List of Biosimilars Companies in Taiwan - 3

GlycoNex Inc. was founded in 2001, in alliance with The Biomembrane Institute (TBI) from Washington University and Dr. Sen-Itiroh Hakomori, a member of the National Academy of Sciences (USA). GlycoNex was the first pharmaceutical company in Taiwan to combine cancer-related glycan identification with human monoclonal antibody development. GlycoNex Inc. possesses a complete and detailed technological platform for anti-glycan antibody development, including multiple acquired licensed patents. Our pipeline consists of new drug development in parallel with biosimilars. Our new drugs were selected and developed through a detailed antigen/antibody characterization and cell line development. In 2009, we licensed GNX8 to Otsuka Pharmaceutical Co., Ltd. In 2019, our first-in-class new drug GNX102 received FDA IND approval. In 2020, we initiated our Clinical Trial Phase I dose-escalation study for GNX102 and received TFDA IND approval. In parallel, our biosimilar products Denosumab and Aflibercept have completed different volumes of pilot studies and data ready for review. We aim to look for opportunities of out-licensing our products or co-develop in cooperation.

美時化學製藥股份有限公司（股票代碼：1795）成立於 1966 年，目前為台灣營收規模最大的製藥公司，也是一家全球性的製藥公司。美時專注於新藥和學名藥的商業化，致力爲患者提供更好、更安全、更易取得的藥品。公司擁有亞洲公認的一流研發和製造平台，並在包括美國、歐洲、日本、中國和巴西在內的幾乎所有全球市場建立了合作夥伴關係。美時在亞洲和美國進行超過 100 多個戰略選擇的製藥項目，其中包括 250 多種商業化產品。公司通過內部研發投資和合作授權，投資高門檻的腫瘤用藥、複雜學名藥以及 505（b）2 和 NCE 組成的多元化最佳產品組合，並透過戰略合作夥伴的支持下加強生物相似藥產品，以加强其產品組合競爭力。美時有亞洲地區最頂尖的研發中心與生產設備，也是台灣唯一同時獲得美國 FDA、歐盟 EMA、日本 PDMA、中國 FDA、及巴西 ANVISA 認證的藥廠。 Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with global presence, focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. The Company has a recognized best-in-class R&D and manufacturing platform in Asia and has established partnerships in nearly every global market including the U.S., Europe, Japan, China, and Brazil. Lotus runs over 100 strategically selected pharmaceutical projects in development and registrations across Asia and the US, with over 250 commercial products. The Company invests in diversified best portfolio consisting of high-barrier oncology, complex generics as well as 505(b)2 and NCE via internal R&D investment and licensing-in partnership, and also strengthens its portfolio competitiveness by adding biosimilar products with support from strategic partners. Its industry-leading infrastructure certified by most of the advanced regulatory authorities around the world, including US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.

Established in 2012, Medigen Vaccine Biologics Corp (MVC) is a subsidiary of Medigen Biotechnology Corp (www.medigen.com.tw), Taipei, Taiwan. MVC develops vaccines and biosimilars for important unmet medical needs. Our focus is to deliver affordable medicines for developing countries and with a particular focus on SE Asia. We aim to become one of the leading pharmaceutical companies for Taiwan and global communities. Humanity, innovation, and quality are MVC core values. We integrate biomedical technologies to improve human health so that every person, from infants to seniors, has a chance to be free from infectious diseases. Our most advanced products are MVC-1901 and MVC-EVA71. MVC-1901 is a spike-protein-based subunit vaccine for COVID-19. Based on a very large phase 2 trial powered to assess safety and efficacy by immunobridging, the vaccine has EUA status in Taiwan. Phase 3 trials for full approval are in progress. MVC-EVC71A is an inactivated whole virus-based vaccine for enteroviral disease in children between 2 months and 12 years of age. The vaccine has recently completed a phase 3 trial and is currently in regulatory review for commercial licensing.