China NMPA approves Zeiss Medical's retinal imaging system
It will aid eye care specialists in China with diagnostic tools to preserve patient vision.
The ultra-widefield FA serves as a tool for evaluating nonperfused retinal regions.
Offering high-resolution and True Color images, the fundus imaging camera is equipped with features such as PrecisionFocus for rapid view of details, QuickCompare for comparing pathology changes found in previous visits of the patient, and AutoBright, which streamlines the imaging process.
ZEISS CLARUS 700 claims to capture 133° in one image and up to 267° with several captures. It also includes live infrared imaging offerings.
The images produced by the platform closely mimic the actual colouration of the fundus as seen in direct clinical observation.
Ultra-widefield FA can identify conditions such as diabetic retinopathy by visualising the peripheral retina.
This is essential for evaluating neovascularisations, vascular leakage, and other microvascular abnormalities.
The high resolution and widefield imaging of the ZEISS CLARUS 700 enable the capture of minute details from the ONH to the periphery, even in the early phase of diseases.
The device also features technology that utilises patented technology to maximise workflow efficiency and reduce the time patients spend in the chair. These features are designed to allow specialists to focus more on patient care.
Various new features have been introduced by the device that enable clinicians to focus on their patients.
These features, leveraging algorithms via patented technology, will aid in reducing the chair time.
ZEISS medical technology chronic disease management head Anuj Kalra said: "By seamlessly integrating ultra-widefield FA imaging with true-colour reproduction, this system delivers unprecedented clarity for comprehensive visualisation from the macular region to the extreme retinal periphery, enhancing efficiency and supporting precise decision-making within the ZEISS Retina Workflow."
In 2023, Zeiss Medical Technology entered a long-term strategic partnership with Boehringer Ingelheim to develop predictive analytics for eye conditions.
"China NMPA approves Zeiss Medical's retinal imaging system" was originally created and published by Medical Device Network, a GlobalData owned brand.
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2 days ago
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HUTCHMED Announces China Approval for ORPATHYS® in Combination with TAGRISSO® for the Treatment of Lung Cancer Patients with MET Amplification After Progression on First-Line EGFR Inhibitor Therapy
— Approval based on Phase III SACHI Trial results which showed a 66% reduced risk of progression or death as compared to platinum-based chemotherapy — — The only all-oral combination treatment option for these patients — — Consistent benefit regardless of first-line EGFR inhibitor therapy — HONG KONG, SHANGHAI and FLORHAM PARK, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ('HUTCHMED') (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application ('NDA') for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) has been granted approval by the China National Medical Products Administration ('NMPA') for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ('EGFR') mutation-positive non-squamous non-small cell lung cancer ('NSCLC') with MET amplification after disease progression on EGFR tyrosine kinase inhibitor ('TKI') therapy. ORPATHYS® is an oral, potent and highly selective MET TKI. TAGRISSO® is a third-generation, irreversible EGFR TKI. This approval also triggers a US$11 million milestone payment from AstraZeneca, which markets both ORPATHYS® and TAGRISSO® in China. ORPATHYS® was the first selective MET inhibitor approved in China, indicated for adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration. This new approval by the NMPA was based on data from the SACHI Phase III trial of the ORPATHYS® and TAGRISSO® combination (NCT05015608), having met the pre-defined primary endpoint of progression-free survival ('PFS') in a pre-planned interim analysis. Primary results were presented at the American Society of Clinical Oncology ('ASCO') Annual Meeting in June 2025. In 2024 the NMPA designated the combination as a Breakthrough Therapy, and in 2025 it granted the NDA Priority Review. Professor Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and Principal Investigator of the SACHI trial, said, 'The approval of the ORPATHYS® and TAGRISSO® combination is a significant milestone in addressing the complex challenges of lung cancer treatment in China, where the EGFR mutation is common amongst NSCLC patients. For patients who develop MET amplification after progressing on EGFR inhibitors, the combination offers a continued all-oral, chemotherapy-free approach to tackle a critical resistance mechanism. As a researcher and clinician, I am excited about the opportunity to offer this targeted therapy to patients, improving their treatment outcomes and quality of life through innovative research.' 'The NMPA approval marks an important step forward in our mission to address MET-driven progression following first-line EGFR-inhibitor therapy in NSCLC patients.' said Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. 'Our collaboration with AstraZeneca, built on a shared vision to transform oncology care, has been crucial in reaching this achievement. We are committed to advancing this partnership, continuing our research into further treatment settings, and bringing this innovative combination to patients in China and beyond.' Ms Mary Guan, General Manager of AstraZeneca China Oncology Business, said: 'This milestone marks the third indication of ORPATHYS® approved in China, bringing a new treatment option to lung cancer patients who develop MET amplification after progressing on EGFR inhibitor therapy. Through our partnership with HUTCHMED, we are committed to expanding the reach of the ORPATHYS® and TAGRISSO® combination to address progression on first-line therapy and help even more patients with this form of lung cancer.' In the intention to treat (ITT) population of the SACHI trial, the ORPATHYS® and TAGRISSO® combination reduced the risk of disease progression by 66% with a median PFS of 8.2 months, compared to 4.5 months for chemotherapy, as assessed by investigators. The independent review committee (IRC) also reported a 60% risk reduction in disease progression, with a median PFS of 7.2 months versus 4.2 months, respectively. The safety profile of the ORPATHYS® and TAGRISSO® combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in both the ORPATHYS® plus TAGRISSO® group and the chemotherapy group, suggesting a favorable safety profile. About NSCLC and MET aberrations Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2 The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and 30-40% of patients in Asia have EGFR-mutated ('EGFRm') NSCLC.3,4,5,6 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 one of the mechanisms of acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.7,8 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. ORPATHYS® is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. 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. 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® and TAGRISSO® Combination Development in EGFR-mutated NSCLC Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO® is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS® in combination with TAGRISSO® has been studied extensively in these patients in the TATTON (NCT02143466) and SAVANNAH (NCT03778229) studies. The encouraging results led to the initiation of several Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836). This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this advanced setting. Positive data from the SACHI randomized Phase III trial led to the filing of a second NDA in China. Strong data from the SAVANNAH single-arm Phase II study was recently presented at the European Lung Cancer Congress (ELCC) in March 2025 demonstrated high, clinically meaningful and durable objective response rate (ORR), with consistent safety results. The SAFFRON randomized Phase III trial is progressing. Following AstraZeneca's consultation with the US Food and Drug Administration ('FDA'), we look forward to completing the SAFFRON trial as soon as possible to support potential US and other global registration filings. The SACHI China Phase III trial met the primary endpoint of PFS during its interim analysis towards the end of 2024 and a NDA was accepted and granted Breakthrough Therapy Designation and Priority Review status in China in December 2024. SACHI evaluated the combination of ORPATHYS® and TAGRISSO® for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC after progression on EGFR TKI compared to platinum-based doublet chemotherapy. Results were presented at the ASCO Annual Meeting in June 2025. In 2023, ORPATHYS® and TAGRISSO® received Fast Track Designation from the US FDA in this setting. The global SAFFRON Phase III trial is currently ongoing to assess the ORPATHYS® plus TAGRISSO® combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO®. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing 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 around the world including in the US, Europe and Japan. For more information, please visit: or follow us on 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 ORPATHYS®, the further clinical development for ORPATHYS®, its expectations as to whether any studies on ORPATHYS® 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 ORPATHYS®, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in other jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of ORPATHYS® for a targeted indication; and HUTCHMED and/or its partner's ability to fund, implement and complete its further clinical development and commercialization plans for ORPATHYS®, and the timing of these events. In addition, as certain studies rely on the use of other drug products such as TAGRISSO® as combination therapeutics with ORPATHYS®, 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 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. This 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@ Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@ Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@ Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 ________________________ 1 World Health Organization. International Agency for Research on Cancer. All cancers fact sheet. Available at: Accessed November 2022. 2 American Cancer Society. What is Lung Cancer? Available at: Accessed November 2022. 3 Knight SB, et al. Progress and prospects of early detection in lung cancer. Open Biol. 2017;7(9): 170070. 4 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. 5 Zhang Y, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48). 6 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. 7 Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074). 8 Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. Journal of Hematology & Oncology. 2019;63.
Business Upturn
2 days ago
- Business Upturn
HUTCHMED Announces China Approval for ORPATHYS® in Combination with TAGRISSO® for the Treatment of Lung Cancer Patients with MET Amplification After Progression on First-Line EGFR Inhibitor Therapy
— Approval based on Phase III SACHI Trial results which showed a 66% reduced risk of progression or death as compared to platinum-based chemotherapy — — The only all-oral combination treatment option for these patients — — Consistent benefit regardless of first-line EGFR inhibitor therapy — HONG KONG, SHANGHAI and FLORHAM PARK, N.J., June 30, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited ('HUTCHMED') (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application ('NDA') for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) has been granted approval by the China National Medical Products Administration ('NMPA') for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ('EGFR') mutation-positive non-squamous non-small cell lung cancer ('NSCLC') with MET amplification after disease progression on EGFR tyrosine kinase inhibitor ('TKI') therapy. ORPATHYS® is an oral, potent and highly selective MET TKI. TAGRISSO® is a third-generation, irreversible EGFR TKI. This approval also triggers a US$11 million milestone payment from AstraZeneca, which markets both ORPATHYS® and TAGRISSO® in China. ORPATHYS® was the first selective MET inhibitor approved in China, indicated for adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration. This new approval by the NMPA was based on data from the SACHI Phase III trial of the ORPATHYS® and TAGRISSO® combination (NCT05015608), having met the pre-defined primary endpoint of progression-free survival ('PFS') in a pre-planned interim analysis. Primary results were presented at the American Society of Clinical Oncology ('ASCO') Annual Meeting in June 2025. In 2024 the NMPA designated the combination as a Breakthrough Therapy, and in 2025 it granted the NDA Priority Review. Professor Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and Principal Investigator of the SACHI trial, said, 'The approval of the ORPATHYS® and TAGRISSO® combination is a significant milestone in addressing the complex challenges of lung cancer treatment in China, where the EGFR mutation is common amongst NSCLC patients. For patients who develop MET amplification after progressing on EGFR inhibitors, the combination offers a continued all-oral, chemotherapy-free approach to tackle a critical resistance mechanism. As a researcher and clinician, I am excited about the opportunity to offer this targeted therapy to patients, improving their treatment outcomes and quality of life through innovative research.' 'The NMPA approval marks an important step forward in our mission to address MET-driven progression following first-line EGFR-inhibitor therapy in NSCLC patients.' said Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. 'Our collaboration with AstraZeneca, built on a shared vision to transform oncology care, has been crucial in reaching this achievement. We are committed to advancing this partnership, continuing our research into further treatment settings, and bringing this innovative combination to patients in China and beyond.' Ms Mary Guan, General Manager of AstraZeneca China Oncology Business, said: 'This milestone marks the third indication of ORPATHYS® approved in China, bringing a new treatment option to lung cancer patients who develop MET amplification after progressing on EGFR inhibitor therapy. Through our partnership with HUTCHMED, we are committed to expanding the reach of the ORPATHYS® and TAGRISSO® combination to address progression on first-line therapy and help even more patients with this form of lung cancer.' In the intention to treat (ITT) population of the SACHI trial, the ORPATHYS® and TAGRISSO® combination reduced the risk of disease progression by 66% with a median PFS of 8.2 months, compared to 4.5 months for chemotherapy, as assessed by investigators. The independent review committee (IRC) also reported a 60% risk reduction in disease progression, with a median PFS of 7.2 months versus 4.2 months, respectively. The safety profile of the ORPATHYS® and TAGRISSO® combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in both the ORPATHYS® plus TAGRISSO® group and the chemotherapy group, suggesting a favorable safety profile. About NSCLC and MET aberrations Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2 The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and 30-40% of patients in Asia have EGFR-mutated ('EGFRm') NSCLC.3,4,5,6 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 one of the mechanisms of acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.7,8 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. ORPATHYS® is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. 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. 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® and TAGRISSO® Combination Development in EGFR-mutated NSCLC Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO® is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS® in combination with TAGRISSO® has been studied extensively in these patients in the TATTON (NCT02143466) and SAVANNAH (NCT03778229) studies. The encouraging results led to the initiation of several Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836). This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this advanced setting. Positive data from the SACHI randomized Phase III trial led to the filing of a second NDA in China. Strong data from the SAVANNAH single-arm Phase II study was recently presented at the European Lung Cancer Congress (ELCC) in March 2025 demonstrated high, clinically meaningful and durable objective response rate (ORR), with consistent safety results. The SAFFRON randomized Phase III trial is progressing. Following AstraZeneca's consultation with the US Food and Drug Administration ('FDA'), we look forward to completing the SAFFRON trial as soon as possible to support potential US and other global registration filings. SACHI: The SACHI China Phase III trial met the primary endpoint of PFS during its interim analysis towards the end of 2024 and a NDA was accepted and granted Breakthrough Therapy Designation and Priority Review status in China in December 2024. SACHI evaluated the combination of ORPATHYS® and TAGRISSO® for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC after progression on EGFR TKI compared to platinum-based doublet chemotherapy. Results were presented at the ASCO Annual Meeting in June 2025. SAFFRON: In 2023, ORPATHYS® and TAGRISSO® received Fast Track Designation from the US FDA in this setting. The global SAFFRON Phase III trial is currently ongoing to assess the ORPATHYS® plus TAGRISSO® combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO®. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing 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 around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn. Forward-Looking Statements This 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 ORPATHYS ® , the further clinical development for ORPATHYS ® , its expectations as to whether any studies on ORPATHYS ® 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 ORPATHYS ® , including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in other jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of ORPATHYS ® for a targeted indication; and HUTCHMED and/or its partner's ability to fund, implement and complete its further clinical development and commercialization plans for ORPATHYS ® , and the timing of these events. In addition, as certain studies rely on the use of other drug products such as TAGRISSO ® as combination therapeutics with ORPATHYS ® , 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 Information This 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 Information This 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 / [email protected] Media Enquiries FTI Consulting – +44 20 3727 1030 / [email protected] Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / [email protected] Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 ________________________ 1 World Health Organization. International Agency for Research on Cancer. All cancers fact sheet. Available at: Accessed November 2022. 2 American Cancer Society. What is Lung Cancer? Available at: Accessed November 2022. 3 Knight SB, et al. Progress and prospects of early detection in lung cancer. Open Biol. 2017;7(9): 170070. 4 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. 5 Zhang Y, et al . The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget . 2016;7(48). 6 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. 7 Uchikawa E, et al . Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074). 8 Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer . Journal of Hematology & Oncology. 2019;63. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
5 days ago
- Yahoo
Innovent Announces Mazdutide, First Dual GCG/GLP-1 Receptor Agonist, Received Approval from China's NMPA for Chronic Weight Management
SAN FRANCISCO and SUZHOU, China, June 27, 2025 /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, announces that China's National Medical Products Administration (NMPA) has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, for chronic weight management in Chinese adults with overweight or obesity. Mazdutide is the world's first dual GCG/GLP-1 receptor agonist approved for weight loss, offering a unique mechanism that enhances weight-loss efficacy while reducing visceral fat and delivering comprehensive metabolic benefits, named by Fierce Pharma as one of the top ten most anticipated drugs globally in 2025. The increasing prevalence of overweight and obesity in China poses an urgent public health challenge requiring immediate intervention. In April 2025, the National Health Commission officially included "Healthy Weight Management Action" in the "Healthy China 2030" initiative. Under the updated plan, the national health authorities aim to build supportive environments for effective weight management, raise public awareness and behavior skills, and promote healthy lifestyles to curb rising rates of overweight and obesity. Aligned with these national priorities and the 2025 weight management campaign, the approval of mazdutide represents a timely and important milestone. Aiming to be an innovative leader in the cardiovascular and metabolic (CVM) disease area, Innovent is committed to accelerating the delivery of this drug to benefit a broad population in China. Scientific and effective treatment options for weight loss are urgently needed in China Overweight and obesity are chronic metabolic diseases characterized by excessive fat accumulation in the body. The pathogenesis of overweight and obesity includes genetic, metabolic, environmental, and behavioral factors. Obesity can significantly increase the risk of various diseases, such as cardiovascular and cerebrovascular, endocrine, specific tumors, respiratory, reproductive, and skeletal diseases, and can seriously affect quality of life[1]. In China, over 500 million adults live with overweight (BMI ≥ 24 kg/m2 and ˂ 28 kg/m2) or obesity (BMI ≥ 28 kg/m2). Nearly 90% of obese adults have comorbidities, including metabolic dysfunction-associated fatty liver disease, which affects around 50% of adults with overweight and over 80% of adults with obesity. The World Obesity Federation (WOF) estimates that obesity costs China around US$283.3 billion in GDP loss in 2020[2]. With such heavy societal burdens, obesity and related chronic diseases have become major public health concerns in China and around the world. In response to the escalating obesity problem, several national policies and clinical guidelines have underscored the need for structured outpatient weight management and earlier pharmacological intervention. The National Health Commission's "Notice on Effective Outpatient Settings and Management of Weight Management" encourages the development of optimized outpatient care models. Additionally, "Guidelines for the Diagnosis and Treatment of Obesity (2024 Edition)" recommended pharmacotherapy when lifestyle interventions fail to meet weight loss goals. The "Guidelines for Long-term Weight Management and Clinical Application of Drugs for Obese Patients (2024 Edition)" issued by the Chinese Society of Endocrinology further advocates for initiating drug treatment early in patients with obesity-related comorbidities. Mazdutide is supported by robust clinical data published in multiple high-impact journals, including Nature, the Lancet sub-journals, and the New England Journal of Medicine. As the first marketed dual GCG/GLP-1 receptor agonist , mazdutide has been recommended by multiple clinical guidelines in China[3],[4],[5],[6] and expert consensus on obesity management on account of its innovative mechanism and solid evidence base. Multiple metabolic benefits of mazdutide in supporting weight management GCG receptors are mainly expressed in the liver, and GCG receptor agonism can inhibit hepatic fat synthesis and promote hepatic lipolysis. As a dual GCG/GLP-1 receptor agonist weight loss drug, mazdutide can deliver significant weight loss efficacy and metabolic benefits such as waist circumstance and liver fat content reductions to adults with overweight or obesity. The approval of mazdutide was mainly based on data from GLORY-1, a Phase 3 pivotal clinical study conducted in Chinese adults with overweight or obesity. The primary endpoint and all key secondary endpoints of the study were successfully achieved in 2024. Results showed that at weeks 32 and 48, the percentage of body weight reduction from baseline and the proportions of participants with a body weight reduction of ≥5%，≥10% and ≥15% in the mazdutide 4 mg group and mazdutide 6 mg group were superior to those of the placebo group. Based on the efficacy estimand, at week 48, the mean percentage changes in body weight relative to baseline in the mazdutide 4 mg, mazdutide 6 mg, and placebo groups were −12.0%, −14.8%, and −0.5%, respectively; The proportion of participants with a body weight reduction ≥ 5% relative to baseline were 73.5%, 82.8%, and 11.5%, respectively; the proportion of participants with a body weight reduction ≥ 15% relative to baseline were 37.0%, 50.6%, and 2.1%, respectively; The mean changes in waist circumference relative to baseline were −9.5 cm, −11.0 cm, and −1.5 cm, respectively. In addition, mazdutide reduced liver fat content in adults with overweight or obesity. Among participants with baseline liver fat content ≥ 10%, the mean percent change from baseline in liver fat content to week 48 were −65.85%, −80.24%, and −5.27% in the mazdutide 4 mg, 6 mg, and placebo groups, respectively. The results of GLORY-1 study have been presented at the American Diabetes Association (ADA) Annual Meeting and published in the New England Journal of Medicine, which have received widespread attention from industry experts and scholars. Mazdutide addresses a critical unmet need in China by offering effective treatment for weight reduction while also improving cardiometabolic indicators in adults with overweight or obesity. Its use may help reduce the long-term societal and economic burdens associated with obesity-related diseases. Professor Linong Ji, the Leading Principal Investigator of GLORY-1, Peking University People's Hospital, stated, "Obesity is a chronic disease that demands a coordinated societal response. With China facing a high prevalence of overweight and obesity, the associated cardiometabolic disease burdens continue to rise. There is an urgent need for weight-loss therapies that are both effective and safe, with proven cardiovascular and metabolic benefits. As the principal investigator of this novel dual GCG/GLP-1 receptor agonist with a unique mechanism of action, I'm proud to see our clinical results recognized by China's national regulatory authority and anticipate its subsequent approval for market launch. My fellow researchers and I hope mazdutide will become a valuable therapeutic option for Chinese adults with overweight or obesity." Dr. Lei Qian from Innovent Biologics, stated, "Mazdutide represents the next-generation dual GCG/GLP-1 receptor agonist. Its clinical development has been made possible by pooling the collective expertise of leading endocrinology experts across China, and its successful approval reflects the NMPA's high recognition of its clinical value and safety. This milestone marks another breakthrough for Innovent in the cardiovascular and metabolic fields. We hope mazdutide will provide another therapeutic option for Chinese adults with overweight or obesity, improve their quality of life, and alleviate societal burdens. Centered on patient needs and innovation, Innovent has established and will continue to expand its rich CVM pipeline with mazdutide as a cornerstone product, aiming to continuously address the public's growing demand for health and quality of life and to serve more patients." About Obesity/Overweight Obesity is a chronic metabolic disease with complex causes, and it serves as a major risk factor for a range of diseases including diabetes, fatty liver disease, cardiovascular and cerebrovascular diseases, kidney disease, joint disorders, sleep-disordered breathing, and cancer. China has the world's largest population of individuals with overweight or obesity, a trend that is likely to rise[7]. Obesity is associated with multiple comorbidities and is a major contributor to reduced life expectancy and quality of life. In 2019, overweight and obesity accounted for 11.1% of deaths from chronic non-communicable diseases in China, nearly doubling from 5.7% in 1990[8]. Despite the chronic nature of obesity and its need for long-term management, treatment options remain limited. While lifestyle interventions remain the cornerstone of treatment, many patients struggle to achieve or maintain meaningful weight reduction. This underscores the urgent need for safe, effective, and sustainable pharmacological interventions. About Mazdutide Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of mazdutide, a dual GCG /GLP-1 receptor agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, liver fat content and improved insulin sensitivity. Mazdutide is approved by NMPA for chronic weight management in adults with overweight or obesity*; and mazdutide currently has another NDA accepted for review by NMPA, for glycemia control in adults with type 2 diabetes. Mazdutide has currently conducted seven Phase 3 clinical studies, including: GLORY-1: A Phase 3 clinical study conducted in Chinese adults with overweight of obesity; GLORY-2: A Phase 3 clinical study conducted in Chinese adults with moderately to severely obesity; GLORY-3: A Phase 3 clinical study comparing mazdutide versus semaglutide in Chinese adults with overweight of obesity accompanied metabolic-associated fatty liver disease (MAFLD); GLORY-OSA: A Phase 3 trial in Chinese participants with obstructive sleep apnea (OSA) and obesity; DREAMS-1: A Phase 3 clinical study conducted in Chinese adults with untreated type 2 diabetes; DREAMS-2: A Phase 3 clinical study comparing mazdutide versus dulaglutide in Chinese adults with type 2 diabetes who have poor glycemia control with oral medication; DREAMS-3: A Phase 3 clinical study comparing mazdutide versus semaglutide in Chinese adults with type 2 diabetes and obesity; Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints and the other four studies are currently ongoing. In addition, several new clinical studies of mazdutide are initiated or planned, including: A Phase 3 trial in adolescents with obesity; New studies in patients with metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF). *Mazdutide is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial Body Mass Index (BMI) of: BMI ≥ 28 kg/m² (obesity); or BMI ≥ 24 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, or obstructive sleep apnea syndrome and etc.). About Innovent Biologics 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 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, 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. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement 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. REFERENCES [1] Multidisciplinary Clinical Consensus on Diagnosis and Treatment of Obesity (2021 edition), Chinese Journal of Endocrinology and Metabolism. 2021;37(11):959-972. [2] Qin X, Pan J. The Medical Cost Attributable to Obesity and Overweight in China: Estimation Based on Longitudinal Surveys. Health Econ. 2016;25(10):1291-1311. doi:10.1002/hec.3217 [3] Guideline for Chronic Weight Management and Clinical Practice of Anti-obesity Medications (2024 version). Chinese Journal of Endocrinology and Metabolism. 2024,40(7): 545-564 [4] Expert Consensus on Weight Management for Type 2 Diabetes Mellitus. International Journal of Endocrinology and Metabolism.2024,44(5):359-370 [5] Expert Consensus on Glucagon-like Peptide-1 Receptor Agonist Analogs Combined with Lifestyle Intervention for Weight Loss (2024 Edition). Chinese Journal of Diabetes, 2024 [6] Interpretation of National Health Commission of the People's Republic of China. National Clinical Practice Guideline on Obesity Management (2024 Edition). Chinese Medical Journal, 2025, *105*(18): 1387-1391. [7] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373-92 [8] Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. 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