A single-centre, non-randomised, single-arm clinical study: evaluating the efficacy and safety of radiotherapy in combination with ripretinib for unresectable advanced GIST

Start Date01 Apr 2024

Sponsor / Collaborator

The Second Affiliated Hospital of Chongqing Medical University

NCT05734105 / RecruitingPhase 3

An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated With Imatinib

This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.

Start Date13 Dec 2023

Sponsor / Collaborator

Deciphera Pharmaceuticals, Inc.

NCT05957367 / RecruitingPhase 1/2

A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies

This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of DCC-3116 in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of DCC-3116 with other anticancer agents.

Start Date28 Sep 2023

Sponsor / Collaborator

Deciphera Pharmaceuticals, Inc.

100 Clinical Results associated with Ripretinib

100 Translational Medicine associated with Ripretinib

100 Patents (Medical) associated with Ripretinib

113

Literatures (Medical) associated with Ripretinib

01 May 2024·Anti-cancer agents in medicinal chemistry

An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021)

Review

Author: Gupta, Ghanshyam Das ; Jain, Ankit ; Vishakha, S ; Verma, Sant Kumar ; Navneesh, N ; Patel, Preeti ; Kurmi, Balak Das

Abstract::

New drugs being established in the market every year produce specified structures for selective biological targeting. With medicinal insights into molecular recognition, these begot molecules open new rooms for designing potential new drug molecules. In this review, we report the compilation and analysis of a total of 56 drugs including 33 organic small molecules (Mobocertinib, Infigratinib, Sotorasib, Trilaciclib, Umbralisib, Tepotinib, Relugolix, Pralsetinib, Decitabine, Ripretinib, Selpercatinib, Capmatinib, Pemigatinib, Tucatinib, Selumetinib, Tazemetostat, Avapritinib, Zanubrutinib, Entrectinib, Pexidartinib, Darolutamide, Selinexor, Alpelisib, Erdafitinib, Gilteritinib, Larotrectinib, Glasdegib, Lorlatinib, Talazoparib, Dacomitinib, Duvelisib, Ivosidenib, Apalutamide), 6 metal complexes (Edotreotide Gallium Ga-68, fluoroestradiol F-18, Cu 64 dotatate, Gallium 68 PSMA-11, Piflufolastat F-18, 177Lu (lutetium)), 16 macromolecules as monoclonal antibody conjugates (Brentuximabvedotin, Amivantamab-vmjw, Loncastuximabtesirine, Dostarlimab, Margetuximab, Naxitamab, Belantamabmafodotin, Tafasitamab, Inebilizumab, SacituzumabGovitecan, Isatuximab, Trastuzumab, Enfortumabvedotin, Polatuzumab, Cemiplimab, Mogamulizumab) and 1 peptide enzyme (Erwiniachrysanthemi-derived asparaginase) approved by the U.S. FDA between 2018 to 2021. These drugs act as anticancer agents against various cancer types, especially non-small cell lung, lymphoma, breast, prostate, multiple myeloma, neuroendocrine tumor, cervical, bladder, cholangiocarcinoma, myeloid leukemia, gastrointestinal, neuroblastoma, thyroid, epithelioid and cutaneous squamous cell carcinoma. The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.

01 Jan 2024·European journal of cancer (Oxford, England : 1990)

Efficacy and safety of ripretinib vs. sunitinib in patients with advanced gastrointestinal stromal tumor previously treated with imatinib: A phase 2, multicenter, randomized, open-label study in China

Article

Author: Fang, Yong ; Dong, Juan ; Qu, Hongyan ; Shen, Lin ; Ye, Yingjiang ; Liang, Bin ; Cai, Zhaolun ; Zhou, Yongjian ; Zhang, Xinhua ; Lei, Cheng ; Wu, Xin ; Tan, Ming ; Jin, Jiejie ; Wang, Haijiang ; Wang, Ming ; Zhang, Nan ; Li, Yong ; Zhang, Bo ; Zhou, Ye ; Ling, Jiayu ; Liu, Zhuo ; Huang, Zhao ; Zheng, Hualong ; Zhang, Jun ; Zhang, Peng ; Li, Jian ; Qiu, Haibo ; Zhou, Yanbing ; Zhang, Yanqiao ; Jiao, Xuelong ; Tao, Kaixiong ; Wu, Xingye ; Ma, Yue ; Zhu, Yuping ; Shen, Kuntang ; Peng, Zhangyan

AIM:

A bridging study of INTRIGUE study to assess the efficacy and safety of ripretinib versus sunitinib as second-line treatment in Chinese GIST patients.

METHODS:

This was a phase 2, multicenter, randomized, open-label study in China. GIST patients previously treated with imatinib were randomized (1:1) to receive ripretinib 150 mg once daily (QD) by continuous dosing in 42-day cycles or sunitinib 50 mg QD in 42-day cycles (four weeks on/two weeks off). Primary endpoint was progression-free survival (PFS) by independent radiological review (IRR).

RESULTS:

Between 6 December 2020 and 15 September 2021, 108 patients were randomized to receive ripretinib (n = 54) or sunitinib (n = 54) (all-patient [AP] intention-to-treat [ITT] population). Seventy patients had primary KIT exon 11 mutations (ripretinib, n = 35; sunitinib, n = 35; Ex11 ITT population). By data cut-off (20 July 2022), in AP ITT population, PFS by IRR was comparable between ripretinib and sunitinib arms (HR 0·99, 95 % CI 0·57, 1·69; nominal p = 0·92; median PFS [mPFS] 10·3 vs 8·3 months). In Ex11 ITT population, PFS by IRR was longer for ripretinib than sunitinib (HR 0·46, 95 % CI 0·23, 0·92; nominal p = 0·03; mPFS not reached in ripretinib arm and 4·9 months in sunitinib arm). Fewer patients experienced grade 3/4 treatment-related treatment-emergent adverse events with ripretinib (17%) versus sunitinib (56%).

CONCLUSIONS:

Ripretinib demonstrated similar efficacy and a favorable safety profile versus sunitinib as second-line treatment in Chinese GIST patients. Furthermore, ripretinib provided greater clinically meaningful benefit versus sunitinib in patients with KIT exon 11 mutation.

01 Jan 2024·Journal of the Chinese Medical Association : JCMA

Major adverse cardiovascular events of vascular endothelial growth factor tyrosine kinase inhibitors among patients with different malignancy: A systemic review and network meta-analysis

Review

Author: Hsieh, Fang-I ; Chen, Jin-Hua ; Chen, Yen-Chou

Background::

Vascular endothelial growth factor tyrosine kinase inhibitors (VEGF-TKIs) are a common cancer treatment. However, the pharmacologic characteristics of VEGF-TKIs may influence cardiovascular risks. The relative risks of major adverse cardiovascular events (MACEs) associated with VEGF-TKIs are poorly understood.

Methods::

We searched PubMed, Embase, and ClinicalTrials.gov from inception until August 31, 2021, for phase II/III randomized controlled trials of 11 VEGF-TKIs (axitinib, cabozantinib, lenvatinib, pazopanib, ponatinib, ripretinib, regorafenib, sorafenib, sunitinib, tivozanib, and vandetanib). The endpoints were heart failure, thromboembolism, and cardiovascular death. The Mantel-Haenszel method was used to calculate the risk of VEGF-TKI among users by comparing it to nonusers. Pairwise meta-analyses with a random-effects model were used to estimate the risks of the various VEGF-TKIs. We estimated ranked probability with a P-score and assessed credibility using the Confidence in Network Meta-Analysis framework.

Results::

We identified 69 trials involving 30 180 patients with cancer. The highest risk of MACEs was associated with high-potency tivazonib (odds ratio [OR]: 3.34), lenvatinib (OR: 3.26), and axitinib (OR: 2.04), followed by low-potency pazopanib (OR: 1.79), sorafenib (OR: 1.77), and sunitinib (OR: 1.66). The risk of heart failure significantly increased in association with less-selective sorafenib (OR: 3.53), pazopanib (OR: 3.10), and sunitinib (OR: 2.65). The risk of thromboembolism significantly increased in association with nonselective lenvatinib (OR: 3.12), sorafenib (OR: 1.54), and sunitinib (OR: 1.53). Higher potency (tivozanib, axitinib) and lower selectivity (sorafenib, vandetanib, pazopanib, sunitinib) were associated with a higher probability of heart failure. Low selectivity (lenvatinib, cabozantinib, sorafenib, sunitinib) was associated with a higher probability of thromboembolism.

Conclusion::

Higher-potency and lower-selectivity VEGF-TKIs may influence the risks of MACEs, heart failure, and thromboembolism. These findings may facilitate evidence-based decision-making in clinical practice.

News (Medical) associated with Ripretinib

03 Jun 2024

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Deciphera Pharmaceuticals Announces Oral Presentation of Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) at the 2024 ASCO Annual Meeting and Online Publication in The Lancet

– MOTION Phase 3 Data Demonstrate Robust Efficacy, Clinically Meaningful Improvements in Quality-of-Life Measures, and Well-Tolerated Safety Profile, Positioning Vimseltinib as Potential New TGCT Treatment – – Company Expects to Submit a New Drug Application (NDA) in the Second Quarter of 2024 and Marketing Authorisation Application (MAA) in the Third Quarter of 2024 – WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals LLC, (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced that results from the Company’s MOTION pivotal Phase 3 study of vimseltinib in patients with TGCT are being highlighted in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois, and have been published in The Lancet. The article titled “Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a randomised phase 3 trial” is now available online and will be published in a future print issue of The Lancet. “The results from the MOTION pivotal Phase 3 study provide compelling evidence that vimseltinib can address the unmet medical need in TGCT for an effective and well-tolerated therapy without cholestatic hepatotoxicity,” said Hans Gelderblom, M.D., Ph.D., Chair of the Department of Medical Oncology at Leiden University Medical Center and senior author of the manuscript. “In addition to its robust antitumor activity and tolerability, vimseltinib also demonstrated clinically significant functional and symptomatic improvements in key quality-of-life measures, which can provide long-term, meaningful benefits to TGCT patients.” “Building upon the strong efficacy results disclosed previously at topline, we are excited to share details on the statistically significant and clinically meaningful improvements that vimseltinib offered TGCT patients across all six key secondary endpoints, along with its favorable safety profile,” said Matthew L. Sherman, M.D., Executive Vice President and Chief Medical Officer of Deciphera. “We remain on track to submit an NDA for vimseltinib in the second quarter of 2024, and an MAA in the third quarter of 2024, and look forward to bringing this important new therapy to TGCT patients globally.” In addition to the results from the MOTION pivotal Phase 3 study, the Company will also be presenting a trial-in-progress poster for the ongoing Phase 1/2 study of DCC-3116 in combination with ripretinib at the 2024 ASCO Annual Meeting. Both presentations are available on the Company’s website at . Presentation details are as follows: Abstract Number: 11500 Title: Efficacy, safety, and patient-reported outcomes of vimseltinib in patients with tenosynovial giant cell tumor: Results from the phase 3 MOTION trial. Presenter: William D. Tap, M.D., FASCO, Memorial Sloan Kettering Cancer Center Presentation Date: Monday, June 3, 2024 Presentation Time: 3:00 – 3:12 PM CT Key Highlights: Study Design: The MOTION pivotal Phase 3 study is a two-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed). In Part 1, patients (n=123) were randomized two-to-one to receive either 30 mg twice weekly of vimseltinib (n=83) or placebo (n=40) for 24 weeks. The results for Part 1 of the study are based on a data cutoff date of August 22, 2023. The open-label Part 2 portion of MOTION, in which patients from both the vimseltinib and placebo arms receive treatment with vimseltinib, remains ongoing. ORR: The primary endpoint of the study is ORR at Week 25 as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent radiologic review (IRR). The study met its primary endpoint in the intent-to-treat (ITT) population demonstrating statistically significant and clinically meaningful improvement versus placebo in ORR at Week 25 based on IRR per RECIST v1.1. In the ITT population, the ORR at Week 25 was 40% (95% CI: 29%, 51%) for the vimseltinib arm and 0% (95% CI: 0%, 9%) for the placebo arm resulting in a response difference (vimseltinib versus placebo) of 40% (95% CI: 29%, 51%) (p<0.0001). Secondary Endpoints: In addition to meeting the primary endpoint, the study also achieved statistically significant and clinically meaningful improvements versus placebo in all six key secondary endpoints assessed at Week 25 including ORR by tumor volume score (TVS), active range of motion (ROM), physical function, stiffness, quality of life, and pain. ORR by TVS: The ORR at Week 25 based on IRR per TVS was 67% (95% CI: 56%, 77%) for the vimseltinib arm and 0% (95% CI: 0%, 9%) for the placebo arm (p<0.0001). Active ROM: Treatment with vimseltinib demonstrated an improvement in mean change from baseline in active ROM at Week 25 of 18.4% versus a 3.8% improvement for placebo (p=0.0077). Physical Function by PROMIS-PF: Treatment with vimseltinib demonstrated an improvement in mean change from baseline in PROMIS-PF at Week 25 of 4.6 versus 1.3 for placebo (p=0.0007). Worst Stiffness Numeric Rating Scale (NRS): Patients treated with vimseltinib reported a decrease of 2.1 versus 0.3 for placebo in worst stiffness (p<0.0001). Quality of Life by EuroQol Visual Analogue Scale (EQ-VAS): The mean change from baseline for EQ-VAS was significantly higher with 13.5 in the vimseltinib arm versus 6.1 in the placebo arm (p=0.016). Brief Pain Inventory (BPI) Worst Pain Response Rate: The BPI worst pain response rate was 48% for patients receiving vimseltinib versus 23% for placebo (p=0.0056). Safety and Tolerability: Vimseltinib was well tolerated with most treatment-emergent adverse events (TEAEs) were grade 1 or 2. There was no evidence of cholestatic hepatotoxicity, drug-induced liver injury, or hair hypopigmentation. Serum enzyme elevations were consistent with the known mechanism of action of CSF1R inhibitors. TEAEs leading to treatment discontinuation was 6% in the vimseltinib arm. If approved, vimseltinib offers an effective systemic treatment to patients with TGCT and provides proven functional health and symptomatic benefit to a population living with substantial morbidity and limited treatment options. Abstract Number: TPS11587 Title: DCC-3116 in combination with ripretinib for patients with advanced gastrointestinal stromal tumor: A phase 1/2 study. Presenter: Sreenivasa Chandana, M.D., Ph.D., START Midwest, The Cancer & Hematology Centers Session Date: Saturday, June 1, 2024 Session Time: 1:30 – 4:30 PM CT Key Highlights: This is a phase 1/2, multicenter study designed to evaluate the safety, tolerability, and efficacy of DCC-3116 in combination with ripretinib. In Part 1, eligible patients will receive escalating oral doses of DCC-3116 combined with ripretinib 150 mg once daily (QD); the safety will be evaluated and the recommended phase 2 dose (RP2D) will be determined. In Part 2, eligible patients will receive the RP2D of DCC-3116 in combination with ripretinib 150 mg QD; antitumor activity will be evaluated. The trial is currently enrolling in the phase 1 dose escalation portion. About Deciphera Pharmaceuticals Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s switch-control inhibitor for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Iceland, Israel, Liechtenstein, Macau, New Zealand, Norway, Singapore, Switzerland, Taiwan, The United Kingdom, and the United States. For more information, visit and follow us on LinkedIn and X (@Deciphera). Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations and timing regarding the potential for our preclinical and/or clinical stage pipeline assets to be first-in-class and/or best-in-class treatments, the timing of our NDA and MAA submissions for vimseltinib, and plans to present trial-in-progress poster for the ongoing Phase 1/2 study of DCC-3116 in combination with ripretinib at the 2024 ASCO Annual Meeting. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: (i) risks associated with the timing of the closing of the proposed transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed transaction will not occur; (ii) uncertainties as to how many of Deciphera’s stockholders will tender their shares in the offer; (iii) the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; (iv) the possibility that competing offers will be made; (v) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; (vi) unanticipated difficulties or expenditures relating to the proposed transaction, the response of business partners and competitors to the announcement of the proposed transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction; (vii) Deciphera’s ability to successfully demonstrate the efficacy and safety of its drug or drug candidates, and the preclinical or clinical results for its product candidates, which may not support further development of such product candidates; (viii) comments, feedback and actions of regulatory agencies; (ix) Deciphera’s ability to commercialize QINLOCK® and execute on its marketing plans for any drugs or indications that may be approved in the future; (x) the inherent uncertainty in estimates of patient populations, competition from other products, Deciphera’s ability to obtain and maintain reimbursement for any approved product and the extent to which patient assistance programs are utilized; and (xi) other risks identified in our Securities and Exchange Commission (SEC) filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. The Deciphera logo and the QINLOCK® word mark and logo are registered trademarks and the Deciphera word mark is a trademark of Deciphera Pharmaceuticals, LLC.

Clinical ResultPhase 3Phase 1ASCODrug Approval

08 May 2024

·www.biospace.com

Zai Lab Announces First Quarter 2024 Financial Results and Recent Corporate Updates

Net product revenue of $87.1 million for the first quarter of 2024, representing 39% y-o-y growth; 43% y-o-y growth at constant exchange rate (CER) VYVGART® (efgartigimod alfa injection) sales of $13.2 million for the first quarter of 2024, driven by increased patient access; an estimated 2,700 new patients were treated with VYVGART in the first quarter of 2024 Regulatory reviews ongoing for sulbactam-durlobactam for ABC, efgartigimod SC for gMG, and repotrectinib for ROS1+ NSCLC; sBLA submitted for efgartigimod SC in CIDP Strong balance sheet with a cash position1 of $750.8 million as of March 31, 2024, compared to $806.5 million as of December 31, 2023 Company to host conference call and webcast on May 9, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the first quarter of 2024, along with recent product highlights and corporate updates. “Our first quarter results demonstrate strong commercial execution and pipeline progress across our potential first- and best-in-class product portfolio,” said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. “The launch of VYVGART is off to an impressive start with $13.2 million of sales in the first quarter. Looking ahead, we expect to accelerate commercial performance for the remainder of the year and are preparing for three new potential launches in 2024. We are also excited by the progress of our late-stage pipeline and we are on track to achieve the objectives outlined in our five-year strategic plan, including significant revenue growth and profitability by the end of 2025.” “Our net revenues grew 39% y-o-y or 43% y-o-y at CER in the first quarter, driven by strong execution with the launch of VYVGART and uptake of our existing portfolio,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “With VYVGART’s launch in gMG at the end of last year, and multiple new products and indications expected to launch over the near-term, we are now entering a period of robust growth for Zai Lab. Our significant growth, coupled with our focus on driving efficiencies and productivity across the organization, will drive the evolution of Zai Lab into a profitable, high growth business by the end of 2025. Furthermore, we will continue to focus on expanding our global portfolio through our internal discovery activities and strategic business development,” Mr. Smiley concluded. First-Quarter 2024 Financial Results Product revenue was $87.1 million in the first quarter of 2024, compared to $62.8 million for the same period in 2023, representing 39% y-o-y growth and 43% y-o-y growth at CER. This increase was primarily driven by increased sales volumes, including from the launch of VYVGART last September and decreased sales rebates to distributors resulting from price reductions in connection with listings on China’s National Reimbursement Drug List (NRDL) for certain products. This revenue growth included the following: ZEJULA®: $45.5 million in the first quarter of 2024, an increase of 7% y-o-y from $42.7 million for the same period in 2023, driven by increased hospital sales in first-line ovarian cancer and increased duration of treatment and supported by the renewal of ZEJULA’s NRDL listing for the maintenance treatment of adult patients with first-line and recurrent ovarian cancer, effective January 1, 2024. VYVGART®: $13.2 million in the first quarter of 2024, compared to nil for the same period in 2023, driven by positive physician and patient reception as well as increased patient access as VYVGART is added to hospital formularies. VYVGART was launched for the treatment of generalized myasthenia gravis (gMG) in September 2023 and was subsequently included for first-time NRDL listing effective, January 1, 2024. OPTUNE (Tumor Treating Fields): $12.5 million in the first quarter of 2024, a decrease of 6% y-o-y from $13.3 million for the same period in 2023. Although revenue declined y-o-y for OPTUNE, it increased 49% versus the fourth quarter of 2023, with continued recovery of patient volume expected throughout 2024. QINLOCK®: $6.1 million in the first quarter of 2024, an increase of 367% y-o-y from $1.3 million for the same period in 2023, driven by its inclusion in the NRDL in the first quarter of 2023 for the fourth-line treatment of advanced gastrointestinal stromal tumors (GIST). NUZYRA®: $9.9 million in the first quarter of 2024, an increase of 81% y-o-y from $5.5 million for the same period in 2023, driven by the NRDL listings for the IV formulation of NUZYRA for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in the first quarter of 2023 and the oral formulation for these indications in the first quarter of 2024. Research and Development (R&D) expenses were $54.6 million in the first quarter of 2024, compared to $48.5 million for the same period in 2023. This increase was primarily due to increased clinical trial expenses related to newly initiated studies and progress of existing studies, partially offset by a decrease in milestone fees for our licensed products. Selling, General and Administrative expenses were $69.2 million in the first quarter of 2024, compared to $62.5 million for the same period in 2023. This increase was primarily driven by higher general selling expenses and headcount growth associated with the VYVGART launch. Net loss was $53.5 million in the first quarter of 2024, or a loss per ordinary share attributable to common stockholders of $0.05 (or loss per American Deposit Share (ADS) of $0.55), compared to a net loss of $49.1 million for the same period in 2023, or a loss per ordinary share of $0.05 (or loss per ADS of $0.51). Cash and cash equivalents, short-term investments, and current restricted cash totaled $750.8 million as of March 31, 2024, compared to $806.5 million as of December 31, 2023. Corporate Update In April 2024, Andrew Zhu joined Zai Lab as our Chief Commercial Officer in Greater China2. Mr. Zhu’s rich experience in building innovative business models and resource integration will help us further enhance our commercial operations and drive sales and profit growth across Greater China. He joins us from Simcere Zaiming, where he most recently served as Chief Operating Officer responsible for the commercial and pharmaceutical business. He previously served in various operational, sales, and marketing leadership roles at leading global biopharmaceutical companies, including AstraZeneca, Roche, Sanofi, and Bristol Myers Squibb (BMS). Recent Pipeline Highlights Below are key product updates since our last earnings release: Oncology Pipeline Tumor Treating Fields: In March 2024, Zai Lab partner Novocure announced positive topline results from the Phase 3 METIS clinical trial for brain metastases from non-small cell lung cancer (NSCLC). The primary endpoint was met with Tumor Treating Fields therapy and supportive care demonstrating a significant improvement in time to intracranial progression versus supportive care alone (21.9 months median versus 11.3 months, respectively). These results will be presented as a late-breaking abstract at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 3. We are participating in the Greater China portion of the METIS trial. Bemarituzumab (FGFR2b): We are enrolling patients in Greater China for the global Phase 3 FORTITUDE-101 and FORTITUDE-102 studies: FORTITUDE-101 is a Phase 3 study of bemarituzumab plus chemotherapy in first-line gastric cancer. FORTITUDE-102 is a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in first-line gastric cancer. Tisotumab Vedotin (Tissue Factor ADC): In April 2024, Zai Lab partner Pfizer Inc. and Genmab A/S announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) granting full approval for tisotumab vedotin (or TIVDAK®) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. We are participating in the global Phase 3 innovaTV 301 trial and extension study in Greater China. Adagrasib (KRASG12C): We are evaluating the clinical data of the global Phase 3 KRYSTAL-12 study evaluating adagrasib in previously treated patients with KRASG12C-mutated NSCLC as we decide on next steps in the development of this product across indications. ZL-1310 (DLL3 ADC): In March 2024, Zai Lab presented findings from preclinical studies highlighting the therapeutic potential of ZL-1310 at the European Lung Cancer Congress (ELCC) 2024. We are enrolling patients in the United States and Greater China in the global Phase 1 study in relapsed and refractory second-line+ small cell lung cancer (SCLC) who have progressed after platinum-based treatment. ZL-1218 (CCR8): We are enrolling patients in the United States, Europe, and Greater China in the global Phase 1 study of ZL-1218 as a single agent and in combination with pembrolizumab in patients with advanced solid tumor malignancies. Autoimmune Disorders, Infectious Disease, and Neuroscience Pipeline Efgartigimod (FcRn): In April 2024, Zai Lab submitted an sBLA for efgartigimod SC for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) to the National Medical Products Administration (NMPA). Xanomeline-Trospium (or KarXT) (M1/M4-agonist): In April 2024, Zai Lab partner BMS presented new interim long-term data from the Phase 3 EMERGENT program at the Annual Congress of the Schizophrenia International Research Society (SIRS). In the new interim analysis of long-term efficacy data from the Phase 3 EMERGENT-4 open-label extension trial, KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks. In the new pooled interim long-term safety and metabolic outcomes from the Phase 3 EMERGENT-4 and EMERGENT-5 trials, KarXT demonstrated a favorable long-term metabolic pro most patients experienced stability or improvements on metabolic parameters over 52 weeks of treatment. We are enrolling patients in a registrational bridging study in mainland China. Anticipated Major Milestones in 2024 Oncology Repotrectinib Potential NMPA approval of our NDA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. Tumor Treating Fields Zai Lab to submit a Marketing Authorization Application (MAA) to the NMPA in second-line+ NSCLC, following progression on or after platinum-based therapy. Novocure to provide a topline data readout from the Phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer in the fourth quarter of 2024. We are participating in the study in Greater China. ZL-1310 (DLL3 ADC) Potential dose escalation data from the global Phase 1 study in relapsed and refractory second-line+ SCLC at the end of 2024 or early 2025. Neuroscience, Autoimmune Disorders, and Infectious Diseases (NSAiID) Efgartigimod (FcRn) Potential NMPA approval of the BLA for efgartigimod SC for gMG. We plan to join in the registrational study of efgartigimod SC in Thyroid Eye Disease (TED) in Greater China in the second half of 2024. Sulbactam-Durlobactam (SUL-DUR) Potential NMPA approval of our NDA for infections caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (ABC). Xanomeline-Trospium (KarXT) (M1/M4-agonist) Zai Lab to complete patient enrollment in the China bridging study in schizophrenia. Zai Lab to join the global Phase 3 ADEPT-2 and ADEPT-3 studies in Alzheimer’s disease with psychosis in Greater China in mid-year. BMS to report data from the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety for treatment of schizophrenia in the second half of 2024. ZL-1102 (IL-17 Humabody®) Zai Lab to initiate a global Phase 2 study in mild-to-moderate chronic plaque psoriasis in the second quarter of 2024. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast tomorrow, May 9, 2024, at 8:00 a.m. ET (8:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at . Participants must register in advance of the conference call. Details are as follows: Registration Link: All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company's website. About Zai Lab Zai Lab (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, autoimmune disorders, infectious diseases, and neuroscience. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit or follow us at . Non-GAAP Measures In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars, which are non-GAAP measures. We believe that these non-GAAP measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on trends. Although we believe the non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to accompanying GAAP financial measures. Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our strategy and plans; potential of and expectations for our business and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our future financial and operating results; and financial guidance, including with respect to our planned sources and uses of cash and our expected path to profitability. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by 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 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. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by 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 our 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 and on the SEC’s website at . 1 Cash position includes cash and cash equivalents, current restricted cash, and short-term investments. 2 Mainland China, Hong Kong, Macau, and Taiwan (collectively, Greater China). Zai Lab Limited Unaudited Condensed Consolidated Balance Sheets (in thousands of U.S. dollars ($), except for number of shares and per share data) March 31, 2024 December 31, 2023 Assets Current assets Cash and cash equivalents 650,780 790,151 Restricted cash, current 100,000 — Short-term investments — 16,300 Accounts receivable (net of allowance for credit losses of $18 and $17 as of March 31, 2024 and December 31, 2023, respectively) 60,422 59,199 Notes receivable 15,363 6,134 Inventories, net 37,851 44,827 Prepayments and other current assets 24,224 22,995 Total current assets 888,640 939,606 Restricted cash, non-current 1,114 1,113 Long term investments 14,109 9,220 Prepayments for equipment 89 111 Property and equipment, net 52,386 53,734 Operating lease right-of-use assets 15,187 14,844 Land use rights, net 3,034 3,069 Intangible assets, net 12,398 13,389 Long-term deposits 1,480 1,209 Total assets 988,437 1,036,295 Liabilities and shareholders’ equity Current liabilities Accounts payable 88,121 112,991 Current operating lease liabilities 7,536 7,104 Short-term debts 48,273 — Other current liabilities 48,176 82,972 Total current liabilities 192,106 203,067 Deferred income 26,297 28,738 Non-current operating lease liabilities 7,540 8,047 Other non-current liabilities 325 325 Total liabilities 226,268 240,177 Commitments and contingencies Shareholders’ equity Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 978,197,710 and 977,151,270 shares issued as of March 31, 2024 and December 31, 2023, respectively; 973,285,510 and 972,239,070 shares outstanding as of March 31, 2024 and December 31, 2023, respectively) 6 6 Additional paid-in capital 2,993,282 2,975,302 Accumulated deficit (2,249,451 ) (2,195,980 ) Accumulated other comprehensive income 39,168 37,626 Treasury Stock (at cost, 4,912,200 shares as of both March 31, 2024 and December 31, 2023) (20,836 ) (20,836 ) Total shareholders’ equity 762,169 796,118 Total liabilities and shareholders’ equity 988,437 1,036,295 Zai Lab Limited Unaudited Condensed Consolidated Statements of Operations (in thousands of $, except for number of shares and per share data) Three Months Ended March 31, 2024 2023 Revenue 87,149 62,797 Expenses Cost of sales (33,619 ) (21,337 ) Research and development (54,645 ) (48,472 ) Selling, general, and administrative (69,194 ) (62,510 ) Loss from operations (70,309 ) (69,522 ) Interest income 9,658 10,232 Interest expenses (113 ) — Foreign currency (losses) gains (2,068 ) 8,912 Other income, net 9,361 1,234 Loss before income tax (53,471 ) (49,144 ) Income tax expense — — Net loss (53,471 ) (49,144 ) Loss per share - basic and diluted (0.05 ) (0.05 ) Weighted-average shares used in calculating net loss per ordinary share - basic and diluted 973,145,760 961,444,780 Zai Lab Limited Unaudited condensed consolidated statements of comprehensive loss (in thousands of $) Three Months Ended March 31, 2024 2023 Net loss (53,471 ) (49,144 ) Other comprehensive income, net of tax of nil: Foreign currency translation adjustments 1,542 (8,413 ) Comprehensive loss (51,929 ) (57,557 ) Zai Lab Limited Non-GAAP Measures (in thousands of $) Three Months Ended March 31, Year over Year % Growth 2024 2023 As reported At CER* Revenue 87,149 62,797 39 % 43 % Loss from operations (70,309 ) (69,522 ) 1 % 3 % * The growth rates at CER were calculated assuming the same foreign currency exchange rates were in effect for the current and prior year periods.

Phase 1Phase 3Financial StatementClinical ResultPhase 2

03 May 2024

·www.fiercepharma.com

Fierce Pharma Asia—Ono buys Deciphera for $2.4B; Novartis expands PeptiDream collab; WuXi Bio exits BIO 2024

Ono's $2.4 billion acquisition of Deciphera, Novartis' new radioligand therapy deal with PeptiDream, and WuXi Biologics' withdrawal from BIO 2024 made our news this week. Japan's Ono Pharmaceutical will buy kinase inhibitor expert Deciphera for $2.4 billion. Novartis invests further in radiopharmaceuticals with two deals. WuXi Biologics has withdrawn from the 2024 BIO International Convention as the U.S. grows hostile against certain Chinese biotech companies. And more. 1. Japan's Ono pays $2.4B for Qinlock maker Deciphera as biotech readies another approval run Ono Pharmaceutical, which sells the PD-1 inhibitor Opdivo in Japan, is buying Deciphera Pharmaceuticals for $2.4 billion. Besides the FDA-approved gastrointestinal stromal tumor drug Qinlock, Deciphera comes with a kinase inhibitor discovery platform. Ono also expects the acquisition to accelerate its business development in the U.S. and Europe, CEO Gyo Sagara said. 2. Novartis pays PeptiDream $180M as radiopharma big bang continues Novartis made two radiopharmaceutical deals this week. It penned a $180 million peptide-drug conjugate deal with Japan’s PeptiDream. The deal includes up to $2.71 billion in potential milestones. PeptiDream will develop macrocyclic peptides against targets selected by Novartis for conjugation with radionuclides. In the second deal, Novartis agreed to acquire Mariana Oncology for $1 billion upfront. 3. WuXi Biologics withdraws from 2024 BIO convention amid worsening geopolitical tensions WuXi Biologics has pulled out of the 2024 BIO International Convention. Both WuXi Bio and WuXi AppTec will be absent from the biotech event of the year, despite consistently having a presence there in the past few years. Their absence comes amid a U.S. biosecurity crackdown targeting certain Chinese drug manufacturers and service providers. 4. Takeda ditches industry trade group BIO following exits by WuXi AppTec, Pfizer and UCB Meanwhile, Takeda has left the Biotechnology Innovation Organization (BIO). “We believe it will allow us to further refine the focus of our resources and continue to play an active role in advancing innovation and advocating for policies that put patients first while improving the global health care ecosystem,” a Takeda spokesperson said in a statement. 5. AstraZeneca, Daiichi tout Enhertu trial win in earlier, broader HER2-low breast cancer AstraZeneca and Daiichi Sankyo said their Enhertu has beat chemotherapy on progression-free survival in HR-positive, HER2-low metastatic breast cancer patients who had tried at least one prior line of endocrine therapy. The readout came from the phase 3 DESTINY-Breast06 trial, which could potentially move the antibody-drug conjugate one line earlier and to HER2-ultralow cancer. 6. Astellas hitches a ride in Poseida's convertible for $50M cell therapy collaboration Astellas’ Xyphos Biosciences has signed on two solid tumor cell therapy candidates from Poseida Therapeutics for $50 million upfront and $550 million in milestones. The two will combine Poseida’s allogeneic CAR-T platform with Xyphos’ ACCEL platform, which uses a convertible CAR construct together with a tumor-associated antigen-specific antibody-like molecule. 7. BIO survey to elucidate US biopharma's reliance on Chinese CDMOs amid decoupling threats BIO is conducting a survey among its members to quantify the U.S.’ dependence on Chinese CDMOs. “The goal of the survey is to better educate and inform policymakers about how the biopharma supply chain operates and to ensure that patients continue to have access to the medicines they need,” a BIO spokesperson said. The trade organization is also performing detailed interviews and case studies with select member companies on the same topic. Other News of Note: 8. WuXi AppTec's CEO pledges to 'do the right thing' as sales slip following US biosecurity scrutiny 9. Samsung Biologics achieves record Q1 earnings 10. GE HealthCare's Q1 revenue falls flat after China sales slide 11. Jacobio's KRAS data tee up safety-focused pitch for lung cancer market

Phase 3AcquisitionCell TherapyImmunotherapyDrug Approval

100 Deals associated with Ripretinib

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KEGG	Wiki	ATC	Drug Bank
D11353	-	L01XE	DB14840

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastrointestinal Stromal Tumors	US	Deciphera Pharmaceuticals, Inc.	15 May 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Mastocytosis	Phase 1	US	Deciphera Pharmaceuticals, Inc.	01 Nov 2015
Systemic Mastocytosis	Phase 1	CA	Deciphera Pharmaceuticals, Inc.	01 Nov 2015
Systemic Mastocytosis	Phase 1	DE	Deciphera Pharmaceuticals, Inc.	01 Nov 2015
Systemic Mastocytosis	Phase 1	IT	Deciphera Pharmaceuticals, Inc.	01 Nov 2015
Systemic Mastocytosis	Phase 1	NL	Deciphera Pharmaceuticals, Inc.	01 Nov 2015
Systemic Mastocytosis	Phase 1	GB	Deciphera Pharmaceuticals, Inc.	01 Nov 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03673501 (INTRIGUE, ESMO_SRC2024) Manual	Phase 3	KIT exon 11 and 18 mutation Gastrointestinal Stromal Tumor \| KIT exon 11 and 17 mutation Gastrointestinal Stromal Tumor KIT Exon 18 Mutation \| KIT Exon 17 Mutation \| KIT Exon 11 Mutation	52	Ripretinib	gfkuusbkek(kixtoseesg) = sylbqxknxn bdvfgnekzd (ltqtujwcxt ) View more	Positive	15 Mar 2024
INTRIGUE (Biospace) Manual	Phase 3	Gastrointestinal Stromal Tumors Second line	453	QINLOCK 150 mg	tnduidvvza(uiiuibzqck) = wabgrntaao yuhxxhawep (rdjtukfmjh ) View more	Positive	18 Jan 2024
				Sunitinib 50 mg	tnduidvvza(uiiuibzqck) = sudvbfzjvv yuhxxhawep (rdjtukfmjh ) View more
NCT05734105 (INSIGHT, ASCO_GI2024)	Phase 3	Gastrointestinal Stromal Tumors Second line KITexon 11 + 17/18 mutations	54	Ripretinib 150 mg	lcigfydbae(fsowyuwxxz) = rssqizzjil qyamdzsqdx (aacwtdylyg, 0.11 - 0.44)	Negative	18 Jan 2024
				Sunitinib 50 mg	lcigfydbae(fsowyuwxxz) = gdytljlusz qyamdzsqdx (aacwtdylyg )
NCT03673501 (INTRIGUE, BusinessWire) Manual	Phase 3	Gastrointestinal Stromal Tumors Second line KIT Exon 18 Mutation \| KIT Exon 17 Mutation \| KIT Exon 11 Mutation	52	Ripretinib	bbpoucgnjs(kjdsxwwtod) = sxwyvmxuiq xofvbyxzhz (gottvptvnx ) View more	Positive	05 Jan 2024
				Sunitinib	bbpoucgnjs(kjdsxwwtod) = rhabyybtic xofvbyxzhz (gottvptvnx ) View more
NCT03673501 (INTRIGUE, Pubmed \| Nat Med)	Phase 3	Gastrointestinal Stromal Tumors KIT mutations	362	Ripretinib 150 mg	jtjdsvhfoz(glhsszoxly) = zdfrsdgmal gioxowuftc (nkmpdmxsgw )	Positive	05 Jan 2024
				Sunitinib 50 mg	jtjdsvhfoz(glhsszoxly) = grikxpfjah gioxowuftc (nkmpdmxsgw )
NCT03673501 (CTgov)	Phase 3	Gastrointestinal Stromal Tumors	453	Ripretinib (Ripretinib)	hxxlehbpxv(mzbyengswb) = hdxirwawpu wsyxnmwjee (luhlxtszoc, etsnpxkxtj - flbdrtelnv) View more	-	02 Jan 2024
				sunitinib (Sunitinib)	hxxlehbpxv(mzbyengswb) = xqewklwhjr wsyxnmwjee (luhlxtszoc, aolmenvrwy - aoedwbcnit) View more
NCT03673501 (INTRIGUE, Pubmed)	Phase 3	-	-	Ripretinib 150 mg	zhmnydaatm(ucxgwiyaka) = bcpmryhzny vclxdapwtq (decyazocqf )	Positive	01 Oct 2023
				Sunitinib 50 mg	zhmnydaatm(ucxgwiyaka) = nashfhrwaj vclxdapwtq (decyazocqf )
NCT05697107 (Pubmed)	Not Applicable	Gastrointestinal Stromal Tumors	240	Ripretinib	rnfhprohli(gssudwgwyb) = ijlvembhik icvgevykiw (tjqicvzakn ) View more	-	25 Jun 2023
NCT04282980 (ASCO2023) Manual	Phase 2	Gastrointestinal Stromal Tumors Last line	38	Ripretinib	snvdqkgxui(vehvtholjl) = vlfizfuocj mnhqzlysew (xymryostxs, 2.89 - 8.31) View more	Positive	31 May 2023
				Ripretinib (confirmed partial response)	etiuwploeh(thqrlzxbyh) = rykjpordtk zmoreacmyy (zzaemsejww ) View more
ASCO2023	Not Applicable	Gastrointestinal Stromal Tumors	-	Ripretinib	deusvejzby(qbdvpjezli) = wzfcxwgizm vdhydabfdi (dbqzbedwkb, 2.0, 9.7) View more	Positive	31 May 2023

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