ShanghaiJuly 26, 2022/ PR Newswire /-- on July 25, 2022, Fuhong Hanlin (2696.HK) announced that its business partner Cipla Limited ("Cipla") had received the relevant registration certificate for the 150mg/ bottle developed and produced independently by Fuhong Hanlin.®(trastuzumab, European trade name: Zercepac®) approved by the Australian Drug Administration (Therapeutic Goods Administration, TGA) to be listed under the trade name Tuzucip®And Trastucip®Covering all indications approved by the original trastuzumab in Australia. At present, Fuhong Hanlin is working with Cipla in Australia, and this approval will help both sides work together to make Hanqu excellent.®To more Australian patients.
Accelerate the navigation of the sea, globalListing in 20 countries
Han Quyou®It is a trastuzumab bioanalogue independently developed by Fuhong Hanlin in accordance with the regulations of China, the European Union and the United States. It was approved by the European Commission and China's State Drug Administration (NMPA) in July and August 2020. It is the first China-Europe double-batch monoclonal antibody drug independently developed by China. As the representative of domestic bio-drug "going out to sea", Zercepac®(150mg) has been successfully listed in about 20 European countries and regions, including the United Kingdom, Germany, Spain, France and Italy, and its 60mg and 420mg specifications have also been approved in the European Union.
Fu Hong Hanlin carried out a series of head-to-head comparison studies on Hanqu you, including quality comparison studies, preclinical studies, clinical phase I and international multicenter clinical III studies, etc., which proved Hanqu excellent.®It is highly similar to the original trazumab in terms of quality, safety and efficacy. This time, Han qu is excellent.®The approval is mainly based on a review of a series of research data by TGA in Australia, and the relevant application materials are mainly based on the information submitted by the product to the European Commission for Marketing Authorization (Market Authorization Application,MAA). The approved indications include: 1) early breast cancer with positive HER2; 2) locally advanced breast cancer with positive HER2; 3) metastatic breast cancer with overexpression of HER2; and 4) advanced gastric or gastroesophageal borderline adenocarcinoma with positive HER2.
Expand business value to benefit patients around the world
In 2018, the company signed a license and supply agreement with Cipla, awarding Cipla Hanqu you®The right to exclusive development and commercialization in a number of countries, including Australia, and is exclusively supplied by Fuhong Hanlin's production base in China. Han Quyou®The production and quality control links comply with the highest international standards, and the Xuhui base is the first production base in China to obtain China-Europe double GMP certification for the production of independent research and development of antibody biopharmaceuticals, and the production base and its supporting quality management system have also passed a number of on-site inspections and audits by NMPA, the European Drug Administration (EMA), the European Union quality Authorization (QP) and the company's international business partners. May 2022, Han Quyou®The supplementary application for changing the production site has been approved by NMPA. The approved Songjiang base (1) has a planned production capacity of 24000L, which can all be applied to Hanquyou.®Commercial production, strongly support the continuous volume of products.
At present, Han Quyou®The 150mg specification has completed bidding and health insurance access in all provinces in China, while the 60mg specification has completed bidding in 23 provinces and health insurance access in 30 provinces, benefiting nearly 70, 000 patients in China so far. In addition, the company also works with world-class biopharmaceutical companies such as Cipla, Accord, Abbott, Eurofarma, Mabxience and Jacob Pharmaceutical, covering more than 90 countries and regions in the United States, Canada, Europe and many emerging countries. Looking to the future, Fuhong Hanlin will give full play to the company's advantages of global linkage, integration and innovation, and continue to promote the company's omni-directional evolution strategy towards international Biopharma. At the same time, it will further improve Hanqu excellent by building more new strategic partnerships.®The accessibility and influence in more countries and regions around the world bring hope to more patients.
About Fuhong Hanlin
Fuhong Hanlin (2696.HK) is an international and innovative biopharmaceutical company, committed to providing affordable high-quality biopharmaceuticals to patients around the world, covering oncology, autoimmune diseases, ophthalmology and other fields. Five products have been listed in China, one product has been listed in Europe, 13 indications have been approved, and two registration applications have been accepted by the China Drug Administration. Since its establishment in 2010, Fuhong Hanlin has built an integrated biopharmaceutical platform with efficient and innovative independent core competencies throughout the R & D, production and commercial operation industry chain. The company has established a perfect and efficient global innovation center to carry out production and quality control in accordance with the International Pharmaceutical production quality Management Code (GMP) standards, and constantly consolidate the integrated production platform, among which Shanghai Xuhui Base has obtained China and EU GMP certification, Songjiang Base (1) has also obtained Chinese GMP certification.
Fuhong Hanlin prospectively laid out a diversified and high-quality product line, covering more than 20 kinds of innovative monoclonal antibodies, and comprehensively promoted its own anti-PD-1 monoclonal antibody H drug.®Combined tumor immunotherapy. After Hanlikang, the first bioanalogous drug in China®(rituximab), the first China-Europe double-batch monoclonal antibody drug developed by China and Europe.®(trastuzumab, European trade name: Zercepac®Australian trade name: Tuzucip®And Trastucip®), Han Dayuan®(Adamumab) and Han Beitai®(bevacizumab) has been approved to be put on the market, and the innovative product Hans shape®(Srulliumab) has been approved for the treatment of microsatellite highly unstable (MSI-H) solid tumors, and applications for registration of two indications for squamous non-small cell lung cancer and extensive small cell lung cancer are also under review. At the same time, the company has carried out more than 20 clinical trials on 12 products and 10 combined immunotherapy schemes worldwide, authorizing a comprehensive coverage of the mainstream biomedical markets in Europe and the United States and many emerging markets.
AboutCipla
Founded in 1935, Cipla, a global pharmaceutical company, focuses on flexible, sustainable growth and generic drug development, and continuously optimizes its product portfolio in India, South Africa, North America and other key regulatory and emerging markets. The advantages of Cipla in respiratory, antiretroviral, urology, cardiology and central nervous system have been widely recognized. Through 47 production sites around the world, Cipla uses its international top technology platform to produce more than 1500 products in more than 50 dosage forms, meeting the needs of more than 80 markets around the world. Its sales rank third in the Indian pharmaceutical industry (IQVIA MAT, May 2022), the private pharmaceutical market in South Africa ranks third (IQVIA YTD, May 2022), and it is also one of the most well-known generics companies in the US market. Over the past 80 years, Cipla has focused on changing patients' drug use. In 2001, Cipla offered triple antiretroviral therapy for AIDS in Africa for less than $1 a day, an industry model initiative widely recognized as contributing more inclusiveness, accessibility and affordability to the campaign against AIDS. As a highly responsible enterprise, Cipla's humanitarian strategy around the goal of "caring for life" and its network of good relationships wherever it goes, has become a trusted partner of global health institutions, the same industry, and all stakeholders.