Xiamen (China), Castres (France), February 23rd, 2022 – Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE:300685), and the French pharmaceutical group Pierre Fabre announced that the companies have entered into a collaboration to develop Companion Diagnostic (CDx) kits in China, supporting encorafenib and binimetinib marketing authorization applications.
AmoyDx will provide Pierre Fabre with kits to detect BRAF mutation in tumor samples. These Companion Diagnostics (CDx) candidate kits are currently being validated in two clinical studies in China, to demonstrate they are correctly selecting the right patients for optimized use of treatment with encorafenib +/- binimetinib.
“We are honored to establish the collaboration with Pierre Fabre, an expert in oncology drug development. We share the same ambition as Pierre Fabre to bring the best cancer therapy and precision medicine solution to patients. AmoyDx has been focusing on tumor molecular diagnosis since its establishment in 2008. We look forward to providing Pierre Fabre with excellent companion diagnostic service through our expertise in precision medicine.” said Li-Mou Zheng, Ph.D., Founder and Chairman of AmoyDx.
“Pierre Fabre is committed to support Chinese physicians providing the right drug to the right patients at the right time. We are delighted to begin a collaboration with AmoyDx, an expert in molecular diagnosis, to develop the most accurate companion tests for our targeted therapies. This will contribute to identify the patient’s type of cancer very precisely and therefore to propose the most suitable treatment.” added Jean Luc Lowinski, Medical Care Business Unit CEO of Pierre Fabre.
About companion diagnostic
An in vitro companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Companion diagnostics can identify patients who are most likely to benefit from a particular therapeutic product, or to be at increased risk for serious adverse reactions as a result of treatment with the therapeutic product or to monitor response to treatment with the therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness or for whom the therapeutic product has been adequately studied and found to be safe and effective.
About encorafenib and binimetinib
In the European Union, the combination of encorafenib and binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, and encorafenib is also indicated in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.
Encorafenib and binimetinib are not registered in China. Pierre Fabre has been granted exclusive rights to commercialize encorafenib and binimetinib in Europe and Asia (excluding Japan and South Korea).
Amoy Diagnostics Co., Ltd. is a pioneer and globally leading company in the field of molecular diagnostics for precision oncology, focusing on companion diagnostics product development and commercialization. A rich product portfolio has been established with more than twenty products approved by China NMPA, EU authority, Japan MHLW, South Korea MFDS, etc. Patients in more than 60 countries are benefiting from AmoyDx products. With multiple technological platforms and full capability for companion diagnostics product development and commercialization, AmoyDx has become an important diagnostics partner of many pharmaceutical companies over the globe. For more information, please visit www.amoydiagnostics.com.
About Pierre Fabre
Pierre Fabre is a French health and beauty care company with 35-years of experience in innovation, development, manufacturing and commercialization in oncology, and the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.
Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncology, Pierre Fabre Dermatology, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.
The company has recently reaffirmed oncology as one of its main R&D and commercial priorities, focusing on targeted therapies, biotherapies and immuno-oncology. Its therapeutic areas include unmet medical needs, and cover colorectal, breast, lung cancers, melanoma and pre-cancerous conditions such as actinic keratosis.
In 2020, Pierre Fabre generated €2.3 billion in revenues, 65% of which came from international sales.
Established in the South-West of France since its creation, the Group manufacturs over 95% of its products in France and employs some 10,000 people worldwide. Its products are distributed in about 130 countries.
Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognised public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.
In 2020, Ecocert Environnement assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard for the 2nd consecutive year and confirmed its “Excellence” level.
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