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增加汉曲优®美国及加拿大授权,复宏汉霖(02696)携手Accord全面覆盖欧美市场

Increase the license of Hanquyou ®in the United States and Canada, Fuhong Hanlin (02696) join hands with Accord to cover the European and American markets

智通财经 ·  Sep 30, 2020 17:08

On September 30,2020, Fuhong Hanlin (02696) announced that it was working with Accord Healthcare Inc. (referred to as "Accord US") has reached a cooperation agreement to grant it exclusive development and commercial rights in the United States and Canada to HLX02 (Chinese brand name: Hanquyou ®, EU brand name: Zercepac ®). The conclusion of this cooperation indicates that the commercial layout of HLX02 has fully covered the mainstream biological drug market in Europe and the United States, and can participate in the international competition on behalf of Chinese biosimilar drugs, which is expected to bring high-quality and high-price treatment for patients all over the world.

Based on the terms of the cooperation, the major milestone payments that Accord US will pay to Fuhong Hanlin include: 1) the down payment of US $27 million after the signing of the formal license agreement; 2) the regulatory milestone payment, totaling no more than US $13 million. Based on the research data obtained by Fuhong Hanlin, Accord US will be responsible for completing the registration of HLX02 in the United States and Canada and obtaining listing permits. 3) the sales milestone payment will be paid according to the accumulated net sales in the region, and US $25 million will be paid to Fuhong Hanlin for every $500m of net sales. In addition, Fuhong Hanlin will also be eligible for a double-digit percentage of net profit classification royalties in the future, up to 50%. According to the IQVIA report, the market size of trastuzumab and its bioanalogues in North America has exceeded 3 billion US dollars in 2019, and the demand of patients for drugs is increasing year by year. Fuhong Hanlin is expected to receive a sales milestone payment of $150 million when HLX02's cumulative sales in the United States and Canada reach $3 billion.

Hanqu you ®(EU trade name: Zercepac ®) is a trastuzumab independently developed and produced by Fuhong Hanlin in accordance with EU and Chinese regulations on bioanalogous drugs. In July and August 2020, it was approved by the European Commission and China's State Drug Administration to be marketed. It became the first domestic McAb bioanalogue in both China and Europe, and all indications of the original trastuzumab were approved, including: 1) HER2 positive early breast cancer. 2) HER2 positive metastatic breast cancer, 3) HER2 positive metastatic gastric adenocarcinoma or gastroesophageal borderline adenocarcinoma. The commercialization of Hanquyou ®in the domestic market is promoted by Fuhong Hanlin's independent commercialization team. at present, its first prescription has been released and has been officially put into clinical application. The commercialization of the product in the EU is undertaken by partner Accord Healthcare Ltd (Accord UK) and will be sold in all EU member states as well as in the European Economic area countries Norway, Iceland and Liechtenstein, and has recently taken the lead in the United Kingdom, Germany, Portugal and Spain.

Fuhong Hanlin prospectively carried out the global commercial layout of HLX02. In June 2018, the company signed a license agreement with Accord UK, granting its HLX02 exclusive commercial rights in Europe, parts of the Middle East and North Africa, and some CIS countries. Since then, the two sides reached further cooperation in June 2020 to make agreements on the new specifications of HLX02 and its corresponding milestone payment arrangements, license fee adjustment, etc., in order to reduce the cost of medication per unit dose of patients, meet the personalized drug needs of patients, and pave the way for the continuous development of overseas markets. Based on the friendly cooperation between Fuhong Hanlin and Accord UK, Accord continues to strengthen its confidence in Fuhong Hanlin's product quality and industry leadership, and actively promoted the cooperation between Fuhong Hanlin and Accord US. This is not only the further recognition of the high-quality biopharmaceuticals independently developed by Fuhong Hanlin in the international market, but also an important measure for Fuhong Hanlin to actively promote its international layout. Mr. Jeff Hampton, President of Accord US, said, "We are very pleased to reach a cooperation with Henlius on the further promotion of HLX02 in the North American market. The conclusion of this cooperation is another fulfillment of our commitment to provide quality and affordable products and improve drug accessibility for cancer patients, and HLX02 will add brilliance to Accord's existing rich cancer treatment pipeline. "

While entering the mainstream biopharmaceutical market in Europe and the United States, the company also regards the development of emerging markets as the focus of its globalization strategy. In addition to Accord, Fuhong Hanlin has reached strategic commercial cooperation with many leading global pharmaceutical companies, including Jacobson Pharmaceutical, Cipla and Mabxience, covering Hong Kong, Macau, Malaysia, Australia, New Zealand, Colombia, Argentina, Uruguay, Paraguay, as well as more than 80 countries and regions in Europe, Middle East-North Africa and CIS. In the future, Fuhong Hanlin will take HLX02 as an excellent example to build the international quality of products and go to the international market, continue to practice the core concept of "affordable innovation and trustworthy quality", and continue to expand the international layout of more products, so that the high-quality biopharmaceuticals made in China will benefit more patients around the world, and become the most trusted innovative biomedical company in the world.

The translation is provided by third-party software.


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