Serplulimab

WALTHAM, Mass. & SHANGHAI--( BUSINESS WIRE )--Palleon Pharmaceuticals, a company pioneering glyco-immunology drug development to treat autoimmune diseases and cancer, today announced a collaboration and license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) to develop and commercialize Palleon’s first-in-class human sialidase enzyme therapeutic, E-602, in combination with Henlius’ self-developed HANLIKANG (rituximab) in patients with autoimmune diseases, including lupus nephritis (LN). Depleting B cells with targeted antibodies such as rituximab (anti-CD20 mAb) is an established treatment for several autoimmune diseases, however, many patients have inadequate response to these drugs. Glyco-immunology provides a new approach to treating autoimmunity by enhancing depletion of activated memory B cells, the pathogenic subset of B cells associated with disease progression and often resistant to antibody-mediated depletion. E-602 enzymatically degrades sialoglycans—immunosuppressive cell surface sugars that protect pathogenic memory B cells from depletion by B cell-targeted antibodies. Preclinical studies of E-602 in combination with rituximab demonstrate improved outcomes versus rituximab alone without the risk of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) associated with CAR T and T cell engagers. E-602 has demonstrated a favorable safety profile with no dose-limiting toxicities in human clinical trials, which makes it suitable for the outpatient community setting. “Palleon’s glycan editing therapeutic has the potential to significantly improve treatment outcomes in patients who have autoimmune diseases including lupus nephritis, with a therapy that achieves optimal patient accessibility, including delivery in community outpatient settings,” said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. “We look forward to continuing our successful partnership with Henlius and expanding glyco-immunology drug development to address a new category of patients in need of better treatment options.” Under the terms of the agreement, Henlius received an exclusive China license to Palleon’s E-602. Palleon is eligible to receive up to $95.3 million in certain predetermined development and commercial milestones, in addition to royalties upon E-602 commercialization in China. Henlius shall perform and fund E-602 development in China in combination with HANLIKANG for the treatment of lupus nephritis. This partnership expands upon Palleon and Henlius’ ongoing collaboration in oncology formed in June 2022 to co-develop targeted sialidase therapies in cancer. “We are pleased to expand our collaboration with Palleon Pharmaceuticals, the leader in the novel field of glyco-immunology,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. “HANLIKANG is the only rituximab approved for an autoimmune indication in China. We are committed to bringing better therapies to patients who suffer from lupus nephritis and other autoimmune conditions for which current treatment options are not always sufficient.” E-602 is a first-in-class human sialidase enzyme therapeutic developed from Palleon’s EAGLE glycan editing platform. HANLIKANG (rituximab) is the first-ever biosimilar developed and approved in China. About Palleon Pharmaceuticals Palleon Pharmaceuticals is the leading biotechnology company developing drugs that harness glyco-immunology to treat cancer and autoimmune diseases. The company’s proprietary platforms enable new target discovery, patient selection, and the development of novel therapeutics for devastating diseases characterized by immune system dysfunction. The groundbreaking discoveries of Palleon Co-Founder and Nobel laureate Carolyn Bertozzi enabled development of the company’s glycan editing therapeutic platform. www.palleonpharma.com 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. To date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 25 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. Henlius has established a global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has proactively 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 the 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 the 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 tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (nsNSCLC), 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.

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