Shanghai, China, June, 24, 2020 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Company entered into an Amendment to the License Agreement concluded in June 2018 with Accord Healthcare Limited (“Accord”). Pursuant to the amendment, licenses will be granted for new dosage forms of HLX02 (trastuzumab for injection) in addition to the previously granted dosage form. Accord shall pay the Company an amount of milestone fees not exceeding USD3.08 million in total according to the marketing application progress and drug delivery progress of HLX02’s new dosage forms. The percentage of profits paid to Henlius as royalties will also increase. In June 2018, Accord was granted exclusive commercial rights of HLX02 in over 70 countries and regions in Europe, the Middle East and North Africa and the Commonwealth of Independent States. The newly granted dosage forms will not only bring down the unit cost for patients but also enable flexible dosage combination and satisfy customised dosing needs, laying a solid foundation for exploring the global market in the future.
HLX02 is a trastuzumab biosimilar independently developed by the Company in accordance with the biosimilar guidelines in China and the European Union (EU). Quality analytical studies, non-clinical similarity studies and clinical studies have been conducted to ensure high similarity of HLX02 to the originator in terms of quality, safety and efficacy. Potential indications of HLX02 include HER2-positive early-stage breast cancer, HER2-positive metastatic breast cancer and untreated HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
Approaching approval in China and the EU
As a significant milestone of the globalisation strategy of the Company, HLX02 is the first Chinese monoclonal antibody (mAb) biosimilar with marketing applications filed both in China and in the EU. In April 2019, the NDA of HLX02 was accepted for review and subsequently assigned to priority review list by the National Medical Products Administration (NMPA) with great potential to be approved soon. In May 2020, the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for HLX02. The final approval of the marketing authorisation application of HLX02 in the EU is also expected in the near future.
Strictly follows the internationally highest standards
The recognition from global health authorities attributes to Henlius’ long-term commitment to high quality. HLX02 is the first Chinese biosimilar with the EU Good Manufacturing Practice (GMP) certificates. The drug substance (DS) line and drug product (DP) line for HLX02 have successfully passed the EU GMP on-site inspection, which means that the China-developed antibody drug is breaking the GMP barriers to be launched on international market, laying a solid foundation for the company to further expand its global footprints. HLX02 is also the first Chinese biosimilar evaluated in an international multi-centre Phase 3 clinical study aiming for head-to-head comparison between HLX02 and the originator. The Study enrolled a total of 649 patients with untreated HER2-positive recurrent or metastatic breast cancer across the 89 clinical sites in China, the Philippines, Poland and Ukraine. Results from the study demonstrated that HLX02 has no statistically meaningful differences from the originator.
Expands global footprints to benefit more patients
To satisfy the unmet demands for affordable and quality biologic medicines，Henlius has proactively established HLX02’s presence in the markets both at home and abroad. For the domestic market, Henlius has assembled an in-house commercial team and created an innovative business model for HLX02. For the global market, on top of Accord, Henlius has reached partnerships with global leading pharmaceutical companies including Cipla, Mabxience, Jacobson, etc., with products licenced out to nearly 80 countries and regions altogether all over the world. The emerging market, where biosimilar remains an infant industry, is a priority in the global strategy of Henlius. The established resources of the partners will also help ensure continued patient access to affordable and quality products of Henlius. In the future, Henlius will join forces with more and more partners to bring its internationally recognised products to more patients both at home and abroad.
About Accord Healthcare
Headquartered in the United Kingdom (UK), Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world.
This global footprint enables Accord to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients’ access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has three R&D facilities in Shanghai, Taipei and California and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monocolonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Up to date, in addition to 汉利康Ⓡ (HLX01, rituximab) launched commercially and two products (HLX02 trastuzumab and HLX03 adalimumab) under New Drug Application (NDA) review to be potentially launched within 2020, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. Products have been licensed out to nearly 100 countries and regions. Moreover, the business partner Accord submitted a Marketing Authorisation Application (MAA) for HLX02 to European Medicines Agency (EMA). In May 2020, Henlius received the EMA Committee for Medicinal Products for Human Use (CHMP) positive opinion for HLX02, which is expected to become the first China-manufactured biosimialr to be launched in the EU markets.