Bevacizumab biosimilar(Shanghai Henlius)

HANQUYOU shipped to the United States, offering high-quality, affordable treatment options to North American patients - Henlius' first product exported to the U.S., enabling commercial supply to regions including China, Europe, Latin America, the Middle East, North America, and Southeast Asia - HANQUYOU approved in 50 countries and regions, benefiting over 220,000 patients - SHANGHAI, Dec. 2, 2024 /PRNewswire/ -- On November 29, 2024, Henlius' independently developed and produced trastuzumab biosimilar, HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac® in Europe), departed from Henlius' Songjiang First Plant, heading to the U.S. This milestone marks the company's first commercial supply to North America, representing a significant breakthrough in its global expansion. With this achievement, Henlius has successfully extended its commercial supply network to include China, Europe, Latin America, the Middle East, North America and Southeast Asia. Ms. Wei Huang, President of Henlius, stated that, "The U.S., as the world's largest biopharmaceutical market, imposes stringent requirements on drug supply systems and the comprehensive strengths of companies. The successful entry of HANQUYOU into the U.S. market not only expands our international footprint but also lays a solid foundation for the globalization of our other products. Since the commercial launch of HANQUYOU in 2020, we have successfully shipped approximately 6.5 million units globally, continuously enhancing our production and supply capabilities in our relentless effort to benefit more patients." Dr. Frank Ye, Vice President and Chief Quality Officer, stated that, "High quality is the key to establishing a firm foothold on the global stage, earning customer trust, and enabling products to succeed in international markets. More importantly, it serves as the solid foundation for us to benefit more patients worldwide as medicine quality directly impacts patient lives. At Henlius, we remain committed to upholding the highest international standards of quality, delivering high-quality biologics to even more patients." HANQUYOU is a China-developed mAb biosimilar approved in China, the European Union (EU) and U.S. It is now approved in 50 countries and regions including the U.S., United Kingdom (UK), Canada, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, and it is reimbursed nationally in countries and regions including China, the UK, France and Germany. To date, HANQUYOU has benefited over 220,000 patients with HER2 positive breast and gastric cancer worldwide. HANQUYOU's extensive global reach is a testament to Henlius' relentless pursuit of excellence in product quality. Henlius has established a quality management system that meets international standards. Its three production sites – Xuhui Facility, Songjiang First Plant and Songjiang Second Plant – along with their quality management systems, have successfully passed approximately 100 inspections and audits conducted by regulatory agencies and international business partners across various countries. The company has been GMP-certified by China, the U.S., the EU as well as PIC/S member countries such as Indonesia and Brazil, equipped with a solid foundation for the global supply of its products. The successful U.S. launch of HANQUYOU also dates from Henlius' exclusive partnership with Intas and its subsidiary, Accord. In collaboration with leading global biopharmaceutical companies such as Accord, Abbott, Eurofarma, and KGbio, Henlius has proactively established a global commercial layout for HANQUYOU. Looking ahead, Henlius will continue to strengthen its collaborations with global partners to accelerate the global launch of more high-quality medicines, benefiting more patients worldwide. 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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules 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, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), 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. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI, Nov. 8, 2024 /PRNewswire/ -- On the morning of November 7, at the 7th China International Import Expo (CIIE), Henlius (2696.HK) entered into a strategic collaboration with AL-TIRYAQ AL-KHALAWI Medical Company ("SVAX"), a subsidiary entity of Saudi Arabia's prominent family business group in the healthcare sector, the Fakeeh Family. The two parties will establish joint ventures in Saudi Arabia to integrate Henlius' leading capabilities in the research, development, and manufacturing of biologics with SVAX's local expertise in registration, market access, and commercialization. The collaboration seeks to advance the global registration and commercialization of multiple Henlius products and enhance the accessibility of advanced biologics across the Middle East, North Africa, and Türkiye (MENAT) countries, and benefit more patients. The signing ceremony was attended by Ms. Weilai Shen, Director of the Foreign Economic Cooperation Department of the Shanghai Municipal Commission of Commerce, Mr. Gang Ling, The Science and Economy Commission of the People's Government of Shanghai Pudong New Area, Mr. Qiyu Chen, Co-CEO of Fosun International, Mr. Yifang Wu, Chairman of Fosun Pharma, Mr. Wenjie Zhang, Executive President of Fosun Pharma and Chairman of Henlius, Mr. Ammar Fakeeh, Chairman of the Family Business, and Prof. Mazen M. Hassanain, Founder and Managing Director of SVAX. According to the agreement, Henlius and SVAX will establish joint ventures for commercialization and manufacturing in Saudi Arabia and will collaborate on a series of Henlius products in the MENAT region, including HANDAYUAN (adalimumab, HLX03) and HANBEITAI (bevacizumab, HLX04), to conduct local commercial and manufacturing activities. In addition, the two parties will initially focus on jointly investing in the development of Henlius' investigational biosimilar of pembrolizumab, HLX17, to accelerate its global registration and commercialization. Mr. Wenjie Zhang, Executive President of Fosun Pharma and Chairman of Henlius, stated, "Our collaboration with SVAX is a crucial step in Henlius' global blueprint, strengthening our presence in key markets while enhancing our international competitiveness. Through this partnership, we aim to drive innovation and growth for both parties, advance the research and manufacturing of high-quality biologics, and deliver more affordable therapies to patients in MENAT countries, thereby contributing to the global healthcare initiative. " Dr. Jason Zhu, CEO of Henlius, said, "We are delighted to collaborate with SVAX. This partnership not only complements our global strategy but also reaffirms our commitment to 'patient-centered' care. SVAX's dedication to innovation and improving regional healthcare closely aligns with Henlius' mission. Together, by combining SVAX's extensive resources and local expertise in MENAT with Henlius' global outlook and innovative capabilities, we are poised to bring more high-quality, innovative biologics to patients across the region and beyond." Mr. Ammar Fakeeh, Chairman of the Family Business, stated, "We are honored to forge this strategic partnership with Henlius, whose excellence in biopharmaceutical innovation perfectly complements our mission to elevate healthcare in the MENAT region. By joining forces, we are enhancing access to essential, high-quality biologics and strengthening the foundations of a resilient healthcare ecosystem in Saudi Arabia and beyond. This collaboration represents an important step forward in delivering advanced therapies to patients, embodying our commitment to health, innovation, and sustainable impact." Prof. Mazen Hassanain, Founder and Managing Director of SVAX, stated, "We at SVAX are delighted to enter this strategic partnership with Henlius, a company known for its commitment to high-quality and innovative biologic medicines. Combining our knowledge and experience in regulatory, marketing, sales, and local manufacturing with Henlius' expertise in biopharmaceutical development and global supply, we aim to bring cutting-edge therapies to the MENAT region and impact patients' lives. This partnership aligns with our dedication to advancing healthcare in the Kingdom of Saudi Arabia and beyond, fostering an ecosystem where life-changing therapies are accessible to those who need them. Together with Henlius, we look forward to driving growth, innovation, and healthcare accessibility across the region." As a global, innovative biopharmaceutical company, Henlius is dedicated to offering high-quality, affordable, and innovative biologic medicines for patients worldwide, focusing on oncology, autoimmune diseases, and ophthalmic diseases. Henlius continuously enhances the development and operational efficiency of its integrated R&D, production, and commercialization platform. Through various measures to improve product accessibility, the company drives the commercial growth of core products and achieves sustained high-quality profitability. Henlius has proactively built a diversified, high-quality product pipeline covering over 50 molecules. Six products have been launched in China, three have been approved for marketing in overseas markets, and 24 indications are approved worldwide, benefiting over 670,000 patients. Specifically, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S. and Zercepac® in Europe) has been approved in 49 countries and regions globally, making it the China-developed mAb biosimilar with the most marketing approvals and benefiting over 215,000 patients with breast and gastric cancer. Henlius collaborates with international partners to promote China's biopharmaceutical innovation and advance global development, with a presence across Asia, Europe, Latin America, North America, and Oceania. The MENAT region represents a significant part of the global pharmaceutical market. With growing healthcare needs and supportive government policies, the biopharmaceutical industry in the area is witnessing a rapid transformation. In June 2024, Zercepac® successfully shipped to Saudi Arabia, becoming the first China-developed monoclonal antibody (mAb) to enter the Middle Eastern market. The strong tie between Henlius and SVAX will help achieve joint development for the two parties and foster pharmaceutical innovation in emerging markets. Henlius remains committed to enhancing its global competitiveness, meeting global clinical needs, and spurring biopharmaceutical innovation. About SVAX SVAX is a pioneering Saudi company with a mission to localizing biomanufacturing within Saudi Arabia and ensuring a steady, high-quality supply of vaccines and biologics for the region. Established to bolster national health security, SVAX actively supports the region's preparedness for pandemics against infectious diseases. Aligned with Saudi Vision 2030 and the Saudi National Biotechnology Strategy, the company is at the forefront of nationalizing the biomanufacturing sector by employing highly skilled Saudi scientists and professionals. SVAX is distinguished as a local developer and manufacturer of essential biologics that serves Saudi Arabia and the broader MENAT region. The company operates through three strategic business segments: innovation, manufacturing, and advisory services. Its innovation efforts are focused on advanced R&D in biologics and vaccines, driving forward innovation and collaboration to bring cutting-edge therapies to market. In manufacturing, SVAX is establishing a state-of-the-art technologies and facilities to produce vaccines and biologics that meet global standards. Meanwhile, through its advisory services, SVAX offers expert consulting to support and accelerate the development of a strong biotech industry across the region. Through these initiatives, SVAX is uniquely positioned to drive transformative change in biomanufacturing, ensuring that the region remains resilient, innovative, and prepared for future healthcare challenges. 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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules 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, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), 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. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED