關於 cookie 的說明

本網站使用瀏覽器紀錄 (Cookies) 來提供您最好的使用體驗,我們使用的 Cookie 也包括了第三方 Cookie。相關資訊請訪問我們的隱私權與 Cookie 政策。如果您選擇繼續瀏覽或關閉這個提示,便表示您已接受我們的網站使用條款。

搜尋結果Search Result

符合「India」新聞搜尋結果, 共 3351 篇 ,以下為 169 - 192 篇 訂閱此列表,掌握最新動態
Sungrow Hits 20GW Shipment in India: Providing Pioneer PV Inverters for a Sustainable Future

NEW DELHI, Nov. 17, 2023 /PRNewswire/ -- Sungrow, the global leading PV inveter and energy storage system supplier, reached a significant milestone in India, having shipped a cumulative total of 20GW of photovoltaic inverters in the region. This achievement highlights Sungrow's position as a leading provider of clean energy solutions in India. India, a country with vast solar energy potential, has long been a key market for Sungrow. Sungrow entered the Indian market in 2014 and established an Indian branch, along with three offices in New Delhi, Mumbai, and Bengaluru. It is worth noting that Sungrow also established its India manufacturing facility with 10 GW in annual production capacity, and has completed five years of manufacturing in India, which displays the positive impact of Sungrow participation in the "Make in India" initiative and offering more local job opportunities. Sungrow's 20GW milestone is a testament to the Company's strong commitment to meeting India's growing demand for clean energy. Sungrow's photovoltaic inverters are at the forefront of solar technology, efficiently converting solar energy into electricity to power homes and businesses across the country, for instance, the innovative "1+X" modular central inverter and the new generation 320kW string inverter etc. have quickly increased Sungrow's market share. "At Sungrow, we hope to create a sustainable world by providing innovative and reliable clean energy solutions," said Sunil Badesra, Country Head of Sungrow India. "We are proud of our achievements in India and look forward to continuing our partnership with local enterprises and communities to promote clean energy and reduce carbon emissions." Sungrow has been actively engaged in India's burgeoning solar energy sector. It has already reached several GW of partnerships with Indian power giants, such as TATA Power, Adani Green, Renew Power, Azure Power, O2 Power, Mahindra, ACME, S&W, L&T, and others.  In addition, Sungrow actively participates in the formulation of renewable energy policies and standards within Indian government departments, conducting extensive research and development in clean energy technology in collaboration with local universities and scientific research institutions, as well as other public service activities, according to Sunil. Sungrow remains committed to expanding its presence in India and other global markets. The Company will continue to innovate and offer advanced clean energy solutions tailored to meet each region's specific needs. Sungrow will also help India achieve 50% renewable energy electricity by 2030, a substantial increase from 38% in 2020 with partners. About Sungrow  Sungrow Power Supply Co., Ltd. ("Sungrow") is the world's most bankable inverter brand with over 405 GW installed worldwide as of June 2023. Founded in 1997 by University Professor Cao Renxian, Sungrow is a leader in the research and development of solar inverters with the largest dedicated R&D team in the industry and a broad product portfolio offering PV inverter solutions and energy storage systems for utility-scale, commercial & industrial, and residential applications, as well as internationally recognized floating PV plant solutions, NEV driving solutions, EV charging solutions and renewable hydrogen production systems. With a strong 26-year track record in the PV space, Sungrow products power over 150 countries worldwide. For more information about Sungrow, visit www.sungrowpower.com. 

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 641 加入收藏 :
QIMA Expands Consumer Products Testing Capabilities with New Facility in India

The State-of-the-Art Lab Offers Flexibility for Textiles, Toys and Chemicals Industries TIRUPUR, India, Nov. 15, 2023 /PRNewswire/ -- QIMA, a leader in testing, inspection, certification and compliance solutions, has opened the doors of its latest product testing facility in Tirupur, India. This strategic expansion reinforces QIMA's commitment to serve the evolving needs of its global manufacturing partners, brands and retailers, enhancing its presence in key sourcing countries. Located in the city of Tirupur, one of the most recognized sourcing hubs in Southeast Asia, the new laboratory is positioned to serve brands and suppliers in the textile and toys industries. The new lab is ISO 17025 accredited and has obtained CPSC approval for toys, which provides a tremendous resource for brands in the United States looking to source from India. As global supply chains continue to diversify geographically, the addition of the Tirupur lab complements QIMA's global labs network, with established presence in Asia (China, Hong Kong SAR, Bangladesh, Vietnam), Europe (Germany) and Americas (U.S., Mexico). "The expansion of QIMA's India presence underscores our understanding and commitment to meeting and exceeding the quality expectations of the world's largest manufacturers and their consumers," says Sebastien Breteau, CEO of QIMA. "We recognize the impact of India on the supply chain and the country's ambition to realize its full manufacturing potential. The new QIMA lab is ready to support our clients with complete quality and compliance solutions in the region." "The Tirupur lab will significantly improve efficiency and workflow for our global testing practice", Lab Manager Baalaji KC, states, "The textile industry relies on a well-connected lab network, and our new QIMA facility in India is a key addition. It enables both local and global suppliers who produce for various brands around the world, to have in-country support throughout the entire process, with fast turnaround and optimized pricing." The lab is currently in operation and testing textile products according to product safety regulations including REACH, CPSIA and 16 CFR. The location of the lab is in close proximity to major manufacturing sites and buying offices, facilitating quick response, developing an even greater strategic advantage for QIMA and its partners. About QIMA QIMA is more than a testing, inspection, certification, and compliance company; QIMA is on a mission to offer clients smart solutions to make products consumers can trust. With a global reach spanning 100+ countries, QIMA serves the consumer products, food and life sciences industries, supporting more than 30,000 brands, retailers, manufacturers and food growers. The company combines on-the-ground expertise with digital solutions to bring accuracy and visibility for quality, safety and compliance data. What sets QIMA apart is its unique culture: 5,000 employees live and make decisions every day by the QIMA Values. With client passion, integrity, and a commitment to making things simple, QIMA continues to disrupt the Testing, Inspection and Certification industry.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 859 加入收藏 :
XCMG Machinery Going Glocal: the 2,000th Excavator That Made in India Rolls Off Assembly Line

CHENNAI, India, Nov. 3, 2023 /PRNewswire/ -- XCMG Machinery ("XCMG", SHE:000425) has celebrated the 2,000th excavator which is locally produced in its factory in India on October 20, marking a significant milestone as XCMG ventures further in global business development that takes root in localized operations. XCMG Machinery Going Glocal: the 2,000th Excavator That Made in India Rolls Off Assembly Line. "Since its establishment, XCMG Machinery (India) has developed an integrated product portfolio customized for the construction conditions in India, set up experienced and stable management and manufacturing teams, and has doubled the sales. Looking ahead, XCMG Machinery (India), as the prominent manufacturing center in South Asia, will continue to cultivate in the India market and expand to cover the neighboring countries," said Tu Hui, general manager of XCMG Machinery (India). XCMG's Glocal strategy of advancing localized operation continues to empower industry development, support major infrastructure projects worldwide, and support the cultivation of technical talents. The XGC150-IA crawler crane has participated in India's longest sea bridge - Mumbai Trans Harbour Link (MTHL) project which was completed earlier this year. With a total length of 21.8 kilometers, the bridge will cut the commuting time between Mumbai and New Mumbai from two hours to 20 minutes, a boost to the local economy. In May, XCMG inaugurated its first overseas talent training base in its factory in India, an integrated global training center of technical capabilities, services, sales and brand development and product promotion. XCMG currently has two subsidiaries in India, the XCMG India Manufacturing ("XCMM India") and SCHWING Stetter India. Founded in 2017 and put into operation in 2021, XCMM India produces and assembles a wide range of products including excavators, loaders, road rollers, wide-body pump trucks and more, it has an annual production capacity of 8,500 units of construction machinery equipment and 3,500 sets of self-manufactured components with joined force from over 300 India employees, of 33% females. Meanwhile, XCMM India launched a series of charity events to co-create a fresh environment through the tree planting event, while fostering an equal, diverse and inclusive community with Pongal and Diwali celebrations and community donations of stationery and gifts. SCHWING Stetter India was established in 1998 and produces concrete machinery equipment including pump trucks and mixers, it also sells and provides services for all series of XCMG products. Its annual production capacity of concrete machinery is around 25,000 units and the company has 2,700 Indian employees. XCMG now has 28 offices and 82 dealers in India, and the locally manufactured products are selling across the regions of South Asia, the Middle East, and Africa. "India is the largest construction machinery market in South Asia and an indispensable key region of XCMG's international strategy, and the group fully supports the development of its Indian subsidiaries that are becoming the benchmark of XCMG's overseas manufacturing bases," said Zhang Lina, Chief Cultural Officer of Excavator Division, XCMG.  

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 2869 加入收藏 :
Prime Minister Narendra Modi calls for India to take global leadership in 6G at Asia's biggest Tech Show India Mobile Congress 2023 with participation from 67 countries

NEW DELHI, Oct. 31, 2023 /PRNewswire/ -- Indian Prime Minister Narendra Modi praised the swift roll-out of 5G in India and raised the clarion call for India to take a leadership role globally in 6G at the 7th Edition of India Mobile Congress (IMC) 2023, the largest telecom, media and technology forum in Asia. Jointly organized by the Department of Telecommunications (DoT), Government of India and the Cellular Operators Association of India (COAI), the three-day forum-cum-exhibition held from 27th-29th October, 2023 witnessed participation from over 67 countries under the theme of Global Digital Innovation.  Hon'ble Prime Minister of India Narendra Modi Inaugurates India Mobile Congress 2023 in New Delhi, India In his inaugural speech, PM Modi also announced the '100 5G lab Initiative', which aims to develop 5G applications to foster innovation across socio-economic sectors and build a 6G-ready ecosystem in the country. According to Mr. Ramakrishna P, CEO, India Mobile Congress (IMC), "It has been a great experience seeing IMC grow over the years to emerge as a platform showcasing India's growing prowess as a technology, telecom and manufacturing powerhouse to the world. This year's edition showcased over 620 use cases, 5G technologies, 6G demos, AI/ML, IoT, Network automation, semiconductors, electronic manufacturing, green tech and women in tech. A notable addition to this year's IMC was Aspire, a pioneering start-up initiative showcasing around 400 startups from across the country. Several educational institutions also showcased their innovations. We are especially enthused with the noteworthy participation from over 67 countries and look forward to increased global representation in the coming years." During IMC 2023, more than 400 speakers participated in over 80 sessions conducted on a range of subjects including Industry 4.0, 5G Applications, Enterprise Digital Transformation, Sustainable Development, Monetizing Connectivity, Role of India in global semiconductor landscape, 6G standardization, Meeting India's telecommunications needs, Network Evolution beyond 5G, Evolution of AI and Future of Networks and others. Besides leading Indian companies, notable international brands like Ericsson, Intel, Nokia, Cisco, Accenture, AMD, Qualcomm, MediaTek, Red Hat, Bosch, VMware, Ciena and others were also present at IMC 2023. India Mobile Congress 2023 also recognized outstanding achievements in the Information and Communication Technology (ICT) and Telecom, Media, and Technology (TMT) sectors in over 16 diverse categories at the coveted IMC 2023 awards.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 681 加入收藏 :
Henlius Deepens Collaboration with Intas to bring Henlius' Novel anti-PD-1 mAb Serplulimab to Europe and India

The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India  Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive €42 million upfront payment, double-digit royalties and up to €143 million in regulatory and commercial milestone payments  SHANGHAI, Oct. 27, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) has entered into an exclusive license agreement with Intas Pharmaceuticals Limited ("Intas") for the development and commercialisation in Europe and India for several indications including ES-SCLC, and specific formulation of HANSIZHUANG (serplulimab injection), Henlius' novel anti-PD-1 mAb. In June 2018, Henlius and Accord Healthcare Ltd., a subsidiary of Intas, entered into a license agreement, under which Henlius granted Accord exclusive commercialisation rights of HLX02 (trastuzumab for injection, trade name in China: HANQUYOU; trade name in Europe: Zercepac®; trade names in Australia: Tuzucip®/Trastucip®) in certain countries and regions in Europe, the Middle East, North Africa, and the Commonwealth of Independent States. In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada. This collaboration marks a deepening of the strategic partnership between the two companies and opens up new development opportunities for serplulimab's global layout. Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing and supply upon launch and will receive a €42 million upfront payment, up to €43 million in regulatory milestones, up to €100 million in commercial sales milestones, and double-digit royalties on net profit from Intas in the licensed territory. "With superior efficacy and data quality, HANSIZHUANG (serplulimab) has become the world's first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for 4 indications in China, benefiting over 40,000 Chinese patients. Its marketing application has been validated by the European Medicines Agency (EMA) in March 2023," said Jason Zhu, Executive Director, Chief Executive Officer, and Chief Financial Officer of Henlius. "By continuously partnering with Intas, we hope to accelerate serplulimab's wider accessibility globally and contribute to the improvement of patient outcomes." Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, "Henlius and Intas first entered into a collaboration in 2018. Over the past 5 years, we have worked closely together and expanded the internationalisation of HANQUYOU (Zercepac® in Europe), which has been successfully approved in 40+ overseas countries, benefiting patients in Europe and MENA. Building on the successful collaboration, we look forward to working with Intas to accelerate the launch of serplulimab in Europe and India, and to continue our mission to offering high-quality and affordable biologics to patients around the world." Binish Chudgar, Vice-Chairman & Managing Director, Intas Pharmaceuticals Ltd., said, "We are excited to reinforce our long-standing partnership with Henlius. This collaboration will further bolster Intas' global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide. The forthcoming launch of serplulimab in Europe and India will mark a crucial landmark in our mission to enable access to advanced biologics, ensuring patients across the world receive the high-quality treatments they deserve." Paul Tredwell, Executive Vice President of EMENA., Accord, said, "I am delighted to strengthen our partnership with Henlius. The launch of serplulimab will further solidify Accord as a leader in providing specialty medicines. This marks our second novel launch in just two years, adding to our existing platform of supplying up to 25% of chemotherapy medicines in our region, exemplifying our commitment to innovation and growth and our mission to improve access to value-based medicines for patients." The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA) and Nature Medicine. Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., enrolling more than 3,600 subjects globally. And the proportion of Caucasians is over 30% in two multi-regional clinical trials (MRCTs). Its global clinical trial data will further support marketing applications in global markets and lay a foundation for clinical applications all over the world in the future. In 2022, serplulimab was successively granted orphan drug designations by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC, which will enable it to benefit from certain policy support for research and development, registration, and commercialisation in the U.S. and Europe. The EMA has validated the application for serplulimab and it is expected to be approved in the first half of 2024. The company is also steadily advancing the bridging head-to-head trial in the U.S. to compare serplulimab to standard-of-care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to propel the product towards U.S. market approval. In the meantime, Henlius pro-actively advances the commercialisation of HANSIZHUANG in overseas markets at high speed. Henlius granted KGbio exclusive rights to develop and commercialize HANSIZHUANG in 10 ASEAN member countries and 12 MENA countries. Furthermore, Henlius and Fosun Pharma have entered into an exclusive license agreement for HANSIZHUANG in the U.S. HANSIZHUANG's coverage footprint now includes the U.S., Europe, Southeast Asia, MENA, and India. In the future, Henlius will join hands with its international partners to make full use of their respective resources and advantages to actively promote the development and commercialisation of HANSIZHUANG globally, to enable it to cover a wider range of countries and regions and to provide more therapeutic choices for more patients. About HANSIZHUANG (serplulimab) HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 4 indications are approved for marketing in China, 1 marketing application is under review in the EU, and more than 10 clinical trials are ongoing across the world. HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). Its marketing applications of the first-line treatment for ES-SCLC are under review by the EMA. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial approvals in China, the U.S., the EU and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine and the British Journal of Cancer, respectively. Furthermore, HASIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way. About Intas Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing companies in the world. The company has set up a network of subsidiaries under the name Accord for marketing and selling in the highly regulated markets of EU, US, Canada, South Africa, Australia, Asia Pacific, CIS and MENA regions. Intas is present in 85+ countries worldwide with more than 69% of its revenue coming from global business, particularly the highly regulated markets of the EU and the US. Currently ranked 6th (As per IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical market, it is also the largest privately owned Indian generic pharmaceutical company. While Intas has established leadership in key therapeutic segments like CNS, Cardiovascular, Diabetology, Plasma Therapy, Cell and Gene Therapy, Gastroenterology, Urology and Oncology in India, the company is known for its range of products in Oncology and other hospital-based therapeutic segments in the EU and US. Intas' success and growth are a direct influence of Intas' extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, of which eleven are in India, and the rest in the U.K., Greece, and Mexico. Between them, the facilities are accredited by top global regulators such as the US FDA, EMA, MHRA, TGA, and others. Every year, the company invests 6-7% of its revenues in R&D. Currently, Intas has over 10,000 product registrations worldwide and a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars and NDDS products. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 2 marketing applications have been accepted for review in the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 559 加入收藏 :
Henlius Deepens Collaboration with Intas to bring Henlius' Novel anti-PD-1 mAb Serplulimab to Europe and India

The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive €42 million upfront payment, double-digit royalties and up to €143 million in regulatory and commercial milestone payments SHANGHAI, Oct. 27, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) has entered into an exclusive license agreement with Intas Pharmaceuticals Limited ("Intas") for the development and commercialisation in Europe and India for several indications including ES-SCLC, and specific formulation of HANSIZHUANG (serplulimab injection), Henlius' novel anti-PD-1 mAb. In June 2018, Henlius and Accord Healthcare Ltd., a subsidiary of Intas, entered into a license agreement, under which Henlius granted Accord exclusive commercialisation rights of HLX02 (trastuzumab for injection, trade name in China: HANQUYOU; trade name in Europe: Zercepac®; trade names in Australia: Tuzucip®/Trastucip®) in certain countries and regions in Europe, the Middle East, North Africa, and the Commonwealth of Independent States. In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada. This collaboration marks a deepening of the strategic partnership between the two companies and opens up new development opportunities for serplulimab's global layout. Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing and supply upon launch and will receive a €42 million upfront payment, up to €43 million in regulatory milestones, up to €100 million in commercial sales milestones, and double-digit royalties on net profit from Intas in the licensed territory. "With superior efficacy and data quality, HANSIZHUANG (serplulimab) has become the world's first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for 4 indications in China, benefiting over 40,000 Chinese patients. Its marketing application has been validated by the European Medicines Agency (EMA) in March 2023," said Jason Zhu, Executive Director, Chief Executive Officer, and Chief Financial Officer of Henlius. "By continuously partnering with Intas, we hope to accelerate serplulimab's wider accessibility globally and contribute to the improvement of patient outcomes." Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, "Henlius and Intas first entered into a collaboration in 2018. Over the past 5 years, we have worked closely together and expanded the internationalisation of HANQUYOU (Zercepac® in Europe), which has been successfully approved in 40+ overseas countries, benefiting patients in Europe and MENA. Building on the successful collaboration, we look forward to working with Intas to accelerate the launch of serplulimab in Europe and India, and to continue our mission to offering high-quality and affordable biologics to patients around the world." Binish Chudgar, Vice-Chairman & Managing Director, Intas Pharmaceuticals Ltd., said, "We are excited to reinforce our long-standing partnership with Henlius. This collaboration will further bolster Intas' global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide. The forthcoming launch of serplulimab in Europe and India will mark a crucial landmark in our mission to enable access to advanced biologics, ensuring patients across the world receive the high-quality treatments they deserve." Paul Tredwell, Executive Vice President of EMENA., Accord, said, "I am delighted to strengthen our partnership with Henlius. The launch of serplulimab will further solidify Accord as a leader in providing specialty medicines. This marks our second novel launch in just two years, adding to our existing platform of supplying up to 25% of chemotherapy medicines in our region, exemplifying our commitment to innovation and growth and our mission to improve access to value-based medicines for patients." The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA) and Nature Medicine. Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., enrolling more than 3,600 subjects globally. And the proportion of Caucasians is over 30% in two multi-regional clinical trials (MRCTs). Its global clinical trial data will further support marketing applications in global markets and lay a foundation for clinical applications all over the world in the future. In 2022, serplulimab was successively granted orphan drug designations by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC, which will enable it to benefit from certain policy support for research and development, registration, and commercialisation in the U.S. and Europe. The EMA has validated the application for serplulimab and it is expected to be approved in the first half of 2024. The company is also steadily advancing the bridging head-to-head trial in the U.S. to compare serplulimab to standard-of-care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to propel the product towards U.S. market approval. In the meantime, Henlius pro-actively advances the commercialisation of HANSIZHUANG in overseas markets at high speed. Henlius granted KGbio exclusive rights to develop and commercialize HANSIZHUANG in 10 ASEAN member countries and 12 MENA countries. Furthermore, Henlius and Fosun Pharma have entered into an exclusive license agreement for HANSIZHUANG in the U.S. HANSIZHUANG's coverage footprint now includes the U.S., Europe, Southeast Asia, MENA, and India. In the future, Henlius will join hands with its international partners to make full use of their respective resources and advantages to actively promote the development and commercialisation of HANSIZHUANG globally, to enable it to cover a wider range of countries and regions and to provide more therapeutic choices for more patients. About HANSIZHUANG (serplulimab) HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 4 indications are approved for marketing in China, 1 marketing application is under review in the EU, and more than 10 clinical trials are ongoing across the world. HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). Its marketing applications of the first-line treatment for ES-SCLC are under review by the EMA. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial approvals in China, the U.S., the EU and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine and the British Journal of Cancer, respectively. Furthermore, HASIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way. About Intas Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing companies in the world. The company has set up a network of subsidiaries under the name Accord for marketing and selling in the highly regulated markets of EU, US, Canada, South Africa, Australia, Asia Pacific, CIS and MENA regions. Intas is present in 85+ countries worldwide with more than 69% of its revenue coming from global business, particularly the highly regulated markets of the EU and the US. Currently ranked 6th (As per IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical market, it is also the largest privately owned Indian generic pharmaceutical company. While Intas has established leadership in key therapeutic segments like CNS, Cardiovascular, Diabetology, Plasma Therapy, Cell and Gene Therapy, Gastroenterology, Urology and Oncology in India, the company is known for its range of products in Oncology and other hospital-based therapeutic segments in the EU and US. Intas' success and growth are a direct influence of Intas' extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, of which eleven are in India, and the rest in the U.K., Greece, and Mexico. Between them, the facilities are accredited by top global regulators such as the US FDA, EMA, MHRA, TGA, and others. Every year, the company invests 6-7% of its revenues in R&D. Currently, Intas has over 10,000 product registrations worldwide and a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars and NDDS products. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 2 marketing applications have been accepted for review in the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 512 加入收藏 :
ESMT joins Electronica India 2023
發表時間 :
2025 年 3 月 28 日 (星期五) 農曆二月廿九日
首 頁 我的收藏 搜 尋 新聞發佈