Gathering Pace in Commercialization, Making the Most out of Integrated Value Chain

By the end of 2020, Henlius has launched three products including 汉利康®, the first biosimilar approved in China, 汉曲优®/Zercepac®, the first self-developed Chinese monoclonal antibody (mAb) approved in both China and Europe and 汉达远® , the Company's first product for the treatment of auto-immune diseases, among which the launch of 汉曲优®/Zercepac® in the EU market brought Henlius one step closer to its globalization.

 

汉利康®, the first Chinese biosimilar, was approved by the National Medical Products Administration (NMPA) in February 2019 and indicated for non-Hodgkin lymphoma and chronic lymphocytic leukemia. It has benefited more than 30,000 patients ever since its launch. The domestic commercial sales of 汉利康® were handled by Jiangsu Fosun, a subsidiary of Fosun Pharma. By the end of 2020, provincial medical insurance access work has been finished in 30 provinces and municipalities. Tendering process has been completed in 28 provinces and municipalities. Nearly 70% of the core hospitals have admitted it. With the approval for new indications and new dosage form of 500mg/50ml/vial, as well as the addition of 2,000L production scale in 2020, it is expected to reach more patients in the future.

 

汉曲优® / Zercepac® , indicated for HER2 positive breast cancer and gastric cancer, was successively approved by the European Commission (EC) and the NMPA in July and August 2020. Henlius had made full efforts to penetrate the Chinese market by completing all the provincial medical insurance access work and tendering process in 28 provinces and municipalities, laying a strong foundation for the sales growth. In global market, Henlius joined force with its business partner Accord to actively promote the commercialization of Zercepac® in the EU. By the end of 2020, Zercepac® had successfully entered a number of top hospitals in the United Kingdom as well as nearly 20 EU countries and regions including Germany, Spain, France, Italy, Ireland, Hungary, etc.

 

汉达远® was approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis as the first product indicated for auto-immune diseases of the Company. Its successful launch marks the expansion of Henlius’ commercial pipeline into the field of autoimmune diseases as well as the broadening of the target patient scope. Jiangsu Wanbang, a subsidiary of Fosun Pharma, is responsible for the domestic commercial sales of 汉达远®. Tendering process has been finished in 22 provinces and municipalities.

 

In addition to the three launched products, Henlius pressed forward with the products to be commercialized in the near future. HLX01 (rituximab injection) indicated for rheumatoid arthritis and HLX04 (bevacizumab injection) were both accepted for NDA review by the NMPA, with the commercial launch expected respectively in Q4 2021 and 2021/the first half of 2022 in China. Looking forward, the Company will further build up a commercialization team of market-leading presence and highly-efficient business model to make biosimilar more affordable and accessible, making the most out of its commercialized products.

 

Continuing the Momentum for Diversified Innovation

 

Apart from the above-mentioned biosimilars, Henlius continued its momentum for a diversified innovation. Building upon the accumulated resources and technologies in the field of biologic medicines, Henlius has been unlocking the potential of the candidate targets including HER2、EGFR、PD-L1、c-MET、DR4、S1 Protein of SARS-CoV-2、LAG-3, TROP2 ,etc. Meanwhile, Henlius has built a forward-looking presence in innovative targets, bispecific antibodies as well as the antibody-drug conjugates (ADC). Up to date, 21 products and 2 mAb combination therapies have been approved for more than 30 clinical trials worldwide. More than 20 clinical trials for 10 products and 8 combination therapies have been carried out in various countries and regions, including China, the EU, Australia, Ukraine, the Philippines, Turkey, etc.

 

Particularly, Henlius built an all-inclusive presence in tumor indications with regards to its core innovative mAb product anti-PD-1 mAb HLX10. Steady progress has been made in the clinical studies of 2 monotherapies and 8 combination therapies with HLX10 (PD-1) as the core for the treatment of MSI-H solid tumors, lung, hepatocellular, esophageal, head and neck, gastric cancers, etc. About 2,000 patients have been enrolled in China, Turkey, Poland, Ukraine, Russia, etc., making HLX10 one of the PD-1 products boasting a large global clinical data pool. Henlius is expected to file the NDA of HLX10 (PD-1) in China at the end of March or in the beginning of April 2021. The NDA filing of HLX10 (PD-1) in combination with chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) indication in China will also be expected in the second half of 2021.

 

In 2020, Henlius entered into an exclusive license agreement with Chiome from Japan. Chiome agreed to grant Henlius an exclusive right and license to antibodies targeting human TROP2 and related intellectual property rights to research, develop, manufacture and commercialize the licensed product in China (including Hong Kong, Macau and Taiwan China). Its potential is being uncovered with regards to ADC, bispecific antibodies and combination therapies. Henlius was also on a solid growth trajectory to develop COVID-19 candidate drugs in 2020. The Investigational New Drug (IND) applications of HLX71 (ACE2-Fc fusion protein) was approved by the U.S. Food and Drug Administration (FDA). The Company will initiate the clinical studies of HLX71 in the United States in the future.

 

Breakthroughs in Capacity and Quality Making Affordable Innovation Possible

 

Breakthroughs in capacity and quality were made by scaling up the production capacity in the three manufacturing facilities and benchmarking against the international quality standards. Xuhui facility has passed the multiple on-site inspections conducted by the NMPA, European Medicines Agency (EMA), EU QP (Qualified Person) and was certificated by China and the EU GMP, laying the solid foundation for the product launch in global market. In terms of capacity, Henlius scaled up its production capacity to 20,000L in Xuhui Facility in 2020. A prefilled needle production line is also planned to be added in 2021 to address the short-term market demand. To further ramp up the capacity, Henlius has also promoted the construction of Songjiang First Plant and Songjiang Second Plant. In 2020, the production capacity of Songjiang First Plant has been increased to 24,000L. For the Phase I project of Songjiang Second Plant, the pile foundation works and structure of the main production buildings have been completed. It is to be completed and put into trial production and subject to relevant verifications in 2021.

 

Henlius continued to explore the power of advanced production technology such as continuous manufacturing technology. The construction, commission and verification of the pilot workshop had been completed by the end of 2020.

 

Expanding Global Footprint with Strategic Partners

 

In 2020, Henlius successively secured partnership with Mabxience and Accord to build market presence of 汉曲优® in the global major markets. Meanwhile, Henlius joint force with Essex to co-develop its HLX04-O (recombinant humanized anti-VEGF mAb injection) indicated for ophthalmic diseases such as wet age-related macular degeneration (wAMD) and to grant an exclusive license to Essex to develop, manufacture and commercialize HLX04-O in the field of human ophthalmic therapies globally. Henlius and Essex will speed up the global multi-centre clinical trials of HLX04-O and apply marketing authorization in different countries and regions around the globe based on the research results. So far, the filing of clinical trial for HLX04-O has been approved by the Therapeutic Goods Administration, Australia and FDA, the United Stated. The multi-centre Phase 3 clinical study of the project is intended to be initiated in the near future. Looking forward, Henlius will continue to expand its global footprint, explore further license-in/out cooperation and ensure a global market coverage.

 

In the future, Henlius will continue to put commercialization on top priority, make the most out of the launched products and capitalize on first-entrant advantages in the field of biosimilar. Underpinned by the patient-centric strategy, Henlius looks forward to addressing the unmet needs by accelerating innovation and exploring pipeline opportunities through strategic collaboration and in-house innovation, highlighting its commitments to bringing more affordable and high-quality innovative products to more patients.