Latest news with #NationalMedicalProductsAdministration
Yahoo
a day ago
- Health
- Yahoo
China NMPA approves Zeiss Medical's retinal imaging system
China's National Medical Products Administration (NMPA) has approved Zeiss Medical Technology's retinal imaging system, the ZEISS CLARUS 700, with fluorescein angiography (FA). 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. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
5 days ago
- Business
- Yahoo
Akeso gains NMPA approval for cadonilimab to treat cervical cancer
China's National Medical Products Administration (NMPA) has approved Akeso's PD-1/CTLA-4 bispecific antibody, cadonilimab, to treat persistent, recurrent or metastatic cervical cancer. This third indication approval allows its use in combination with platinum-based chemotherapy and potentially bevacizumab. The therapy is also approved for treating advanced gastric cancer and relapsed or metastatic cervical cancer after platinum-based chemotherapy failure. The NMPA approval is based on the results from the Phase III COMPASSION-16 study. Patients treated with cadonilimab in this trial exhibited efficacy benefits, particularly those whose tumours tested negative for PD-L1 expression, when compared to the control group. The study achieved both overall survival (OS) and progression-free survival (PFS) endpoints. Further insights from COMPASSION-16 revealed that irrespective of PD-L1 status or bevacizumab use, patient subgroups experienced enhanced outcomes with cadonilimab therapy. The inclusion of this new agent in 16 clinical guidelines features its growing importance across oncology fields such as gastric and gynaecological cancers. Akeso founder, chairwoman, president and CEO Xia Yu commented: 'Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings. 'This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and patient quality of life. 'This achievement reflects Akeso's robust innovation capabilities and commitment to cancer patient outcomes, and aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide.' More than 30 ongoing Phase II and III trials are evaluating cadonilimab's potential against other malignancies, including lung and pancreatic cancers. "Akeso gains NMPA approval for cadonilimab to treat cervical cancer" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
29-05-2025
- Business
- Yahoo
China's HER2-Targeted ADC Trastuzumab Rezetecan Gains NMPA Approval for HER2-Mutant NSCLC
SHANGHAI, May 29, 2025 /PRNewswire/ -- The National Medical Products Administration has recently granted approval for Trastuzumab rezetecan, China's first domestically developed antibody-drug conjugate (ADC), for treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations who have previously received at least one systemic therapy. The approval of Trastuzumab rezetecan was based on the pivotal HORIZON-Lung study led by Professor Lu Shun at Shanghai Chest Hospital, which demonstrated groundbreaking efficacy in HER2-mutant locally advanced or metastatic NSCLC patients who have received prior systemic therapy. The trial achieved a median follow-up of 14.2 months, an IRC-confirmed objective response rate (ORR) of 74.5%, and a median progression-free survival (mPFS) of 11.5 months—thereby doubling the efficacy of conventional treatments. In addition, Trastuzumab rezetecan significantly reduced the toxicity risks typically associated with conventional ADCs. These results have redefined global benchmarks for ADC research and garnered significant attention from the international scientific community. Trastuzumab rezetecan has achieved breakthroughs in both efficacy and safety through pioneering molecular design from the ground up, a milestone made possible by Hengrui Pharmaceuticals' decade-long development of its ADC R&D platform, the Hengrui Rapid Modular ADC Platform (HRMAP). HRMAP enables end-to-end capabilities spanning molecular design, preclinical optimization, and clinical translation. To date, Hengrui has advanced over 10 differentiated ADC candidates into clinical development, including Trastuzumab rezetecan, its flagship HER2-targeted ADC therapy. Shun Lu, MD, PhD, Director of oncology department (Shanghai Lung Tumor Clinical Medical Center)，China, and principal investigator of Horizon-Lung, said, "the HORIZON-Lung study validates Trastuzumab rezetecan as a transformative therapy for HER2-mutant NSCLC, addressing a critical unmet need for advanced HER2-driven NSCLC patients in China. Grounded in epidemiological data that accurately reflect China's NSCLC epidemiological landscape, this therapeutic advance not only provides a novel treatment option for patients, but also heralds China's emergence as a pioneering force in shaping the global ADC landscape for precision oncology. Beyond its established efficacy in lung cancer, Trastuzumab rezetecan has demonstrated significant clinical advances across multiple tumor types, with eight additional indications—including breast cancer, colorectal cancer, gastric cancer, biliary tract cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer—receiving Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA). View original content: SOURCE Hengrui Pharma Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
16-05-2025
- Health
- Yahoo
Xuanzhu Biopharm's Xuanyuening® (BireociclibTablets) Approved for Dual Indications, Bringing Innovative Breakthroughs to Breast Cancer Treatment
HONG KONG, May 15, 2025 /PRNewswire/ -- On May 15, 2025, the latest announcement released by the National Medical Products Administration attracted widespread attention in the oncology community and the pharmaceutical market. Bireociclib tablets (trade name: Xuanyuening®), a Class 1 anti-tumor new drug independently developed by Xuanzhu Biopharmaceutical was officially approved for marketing. This innovative drug is indicated for two important conditions in HR+/HER2- breast cancer. It not only injects new vitality into the domestic breast cancer treatment field but also brings new hope to a large number of breast cancer patients. Bireociclib tablets are applicable to adult patients with advanced or metastatic breast cancer who are positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2). On the one hand, it can be combined with fulvestrant for patients with disease progression after previous endocrine therapy. On the other hand, it is the only CDK4/6 inhibitor approved in China as monotherapy for the patients with disease progression after receiving two or more endocrine therapies and one chemotherapy in the metastatic stage. According to authoritative data, approximately 420,000 new breast cancer cases are diagnosed in China each year, among which nearly 100,000 are advanced breast cancer patients. The launch of Bireociclib tablets undoubtedly provides a new and effective treatment option for this large patient group. Globally, breast cancer is the most common malignant tumor among women, with approximately 70% being the hormone receptor-positive subtype. Although the advent of CDK4/6 inhibitors has significantly extended patients' survival, current treatments still face many challenges. The efficacy of existing drugs is limited in premenopausal patients; patients with visceral crisis have a poor prognosis; some patients have difficulty tolerating the adverse reactions of the drugs; and the problem of primary drug resistance is also prominent. Bireociclib tablets, with their innovative multi-target mechanism of action (acting on CDK2, 4, 6, and 9), can precisely block the tumor cell proliferation pathway while significantly reducing the incidence of hematological toxicity. This not only achieves a strong and continuous inhibition of tumors but also greatly improves patients' tolerance to treatment, bringing new possibilities for addressing existing treatment bottlenecks. The clinical trials of Bireociclib tablets, which were carried out in line with the characteristics of breast cancer patients in China, have highly valuable data. There are differences in the onset characteristics of breast cancer patients between China and Western countries. Chinese patients have an earlier median age of onset, a higher proportion of Luminal B-type tumors, primary drug resistance, and chemotherapy populations, which lead to a relatively poor prognosis. The clinical research of Bireociclib tablets is precisely tailored to the Chinese treatment situation. In the research group, 23.9% of patients had received advanced chemotherapy, 25.6% were primary drug-resistant patients, 37% were premenopausal patients, and 68.2% had visceral metastases. When used in combination, the median progression-free survival of second-line treatment patients reached 14.7 months (assessed by researchers), and the result evaluated by the Blinded Independent Review Committee (BIRC) was as long as 17.5 months. Notably, Bireociclib tablets achieved a breakthrough application in single-drug posterior line treatment, with patients having a progression-free survival of up to 11 months, setting a new record for similar therapies globally and providing a better solution for the posterior line treatment of advanced breast cancer worldwide. In terms of market potential, with the increase in the incidence of breast cancer and the growing demand of patients for more effective treatment options, Bireociclib tablets have broad market prospects. According to market research institutions, the market size of CDK4/6 inhibitors in China is expected to reach tens of billions of yuan in the next five years. Bireociclib tablets, with their unique dual indications and excellent efficacy, are expected to occupy an important share in the market. At present, Xuanzhu Bio has simultaneously launched the work of accessing the national medical insurance system, aiming to achieve the treatment goals of "accessible, affordable, and effective" for patients and actively contribute to the implementation of the "Healthy China" strategy. This initiative not only reflects the corporate social responsibility but also will further promote the widespread application of Bireociclib tablets in clinical treatment, bringing health benefits to more breast cancer patients. About Xuanzhu Biopharm Xuanzhu Biopharmaceutical is the innovative drug subsidiary of Sihuan Pharmaceutical. It is an innovative pharmaceutical company with roots in China and a global perspective, focusing on major diseases such as digestion, oncology and non-alcoholic steatohepatitis, and is committed to the research and development, production and commercialization of class 1 drugs with core proprietary intellectual property rights. The company has a first-class R&D team, all core personnel have years of experience in new drug research and development. The company has two R&D platforms: small molecule chemistry and large molecule biologics. The dual engines drive the company's innovation and development, forming a product pipeline that covers small molecule chemistry, large molecule biopharmaceuticals, antibody-drug conjugate (ADC) and other types of products. With a focus on unmet major clinical needs, the company is committed to developing into a first-class innovative pharmaceutical company with independent research and development, production, and sales capabilities. About Sihuan Pharmaceutical Founded in 2001 and listed on the Main Board of The Stock Exchange of Hong Kong Limited in 2010, Sihuan Pharmaceutical is an international medical aesthetic and pharmaceutical company led by innovation, with an independent and leading research and development technology platform, a rich global product pipeline, strong product registration capability, a full dosage form production platform with high efficiency and low cost and a mature and excellent sales system. Adhering to the overall strategic goal for the "full promotion of a two-wheel drive strategy of its medical aesthetics and biopharmaceutical businesses", Sihuan Pharmaceutical endeavors to build itself into a leading medical aesthetics and biopharmaceutical company in China. Contact: Sihuan IR DepartmentT: +852 36283911E: ir@ View original content: SOURCE Sihuan Pharmaceutical Holdings Group Ltd. 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Business Times
30-04-2025
- Health
- Business Times
China asks drugmakers, hospitals to find US import substitutes
[NEW YORK] China has asked some of its state-owned drugmakers to study how they can reduce reliance on the US for pharmaceutical products and raw materials, sources familiar with the matter said, as Beijing prepares for a potential decoupling that threatens its medical supply. Chinese drug regulator National Medical Products Administration conveyed the message to executives of state-owned drugmakers earlier this year, said the sources, who asked not to be identified as the deliberations are private. The directive was to assess the feasibility of replacing US-made healthcare products. The goods identified for potential replacement – by either sourcing locally or from other countries such as Japan – range from ingredients and supplies used to make drugs to lab equipment and testing reagents, the sources said. The discussion started soon after Donald Trump returned to the White House in January, and at least two Chinese state-owned drugmakers have since completed taking stock of their US exposure, the sources said. The effort underscores Beijing's broader plan to check vulnerabilities arising from its trade war with the US. The tit-for-tat escalation has seen both sides ratchet up tariffs on each other's goods to over 100 per cent, threatening to wipe out commerce between the world's two largest economies. Separately, China's health regulator National Health Commission also told some of the country's top hospitals to study the feasibility of replacing US imported products with homegrown ones or those from other countries, according to one of the sources. BT in your inbox Start and end each day with the latest news stories and analyses delivered straight to your inbox. Sign Up Sign Up China's large hospitals are major buyers of advanced medical equipment such as Magnetic Resonance Imaging and ultrasound scans produced by American firms including GE HealthCare Technologies and Medtronics. In addition to medical devices, hospitals in China also procure US-made reagents, drugs and other medical consumables for testing and treatments. Drugmakers also source antibodies, culture mediums, fillers and other ingredients used in clinical research and manufacturing from the US. China also imports blood products such as plasma and albumin from America. There will not be any immediate substitution of US medical imports, as Chinese regulators will have to review any alternative supplies submitted by drugmakers to ensure such replacement will not compromise quality and safety, the sources said. The National Medical Products Administration and National Health Commission did not respond to Bloomberg's faxed requests for comments. At the same time, there are signs that trade tensions could ease – Trump promised to be 'very nice' in any trade talks with China while Beijing is reportedly considering suspending its 125 per cent tariff on some US imports. Still, the medical goods substitution plan marks China's effort to not be held to ransom in the long run as its relations with the US have continued to deteriorate. China's retaliatory tariff against US imports is already taking a toll on hospitals and drugmakers. Without tariff exemptions, some imported pharmaceutical goods have seen prices hikes, local medical science online portal Dingxiangyuan reported on Monday (Apr 28), citing suppliers and researchers. Some hospitals have 5 per cent of their drug supply coming from the US, which is now subject to China's 125 per cent tariff, Michael Hart, president of the American Chamber of Commerce in China, told reporters during a briefing in Beijing on Friday. While China has long pushed for domestic replacement of imported medical products and already manufactures most commonly used medicines and ingredients as well as essential medical equipment, Chinese drugmakers still import substantial amounts of raw materials from the US, due in part to lower quality of domestic alternatives. Replacing cutting-edge medical gear from the US in the near term remains challenging, as domestic firms have yet to develop such technically sophisticated products. BLOOMBERG
