July 29, 2020Fuhong Hanlin-B(02696) Joint partner Accord Healthcare Limited ("Accord") jointly announced that the European Commission (European Commission,EC) has approved trastuzumab (HLX02, EU trade name: Zercepac ®) developed and produced by Fuhong Hanlin to be marketed in the EU, which has obtained all the indications approved by the original drug in the EU: 1) HER2 positive early breast cancer; 2) HER2 positive metastatic breast cancer; 3) HER2 positive metastatic gastric cancer. Fuhong Lintrazumab has become the first "Chinese nationality" monoclonal antibody similar drug to enter the European market, opening up a precedent for Chinese pharmaceutical companies to participate in the "World Cup" competition of monoclonal antibody similar drugs.

The European Union is the first region in the world to formulate guidelines for bioanalogues, and it is also the most important mature market for bioanalogues in the world. In May 2020, the Human Pharmaceutical products Committee of the European Drug Administration (European Medicines Agency, EMA) (Committee for Medicinal Products for Human Use, CHMP) reached a positive review opinion after a series of strict reviews of Zercepac ®, and recommended EC to approve the application for listing and sales license of Zercepac ®. According to the final review decision published by EMA, "in accordance with the EU requirements for bioanalogues, Zercepac®With reference drug Herceptin®Highly similar structure, purity and biological activity. In addition, clinical studies of HER2 positive metastatic breast cancer patients showed that Zercepac®And Herceptin®The clinical effect is equivalent. These data are sufficient to prove that Zercepac®The efficacy and safety are similar to those of reference drugs for approved indications. [1] with the approval of HLX02 (EU trade name: Zercepac ®) in Europe, its commercialization will be undertaken by Accord and will be available for sale in all EU member states as well as in the European Economic area countries Norway, Iceland and Liechtenstein. Sales of the original trazumab and its bioanalogues in the European Union, Norway, Iceland and Liechtenstein reached $1.37 billion in 2019, according to IQVIA MIDASTM data.

Fuhong Han lintrazumab has been recognized by international authoritative drug regulatory agencies, thanks to the company's long-term strict requirements on product quality. Under the persistence and leadership of the company's two co-founders, Dr. Liu Shigao and Dr. Jiang Weidong, the development and production process of HLX02 (EU trade name: Zercepac ®) are up to the international quality standards, and developed in accordance with the relevant regulations of biological similar drugs in China and the European Union, and carried out a number of head-to-head studies with the original trastuzumab. It includes quality comparative study, non-clinical similarity study, clinical phase 1 and international multicenter clinical phase 3 study. The production base of HLX02 (EU trade name: Zercepac ®) has obtained EU GMP certification, and it is also the first GMP factory in China to obtain EU GMP certification for the production of independent research and development of antibody biological drugs, breaking the GMP barriers of domestic monoclonal antibody biological drugs listed overseas, and playing a vital role in successfully landing products in the European market.

Professor Xu Binghe, principal researcher of HLX02 (EU trade name: Zercepac ®) international multicenter clinical phase 3 study, said: "I am honored to see that the efficacy and safety of bioanalogs independently developed by Fuhong Hanlin have been affirmed by international authoritative drug regulatory agencies. The clinical trials of bioanalogues in China have also been recognized by EMA, which is a major leap in the course of domestic clinical trials. Look forward to seeing more and more countries and regions with HER2-positive breast cancer and gastric cancer patients receive 'Chinese nationality' trastuzumab treatment, contributing to China's' good voice'in HER2 targeted therapy. "

Dr. Liu Shigao, co-founder and CEO of Fuhong Hanlin, said: "We have always been 'high-quality biological drugs for the benefit of global patients' as our mission, and this EU approval of trastuzumab is an important milestone in the company's international strategy. it marks that we meet the international quality standards in the research and development and production of biological drugs. We will work with our partner Accord to advance the follow-up work of Zercepac ®in Europe as soon as possible, and further expand the accessibility in other regions to bring high-quality monoclonal antibody biomedical treatment options to more patients around the world. "

Mr. Paul Tredwell, Vice President (EMENA region) of Accord, said: "the Accord anti-tumor product line is expanding and is now able to provide more than 30 high-quality, affordable treatments to patients in Europe. Zercepac ®is a high-quality biomedicine from Fuhong Hanlin and the first monoclonal antibody drug marketed by Accord. Its approval has injected new vitality into the Accord anti-tumor product pipeline. We will continue to consolidate our ability to promote the marketing of high-quality complex biopharmaceuticals so as to continuously enhance patient accessibility and provide more choices for the health care system. "