全球制药公司Cipla成立于1935年，专注于灵活、可持续增长和仿制药的开发，并在印度、南非、北美和其他关键监管和新兴市场不断优化其产品组合。Cipla在呼吸学、抗逆转录病毒、泌尿学、心脏病学和中枢神经系统方面的优势得到了普遍认可。通过遍布于世界各地的47处生产基地，Cipla利用其国际顶尖的技术平台生产出50多种剂型的1500多种产品，满足了全球范围内80多个市场的需求。其销量在印度制药行业排名第三（IQVIA MAT，2022年5月），南非私营制药市场排名第三（IQVIA YTD, 2022年5月），同时也是美国市场中最知名的仿制药企业之一。在过去的80年间，Cipla一直将改变病患的用药状况作为工作的导向。2001年，Cipla在非洲以每天不到1美元的价格提供了艾滋病的抗逆转录病毒三重疗法，这一行业范例的举措被广泛认为对抵抗艾滋病运动贡献了更多的包容性、可及性和可负担性。作为一个具有高度责任感的企业，Cipla围绕“关爱生命”这一目标所践行的人道主义策略和其在所到之处建立的良好关系网络，成为全球医疗卫生机构、同行业以及所有利益相关者信赖的合作伙伴。 Henlius HANQUYOU Received TGA Approval in AustraliaShanghai, China, Jul, 25th, 2022 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company’s business partner Cipla Limited (“Cipla”) has received the relevant registration certificates from the Therapeutic Goods Administration of Australia (“TGA”) for the approval of Henlius’ self-developed and manufactured HANQUYOU (trastuzumab, trade name in Europe: Zercepac®) with the specification of 150mg/vial in Australia under the trade names Tuzucip® and Trastucip®, covering all indications of the reference trastuzumab approved in Australia. At present, Henlius is working with Cipla in Australia and this approval will help both parties bring HANQUYOU to more patients in Australia.Henlius independently developed HANQUYOU in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), US Food and Drug Administration (USFDA) and other international biosimilar guidelines. It was approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020, respectively, and became the first Chinese mAb biosimilar to enter both the European Union (EU) and China markets. In particular, Zercepac® (150mg/vial) has launched in about 20 European countries and regions, including the United Kingdom, Germany, Spain, France, and Italy, and the dosage forms of 60mg/vial and 420mg/vial were also approved for marketing in the EU.Henlius has taken multiple head-to-head comparisons between HANQUYOU and the reference trastuzumab, including comparative quality studies, preclinical studies, a phase 1 clinical study and a global multi-certre phase 3 clinical study. These data proved that HANQUYOU and reference trastuzumab are highly similar in terms of quality, safety and efficacy. The approval of HANQUYOU by TGA of Australia was mainly based on the review of a series of studies. The relevant application materials are mainly based on the information in the Marketing Authorization Application (MAA) in relation to the product submitted to the EU. HANQUYOU has been approved in Australia for the treatment of HER2-positive early breast cancer, HER2-positive locally advanced breast cancer, HER2-overexpressing metastatic breast cancer and HER2-positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction.In 2018, Henlius granted Cipla the exclusive rights to develop and commercialize HANQUYOU in several countries including Australia and is solely responsible for the production and supply of HANQUYOU for Cipla in the licensed territories. The manufacturing facilities for HANQUYOU and the quality management system are in line with global standards. Among them, the Xuhui Facility has obtained Good Manufacturing Practice (GMP) certifications from China and the EU, making it the first plant that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies in China. Also, the facility has successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency, the EU qualified person, and multiple international business partners. In May 2022, Songjiang First Plant has been approved for the commercial manufacturing of HANQUYOU by the NMPA with a total capacity of 24,000L, to support the growing global demands for the product.To date, the 150mg form of HANQUYOU has completed the tendering process on the procurement platform and was included in the medical insurance procurement platform for all provinces in the Chinese mainland while the 60mg form has completed the tendering process on the procurement platform in 23 provinces and was included into the medical insurance procurement platform in 30 provinces in the Chinese mainland, benefiting nearly 70,000 patients. In addition, the company has actively collaborated with global partners such as Cipla, Accord, Abbott, Eurofarma, Mabxience, Jacobson, etc. to bring HANQUYOU to patients in over 90 countries and regions, covering the United States, Canada, Europe, and many emerging markets. Looking forward, Henlius will give full play to the company’s footprints in innovation and globalization, continue to promote the implementation of the company’s all-round evolution strategy towards a global Biopharma and boost the accessibility and influence of Henlius’ products in the global market by reaching out to more strategic partners and bring hope to more patients.
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 in Europe, 13 indications approved worldwide, and 2 New Drug Applications (NDAs) accepted for review in China. 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, 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 tumors and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What’s more, Henlius has conducted over 20 clinical studies for 12 products and 10 combination therapies.
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 47 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT May’22), 3rd largest in the pharma private market in South Africa (IQVIA MAT May’22), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders.