Fu Hong Hanxuan Qutozhu Single Resistance received positive review opinion of the EMA

Introduction: Once approved, HLX02 (Qutozhu monotom) will be granted a centralized listing permit in all EU Member States and Iceland, Liechtenstein and Norway (each in the European Economic Area (EEA) countries)Fu Hong Hanxuan announced yesterday that HLX02 ("HLX02") ("HLX02") was recently submitted by Accord HealthCare S.L.U(a wholly owned subsidiary of the company's business partner Accord Healthcare Limited)) for HER2-positive early-stage breast cancer, HER2-positive metastatic breast cancer, and untreated-positive herded gastric or gastric esophagus cancerMAA ("MAA") has been actively reviewed by the European Medicines Agency ("EMA") Committee for Human Pharmaceutical Products ("CHMP") and recommended the approval of MAATHE REVIEW OF CHMP WILL BE SUBMITTED TO THE EUROPEAN COMMISSION (EC) ("EC"), WHICH WILL TAKE INTO REFERENCE TO CHMP'S COMMENTS AND MAKE A FINAL REVIEW DECISION OVER THE NEXT 2-3 MONTHSOnce approved, HLX02 will be licensed for a centralized listing in all EU member states and Iceland, Liechtenstein and Norway (each in the European Economic Area (EEA) countries)'s positive comments on the EMA are based on a review of a range of HLX02 studies, including quality-to-quality studies, preclinical studies, and clinical studiesThese data demonstrate a high degree of similarity between HLX02 and reference drugs (Herceptin ®) in terms of quality, safety and efficacyIn April 2020, Shanghai Fuhong Hanxuan Biopharmaceutical Co., Ltd., a wholly-owned subsidiary of the company, received two "Certificate s of GMP Compliance of a Manufacturer" issued by the Polish health supervisory body, Chief Pharmaceutical, the Company's biopharmaceutical production base in Xuhui District, Shanghai, successfully passed the EU GMP verification of the HLX02 Original Liquid (DS) and Preparation (DP) linesHLX02 is a mono-antibiotic drug developed by the company in accordance with the EU Biosimilar Medicine Guidelines for the treatment of HER2-positive early-stage breast cancer, HER2-positive metastatic breast cancer and untreated HER2-positive metastatic gastric cancer or gastric esophagus junction adenocarcinomaIn April 2019, HLX02's new drug listing application (NDA) was accepted by the National Drug Administration and subsequently included in the priority review processIn June 2019, the EMA accepted the MAA submitted by Accord Healthcare S.L.Uin regard to HLX02as of the date of the announcement, the Qutozhu monotortitudes listed in the European Union and Iceland, Liechtenstein and Norway (each of the EEA countries) are mainly ® of Roche, Herzuma ® of Celltrion, Ontruzant ® of Samsung Bioepis, etc., according to IQVIA MIDAS TM Data (IQVIA is the world's leading provider of professional information and strategic consulting services for the pharmaceutical and health industry) with sales of approximately US$1.368 billion in the European Union and Iceland, Liechtenstein and Norway (each in EEA countries) in 2019June 20, 2018, the Company signed the License Agreement with AccordThe company grants Accord exclusive commercialization of HLX02 products in Europe (53 countries including the United Kingdom, France, Germany and Italy), the Middle East and North Africa (17 countries) and some CIS countriesUnder the agreement, Accord will pay the company up to $40.5 million in down payments and milestone fees In addition, during the agreed period, Accord shall pay the Company's license fee in the proportion of net sales generated by 13.5% to 25% of the net sales in accordance with hlX02's annual net sales within the License area