EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

— New data demonstrate efficacy for the oral treatment combination to address MET-driven resistance in EGFR-mutated lung cancer — — MET is a common biomarker in this setting for patients who develop resistance to EGFR targeted therapies — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 16, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces positive high-level results from the SAVANNAH Phase II trial that showed TAGRISSO® (osimertinib) plus ORPATHYS® (savolitinib) demonstrated a high, clinically meaningful and durable objective response rate (“ORR”) for patients with epidermal growth factor receptor-mutated (“EGFRm”) non-small cell lung cancer (“NSCLC”) with high levels of MET overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with TAGRISSO®. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. In 2023, TAGRISSO® plus ORPATHYS® received Fast Track designation from the US Food and Drug Administration (FDA) in this setting. ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. It is approved in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. While EGFR-targeted therapy can provide a substantial survival benefit to patients with EGFRm NSCLC, most will eventually develop resistance to their treatment, with MET being a common resistance biomarker.1 Among patients screened for enrollment in SAVANNAH, an estimated 62% had tumors with MET overexpression and/or amplification, and approximately 34% met the defined high MET level cut-off upon clinical progression. Myung-Ju Ahn, MD, PhD, Professor of Hemato-Oncology at the Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, and principal investigator in the SAVANNAH Phase II trial, said: “Osimertinib can provide patients with EGFR-mutated lung cancer unprecedented survival and has transformed the treatment landscape, but patients can develop resistance due to genes like MET – a common resistance biomarker. These results show that adding savolitinib, a selective MET-inhibitor, while continuing osimertinib treatment helped to deliver a meaningful response among patients whose disease progressed, providing a potential new treatment option following standard-of-care osimertinib.” Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “These positive SAVANNAH results show the benefit of a targeted treatment approach in EGFR-mutated lung cancer patients who experience MET-driven resistance. The improved response rates from ORPATHYS® added to TAGRISSO®, which is the backbone EGFR-mutated lung cancer therapy, reinforce the importance of identifying MET aberration and validate our combination strategy to address resistance while allowing continued TAGRISSO® treatment.” Weiguo Su, Chief Executive Officer and Chief Scientific Officer, HUTCHMED, said: “Previous results from the SAVANNAH Phase II trial provided a novel biomarker approach for identifying patients with MET overexpression and/or amplification who are most likely to benefit from a MET-directed therapy, an existing unmet need. These new, positive results affirm our selective, patient-centric approach, which could allow us to deliver the first biomarker-driven targeted therapy combination option in this setting.” The safety and tolerability of TAGRISSO® plus ORPATHYS® was consistent with the known safety profiles of the combination and each treatment alone. No new safety signals were identified. On August 2022, initial positive ORR results from the SAVANNAH trial were presented at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (WCLC). The global SAFFRON Phase III trial sponsored by AstraZeneca will further assess the TAGRISSO® plus ORPATHYS® combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following TAGRISSO®. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH. About NSCLC and MET aberrationsLung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.2,3 Lung cancer is broadly split into NSCLC and small cell lung cancer.4 Each year there are an estimated 2.4 million people diagnosed with lung cancer globally, with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer.2,4,5 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.6,7,8 MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is the primary mechanism of acquired resistance to EGFR TKIs for metastatic EGFRm NSCLC. Among patients who experience disease progression post-osimertinib treatment, approximately 15-50% present with MET aberration.9,10,11,12,13 The prevalence of MET depends on the sample type, detection method and assay cut-off used.14 About SAVANNAHSAVANNAH is an ongoing global, randomised, Phase II trial sponsored by AstraZeneca studying the efficacy of ORPATHYS® added to TAGRISSO® in patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression and/or amplification who progressed following treatment with TAGRISSO®. Based on the original single-arm trial design, patients were treated with ORPATHYS® 300 or 600 mg once-daily (QD) or 300 mg twice-daily, in combination with oral TAGRISSO® 80 mg QD. In 2022, a registrational component was added to the trial that compared ORPATHYS® 300 mg twice-daily and TAGRISSO® 80 mg QD to ORPATHYS® 300 mg twice-daily and placebo. The trial enrolled over 360 patients in more than 80 centers globally, including in North America, Europe, South America and Asia. The primary endpoint is ORR and key secondary endpoints include progression-free survival and duration of response. About TAGRISSO®TAGRISSO® (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO® (40mg and 80mg once-daily oral tablets) has been used to treat nearly 800,000 patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO® as a treatment for patients across multiple stages of EGFRm NSCLC. There is an extensive body of evidence supporting the use of TAGRISSO® as standard of care in EGFRm NSCLC. TAGRISSO® improved patient outcomes in early-stage disease in the ADAURA Phase III trial, locally advanced disease in the LAURA Phase III trial, late-stage disease in the FLAURA Phase III trial, and with chemotherapy in the FLAURA2 Phase III trial. About ORPATHYS®ORPATHYS® (savolitinib) is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. It is approved in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is the first selective MET inhibitor approved in China and the first in the National Reimbursement Drug List of China (NRDL). It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines. In addition to SAVANNAH and SAFFRON, in China the combination of savolitinib and osimertinib in lung cancer is also being studied in the SACHI and SANOVO Phase III trials. About HUTCHMEDHUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved in the US, Europe and Japan. For more information, please visit www.hutch-med.com or follow us on LinkedIn. Forward-Looking StatementsThis announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of savolitinib, the further clinical development for savolitinib, its expectations as to whether any studies on savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of savolitinib for a targeted indication; and the sufficiency of funding; and AstraZeneca’s ability to successfully develop and commercialize savolitinib.. In addition, as certain studies rely on the use of other drug products such as osimertinib as combination therapeutics with savolitinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise. Medical InformationThis announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Inside InformationThis announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018). CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum+44 (20) 7886 2500 1 Del Re M, et al. Understanding the Mechanisms of Resistance in EGFR-Positive NSCLC: From Tissue to Liquid Biopsy to Guide Treatment Strategy. Int J Mol Sci. 2019;20(16): 3951. 2 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed September 2024. 3 World Health Organization. International Agency for Research on Cancer. World Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf. Accessed October 2024. 4 LUNGevity Foundation. Types of Lung Cancer. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed September 2024. 5 Cheema PK, et al. Perspectives on treatment advances for stage III locally advanced unresectable non-small-cell lung cancer. Curr Oncol. 2019;26(1):37-42. 6 Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. 7 Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in 11. Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12. 8 Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. 9 Soria JC, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018;378(2):113-125. 10 Mok TS, et al. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017;376(7):629-640. 11 Hartmaier R, et al. Tumor genomics in patients (pts) with advanced epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) whose disease has progressed on first-line (1L) osimertinib therapy in the Phase II ORCHARD study. Cancer Res 15 June 2022; 82 (12_Supplement): LB078. 12 Piotrowska, et al. MET amplification (amp) as a resistance mechanism to osimertinib. Journal of Clinical Oncology 2017 35:15_suppl, 9020-9020. 13 Hartmaier, et al. Detection of MET-mediated EGFR tyrosine kinase inhibitor (TKI) resistance in advanced non-small cell lung cancer (NSCLC): biomarker analysis of the TATTON study. Cancer Res (2019) 79 (13_Supplement): 4897. 14 Coleman N, et al. Beyond epidermal growth factor receptor: MET amplification as a general resistance driver to targeted therapy in oncogene-driven non-small-cell lung cancer. ESMO Open. 2019;6(6).

SAN FRANCISCO and SUZHOU, China, Oct. 7, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), announced that the two parties have entered into a strategic collaboration regarding limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of lung cancer. Under the agreement, Innovent will obtain the exclusive commercialization rights for limertinib in mainland China, and will be entitled to receive a commercialization service fee based on the product's net sales in the region. Ask-Pharm as the MAH holder, will be responsible for the production and commercial supply of limertinib and will be eligible for upfront, regulatory and sales milestone payments. Limertinib is an orally administrated, third-generation novel EGFR TKI with proprietary rights. Two New Drug Applications (NDAs) for limertinib have been accepted and are under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by a validated diagnostic test, whose disease has progressed after EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, limertinib's efficacy and safety were compared with gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and detailed data and analysis will be presented at future academic conferences or published in academic journals. Previously, results of limertinib from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent's leadership in oncology. Together with our partners, Innovent has successfully developed a series of high-quality innovative medicines for lung cancer treatments, including TYVYT® (sintilimab Injection), BYVASDA® (bevacizumab Injection), Retsevmo® (selpercatinib), Dupert® (fulzerasib) and Taletrectinib (ROS1 Inhibitor, NDA under review). The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer. Innovent remains committed to investing in innovation and collaborative partnerships, aiming to enhancing the accessibility and affordability of innovative therapies in China to benefit even more patients." Mr. Jingfei Ma, Director and General Manager of ASK Pharm, stated: "We are pleased to form a strategic partnership with Innovent Biologics. Oncology is one of the four core areas of focus for ASK Pharm, and our oncology product line spans chemotherapy drugs, small molecule targeted drugs, and biologics. Limertinib, ASK Pharm's first innovative drug, targets the cancer type with the highest incidence and mortality rates in China. Focused on addressing the most common mutations in lung cancer, Ask-Pharm is committed to providing effective drugs for the vast number of patients with EGFR-mutated lung cancer. Innovent has a rich product pipeline in the field of lung cancer, which can form advantageous synergies with limertinib. In addition, with Innovent's professional and efficient marketing team and proven commercialization capabilities, we are confident that this cooperation will help limertinib to fully realize its clinical value, so that more patients can benefit from it." About EGFR mutation-positive non-small-cell lung cancer (NSCLC) Lung cancer is the leading cause of cancer-related death and the second more common cancer worldwide. In China, it has both the highest incidence and mortality rates among malignant tumors. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancers, and approximately 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is not eligible to surgical resection. EGFR is the most frequent driver mutation in NSCLC, with 30% to 50% of Asian NSCLC patients having EGFR mutations. EGFR-TKIs are the recommended first-line standard of care for this group, with third-generation EGFR inhibitors offering the broadest applicability. About Limertinib Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, classified as a new molecular entity. Two New Drug Applications (NDAs) of limertinib are currently under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by an approved test, whose disease has progressed following EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, the efficacy and safety of limertinib were compared to gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and the results will be presented at future academic conferences or published in academic journals. Results from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement regarding limertinib in mainland China. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications (NDA) under regulatory review, 3 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas. ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, the innovative anti-tumor drug Limertinib are in the NDA stage, while ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in China's pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as "Top Ten National R&D Innovators", "Best National Enterprise for Investment", and "National Torch Program High-Tech Enterprises". For more information, visit . Innovent's 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", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Limertinib is intended for the treatment of patients with lung cancer. Credit: New Africa/Shutterstock. Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (ASK Pharm) have signed a strategic partnership agreement for the commercialisation of limertinib to treat lung cancer. Limertinib is an orally administrated third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This collaboration will grant Innovent exclusive rights to commercialise the asset within mainland China, and entitles the company to a service fee based on net sales. ASK Pharm will serve as the marketing authorisation holder and will oversee the manufacturing and commercial distribution of the product. ASK Pharm is entitled to upfront payments and milestone payments contingent on meeting regulatory and sales goals. See Also: Activist investor Starboard forges $1bn stake in Pfizer to swing profits Healthcare Payers for the Pharmaceutical Industry Two new drug applications for limertinib are currently under review by China’s National Medical Products Administration. One application is for an indication to treat adults with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), post-EGFR TKI therapy progression. The other is for the first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations in adults. The efficacy and safety of limertinib were evaluated in a randomised, multicentre, double-blind, controlled Phase III clinical trial comparing it to gefitinib for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. The trial successfully met its primary endpoint, indicating a potential new option for patients with this form of lung cancer. Innovent founder, chairman and CEO Dr Michael Yu stated: “We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent’s leadership in oncology. “Together with our partners, Innovent has successfully developed a series of high-quality innovative medicines for lung cancer treatments, including TYVYT (sintilimab Injection), BYVASDA (bevacizumab Injection), Retsevmo (selpercatinib), Dupert (fulzerasib) and Taletrectinib (ROS1 Inhibitor). “The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer.” In August 2024, the company’s Kristen rat sarcoma G12C inhibitor, Dupert (fulzerasib), received China’s National Medical Products Administration (NMPA) approval to treat advanced non-small cell lung cancer (NSCLC) in adults.