunotherapy and chemotherapy (#EP.12.47). In NSCLC patients harboring uncommon EGFR mutations, ZEGFROVY combined with anlotinib demonstrated promising efficacy, including one patient who achieved complete remission of intracranial lesions (#P3.12.43). In a separate real-world case series, ZEGFROVY exhibited clinical efficacy in advanced NSCLC with HER2 exon20ins, with tumor shrinkage obviously observed post-prior treatment failures (#EP.12.46). In treatment-naïve NSCLC patients with EGFR-sensitive mutation and co-mutations, ZEGFROVY in combination with anlotinib achieved an ORR of 77.8% and a DCR of 100% (#P3.12.22). In NSCLC patients with EGFR mutations who failed prior EGFR-TKI therapies, ZEGFROVY, both as monotherapy (#EP.12.43) and in combination with chemotherapy (#P3.12.47), was well tolerated and demonstrated encouraging antitumor activity. Golidocitinib: Janus kinase 1 (JAK1) only inhibitor Plus Anti-PD-1 in Anti-PD-1 Treated Advanced NSCLC Resistance to first-line immune checkpoint inhibitors (ICIs) in non-small cell lung cancer (NSCLC) leads to limited treatment options and poor prognosis. Preclinical and early clinical data have shown synergistic effects between JAK inhibitors and anti-PD-1, suggesting a promising therapeutic strategy in this population. Golidocitinib in combination with anti-PD-1 was being evaluated in immune-resistant NSCLC patients. The study showed a well-tolerated profile, with no DLTs observed in the dose-escalation phase. Ongoing enrollment and data collection will provide deeper insights into clinical utility of golidocitinib (#P1.11.74). Dr. Xiaolin Zhang, CEO of Dizal, remarked, "Dizal is advancing therapies for patients with NSCLC across EGFR exon 20 insertion, uncommon and EGFR-sensitizing mutations to address significant unmet medical needs. Through scientific innovation, we aim to deliver safe, effective and transformative treatments to patients worldwide." - End - About ZEGFROVY®(sunvozertinib) ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The China approval is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication. In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. WU-KONG28, a phase III, multinational, randomized study assessing ZEGFROVY as a first-line treatment for patients with EGFR exon20ins NSCLC, has completed enrollment across 16 countries and regions. Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology. About golidocitinib (DZD4205) Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4). About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with multiple assets in global pivotal studies and two leading assets: ZEGFROVY, approved in both the U.S. and China, and golidocitinib, approved in China. To learn more about Dizal, please visit , or follow us on Linkedin or X. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. Contacts Investor Relations: [email protected] Business Development: [email protected] Media Contact: [email protected] SOURCE Dizal Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3ImmunotherapyDrug ApprovalPriority Review

08 Aug 2025

·www.prnewswire.com

July in Review: 13 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including FDA approval for Aktiia's cuffless blood pressure monitor, Cochlear's new smart cochlear implant system and Varda's $187M Series C funding for space medicine. NEW YORK, Aug. 8, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, July 2025. Photos provided by Cochlear North America, Varda Space Industries Inc. and Aktiia. Lorient Closes $500 Million Fund III to Scale Founder-Led Healthcare Companies Lorient partners with founder-led healthcare companies in the middle market, bringing sector expertise, hands-on operational capabilities, and a repeatable approach to scaling mission-driven businesses. The firm has built a track record of supporting improvements in clinical outcomes, workforce efficiency, and access to care across the U.S. healthcare system. Medicare Drug Pricing Changes Threaten Patient Access to Life-Saving Treatments The brief highlights concerns that the next round of negotiations under the Inflation Reduction Act may unintentionally restrict access to vital medications for Medicare patients. The Centers for Medicare & Medicaid Services' upcoming drug price negotiation program, which includes medications covered by Medicare Part B, would take effect in 2028. OpenEvidence, the Fastest-Growing Application for Physicians in History, Announces $210 Million Round at $3.5 Billion Valuation OpenEvidence rapidly surfaces relevant medical knowledge, synthesizes medical research, and gives clinicians the power to make faster, more evidence-based decisions—accelerating both medical literature review and clinical decision support. By reducing the lag between new evidence and bedside application, OpenEvidence enables improved patient outcomes. Dizal's ZEGFROVY® (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations "We are proud to have developed ZEGFROVY, a first-in-class oral therapy that offers a more effective treatment option with enhanced safety and ease of administration for NSCLC patients with EGFR exon20ins," said Dr. Xiaolin Zhang, CEO of Dizal. Former Sandoz Inc. CEO Don DeGolyer Leads PharmaTech Startup Ategenos as Company Prepares Public Launch Ategenos has been quietly developing a novel platform that integrates pharmaceutical science with real-time digital health technologies to address adherence in critical dose management. The company will share details on its SmartPatch platform and initial partnerships in the coming weeks. The Villages Health ("TVH") Announces Strategic Restructuring and Agreement to be Acquired by CenterWell "Under CenterWell, this healthcare system will continue to be a leading provider of patient-centered, primary care-driven and community-based healthcare. Our primary goal remains to keep our patients healthy and to heal them quickly, as it has always been from the inception of TVH," said Dr. Elliot Sussman, Chairman of the Board and physician founder of The Villages Health. Cochlear Launches World's First and Only Smart Cochlear Implant System This new firmware update pathway will enhance recipients' sound processor upgrades to deliver their best possible hearing experience, giving recipients more ways to access new innovations over time. It is also the first implant with internal memory, which enables unique hearing settings (MAPs) to be securely stored in the implant itself which can be easily transferred to any Nucleus Nexa Sound Processor in the future. Zimmer Biomet Announces Definitive Agreement to Acquire Monogram Technologies, Expanding Robotics Suite with Autonomous Solutions Monogram's semi- and fully autonomous robotic technologies are expected to add new and differentiated capabilities to expand Zimmer Biomet's flagship ROSA® Robotics platform and broad suite of navigation and enabling technologies. Monogram has developed a CT-based, semi-autonomous, AI-navigated total knee arthroplasty (TKA) robotic technology, which received FDA 510(k) clearance in March 2025 and is expected to be commercialized with Zimmer Biomet implants in early 2027. Aktiia's Hilo Band Becomes First Cuffless Blood Pressure Monitor Cleared by FDA for Over-the-Counter Use The milestone sets a new global benchmark for how blood pressure can be effortlessly monitored through wearable, user-friendly technology. With this FDA clearance, Aktiia is now positioned to establish Hilo as the category-defining wearable for cuffless blood pressure monitoring in the U.S. and beyond. Hengrui Pharma and GSK enter agreements to develop up to 12 innovative medicines across Respiratory, Immunology & Inflammation and Oncology The benefits from GSK's therapy area expertise, deep understanding of disease biology, clinical development capability and global commercial scale with Hengrui Pharma's early discovery engine, platform technologies, extensive pre-clinical pipeline of high-value programs and speed of clinical evaluation. Varda Announces $187 million in Series C Funding to Make Medicines in Space Varda's orbital laboratories are the first to process materials outside the International Space Station and mark the beginnings of commercial expansion into low Earth orbit. Due to the lack of gravity, materials such as the active pharmaceutical ingredients in medicines crystallize differently than they would on Earth, creating novel drug formulations that would otherwise be impossible. Waystar to Acquire Iodine Software, Accelerating the AI-Powered Transformation of Healthcare Payments The proposed transaction is expected to accelerate Waystar's ability to transform healthcare payments through its leading cloud-based software platform, empowering more than one million providers with advanced AI capabilities to prevent denials, reduce manual work, and improve financial performance. Waters and BD's Biosciences & Diagnostic Solutions Business to Combine, Creating a Life Science and Diagnostics Leader Focused on Regulated, High-Volume Testing The combined company will continue to operate under the Waters name and retain its listing on the New York Stock Exchange under the ticker symbol WAT. Waters' headquarters will remain in Milford, Mass., and the combined company will maintain a significant presence where the BD Biosciences & Diagnostic Solutions business currently operates. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics Among the health news that was distributed in July, the PR Newswire team was able spot several larger stories that highlight the trends shaping the industry. OBBA: The passage of the One Big Beautiful Bill Act (OBBBA) saw health providers and advocacy groups responding with both concern and praise. Shatterproof, a non-profit dedicated to reducing the burden of substance use disorder in the U.S., found itself on both sides of the bill in its statement applauding the inclusion of the permanent closure of the de minimis loophole, while also being "deeply concerned about the bill's potential impact on access to treatment for individuals living with substance use disorder (SUD)." ENDO 2025: The Endocrine Society's annual meeting took place in San Francisco July 12-15 and drew over 7,000 attendees, nearly 2,500 abstracts and over 200 other sessions. Tyra Biosciences announced details of its abstract to be presented at the meeting. Neurocrine Biosciences sent several ENDO-related announcements, including its presentation of one-year data showing the efficacy of CRENESSITY® (crinecerfont) in adults. To support this, Neurocrine presented data from the CAHtalog® Registry that showed patients are still exposed to excess glucocorticoids and often do not meet clinical targets, which underscores an unmet need that could be filled by CRENESSITY®. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. For more news like this, check out all of the latest health-related releases from PR Newswire. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

10 Jul 2025

·www.fiercepharma.com

Fierce Pharma Asia—Approvals for Innovent, Dizal; BMS partner's bispecific ADC readout

Regulatory approvals for Innovent Biologics and Dizal, and a positive phase 3 readout for Biokin's Bristol Myers Squibb-partnered bispecific ADC made our news this week. In the past two weeks, China approved a first-in-class weight loss drug that Innovent Biologics licensed from Eli Lilly, Dizal won an FDA approval for a challenger to Johnson & Johnson's Rybrevant, while Biokin said a China phase 3 trial of its Bristol Myers Squibb-partnered bispecific antibody-drug conjugate has met a primary endpoint. And more.1. With China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugsChina has approved Innovent Biologics’ mazdutide as the world’s first dual GLP-1/glucagon receptor agonist for chronic weight management. Innovent obtained Chinese rights to the drug from Eli Lilly in 2019. In a Chinese phase 3 trial in patients who were overweight or obese, mazdutide 6mg achieved 14.8% average weight loss at 48 weeks, compared with just 0.5% for placebo.2. Dizal to challenge J&J with FDA approval for lung cancer drug ZegfrovyAstraZeneca spinout Dizal Pharmaceuticals won an FDA accelerated approval for sunvozertinib for previously treated EGFR ex 20-mutated non-small cell lung cancer. To be marketed as Zegfrovy, the oral drug will compete with Johnson & Johnson’s infused Rybrevant, which recently moved into the first-line setting as part of a chemotherapy combination.3. Biokin, having landed BMS deal, posts ph. 3 cancer win for bispecific ADCA phase 3 trial of Biokin’s bispecific antibody-drug conjugate, iza-bren, has hit at least one primary endpoint. The Chinese phase 3 is testing the EGFRxHER3 ADC in pre-treated nasopharyngeal carcinoma with objective response rate and overall survival as the primary endpoints. Bristol Myers Squibb owns ex-China rights to the drug after paying $800 million upfront.4. Roche’s Chugai inks $250M Gero deal to access age-related disease targetsIn a deal potentially worth $250 million, Roche’s Chugai Pharmaceutical is tapping Gero’s AI-based platform to develop antibodies against age-related diseases. Singapore-based Gero will identify therapeutic targets, while Chugai will utilize its antibody engineering technologies. The Japanese company will hold worldwide rights to drugs born from the collaboration.5. Alphabet's Calico stitches $596M deal for Mabwell's anti-aging assetIn another pact around age-related diseases, Alphabet’s Calico Life Sciences is licensing Mabwell Bioscience’s investigational IL-11-directed therapeutics. The deal includes $25 million upfront and up to $571 million in biobucks. It covers 9MW3811, which is in phase 1 trials across China and Australia, as the Chinese biotech highlights the drug’s potential in idiopathic pulmonary fibrosis. 6. Torrent Pharma shells out $1.4B to take over controlling stake in India's JB Pharma from KKRTorrent Pharma has obtained a 46.39% stake in India’s J.B. Chemicals and Pharmaceuticals from private equity firm KKR for 119 billion rupees ($1.4 billion). Torrent can further purchase another 25% of J.B.’s shares from public shareholders. J.B.’s offerings include some hypertension and eye disease brands and CDMO services.7. Taiho’s DMD asset fails to improve functional motor test results in phase 3 trialTaiho Pharmaceutical’s Duchenne muscular dystrophy candidate pizuglanstat failed to better placebo in a phase 3 study. In ambulatory patients, the oral drug failed to show a significant difference in time to rise from the floor after one year of treatment. Another cohort, conducted in non-ambulatory patients, has also been discontinued.8. Shionogi puts more than $600M on the table for Swiss biotech's antibiotic programShionogi is paying about $6.3 million upfront and up to $604 million in milestones for a preclinical antibiotic asset from BioVersys. The candidate, coded BV500, belongs to the antibiotic class of ansamycin and is being developed for nontuberculous mycobacterial infections.Other News of Note: 9. China approves 4 new drugs, including a global first-in-class medicine10. Cell therapy biotech shares first clinical data for in vivo CAR-T that attracted $1B AstraZeneca acquisition11. Novo keeps China manufacturing investments rolling with $112M for new quality testing lab in Tianjin12. Pressuring Merck's Gardasil, China's home-made 9-valent HPV vaccine priced at 60% discount13. Southwest Airlines sues dozens of generic drugmakers for alleged price-fixing scheme14. Biotech VC raises $200M to focus on Japan’s ‘untapped source’ of innovation15. Pfizer, Astellas boost case for Xtandi in early-stage prostate cancer with combo survival win16. Fujifilm Biotechnologies takes lessons from Denmark as debut of massive NC cell culture facility looms17. Fosun's Henlius pens $202M pact for regional rights to HanchorBio's phase 2 CD47 blocker18. US lawmakers refresh scrutiny over GenScript's ties to China (Reuters)19. Takeda survey finds colon cancer patients feel unheard by HCPs, want more info on diagnosis, treatment20. CStone out-licenses PD-L1 inhibitor’s certain European rights to Gentili (release)

Drug ApprovalPhase 3Phase 2Clinical ResultPhase 1

100 Deals associated with Sunvozertinib

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
EGFR ex20ins mutation in non-small cell lung cancer	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	22 Aug 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-small cell lung cancer stage I	Phase 3	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	01 Oct 2025
Non-small cell lung cancer stage IIIA	Phase 3	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	01 Oct 2025
Non-small cell lung cancer stage IIIB	Phase 2	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	18 Feb 2025
Non-squamous non-small cell lung cancer	Phase 2	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	15 Feb 2023
HER2 mutant non-small cell lung cancer	Phase 2	United States	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	10 Jan 2023
HER2 mutant non-small cell lung cancer	Phase 2	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	10 Jan 2023
HER2 mutant non-small cell lung cancer	Phase 2	Taiwan Province	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	10 Jan 2023
metastatic non-small cell lung cancer	Phase 2	United States	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	10 Jan 2023
metastatic non-small cell lung cancer	Phase 2	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	10 Jan 2023
metastatic non-small cell lung cancer	Phase 2	Taiwan Province	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	10 Jan 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03974022 (WU-KONG1 Part B, WCLC2025)	Phase 2	Non-Small Cell Lung Cancer Second line EGFR exon 20 insertion mutations	184	Sunvozertinib 200 mg	dyoguhmwhw(dlyioaxncq) = fsufezgecv tnznvfstdz (mukopcnnjp, 33.6 - 58.5) View more	Positive	09 Sep 2025
NCT03974022 (WU-KONG1 Part B, WCLC2025)	Phase 2		184	Sunvozertinib 300 mg	dyoguhmwhw(dlyioaxncq) = vuhfwooexf tnznvfstdz (mukopcnnjp, 35.1 - 59.5) View more	Positive	09 Sep 2025
NCT06348927 (WUKONG32, WCLC2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line EGFR sensitive mutation (Ex19del, L858R)	16	Sunvozertinib+Anlotinib	mzwreydwqh(ysencbsosb) = kcubchbkha dktfzxwawd (fcgqmbsdxm ) View more	Positive	09 Sep 2025
NCT06195189 (WUKONG36, WCLC2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma Third line \| Second line EGFR sensitive mutation (Ex19del, L858R)	9	Sunvozertinib+Platinum containing dual drug chemotherapy	lbjuakjwpj(xhishpbicm) = rmfqtxqnxb dbbleiyuus (tffhuddttp ) View more	Positive	09 Sep 2025
NCT06276283 (WU-KONG29, WCLC2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma Second line EGFR ex20ins mutation	19	bevacizumab+Sunvozertinib (previously treated patients with EGFRm NSCLC)	cfhnhmnbtg(wsyykbtxjw) = xcnvyorswa ozcehntgft (wuyamwoxcn ) View more	Positive	08 Sep 2025
NCT06276283 (WU-KONG29, WCLC2025)	Phase 2		19	bevacizumab+Sunvozertinib (patients with baseline brain metastasis)	raquabzjhx(qqtfkgqwnz) = wpxlfvifhb vyukryjdwa (avdtjnfpuz ) View more	Positive	08 Sep 2025
NCT03974022 (WU-KONG1B, FDA \| FDA_CDER) Manual	Phase 1/2	EGFR ex20ins mutation in non-small cell lung cancer EGFR Exon 20 Insertion	85	Sunvozertinib 200 mg	zeswqhbasx(sbhksupsbu) = mohlqnfdtb jpeubwlrpl (hucfpdsvec, 35 - 57) View more	Positive	02 Jul 2025
NCT06182761 (WUKONG9, ESMO_ELCC2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR sensitizing mutations	45	Sunvozertinib 300 mg + Anlotinib 12 mg	mbdkyzdygz(kcziytrukk) = yfvyyrodkp nrfpigllwr (ebxpanbayu ) View more	Positive	26 Mar 2025
NCT05559645 \| NCT03974022 \| CTR20192097 (WU-KONG15, Pubmed) Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	40	Sunvozertinib	pirmtzhmcx(dntvitysel) = wxdqshzfdx zeaqtzhfcv (tmxxxmixwc ) View more	Positive	02 Dec 2024
NCT03974022 (WU-KONG1B, ESMO2024) Manual	Phase 2	EGFR ex20ins mutation in non-small cell lung cancer Second line EGFR Exon 20 Mutation	107	Sunvozertinib 300 mg	kgnwqarhgk(alntdinkov) = qaxvhxxcpf ucwnnlzfcd (fnlpyzprzb )	Positive	14 Sep 2024
NCT03974022 (WU-KONG1B, PRNewswire) Manual	Phase 2	Non-Small Cell Lung Cancer EGFR Exon 20 Insertion	111	舒沃哲 300mg	jlaiwcutxw(ysmfriokdw) = ourfswnkky yyvpxdmyts (whtfbocmfi ) View more	Positive	02 Jun 2024
WU-KONG (ASCO2024) Manual	Phase 1/2	EGFR ex20ins mutation in non-small cell lung cancer EGFR Exon 20 Insertion	121	Sunvozertinib	xgaidsdlsj(wuufglopgs) = bkrmxuoals sipgmslqyl (rnqpuztxer ) View more	Positive	24 May 2024
WU-KONG (ASCO2024) Manual	Phase 1/2		121	sunvozertinib	xgaidsdlsj(wuufglopgs) = obdzrabbxv sipgmslqyl (rnqpuztxer ) View more	Positive	24 May 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis