A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

Start Date01 Jan 2030

Sponsor / Collaborator

Lisata Therapeutics, Inc.

NCT07158489

/ Not yet recruitingPhase 2IIT

Protocol SAKK 18/ 25 Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC Progressing on Immune Checkpoint Inhibitors: A Multicenter, Single-arm, Open-label Phase II Trial (ORIGIN2)

This Phase II clinical trial (investigates the efficacy of combining gemcitabine, a chemotherapy agent, with ivonescimab, a bispecific PD-1/VEGF antibody, in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression following chemoimmunotherapy (CIT). Lung cancer remains the leading cause of cancer-related death globally, and treatment options after CIT failure are limited. Gemcitabine has demonstrated immunostimulatory properties, including enhanced T-cell infiltration and reduced immunosuppressive cell populations, which may synergize with immune checkpoint inhibitors. Ivonescimab targets both PD-1 and VEGF pathways, potentially enhancing antitumor immune responses and inhibiting tumor angiogenesis. The trial aims to evaluate the objective response rate (ORR) according to RECIST v1.1 criteria. The combination therapy is expected to offer a novel and effective treatment strategy for patients with relapsed NSCLC, addressing a significant unmet medical need.

Start Date01 Mar 2026

Sponsor / Collaborator-

NCT06998940

/ Not yet recruitingPhase 3IIT

Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil [5-FU] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.

Start Date06 Jan 2026

Sponsor / Collaborator

SWOG

[+1]

100 Clinical Results associated with Gemcitabine Hydrochloride

100 Translational Medicine associated with Gemcitabine Hydrochloride

100 Patents (Medical) associated with Gemcitabine Hydrochloride

15,829

Literatures (Medical) associated with Gemcitabine Hydrochloride

01 Sep 2025·ENVIRONMENTAL POLLUTION

Validation of a large volume-solid phase extraction methodology for biotoxicity assessment of pharmaceuticals in aquatic organisms

Article

Author: Gómez-Canela, Cristian ; Moragrega-Knol, Emma ; Barata, Carlos ; Romero-Alfano, Irene

The growing scarcity of freshwater has intensified the need for alternative water sources, which often require advanced treatments to eliminate contaminants. Among emerging pollutants, pharmaceuticals have become a significant concern due to their persistence and potential impact, making their detection essential. However, analysing these contaminants is challenging due to the extremely low concentrations at which they are present. For chemical analysis, minimal or no sample enrichment is often necessary, while bioanalysis typically requires larger sample volumes and an enrichment factor to conduct comprehensive bioassays across various endpoints. Consequently, sample preconcentration techniques for large water volumes are necessary to improve the sensitivity of subsequent toxicological experiments. In this study, a novel large volume solid-phase extraction (LV-SPE) procedure was validated and evaluated for monitoring multiple pharmaceutical compounds in water samples, while maintaining the traditional solid-phase extraction (SPE) methodology using cartridges. This method proved effective extraction and preconcentration of significant amounts of water, with recoveries between 19 % and 109 % in spiked wastewaters (except for fluvoxamine, remdesivir, tamoxifen and tetracycline, with recoveries <10 %). Furthermore, the optimization of this approach covers an expansive chemical space, enabling the capture of a diverse range of pharmaceutical compounds and enhancing the validity of toxicological studies. Bioassays conducted with Daphnia magna juveniles and Danio rerio embryos validated the method's applicability regarding optimized exposure conditions, the absence of adverse effects from SPE blanks or solvent controls and sensitivity in detecting effects across field samples. Overall, the LV-SPE approach enhances sensitivity and reliability for evaluating pharmaceutical mixtures' risks under realistic conditions.

01 Sep 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Integrated network pharmacology and RNA sequencing analysis to reveal the mechanisms of Qici Sanling decoction in the treatment of gemcitabine resistant bladder cancer

Article

Author: Wang, Wanhui ; You, Bosen ; Geng, Bo ; Zhao, Enyang ; Wang, Jinpeng ; Liu, Weiyang ; Li, Xuedong ; Zhang, Wei ; Li, Zhuolun ; Nan, Yunfeng

Bladder cancer (BCa) is the most prevalent cancer of the urinary system in adults; the prognosis is dismal for BCa treated with gemcitabine (GEM) owing to intrinsic or acquired chemoresistance. This study investigated the potential of Qici Sanling decoction (QCSL), an herbal Chinese medicine, to augment the efficacy of GEM in treating GEM-resistant BCa via network pharmacology and RNA sequencing. We screened 103 active components of QCSL and their 226 targets from the TCMSP database and identified 3985 targets of GEM-resistant BCa via transcriptome sequencing. On the basis of the 69 common targets, a proteinprotein interaction (PPI) network was constructed to identify the top 7 targets. Disease Ontology (DO), Gene Ontology (GO), and Kyoto Encyclopedia of Genes and Genomes (KEGG) functional enrichment analyses were conducted to uncover key pathways. CCK-8 assays, Western blotting, flow cytometry, colony formation, and EdU assays were used to assess the apoptosis and proliferation of GEM-resistant T24 and J82 cells treated with QCSL. The BCa gene set was among the top enriched gene sets in the DO analysis; GO analysis revealed enrichment of 2020 terms linked to GEM resistance, and KEGG analysis revealed 161 enriched signalling pathways. Molecular docking indicated that PTGS2 has high affinity for targets of QCSL components. In vitro experiments demonstrated that cells treated with both QCSL and GEM had significantly reduced viability, increased levels of apoptosis, and decreased proliferative capacity. Thus, QCSL enhances the therapeutic effects of GEM in BCa by promoting cell apoptosis and inhibiting cell proliferation. These findings have significant clinical implications, highlighting a potential combined treatment strategy for GEM-resistant BCa to improve patient outcomes.

01 Sep 2025·BIOMATERIALS

Bioactive polymers as stimulus-responsive anti-metastatic combination agents to treat pancreatic cancer

Article

Author: Sil, Diptesh ; Gendelman, Howard E ; Panja, Sudipta ; Kapoor, Ekta ; Khan, Rubayat I ; Jogdeo, Chinmay M ; Kumari, Neha ; Singh, Amar B ; Ding, Ling ; Siddhanta, Kasturi ; Oupický, David

The intractable and devastating nature of pancreatic ductal adenocarcinoma (PDAC) necessitates an urgent need for novel therapies. This study presents the development of a novel polymer prodrug system for the combination treatment of PDAC, based on an optimized pharmacologically active anti-metastatic macromolecular carrier, PCQ, conjugated with gemcitabine (GEM). Structure-activity relationship evaluations showed that random PCQ copolymers exhibited superior anti-migratory activity compared to the gradient PCQ analogs. GEM was incorporated into the random PCQ copolymers using disulfide linker to prepare a reduction-responsive prodrug, PCQ(r)6-SS-GEM12. The resultant therapeutic system presents a pharmacologically active delivery strategy that targets both the proliferative and the metastatic phenotype in PDAC. The PCQ(r)6-SS-GEM12 prodrug demonstrated a selective release of GEM under the reductive tumor environment leading to a significant inhibition of tumor growth with pronounced anti-metastatic effect. Collectively, our data show that the combination of anti-metastatic PCQ and cytotoxic GEM-based reduction-responsive prodrug polymer offers an innovative strategy to treat PDAC.

772

News (Medical) associated with Gemcitabine Hydrochloride

26 Aug 2025

·ir.immuneering.com

Immuneering Announces Closing of $25 Million Private Placement

CAMBRIDGE, Mass., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, today announced the closing of its previously announced private placement. The private placement was made to top-tier institutional and accredited investors, for total up front gross proceeds of approximately $25 million, before deducting fees and expenses. Immuneering sold: (i) an aggregate of 6,329,113 unregistered shares of the company’s Class A common stock at a purchase price of $3.95 per share (or, for certain investors in lieu of Class A common stock, pre-funded warrants to purchase shares of Class A common stock), and (ii) accompanying purchase warrants to purchase an aggregate of 2,848,096 shares of Class A common stock, with each such warrant representing the right to purchase one share of the company’s Class A common stock at an exercise price of $5.50 per share. The pre-funded warrants were issued for a purchase price equating to $3.949 per pre-funded warrant share (which was the per share purchase price for the Class A common stock less the $0.001 per share unfunded exercise price for each pre-funded warrant). The investors were granted registration rights as part of the transaction. The purchase warrants are exercisable for a period of five years following the date on which the Class A common stock issued and issuable in the transaction are registered for resale. The offer and sale of the securities was made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Leerink Partners acted as a financial advisor to Immuneering for the private placement. This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or other jurisdiction. About Immuneering Corporation Immuneering is a clinical-stage oncology company focused on keeping cancer patients alive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors. Immuneering’s lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of atebimetinib, alone or in combination with other agents, including modified Gemcitabine/nab-paclitaxel (mGnP); and the expected amount and use of proceeds from this financing. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Media Contact: Gina Nugent Gina.nugent.external@immuneering.com Investor Contact: Laurence Watts 619-916-7620 laurence@newstreetir.com

Phase 2

21 Aug 2025

·ir.immuneering.com

Immuneering Announces $25 Million Private Placement

CAMBRIDGE, Mass., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, today announced that it has entered into a definitive securities purchase agreement for a private placement of securities to top-tier institutional and other accredited investors, that is expected to result in up front gross proceeds to the Company of approximately $25 million, before deducting fees and expenses. The closing of the private placement is subject to customary closing conditions and is expected to occur on or about August 26, 2025. “We are excited to announce updated Overall Survival (OS) and Progression-Free Survival (PFS) data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients, planned in the coming weeks. In June, we reported an exceptional 94% OS observed at 6 months in first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP. To put that in perspective, in the pivotal study of standard of care GnP, the 6-month OS was only 67%, and dropped rapidly to only 50% by 8.5 months,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “Our exceptional 6-month overall survival data in first-line pancreatic cancer patients generated strong interest from leading pharmaceutical companies and top-tier investors, including the visionary investors participating in today’s financing. We are developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, which we believe represent an important new way to keep cancer patients alive and help them thrive. The proceeds from this financing will help support our ongoing efforts to bring atebimetinib, our Deep Cyclic Inhibitor of MEK in the MAPK pathway, to as many cancer patients as possible as quickly as possible.” Under the securities purchase agreement, the investors agreed to purchase: (i) an aggregate of 6,329,113 unregistered shares of the company’s Class A common stock at a purchase price of $3.95 per share (or, for certain investors in lieu of Class A common stock, pre-funded warrants to purchase shares of Class A common stock), and (ii) accompanying purchase warrants to purchase an aggregate of 2,848,096 shares of Class A common stock, with each such warrant representing the right to purchase one share of the company’s Class A common stock at an exercise price of $5.50 per share. The pre-funded warrants were issued for a purchase price equating to $3.949 per pre-funded warrant share (which was the per share purchase price for the Class A common stock less the $0.001 per share unfunded exercise price for each pre-funded warrant). The $3.95 per share purchase price for the Company’s Class A common stock represents a premium of approximately 15% as compared to the Company’s last reported closing price on August 20, 2025. The investors will be granted registration rights as part of the transaction. The purchase warrants will be exercisable for a period of five years following the date on which the Class A common stock issued and issuable in the transaction are registered for resale. The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or other jurisdiction. About Immuneering Corporation Immuneering is a clinical-stage oncology company focused on keeping cancer patients alive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors. Immuneering’s lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of atebimetinib, alone or in combination with other agents, including modified Gemcitabine/nab-paclitaxel (mGnP); the expected amount and use of proceeds from this financing; and the timing for release of additional results from the Phase 2a portion of the trial for atebimetinib. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Media Contact: Gina Nugent Gina.nugent.external@immuneering.com Investor Contact: Laurence Watts 619-916-7620 laurence@newstreetir.com

Phase 2Clinical Result

19 Aug 2025

·ir.zailaboratory.com

Zai Lab Announces China National Medical Products Administration Grants Innovative Medical Device Designation for Tumor Treating Fields for Patients with Pancreatic Cancer

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 19, 2025-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the China National Medical Products Administration (NMPA) has granted Innovative Medical Device Designation for Tumor Treating Fields (TTFields) for patients with pancreatic cancer based on the positive results from the Phase 3 PANOVA-3 trial. The Innovative Medical Device Designation allows Zai Lab to take advantage of an expedited approval procedure for TTFields that offers opportunities for the NMPA to prioritize the allocation of review resources to expedite the regulatory review and approval process. “We are excited that TTFields has been granted the Innovative Medical Device Designation, a status that offers expedited registration and priority review by the NMPA. This designation also allows us to submit the application in China before approval in the country of origin,” said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone. We are on track to submit for regulatory approval in China in the second half of 2025 and look forward to collaborating closely with the NMPA throughout the review process.” The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. Zai Lab participated in the study in Greater China (mainland China, Hong Kong, Macau and Taiwan, collectively). In August 2019, the NMPA granted Innovative Medical Device Designation for Optune® in China for the treatment of newly diagnosed and recurrent glioblastoma (GBM). Zai Lab subsequently submitted the regulatory application in September 2019 and received approval in May 2020. Optune is a registered trademark of Novocure GmbH, and Zai Lab markets Optune under license from Novocure GmbH. About PANOVA-3 PANOVA-3 is an international prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of TTFields therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity. The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months. About Pancreatic Cancer in China Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases and 131,203 cancer deaths in 2022, and it is the sixth leading cause of cancer mortality in China1. Pancreatic cancer has a 5-year survival rate of less than 10%, making it the malignancy with the lowest survival rate in China 2. The patients with locally advanced, unresectable pancreatic cancer are no longer operable, so chemotherapy with or without radiation is the only treatment option, with a median overall survival only nine to twelve months. 1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590. 2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol 2021; 27: 4298-4321. About Tumor Treating Fields Tumor Treating Fields (TTFields) is a cancer therapy that uses electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibitors, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about TTFields therapy and its multifaceted effects on cancer cells, visit tumortreatingfields.com. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global. Zai Lab Forward-Looking Statements This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for developing and commercializing TTFields therapy, the potential benefits of TTFields therapy, and the potential treatment of pancreatic cancer. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov. View source version on businesswire.com: https://www.businesswire.com/news/home/20250819525540/en/ For more information, please contact: Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Source: Zai Lab Limited

Phase 3Clinical Result

100 Deals associated with Gemcitabine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01155	Gemcitabine Hydrochloride	L01BC05	DB00441

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Pancreatic Adenocarcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
metastatic non-small cell lung cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Pancreatic adenocarcinoma metastatic	Australia	Sandoz Pty Ltd.	02 Dec 2008
Recurrent ovarian cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Transitional Cell Carcinoma	Japan	Eli Lilly & Co.	25 Nov 2008
Bladder Cancer	Brazil	Libbs Farmacêutica Ltda.	26 May 2008
Biliary Tract Neoplasms	Japan	Eli Lilly & Co.	31 Aug 2001
Lymphoma	Japan	Eli Lilly & Co.	31 Aug 2001
Ovarian Cancer	Japan	Eli Lilly & Co.	31 Aug 2001
Breast Cancer	United States	Eli Lilly & Co.	15 May 1996
Metastatic breast cancer	United States	Eli Lilly & Co.	15 May 1996
Non-Small Cell Lung Cancer	United States	Eli Lilly & Co.	15 May 1996
Pancreatic adenocarcinoma	United States	Eli Lilly & Co.	15 May 1996
Pancreatic Cancer	United States	Eli Lilly & Co.	15 May 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	NDA/BLA	United States	Johnson & Johnson (China) Investment Ltd.	15 Jan 2025
Advanced biliary tract cancer	Phase 3	Taiwan Province	InnoPharmax, Inc.	01 Jul 2025
Recurrent Bladder Cancer	Phase 3	United States	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	China	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Japan	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Argentina	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Belgium	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Brazil	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	France	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Germany	Janssen Research & Development LLC	09 Apr 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03579771 (NEO-GAP, CTgov)	Phase 2	Intrahepatic Cholangiocarcinoma	30	Nab-paclitaxel+Gemcitabine+cisplatin	ltdbnzmohp = ydlmgnulob hxcizsemgo (exffcwrfna, gthymleewp - sdrnrgroxn) View more	-	15 Aug 2025
NCT03739619 (CTgov)	Phase 1/2	Relapsing classical Hodgkin lymphoma \| Refractory Hodgkin Lymphoma \| Classical Hodgkin's Lymphoma ... View more	3	Nivolumab+bendamustine+Gemcitabine	vktxquvyof = fmibjmgtqz nslzhibfes (ihlvmtlerf, kwvyyhrgtf - elttaayytn) View more	-	06 Aug 2025
NCT03697564 (CTgov)	Phase 2	Pancreatic adenocarcinoma \| Pancreatic Cancer	2	Cabiralizumab+Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]+Gemcitabine	tiykudknbz = utqhcruemh fskrqmrlrz (ixighlrgez, jdyfzlnrqw - vkpznedhio) View more	-	06 Aug 2025
NCT04640623 (SunRISe-1, Pubmed \| J Clin Oncol)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	208	TAR-200 plus cetrelimab	rlbclbdlrf(pyojyboicb) = ogzowipclu zymaqpmnme (hyvaqbiavj, 72.6 - 89.8) View more	Positive	30 Jul 2025
				TAR-200 monotherapy	rlbclbdlrf(pyojyboicb) = kftnjfklkn zymaqpmnme (hyvaqbiavj, 53.7 - 80.1) View more
NCT03366415 (Pubmed \| JAMA Oncol) Manual	Phase 3	Nasopharyngeal Carcinoma	420	Gemcitabine + cisplatin (SCRT group)	rwsvhuorpo(anelnilvun) = harcfcxeqw vynumcrceu (phxbrpvgjn, 78.6 - 88.8)	Non-inferior	24 Jul 2025
				GemcitabineGemcitabine + cisplatin (IC plus CCRT group)	rwsvhuorpo(anelnilvun) = vozycbmknh vynumcrceu (phxbrpvgjn, 74.0 - 85.0)
NCT02539537 (PRODIGE 29-UCGI 26 (NEOPAN), Pubmed \| J Clin Oncol)	Phase 3	Pancreatic Cancer	-	FOLFIRINOX	etvxtekaoi(wrzipwzqnd) = nvqcgjhsgf rokuidmkaj (qkjqolgeqp, 7.0 - 11.7) View more	Positive	10 Jul 2025
				Gemcitabine	etvxtekaoi(wrzipwzqnd) = ahnzgariqc rokuidmkaj (qkjqolgeqp, 6.2 - 9.2) View more
NCT05497778 (COMBAT-PC, ESMO_GI2025) Manual	Phase 1	Pancreatic Cancer	17	Lixumistat 400 malbumin-bound paclitaxelIV gemcitabine (Gem) (1000 mg/m²) + Lixumistatticle albumin-bound paclitaxel (NP) (125 mg/m²) and IV gemcitabine (Gem) (1000 mg/m²)	hwyjpbtzze(pkonfuaysn) = pthvmgxgrp cdqcgebyis (mdozwoexxj ) View more	Positive	03 Jul 2025
				LixumistatLixumistat 800 mg QDalbumin-bound paclitaxelIV gemcitabine (Gem) (1000 mg/m²) + LixumistatLixumistat 800 mg QDalbumin-bound paclitaxel (NP) (125 mg/m²) and IV gemcitabine (Gem) (1000 mg/m²)	nqfvaughvj(dtyarwenkn) = cbwjoffoqg olvakgvjgj (evyiqytwzh )
iLSTA (ESMO_GI2025 \| Company_Website) Manual	Phase 1/2	Advanced Pancreatic Ductal Adenocarcinoma First line	30	GemcitabineGemcitabine + nab-paclitaxel + LSTA-1 + Durvalumab OR gemcitabine + nab-paclitaxel+placebo LSTA-1+ placebo durvalumab OR gemcitabinedurvalumab OR gemcitabine+ nab-paclitaxel+ activeo LSTA-1+placebo LSTA-1LSTA-1+ placebo durvalumab	nvchoeseht(aufcvhbyja) = qmffpjacjq soybwyzcgf (avyoaiqtzf ) View more	Positive	03 Jul 2025
				gemcitabine+ nab-paclitaxel+ activeo LSTA-1+placebo LSTA-1+ placebo durvalumab (Cohort 2)	lgzonpqnvr(cmoapvbjrx) = hqwjbigaiv ogbyrpteom (gupcvpmcrp )
NCT03260712 (ESMO_GI2025) Manual	Phase 2	Advanced biliary tract cancer First line	50	Cisplatin/gemcitabine + Pembrolizumab	onxxnqfiwv(tnxjbsixkc) = ssmesryfua jvzdgpympv (zelbsvgzpi, 52 - 70) View more	Positive	03 Jul 2025
				CisplatinCisplatin/gemcitabine + Pembrolizumab (AJCC Stage II/III)	oakbicycxk(yzufdcnrsb) = pxbfchaduo hcuhwxgbgb (ajbsdnsmib, 8.3 - NE) View more
TriNetX Global Collaborative Network (ESMO_GI2025)	Not Applicable	Pancreatic Cancer Second line	1,520	Nanoliposomal irinotecan plus fluorouracil (NI)	xtrwkokevc(lpwaodxoba) = ianioscdio tqdddaggbc (sqxgklzmbz )	Negative	03 Jul 2025
				Fluoropyrimidine-based chemotherapy plus oxaliplatin (OF)	xtrwkokevc(lpwaodxoba) = ucsupeqztm tqdddaggbc (sqxgklzmbz )

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