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Henlius 汉利康®(Rituximab Injection)Wins“Biosimilar Initiative of the Year” at Global Generics & Biosimilars Awards 2019


The 6th Global Generics & Biosimilars Awards 2019 ceremony, organized by Generics Bulletin, a world-renowned trade magazine in UK and co-hosted by IQVIA, a leading global provider of information and innovative technology solutions for healthcare clients, was held on 5 November 2019 in Frankfurt, Germany. At the ceremony, Shanghai Henlius Biotech, Inc. (Henlius, 2696.HK) was highly recognized, winning the award of “Biosimilar Initiative of the Year” (汉利康®, rituximab injection HLX01) and also being shortlisted for the award of “the Company of the Year, Asia-Pacific”. This makes Henlius the first Chinese enterprise to clinch the award.

Henlius stood out from hundreds of enterprises over the past two months, during which the committee comprising about 20 expert judges invited from the generics and biosimilars industries engaged in the judging process independently. The recognition by “Global Generics & Biosimilars Awards 2019” not only highlights Henlius’ impressive performance in the biotech industry, but also recognizes the company’s influence in Asia-Pacific, and even in the global biopharmaceutical markets.

In the passing 2019, Henlius has achieved significant breakthrough in biosimilar field. Its first product, 汉利康® (HLX01, rituximab injection) was granted New Drug Application (NDA) approval by the National Medical Products Administration (NMPA) in February for all the indications of originator approved in China, making it the first biosimilar in China. The first prescription was issued on May 16, making it the first China-developed biosimilar benefiting patients. Moreover, it fills the market gap for biosimilars in China and improves the patients’ access to high quality biological medicine. Over 1000 patients were benefited in the first month after the commercial launch of HLX01.

In 2019, Henlius continued expanding global footprint with its strategy of “In China for Global”. HLX02 (trastuzumab for injection) was accepted by European Medicine Agency (EMA) for reviewing its Marketing Authorization Application (MAA) in June 2019, making it the first China-developed monocolonal antibody (mAb) biosimilar accepted for MAA review by EMA. Henlius differentiated itself with “Global plus Combo” strategy in immno-oncology combination therapy in 2019 utilizing proprietary anti-PD-1/PD-L1 as backbones in combination with other products to conduct global multi-center clinical trials worldwide. In September 2019, Henlius granted KG Bio, a holding subsidiary to Kalbe Farma, an Indonesian pharmaceutical company, the exclusive rights to develop and commercialize HLX10 (anti-PD-1 mAb) in 10 Southeast Asia countries. Henlius will strengthen its market access for HLX10 as part of its international strategy through Kalbe Farma’s extensive sales network. In the past few years, Henlius had proactively expanded its global presence through continuous strategic collaboration with international leading pharmaceutical companies, reaching agreements for the licensing and commercialization of certain products in over 92 countries and regions.

Looking forward, Henlius will continue fully leveraging the integrated platform, expanding global presence, and providing innovative and affordable medicines in alignment with international quality standards for patients worldwide, achieving its long-term vision of becoming the most trusted and admired biotech company.

About GGBA

The Global Generics & Biosimilars Awards (GGBA) reward “best practice” in the two industries, at the same time encouraging improvements in every aspect of the way business is conducted.

Business development initiatives – such as through innovative product development, clever licensing deals or smart legal manoeuvres – are at the heart of the Global Generics & Biosimilars Awards. Equally important will be recognized as the industries’ best executives and leading companies.

Every Award will effectively underscore the efforts made by the global generics and biosimilars industries to make more affordable medicines to benefit more people everywhere.

About Henlius

Henlius(2696.HK) is a leading biopharmaceutical company in China with the vision to offer high-quality, affordable and innovative biologics for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated and efficient global R&D platform with key facilities in Shanghai, Taipei and California. The three R&D centers closely collaborate with each other to ensure a highly productive and cost-efficient R&D process. Starting from biosimilar, Henlius presses forward with novel mAb products and immuno-oncology combination therapies with proprietary anti-PD-1 and PD-L1 mAbs as backbone. Henlius establishes a diversified product pipeline of biosimilars, bio-innovative drugs and combination therapies, and builds an integrated platform covering the whole product lifecycle including R&D, commercial-scale production and commercialization. On September 25, 2019, Henlius was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 2696.

Until now, in addition to one product launched commercially, two products under New Drug Application (NDA) review and one product under Marketing Authorization Application (MAA) review, Henlius has conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their NDA under priority review by the NMPA. HLX02 is also the first China-manufactured biosimilar developed in a global setting. In June 2019, the MAA for HLX02 was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbone in combination with chemotherapy and other mAbs including HLX04 (bevacizumab biosimilar). The global multi-center clinical trials are ongoing in various countries and regions worldwide.