Shanghai Fosun Pharmaceutical : Application for Clinical Trial of Innovative Monoclonal Antibody of a Holding Subsidiary of Shanghai Henlius Permitted by US FDA

Recently, the application for clinical trial of HLX06-recombinant anti- VEGFR2 fully human monoclonal antibody injection (hereafter referred to as the 'New Drug'), self-developed by Taiwan Henlix Biotech Co., Ltd, a holding subsidiary of Shanghai Henlius, which is a member of Fosun Pharma, was permitted by US FDA.

The New Drug is a monoclonal antibody targeted drug with proprietary intellectual rights developed on the research and development platform of innovative monoclonal antibody, and can be used for the treatment of solid tumor. Following HLX07, the first bio-modified monoclonal antibody self-developed by Henlix, the New Drug is the second innovative monoclonal antibody drug that receives the approval of clinical trials from US FDA. With the rapid development of biosimilars, Shanghai Henlius has obtained satisfactory achievements in innovation and will gradually push forward its business layout internationally.

It is noted that the percentage of the total population of the incidence of solid tumors, such as gastric cancer, liver cancer and lung cancer, in China over the world is relatively high and there are over 3 million cancer patients newly increased each year, which demonstrates a huge demand for cancer targeted therapy. Anti-VEGFR2 monoclonal antibody drug is an effective targeted drug for the treatment of terminal cancer patients. Eli Lilly's CyramzaTM（Ramucirumab）, one type of anti-VEGFR2 monoclonal antibody drugs, has marketed globally. However, there areno similar drugs with the same target pots in domestic market of China (excluding Hong Kong, Macau and Taiwan). Different from Ramucirumab in respect of the mechanism of action, HLX06 product self-developed by Henlix is a new 'first in class' drug. At present, Shanghai Henliushas established matureR&D platform formonoclonal antibody similar drugs, bio-modified monoclonal antibody and innovative monoclonal antibody.

With the purpose of providing affordable innovative drugs to patients, Shanghai Henliushas implemented the 'permitting and rewarding both proactive initiative as well as defensive maneuvers' strategic planning for the development of innovative monoclonal antibody by putting great efforts in innovation. Shanghai Henlius will develop monoclonal antibodies for targets that have been clinically approved, to substantially mitigate the risks and costs related to product development. If there is no significant difference between the clinical manifestations of new monoclonal antibody and those drugs which have been already launched to the market, as well as with the same safety level, the product can quickly enter the Chinese market and other emerging countries by virtue of the price advantage. If the innovative monoclonal antibody by clinical validation is indeed in the efficacy or safety is superior to existing drugs, we can cooperate with the international pharmaceutical companies to enter the European and American markets by carrying out international multicenter clinical trials for the benefit of global patients.

Shanghai Henliusis a biopharmaceutical R&D platform of Fosun Pharm. In the future, Shanghai Henlius will continue to facilitate international strategic layoutwhile continuous development of a number of new monoclonal antibody products. Shanghai Henliuswill actively improve the availability and affordability of biologic pharmaceutical products to patientsby taking the patient-oriented approach. Based on the grand mission of 'To improve patients' lives by timely providing them with quality and affordable protein therapeutics through technical innovation and operational excellence',Shanghai Henliuswill consistently explore new development opportunities, striving to be the most admired biotech company providing innovative and affordable medicines to all patients.

Fosun Pharmahas always been taking self-innovation as the core momentum of corporate developmentand continuously optimizedits pharmaceutical R&D system that integrates imitation and innovation.In recent years, we continuedto increase R & D investmentand havecurrently established international presence for R&D with stronger capabilities.